Commission Implementing Regulation (EU) 2025/2218 of 31 October 2025 amending Implementing Regulation (EU) 2023/402 as regards administrative changes to the Union authorisation of the biocidal product family CMIT/MIT SOLVENT BASED and correcting that Regulation
Date: 2025-10-31
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, crude oil, market approval, motor fuel, preservative, storage








L_202502218EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/2218


3.11.2025







            COMMISSION IMPLEMENTING REGULATION (EU) 2025/2218
of 31 October 2025
         
amending Implementing Regulation (EU) 2023/402 as regards administrative changes to the Union authorisation of the biocidal product family ‘CMIT/MIT SOLVENT BASED’ and correcting that Regulation
(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 50(2) thereof,

Whereas:







(1)


On 22 February 2023, Commission Implementing Regulation (EU) 2023/402 (2) granted a Union authorisation, under number EU-0023657-0000, to Nutrition & Biosciences Netherlands B.V. for the making available on the market and use of the biocidal product family ‘CMIT/MIT SOLVENT BASED’. The Annex to that Implementing Regulation provides the summary of product characteristics for that biocidal product family.












(2)


The company Nutrition & Biosciences Netherlands B.V. was acquired by the company MC (Netherlands) 1 B.V. before Implementing Regulation (EU) 2023/402 was adopted, and that Implementing Regulation should therefore have referred to ‘MC (Netherlands) 1 B.V’ in Article 1 thereof as being the authorisation holder, as was correctly done in the summary of the biocidal product characteristics (‘SPC’) for the biocidal product family ‘CMIT/MIT SOLVENT BASED’ in the Annex to that Implementing Regulation.












(3)


On 17 November 2023, 17 July 2024, 13 January 2025 and 4 July 2025, MC (Netherlands) 1 B.V. submitted to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013 (3), notifications of administrative changes to the Union authorisation for the biocidal product family ‘CMIT/MIT SOLVENT BASED’, as referred to in Title 1 of the Annex to that Regulation. The notifications were recorded in the Register for Biocidal Products (‘the Register’) under case numbers BC-FM090134-40, BC-FX098836-92, BC-KB102361-71 and BC-QG108678-28. The notified proposed changes to that authorisation concern the deletion and addition of trade names, the deletion of two biocidal product formulators and the addition of three biocidal product formulators, a change in the address of the authorisation holder and the addition of a manufacturer of the active substance.












(4)


On 3 January 2024, 19 August 2024, 18 February 2025 and 24 July 2025, the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, opinions (4) on the notified administrative changes to the Union authorisation for the biocidal product family ‘CMIT/MIT SOLVENT BASED’, together with a revised summary of the biocidal product characteristics. In the opinions, the Agency concludes that the proposed changes are administrative changes as referred to in Article 50(3), point (a), of Regulation (EU) No 528/2012 and as specified in Title 1, Section 1 and Title 1, Section 2, of the Annex to Implementing Regulation (EU) No 354/2013, and that, after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.












(5)


On 24 July 2025, the Agency transmitted to the Commission a revised SPC of the Union authorisation for the biocidal product family ‘CMIT/MIT SOLVENT BASED’ in all official languages of the Union, covering all the administrative changes applied for, in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.












(6)


The Commission concurs with the opinions of the Agency and therefore considers it appropriate to amend the Union authorisation for the biocidal product family ‘CMIT/MIT SOLVENT BASED’ to introduce the administrative changes requested by MC (Netherlands) 1 B.V.












(7)


Except for the amendments regarding the proposed changes, all other information included in the SPC of ‘CMIT/MIT SOLVENT BASED’, as set out in the Annex to Implementing Regulation (EU) 2023/402, remains unchanged.












(8)


In order to enhance clarity and to ease the access of users and interested parties to the consolidated version of the SPC which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2023/402 should be replaced in its entirety. Due to a change in the format used for the generation of the summary of biocidal product characteristics in the Register in February 2024, the SPC in that Annex should also include some minor editorial and layout changes.












(9)


Implementing Regulation (EU) 2023/402 should therefore be amended accordingly.












(10)


Implementing Regulation (EU) 2023/402 should therefore be corrected accordingly,





HAS ADOPTED THIS REGULATION:



Article 1
Article 1, first paragraph, of Implementing Regulation (EU) 2023/402 is corrected as follows:

                  ‘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.’
               


Article 2
The Annex to Implementing Regulation (EU) 2023/402 is replaced by the text in the Annex to this Regulation.


Article 3
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, 31 October 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)  Commission 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 (OJ L 56, 23.2.2023, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2023/402/oj).

(3)  Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4, ELI: http://data.europa.eu/eli/reg_impl/2013/354/oj).

(4)  ECHA Opinion Nos UAD-C-1703145-38-00/F of 3 January 2024, UAD-C-1760130-45-00/F of 19 August 2024, UAD-C-1803042-40-00/F of 18 February 2025 and UAD-C-1843154-31-00/F of 24 July 2025 on the administrative change of the Union authorisation of the biocidal product family ‘CMIT/MIT SOLVENT BASED’, https://echa.europa.eu/opinions-on-union-authorisation.




ANNEX
Summary of product characteristics for a biocidal product family
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

1.1.   Family name







Name


CMIT/MIT SOLVENT BASED




1.2.   Product type(s)







Product type(s)


PT06: Preservatives for products during storage




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


MC (Netherlands) 1 B.V.




Address


Montrealweg 15 3197KH Botlek Rotterdam NL




Authorisation number


 


EU-0023657-0000





R4BP asset number



 


EU-0023657-0000




Date of the authorisation


 


15.3.2023




Expiry date of the authorisation


 


28.2.2033




1.4.   Manufacturer(s) of the product







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)




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







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

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


 


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)




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 SPC KATHON FP




1.2.   Suffix to the authorisation number







Number


1-1




1.3.   Product type(s)







Product type(s)


PT06: Preservatives for products during storage




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


 


10,8 -12,1  % (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


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

4.1.   Use description


Table 1


Preservation of de-watered crude oil and refined products (middle and light distillate fuels) with a maximum water content of 2 %







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




4.1.1.   Use-specific instructions for use

See general directions for use.
4.1.2.   Use-specific risk mitigation measures

See general directions for use.
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

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

See 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

See general directions for use.
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 1

5.1.   Instructions for use







—


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.
5.2.   Risk mitigation measures







—


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.





When handling the biocidal product:







—


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.








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







—


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.




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







—


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.




5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months
6.   OTHER INFORMATION

-
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)


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

1.1.   Meta SPC 2 identifier







Identifier


Meta SPC: Meta SPC KATHON HP




1.2.   Suffix to the authorisation number







Number


1-2




1.3.   Product type(s)







Product type(s)


PT06: Preservatives for products during storage




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


 


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)




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


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.
P280: Wear protective gloves meeting the requirements of the European Standard EN 374 /protective clothing of at least type 6 EN13034/ Wear chemical goggles meeting the requirements of the European Standard EN 166.
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.
P363: Wash contaminated clothing before reuse.
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.
P273: Avoid release to the environment.
P391: Collect spillage.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Preservation of de-watered crude oil and refined products (middle and light distillate fuels) with a maximum water content of 2 %







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: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Fungi/Yeast
Common name: yeast
Development stage: vegetative cells
Scientific name: Fungi/moulds
Common name: mould
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: 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:






—


Bacteria: 33 to 200 ppm v/v of biocidal product as supplied (0,5 - 3 ppm v/v CMIT/MIT),










—


Fungi (Yeasts/Moulds): 50 to 200 ppm v/v of biocidal product as supplied (0,75-3 ppm v/v CMIT/MIT), contact time needs to be 1-4 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:






—


Bacteria: 33 to 200 ppm v/v of biocidal product as supplied (0,5 - 3 ppm v/v CMIT/MIT), contact time needs to be 1-4 weeks, depending on the dose used.










—


Fungi (Yeasts/Moulds): 50 to 200 ppm v/v of biocidal product as supplied (0,75-3 ppm v/v CMIT/MIT), contact time needs to be 1-4 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 and 25 l nominal, material of construction is HDPE
Drums: 215 l and 220 l nominal, material of construction is HDPE
Intermediate bulk container(IBC): 1 000  l nominal, material of construction is HDPE




4.1.1.   Use-specific instructions for use

See general directions for use.
4.1.2.   Use-specific risk mitigation measures

See general directions for use.
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

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

See 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

See general directions for use.
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 2

5.1.   Instructions for use







—


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.
5.2.   Risk mitigation measures







—


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.





When handling the biocidal product:







—


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.








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







—


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.




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







—


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.




5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 3 months
6.   OTHER INFORMATION

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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)


KATHON HP 120 Biocide


Market area: EU




Authorisation number


 


EU-0023657-0002 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


 


11,3  % (w/w)




Butyl carbitol


2-(2-butoxyethoxy)ethanol


Non-active substance


112-34-5


203-961-6


88,7  % (w/w)







ELI: http://data.europa.eu/eli/reg_impl/2025/2218/oj
ISSN 1977-0677 (electronic edition)