LegalizeCommission Implementing Regulation (EU) 2023/753 of 12 April 2023 granting a Union authorisation for the biocidal product family “C(M)IT/MIT formulations” (Text with EEA relevance)
Article 1
A Union authorisation with authorisation number EU-0025678-0000 is granted to Solenis Switzerland GmbH for the making available on the market and use of the same biocidal product family “C(M)IT/MIT formulations” in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 3 May 2023 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
PART I.
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
| Name | C(M)IT/MIT formulations |
|---|---|
| Product type(s) | PT06: Preservatives for products during storage PT11: Preservatives for liquid-cooling and processing systems PT12: Slimicides |
| --- | --- |
| Name and address of the authorisation holder | Name |
| --- | --- |
| Address | Mühlentalstrasse 38 8200 Schaffhausen CH |
| Authorisation number | |
| R4BP asset number | |
| Date of the authorisation | |
| Expiry date of the authorisation | |
| Name of manufacturer | Solenis Switzerland GmbH |
| --- | --- |
| Address of manufacturer | Mühlentalstrasse 38 8200 Schaffhausen Switzerland |
| Location of manufacturing sites | Solenis Switzerland GmbH site 1 Fütingsweg 20 D-47805 Krefeld Germany Solenis Switzerland GmbH site 2 Wimsey Way, Somercotes DE55 4PA Alfreton United Kingdom of Great Britain and Northern Ireland (the) Solenis Switzerland GmbH site 3 Högastensgatan 18 252 32 Helsingborg Sweden Solenis Switzerland GmbH site 4 AD International B.V. Markweg Zuid 27 4793 ZJ Fijnaart Netherlands (the) |
| Name of manufacturer | Diversey UK Production Ltd |
| --- | --- |
| Address of manufacturer | Cotes Park Industrial Estate, Somercotes DE55 4PA Alfreton United Kingdom of Great Britain and Northern Ireland (the) |
| Location of manufacturing sites | Diversey UK Production Ltd Cotes Park Industrial Estate, Somercotes, DE55 4PA Alfreton United Kingdom of Great Britain and Northern Ireland (the) |
| Name of manufacturer | Diversey Italy Production Srl |
| --- | --- |
| Address of manufacturer | Strada Statale 235 26010 Bagnolo Cremasco (CR) Italy |
| Location of manufacturing sites | Diversey Italy Production Srl Strada Statale 235 26010 Bagnolo Cremasco (CR) Italy |
| Name of manufacturer | Diversey España Production S.L.U |
| --- | --- |
| Address of manufacturer | Avenida Conde Duque 5, 7 y 9, Poligono Industrial La Postura 28343 Valdemoro (Madrid) Spain |
| Location of manufacturing sites | Diversey España Production S.L.U Avenida Conde Duque 5, 7 y 9, Poligono Industrial La Postura 28343 Valdemoro (Madrid) Spain |
| Name of manufacturer | Diversey Netherlands Production BV |
| --- | --- |
| Address of manufacturer | Rembrandtlaan 414 7545ZW Enschede Netherlands (the) |
| Location of manufacturing sites | Diversey Netherlands Production BV Rembrandtlaan 414 7545ZW Enschede Netherlands (the) |
| Name of manufacturer | Diversey Germany Production oHG |
| --- | --- |
| Address of manufacturer | Morschheimer Strasse 12 67292 Kirchheimbolanden Germany |
| Location of manufacturing sites | Diversey Germany Production oHG Morschheimer Strasse 12 67292 Kirchheimbolanden Germany |
| Active substance | C(M)IT/MIT (3:1) |
| --- | --- |
| Name of manufacturer | Specialty Electronic Materials Switzerland GmbH |
| Address of manufacturer | Bachtobelstrasse 3 8810 Horgen Switzerland |
| Location of manufacturing sites | Specialty Electronic Materials Switzerland GmbH site 1 Jiangsu FOPIA Chemicals Co., Ltd, Touzeng Village 224555 Binhuai Town, Binhai County, Yancheng City, Jiangsu, China Specialty Electronic Materials Switzerland GmbH site 2 Rohm and Haas (UK) Ltd. Tyneside Works, Ellison Street, NE32 3DJ Jarrow United Kingdom of Great Britain and Northern Ireland (the) |
| Active substance | C(M)IT/MIT (3:1) |
| --- | --- |
| 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 |
| Active substance | C(M)IT/MIT (3:1) |
| --- | --- |
| Name of manufacturer | Thor Quimicos de México, SA de CV |
| Address of manufacturer | Km 182 Autopista México – Querétaro, Pedro Escobedo 76700 Querétaro Mexico |
| Location of manufacturing sites | Thor Quimicos de México, SA de CV site 1 Km 182 Autopista México – Querétaro, Pedro Escobedo 76700 Querétaro Mexico |
| Active substance | C(M)IT/MIT (3:1) |
| --- | --- |
| Name of manufacturer | Troy Chemical Company BV |
| Address of manufacturer | Poortweg 4C 2612 Delft Netherlands (the) |
| Location of manufacturing sites | Troy Chemical Company BV site 1 Weifang Heaven-sent New Materials Technology Co. Ltd, Binhai Road, Changyi Coastal Economic Development Zone 261312 Weifang China Troy Chemical Company BV site 2 Dalian Xingyuan Chemistry Co., Ltd, Room 1205/1206, Pearl River International Building, No.99, Xinkai Road, Xigang District, Songmudao Chemical Industry Zone, Puwan New District 116308 Dalian China Troy Chemical Company BV site 3 Dalian Bio-Chem Company Limited, Songmudao Plant: Songmudao Chemical Industry, Zone, Puwan New District 116308 Dalian China |
| Active substance | C(M)IT/MIT (3:1) |
| --- | --- |
| Name of manufacturer | Jiangsu FOPIA Chemicals Co., Ltd |
| Address of manufacturer | Touzeng Village, Binhuai Town, Binhai County 224555 Yancheng City China |
| Location of manufacturing sites | Jiangsu FOPIA Chemicals Co., Ltd site 1 Touzeng Village, Binhuai Town, Binhai County 224555 Yancheng City China |
2. PRODUCT FAMILY COMPOSITION AND FORMULATION
| 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 | 2,2 - 20,9 % (w/w) | |
| Formulation type(s) | AL Any other liquid | ||||
| --- | --- |
PART II.
SECOND INFORMATION LEVEL - META SPC(S)
1. META SPC 1 ADMINISTRATIVE INFORMATION
| Identifier | Meta SPC: Meta SPC 3 |
|---|---|
| Number | 1-1 |
| --- | --- |
| Product type(s) | PT06: Preservatives for products during storage PT11: Preservatives for liquid-cooling and processing systems PT12: Slimicides |
| --- | --- |
2. META SPC 1 COMPOSITION
| 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 | 2,2 - 6,5 % (w/w) | |
| Formulation type(s) | AL Any other liquid | ||||
| --- | --- |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
| Hazard statements | 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. H290: May be corrosive to metals. H302: Harmful if swallowed. 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. 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. P362+P364: Take off contaminated clothing and wash it before reuse. 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. P301+P312: IF SWALLOWED: Call a POISON CENTER/ doctor if you feel unwell. P406: Store in a a corrosion-resistant container with a resistant inner liner. P390: Absorb spillage to prevent material damage. |
4. AUTHORISED USE(S) OF THE META SPC
| Product type | PT06: Preservatives for products during storage |
|---|---|
| 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 |
| Field(s) of use | Indoor use Preservation of polymer latexes The biocidal product is recommended for the control of bacteria, yeast and fungi in the manufacture, storage, and transport of latexes, synthetic polymers including Hydrolysed Poly Acryl Amide (HPAM) and biopolymers (e.g. xanthan, dextran..) natural latexes. |
| Application method(s) | Method: closed system Detailed description: Manual and automated application. The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition. |
| Application rate(s) and frequency | Application rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: 14,9 - 50 mg /kg of C(M)IT/MIT (3:1) in final product. - Number and timing of application: The biocidal product is added at single dose at the time of manufacture, storage or shipment. To ensure uniform distribution, slowly disperse using automated metering or manual addition, into product with agitation. Mix thoroughly until evenly dispersed throughout the product. Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products. Professional uses 14,9 - 50 mg /kg of C(M)IT/MIT (3:1) in final product. For the biocidal product as supplied: for industrial use only. |
| Category(ies) of users | Industrial |
| Pack sizes and packaging material | For industrial and professional users: — HDPE flask: 5 L (nominal) — HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal) — Box with HDPE liner: 20 L — HDPE Drum: 110 L, 120 L, 200 L, 260 L — HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L All products should be transport and stored in a vented room. |
— The preservative can be added at any stage of the production of the product.
— Earliest possible addition is recommended for optimal protection.
— Consult the manufacturer to determine the optimal dosage for the various products to be preserved.
— It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.
— The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.
— The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.
— During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM: — Minimisation of manual phases (process automation); — Use of a dosing device; — Regular cleaning of equipment and work area; — Avoidance of contact with contaminated tools and objects; — Good standard of general ventilation; — Training and management of staff on good practice.
— PPE is as follows: — protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information); — protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information); — Eye protection; — Substance/task appropriate respirator if ventilation is inadequate.
— The maximal products concentration used for the preservation of polymer lattices being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM: — Minimisation of manual phases; — Use of a dosing device; — Regular cleaning of equipment and work area; — Good standard of general ventilation; — Training and management of staff on good practice.
See general directions for use.
See general directions for use.
See general directions for use.
| Product type | PT06: Preservatives for products during storage |
|---|---|
| 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 |
| Field(s) of use | Indoor use Preservation of mineral slurries The biocidal product is recommended to control the growth of bacteria in aqueous-based inorganic/mineral slurries and inorganic pigments which are formulated into paints, coatings and paper. |
| Application method(s) | Method: closed system Detailed description: Manual and automated application. The biocidal product should be dispensed as a tankside additive into the circulating use-dilution of the fluid, using a metering pump or by manual pouring, at a point to assure adequate mixing throughout the system. |
| Application rate(s) and frequency | Application rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: 10- 30 mg/kg of C(M)IT/MIT (3:1) in final product. - Number and timing of application: The biocidal product is added at single dose at the time of manufacture, storage or shipment. Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products. Professional uses: 10- 30 mg/kg of C(M)IT/MIT (3:1) in final product. For the biocidal product as supplied: for industrial use only. |
| Category(ies) of users | Industrial |
| Pack sizes and packaging material | For industrial and professional users: — HDPE flask: 5 L (nominal) — HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal) — Box with HDPE liner: 20 L — HDPE Drum: 110 L, 120 L, 200 L, 260 L — HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L All products should be transport and stored in a vented room. |
— The preservative can be added at any stage of the production of the product.
— Earliest possible addition is recommended for optimal protection.
— Consult the manufacturer to determine the optimal dosage for the various products to be preserved.
— It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.
— The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.
— The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.
— During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM: — Minimisation of manual phases (process automation); — Use of a dosing device; — Regular cleaning of equipment and work area; — Avoidance of contact with contaminated tools and objects; — Good standard of general ventilation; — Training and management of staff on good practice.
— PPE is as follows: — protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information); — protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information); — Eye protection; — Substance/task appropriate respirator if ventilation is inadequate.
— The maximal products concentration used for the preservation of mineral slurries being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM: — Minimisation of manual phases; — Use of a dosing device; — Regular cleaning of equipment and work area; — Good standard of general ventilation; — Training and management of staff on good practice.
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