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Commission Implementing Regulation (EU) 2022/1434 of 22 July 2022 granting a Union authorisation for the biocidal product family ‘CMIT-MIT Aqueous 1.5-15’ (Text with EEA relevance)

Type Implementing Regulation

Publication 2022-07-22

State In force

Department European Commission, SANTE

Source EUR-Lex

Article 1

A Union authorisation with authorisation number EU-0025449-0000 is granted to MC (Netherlands) 1 B.V. for the making available on the market and use of the biocidal product family ‘CMIT-MIT Aqueous 1.5-15’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 20 September 2022 until 31 August 2032.

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.

ANNEX

CMIT-MIT Aqueous 1.5-15

Product type(s)

PT02: Disinfectants and algaecides not intended for direct application to humans or animals

PT04: Food and feed area

PT06: Preservatives for products during storage

PT11: Preservatives for liquid-cooling and processing systems

PT12: Slimicides

PT13: Working or cutting fluid preservatives

Authorisation number: EU-0025449-0000

R4BP asset number: EU-0025449-0000

PART I.

FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION

Name	CMIT-MIT Aqueous 1.5-15
Product type(s)	PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area PT06: Preservatives for products during storage PT11: Preservatives for liquid-cooling and processing systems PT12: Slimicides PT13: Working or cutting fluid preservatives
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Name and address of the authorisation holder	Name
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Address	Montrealweg 15 3197KH Botlek Rotterdam NL
Authorisation number
R4BP asset number
Date of the authorisation
Expiry date of the authorisation
Name of manufacturer	AD Productions BV
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Address of manufacturer	Markweg Zuid 27 4794 SN Heijningen, Netherlands (the)
Location of manufacturing sites	AD Productions BV site 1 Markweg Zuid 27 4794 SN Heijningen, Netherlands (the)
Name of manufacturer	Jiangsu FOPIA Chemicals Co., Ltd
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Address of manufacturer	Touzeng Village 224555 Binhuai Town, Binhai County, Yancheng City, Jiangsu, China
Location of manufacturing sites	Jiangsu FOPIA Chemicals Co., Ltd site 1 Touzeng Village 224555 Binhuai Town, Binhai County, Yancheng City, Jiangsu, China
Name of manufacturer	Acquaflex S.R.L
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Address of manufacturer	Vigano di Gaggiano 20083 Milan, Italy
Location of manufacturing sites	Acquaflex S.R.L site 1 Vigano di Gaggiano 20083 Milan, Italy
Name of manufacturer	LABORATORIOS MIRET, S.A.
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Address of manufacturer	Hercules, 18 08228 Terrassa, Barcelona, Spain
Location of manufacturing sites	LABORATORIOS MIRET, S.A. site 1 Hercules, 18 08228 Terrassa, Barcelona, Spain
Name of manufacturer	HYDRACHIM
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Address of manufacturer	Route de Saint Poix 35370 LE PERTRE, France
Location of manufacturing sites	HYDRACHIM site 1 Route de Saint Poix 35370 LE PERTRE, France
Name of manufacturer	DAXEL srl.
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Address of manufacturer	via Pietro Nenni 8 42048 Rubiera RE, Italy
Location of manufacturing sites	DAXEL srl. site 1 via Pietro Nenni 8 42048 Rubiera RE, Italy
Name of manufacturer	Aquatreat Chemical Products Ltd
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Address of manufacturer	Unit 7, Abbey Industrial Estate, 24 Willow Lane CR4 4NA Mitcham, United Kingdom of Great Britain and Northern Ireland (the)
Location of manufacturing sites	Aquatreat Chemical Products Ltd site 1 Unit 7, Abbey Industrial Estate, 24 Willow Lane CR4 4NA Mitcham, United Kingdom of Great Britain and Northern Ireland (the)
Name of manufacturer	Flexfill s.r.o.
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Address of manufacturer	Siřejovická 1213 410 02 Lovosice, Czechia
Location of manufacturing sites	Flexfill s.r.o. site 1 Siřejovická 1213 410 02 Lovosice, Czechia
Name of manufacturer	Sopura SA
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Address of manufacturer	199 rue de trazegnies 6180 Courcelles, Belgium
Location of manufacturing sites	Sopura SA site 1 199 rue de trazegnies 6180 Courcelles, Belgium
Name of manufacturer	Stenco Industrial
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Address of manufacturer	C/ Gran Vial, 50817 Montornès del Vallès, Barcelona, Spain
Location of manufacturing sites	Stenco Industrial site 1 C/ Gran Vial, 50817 Montornès del Vallès, Barcelona, Spain
Name of manufacturer	Veolia WTS France S.A.S.
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Address of manufacturer	44, Rue Paul Sabatier Z.I. Nord 71530 Crissey, France
Location of manufacturing sites	Veolia WTS France S.A.S. site 1 44, Rue Paul Sabatier Z.I. Nord 71530 Crissey, France
Name of manufacturer	QUIPROCALT S.L.
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Address of manufacturer	Calle Lleida, 2 (Pol Ind Empalme) 43712 Llorenç del Penedès. Tarragona, Spain
Location of manufacturing sites	QUIPROCALT S.L. site 1 Calle Lleida, 2 (Pol Ind Empalme) 43712 Llorenç del Penedès. Tarragona, Spain
Name of manufacturer	nv Buckman Laboratories
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Address of manufacturer	Wondelgemkaai 159 9000 Gent, Belgium
Location of manufacturing sites	nv Buckman Laboratories site 1 Wondelgemkaai 159 9000 Gent, Belgium
Name of manufacturer	N.C.R. Biochemical S.p.A.
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Address of manufacturer	Via dei Carpentieri n.8 40050 Castello d’Argile, Italy
Location of manufacturing sites	N.C.R. Biochemical S.p.A. site 1 Via dei Carpentieri n.8 40050 Castello d’Argile, Italy
Name of manufacturer	Alliance Production
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Address of manufacturer	4 BOULEVARD DEODAT DE SEVERAC 31770 COLOMIERS, France
Location of manufacturing sites	Alliance Production site 1 4 BOULEVARD DEODAT DE SEVERAC 31770 COLOMIERS, France
Name of manufacturer	URQUIMIA S.L.
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Address of manufacturer	POL. IND. DE ARASO C/ERREGEOIANA 2G 20305 Irún, Guipúzcoa, Spain
Location of manufacturing sites	URQUIMIA S.L. site 1 POL. IND. DE ARASO C/ERREGEOIANA 2G 20305 Irún, Guipúzcoa, Spain
Name of manufacturer	Kalon Mantenimiento Industrial S.A.
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Address of manufacturer	Avenida de la Industria 4 28823 Coslada, Madrid, Spain
Location of manufacturing sites	Kalon Mantenimiento Industrial S.A. site 1 Avenida de la Industria 4 28823 Coslada, Madrid, Spain
Name of manufacturer	Filtrotech Sarl
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Address of manufacturer	Route des Jeunes 5D 1227 Les Acacias / Genève, Switzerland
Location of manufacturing sites	Filtrotech Sarl site 1 Route des Jeunes 5D 1227 Les Acacias / Genève, Switzerland
Name of manufacturer	Helamin France Sarl
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Address of manufacturer	Le Technoparc, 135 rue Thomas-Edison 01630 Saint Genis Pouilly, France
Location of manufacturing sites	Helamin France Sarl site 1 Le Technoparc, 135 rue Thomas-Edison 01630 Saint Genis Pouilly, France
Name of manufacturer	Odyssée Environnement
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Address of manufacturer	Z.A de la Belle Croix 72510 Requeil, France
Location of manufacturing sites	Odyssée Environnement site 1 Z.A de la Belle Croix 72510 Requeil, France
Name of manufacturer	MSGA SERVIVAP
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Address of manufacturer	50 Rue Jean Zay Bâtiment D1 69800 ST PRIEST, France
Location of manufacturing sites	MSGA SERVIVAP site 1 50 Rue Jean Zay Bâtiment D1 69800 ST PRIEST, France
Name of manufacturer	TECNA ACONDICIONAMIENTOS DE AGUA S.A
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Address of manufacturer	Letxumborro Hiribidea,52 20305 Irun, Guipúzcoa, Spain
Location of manufacturing sites	TECNA ACONDICIONAMIENTOS DE AGUA S.A site 1 Letxumborro Hiribidea,52 20305 Irun, Guipúzcoa, Spain
Name of manufacturer	h2o facilities sa
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Address of manufacturer	av. des Grandes-Communes 8 CH-1213 Petit-Lancy, France
Location of manufacturing sites	h2o facilities sa site 1 av. des Grandes-Communes 8 CH-1213 Petit-Lancy, France
Name of manufacturer	FUPINAX S.L.
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Address of manufacturer	Polígono Industrial El Saladar I, C/ Molina, Nave 4 30564 Lorquí, Spain
Location of manufacturing sites	FUPINAX S.L. site 1 Polígono Industrial El Saladar I, C/ Molina, Nave 4 30564 Lorquí, Spain
Name of manufacturer	Tresch/ chassieu
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Address of manufacturer	3 Rue Blaise Pascal 69680 Chassieu, France
Location of manufacturing sites	Tresch/ chassieu site 1 3 Rue Blaise Pascal 69680 Chassieu, France
Name of manufacturer	DUPUY
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Address of manufacturer	42 Rue Saint Martin 08400 Quatre Champs, France
Location of manufacturing sites	DUPUY site 1 42 Rue Saint Martin 08400 Quatre Champs, France
Name of manufacturer	Veolia Water Technologies & Solutions Belgium BVBA
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Address of manufacturer	Toekomstlaan 54, Industriepark Wolfstee 2200 HERENTALS, Belgium
Location of manufacturing sites	Veolia Water Technologies & Solutions Belgium BVBA site 1 Toekomstlaan 54, Industriepark Wolfstee 2200 HERENTALS, Belgium
Name of manufacturer	Buckman Laboratories (Pty)Ltd
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Address of manufacturer	1 Buckman Boulevard 3700 Hammarsdale, South Africa
Location of manufacturing sites	Buckman Laboratories (Pty)Ltd site 1 1 Buckman Boulevard 3700 Hammarsdale, South Africa
Name of manufacturer	EAUTEX
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Address of manufacturer	28 RUE KELLERMANN 59100 ROUBAIX, France
Location of manufacturing sites	EAUTEX site 1 28 RUE KELLERMANN 59100 ROUBAIX, France
Name of manufacturer	Hydrogel-Chemie Wasseraufbereitungs-Gesellschaft mbH
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Address of manufacturer	Zur Mersch 19 59457 Werl, Germany
Location of manufacturing sites	Hydrogel-Chemie Wasseraufbereitungs-Gesellschaft mbH site 1 Zur Mersch 19 59457 Werl, Germany
Name of manufacturer	sceo
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Address of manufacturer	ZA PECHNAUQUIE SUD 31340 VILLEMR SUR TARN, France
Location of manufacturing sites	sceo site 1 ZA PECHNAUQUIE SUD 31340 VILLEMR SUR TARN, France
Name of manufacturer	Nutrition & Biosciences (Switzerland) GmbH
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Address of manufacturer	Wolleraustrasse 15-17 CH-8807 Freienbach, Switzerland
Location of manufacturing sites	Nutrition & Biosciences (Switzerland) GmbH site 1 Haven 1931 Geslecht 9130 Kallo, Belgium Nutrition & Biosciences (Switzerland) GmbH site 2 Madoerastraat 10 3199 KR Maasvlakte Rotterdam, Netherlands (the)
Name of manufacturer	Theseo Deutschland GmbH
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Address of manufacturer	Kolpingstrasse 4 49835 Wietmarschen Germany
Location of manufacturing sites	Theseo Deutschland GmbH site 1 Kolpingstrasse 4 49835 Wietmarschen Germany
Active substance	C(M)IT/MIT (3:1)
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Name of manufacturer	Jiangsu FOPIA Chemicals Co., Ltd
Address of manufacturer	Touzeng Village 224555 Binhuai Town, Binhai County, Yancheng City, Jiangsu, China
Location of manufacturing sites	Jiangsu FOPIA Chemicals Co., Ltd site 1 Touzeng Village 224555 Binhuai Town, Binhai County, Yancheng City, Jiangsu, China
Active substance	C(M)IT/MIT (3:1)
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Name of manufacturer	Dalian Bio-chem Company Limited
Address of manufacturer	No 18, Mubai Road, Songmudao Chemical Industry Park, PuWan New District, Liaoning Province 116308 Dalian China
Location of manufacturing sites	Dalian Bio-chem Company Limited site 1 No 18, Mubai Road, Songmudao Chemical Industry Park, PuWan New District, Liaoning Province 116308 Dalian China

2. PRODUCT FAMILY COMPOSITION AND FORMULATION

Common name	IUPAC name	Function	CAS 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	2,2 - 20,9 % (w/w)
Formulation type(s)	AL Any other liquid
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PART II.

SECOND INFORMATION LEVEL META SPC(S)

1. META SPC 1 ADMINISTRATIVE INFORMATION

Identifier	Meta SPC: meta-SPC 1 KATHON 13-15 Mg
Number	1-1
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Product type(s)	PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area PT06: Preservatives for products during storage PT11: Preservatives for liquid-cooling and processing systems PT12: Slimicides PT13: Working or cutting fluid preservatives
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2. META SPC 1 COMPOSITION

Common name	IUPAC name	Function	CAS 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	18,8 - 20,9 % (w/w)
Formulation type(s)	AL Any other liquid
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3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements	H302+H332: Harmful if swallowed or if inhaled. H311: Toxic in contact with skin. 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. H290: May be corrosive to metals. EUH071: Corrosive to the respiratory tract.
Precautionary statements	P260: Do not breathe fume. P264: Wash skin thoroughly after handling. 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 protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection . P330: Rinse mouth. P302+P352: IF ON SKIN: Wash with plenty of water. P362+P364: Take off contaminated clothing and wash it before reuse. P301+P312: IF SWALLOWED: Call a Poison Center or doctor if you feel unwell. P333+P313: If skin irritation or rash occurs: Get medical advice. 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]. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P310: Immediately call a Poison Center / doctor . P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P391: Collect spillage. P405: Store locked up. P234: Keep only in original packaging. P390: Absorb spillage to prevent material damage. P406: Store in a corrosion-resistant container with a resistant inner liner.

Hazard statements

H302+H332: Harmful if swallowed or if inhaled. H311: Toxic in contact with skin. 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. H290: May be corrosive to metals. EUH071: Corrosive to the respiratory tract.

Precautionary statements

P260: Do not breathe fume. P264: Wash skin thoroughly after handling. 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 protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection . P330: Rinse mouth. P302+P352: IF ON SKIN: Wash with plenty of water. P362+P364: Take off contaminated clothing and wash it before reuse. P301+P312: IF SWALLOWED: Call a Poison Center or doctor if you feel unwell. P333+P313: If skin irritation or rash occurs: Get medical advice. 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]. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P310: Immediately call a Poison Center / doctor . P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P391: Collect spillage. P405: Store locked up. P234: Keep only in original packaging. P390: Absorb spillage to prevent material damage. P406: Store in a corrosion-resistant container with a resistant inner liner.

4. AUTHORISED USE(S) OF THE META SPC

Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.