Commission Implementing Regulation (EU) 2025/2218of 31 October 2025amending 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)

1. PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1.

Qualitative and quantitative information on the composition of the family

Common nameIUPAC nameFunctionCAS numberEC numberContent (%)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 substance55965-84-910,8 - 12,1 % (w/w)Butyl carbitol2-(2-butoxyethoxy)ethanolNon-active substance112-34-5203-961-60 - 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

IdentifierMeta SPC: Meta SPC KATHON FP

1.2.

Suffix to the authorisation number

Number1-1

1.3.

Product type(s)

Product type(s)PT06: Preservatives for products during storage

1. META SPC 1 COMPOSITION

2.1.

Qualitative and quantitative information on the composition of the meta SPC 1

Common nameIUPAC nameFunctionCAS numberEC numberContent (%)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 substance55965-84-910,8-12,1 % (w/w)

2.2.

Type(s) of formulation of the meta SPC 1

Formulation type(s)AL Any other liquid

1. 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.

1. 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 typePT06: Preservatives for products during storageWhere relevant, an exact description of the authorised usePreservation 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 usersprofessionalPack 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): 1000 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.

1. 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 15000 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 35000 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

1. OTHER INFORMATION

1. 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 BiocideMarket area: EUT2642Market area: EUXC85957Market area: EUSPEC-AID 8Q700Market area: EUPredator 9015Market area: EUFuelClear M15Market area: EUBIOC41770AMarket area: EUBactron B1770Market area: EUKATHON(TM) Fuel 15 BiocideMarket area: EUAuthorisation numberEU-0023657-0001 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)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 substance55965-84-911,3 % (w/w)

1. META SPC 2 ADMINISTRATIVE INFORMATION

1.1.

Meta SPC 2 identifier

IdentifierMeta SPC: Meta SPC KATHON HP

1.2.

Suffix to the authorisation number

Number1-2

1.3.

Product type(s)

Product type(s)PT06: Preservatives for products during storage

1. META SPC 2 COMPOSITION

2.1.

Qualitative and quantitative information on the composition of the meta SPC 2

Common nameIUPAC nameFunctionCAS numberEC numberContent (%)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 substance55965-84-910,8-12,1 % (w/w)Butyl carbitol2-(2-butoxyethoxy)ethanolNon-active substance112-34-5203-961-687,9 - 89,2 % (w/w)

2.2.

Type(s) of formulation of the meta SPC 2

Formulation type(s)AL Any other liquid

1. 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.

1. 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 typePT06: Preservatives for products during storageWhere relevant, an exact description of the authorised usePreservation 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 usersprofessionalPack 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): 1000 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.

1. 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 15000 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 35000 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

1. OTHER INFORMATION

1. 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 BiocideMarket area: EUAuthorisation numberEU-0023657-0002 1-2Common nameIUPAC nameFunctionCAS numberEC numberContent (%)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 substance55965-84-911,3 % (w/w)Butyl carbitol2-(2-butoxyethoxy)ethanolNon-active substance112-34-5203-961-688,7 % (w/w)