LegalizeCommission Implementing Regulation (EU) 2023/402 of 22 February 2023 granting a Union authorisation for the biocidal product family ‘CMIT/MIT SOLVENT BASED’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
Article 1
A Union authorisation with authorisation number EU-0023657-0000 is granted to MC (Netherlands) 1 B.V. for the making available on the market and use of the biocidal product family ‘CMIT/MIT SOLVENT BASED’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
However, the Union authorisation shall not apply in the territory of the Kingdom of Denmark and in the territory of the Kingdom of Belgium, nor shall it apply in the territory of the Federal Republic of Germany for the preservation of fuels for non-rail bound on-road motor vehicles, except for the purpose of research, development or analysis.
The Union authorisation is valid from 15 March 2023 until 28 February 2033.
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 SOLVENT BASED
Product type(s)
PT06: Preservatives for products during storage
Authorisation number EU-0023657-0000
R4BP asset number EU-0023657-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
| Name | CMIT/MIT SOLVENT BASED |
|---|---|
| Product type(s) | PT06: Preservatives for products during storage |
| --- | --- |
| Name and address of the authorisation holder | Name |
| --- | --- |
| Address | Montrealweg 15 3197KH Botlek Rotterdam NL |
| Authorisation number | |
| R4BP asset number | |
| Date of the authorisation | |
| Expiry date of the authorisation | |
| Name of manufacturer | Microbial Control (Switzerland) GmbH |
| --- | --- |
| Address of manufacturer | Hungerbüelstrasse 22 8500 Frauenfeld Switzerland |
| Location of manufacturing sites | Microbial Control (Switzerland) GmbH site 1 AD Productions BV, Markweg Zuid 27 4794 SN Heijningen Netherlands (the) |
| Name of manufacturer | Theseo Deutschland GmbH |
| --- | --- |
| Address of manufacturer | Kolpingstrasse 4 49835 Wietmarschen Germany |
| Location of manufacturing sites | Theseo Deutschland GmbH site 1 Kolpingstrasse 4 49835 Wietmarschen Germany |
| Name of manufacturer | Fuelcare Limited |
| --- | --- |
| Address of manufacturer | Unit 13, Stadium Point Business Park, Oteley Road SY2 6NE Shrewsbury United Kingdom of Great Britain and Northern Ireland (the) |
| Location of manufacturing sites | Fuelcare Limited Unit 13, Stadium Point Business Park, Oteley Road SY2 6NE Shrewsbury United Kingdom of Great Britain and Northern Ireland (the) |
| Active substance | C(M)IT/MIT (3:1) |
| --- | --- |
| Name of manufacturer | Jiangsu FOPIA Chemicals Co., Ltd (Specialty Electronic Materials Switzerland GmbH) |
| Address of manufacturer | Touzeng Village, Binhuai Town 224555 Binhai County, Yancheng City, Jiangsu China |
| Location of manufacturing sites | Jiangsu FOPIA Chemicals Co., Ltd (Specialty Electronic Materials Switzerland GmbH) site 1 Touzeng Village, Binhuai Town 224555 Binhai County, Yancheng City, Jiangsu China |
| Active substance | C(M)IT/MIT (3:1) |
| --- | --- |
| 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 | 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 | 10,8 - 12,1 % (w/w) | |
| Butyl carbitol | 2-(2-butoxyethoxy)ethanol | Non-active substance | 112-34-5 | 203-961-6 | 0 - 89,2 % (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 KATHON FP |
|---|---|
| Number | 1-1 |
| --- | --- |
| Product type(s) | PT06: Preservatives for products during storage |
| --- | --- |
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 | 10,8 -12,1 % (w/w) | |
| Formulation type(s) | AL Any other liquid | ||||
| --- | --- |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
| Hazard statements | 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. EUH071: Corrosive to the respiratory tract. |
|---|---|
| Precautionary statements | P260: Do not breathe vapours. 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. P321: Specific treatment (see supplemental first aid instructions on this label). P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. P302+P352: IF ON SKIN: Wash with plenty of water. 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. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER/ doctor. P362+P364: Take off contaminated clothing and wash it before reuse. P391: Collect spillage. P333+P313: If skin irritation or rash occurs: Get medical advice. P405: Store locked up. P501: Dispose of contents to an approved facility in accordance with local, regional, national and international regulations. |
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 | Preservation of de-watered crude oil and refined products (middle and light distillate fuels) with a maximum water content of 2 % |
| Target organism(s) (including development stage) | Scientific name: Fungi/moulds Common name: mould Development stage: vegetative cells and spores Scientific name: Fungi/Yeast Common name: yeast Development stage: vegetative cells Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells |
| Field(s) of use | Indoor use The biocidal product family is recommended to control microorganisms in de-watered crude oil and refined products (middle and light distillate fuels) with a maximum water content of 2 %. The biocidal product family is not to be used for the preservation of aviation fuels, naphthas, alkenes/olefins and aromatics (simple and more complex structures). |
| Application method(s) | Method: Loading of biocidal product into the blend tank containing de-watered crude oils or refined products (middle and light distillate fuels) Detailed description: The biocidal product is added as a single dose at the time of manufacture, storage or shipment. Dose the biocidal product to the end use fluid at a point to ensure adequate mixing using automated metering or by manual pouring using a safe measuring dosing system.The biocidal product should not be dispensed as supplied into an empty fuel tank. Fuel tanks being treated with the biocidal product should be at least 10% full in order to ensure good homogenisation of the biocidal product, which aids effectiveness of the treatment. Fuel tanks and sumps should be drained of water regularly. Following treatment, drain off dead microorganisms and other debris from the treated fuel which have accumulated at the bottom of the tank . Filters should also be checked frequently and examined for the build-up of suspended solids. Whenever periodic maintenance is carried out, tanks should be checked for microbial growth. |
| Application rate(s) and frequency | Application Rate: Preservation for mid and long term storage and curative treatment 50-100 ppm v/v of biocidal product as supplied. Refined products (middle and light distillate fuels) and de-watered crude oils - Mid/long term preservation: 50 to 150 ppm v/v of biocidal product as supplied - Curative treatment: 200 to 400 ppm v/v of biocidal product as supplied - Number and timing of application: De-watered crude oils: Mid/long-term preservation: — 50 to 150 ppm v/v of biocidal product as supplied (0,75-2,25 ppm v/v CMIT/MIT), contact time needs to be 1 to 4 weeks, depending on the dose used. Curative treatment:: — Bacteria: 200 to 400 ppm v/v of biocidal product as supplied (3 - 6 ppm v/v CMIT/MIT), contact time needs to be 1 to 3 days, depending on the dose used. — Fungi (Yeasts/Moulds): 400 ppm v/v of biocidal product as supplied (6 ppm v/v CMIT/MIT), contact time needs to be 1 to 3 days, depending on the dose used. Refined products (middle and light distillate fuels): Mid/long-term preservation: — 50 to 150 ppm v/v of biocidal product as supplied (0,75-2,25 ppm v/v CMIT/MIT), contact time needs to be 1 to 4 weeks, depending on the dose used. Curative treatment:: — Bacteria: 200 to 400 ppm v/v of biocidal product as supplied (3 - 6 ppm v/v CMIT/MIT), contact time needs to be 1 to 3 days, depending on the dose used. — Fungi (Yeasts/Moulds): 400 ppm v/v of biocidal product as supplied (6 ppm v/v CMIT/MIT), contact time needs to be 1 to 3 days, depending on the dose used. Repeat as necessary when contamination is detected. |
| Category(ies) of users | professional |
| Pack sizes and packaging material | Flasks: 5 l nominal, material of construction is high density polyethylene (HDPE) Pails: 20 l nominal, material of construction is HDPE Pails: 25 l nominal, material of construction is HDPE Drums: 215 l nominal, material of construction is HDPE Drums: 220 l nominal, material of construction is HDPE Intermediate bulk container(IBC): 1 000 l nominal, material of construction is HDPE |
See general directions for use.
See general directions for use.
See general directions for use.
See general directions for use.
See general directions for use.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1
— Always read the label or leaflet before use and follow all the instructions provided.
— Respect the conditions of use of the biocidal product (concentration, contact time, temperature, pH, etc.)
— For preservation during mid/long-term storage, contact time needs to be 1 to 4 weeks, depending on the dose used. For curative treatment, the biocidal effect is achieved after 1-3 days.
— Products are to be used only for mid or long-term storage or for curative treatment. Do not use in case of high turnover systems.
— Check regularly the residual concentration of the active substance (both in the fuel and aqueous phases) between fuel transfers in order to ensure lack of contamination between treatments. The choice of intervals between treatments is based on the check of the residual active substance concentrations.
— Microbiological tests to prove adequacy of preservation have to be undertaken (both in the fuel and aqueous phases) by the user of the product in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
Not authorised for use in the Kingdom of Denmark and in the Kingdom of Belgium.
Applicable in the Federal Republic of Germany only: Do not use the products for the preservation of fuels for non rail bound on road motor vehicles, except for the purpose of research, development or analysis.
— For preservation up to the dose of 6 ppm, the maximum amount of treated de-watered crude oil or refined products emptied daily per site is 15 000 m3.
— For preservation up to the dose of 3 ppm, the maximum amount of treated de-watered crude oil or refined products emptied daily per site is 35 000 m3.
— Wear protective chemical resistant gloves meeting the requirements of the European Standard EN 374 (glove material to be specified by the authorisation holder within the product information) and a protective coverall (at least type 6 EN13034), during product handling phase.
— Wear chemical goggles meeting the requirements of the European Standard EN 166 during product handling phase.
— The following technical and organisational measures should be implemented: — regular cleaning of the equipment and work area;. — the use of a dosing pump for manual loading; — minimisation of manual phases; — adequate ventilation during application of product.
— IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. Call a POISON CENTER or doctor/physician if you feel unwell.
— IF ON SKIN: Rinse skin with water (or shower). Take off immediately all contaminated clothing and wash it before reuse.
— IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
— IF INHALED: Remove person to fresh air and keep comfortable for breathing.
— If skin irritation or rash occurs: Get medical advice/attention.
— Keep the container or label available.
— Release only to an industrial sewage treatment plant (STP).
— Dispose of unused product, its packaging and all other waste, in accordance with local regulations.
— Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets) nor down the drain.
Shelf-life: 24 months
6. OTHER INFORMATION
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7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
| Trade name(s) | KATHON FP 1.5 Biocide | Market area: EU | |||
|---|---|---|---|---|---|
| T2642 | Market area: EU | ||||
| XC85957 | Market area: EU | ||||
| SPEC-AID 8Q700 | Market area: EU | ||||
| Predator 9015 | Market area: EU | ||||
| FuelClear M15 | Market area: EU | ||||
| BIOC41770A | Market area: EU | ||||
| Bactron B1770 | Market area: EU | ||||
| KATHON(TM) Fuel 15 Biocide | Market area: EU | ||||
| Authorisation number | EU-0023657-0001 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 | 11,3 % (w/w) |
1. META SPC 2 ADMINISTRATIVE INFORMATION
| Identifier | Meta SPC: Meta SPC KATHON HP |
|---|---|
| Number | 1-2 |
| --- | --- |
| Product type(s) | PT06: Preservatives for products during storage |
| --- | --- |
2. META SPC 2 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 | 10,8 -12,1 % (w/w) | |
| Butyl carbitol | 2-(2-butoxyethoxy)ethanol | Non-active substance | 112-34-5 | 203-961-6 | 87,9 - 89,2 % (w/w) |
| Formulation type(s) | AL Any other liquid | ||||
| --- | --- |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
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