See Full Document Text
Official Journal EN
of the European Union 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.
(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).
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(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.
(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.
2/18 ELI: http://data.europa.eu/eli/reg_impl/2025/2218/ojEN
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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
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ANNEX
Summary of product characteristics for a biocidal product family
CMIT/MIT SOLVENT BASED
Product type(s)
PT06: Preservatives for products during storage
Authorisation numberEU-0023657-0000
R4BP asset numberEU-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 MC (Netherlands) 1 B.V.
Name and address of the authorisation holder
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
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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
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
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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 Active 55965-84-9 10,8 - 12,1 % (w/
of 5-chloro- substance w)
2-methyl-2h-
isothiazol-
3-one
and 2-methyl-
2h-isothiazol-
3-one (3:1)
Butyl carbitol 2-(2-butoxye Non-active 112-34-5 203-961-6 0 - 89,2 % (w/w)
thoxy)ethanol substance
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
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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 Active 55965-84-9 10,8-12,1 % (w/
of 5-chloro- substance w)
2-methyl-2h-
isothiazol-
3-one
and 2-methyl-
2h-isothiazol-
3-one (3:1)
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.
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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 Preservation of de-watered crude oil and refined products (middle
authorised use and light distillate fuels) with a maximum water content of 2 %
Target organism(s) (including development Scientific name: Fungi/moulds
stage) 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
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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.
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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.
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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.
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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 Market area: EU
FP 1.5
Biocide
T2642 Market area: EU
XC85957 Market area: EU
SPEC-AID Market area: EU
8Q700
Predator Market area: EU
9015
FuelClear Market area: EU
M15
BIO Market area: EU
C41770A
Bactron Market area: EU
B1770
KATHON Market area: EU
(TM) Fuel
15 Biocide
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 Active 55965-84-9 11,3 % (w/w)
of 5-chloro- substance
2-methyl-2h-
isothiazol-
3-one
and 2-methyl-
2h-isothiazol-
3-one (3:1)
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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 Active 55965-84-9 10,8-12,1 % (w/
of 5-chloro- substance w)
2-methyl-2h-
isothiazol-
3-one
and 2-methyl-
2h-isothiazol-
3-one (3:1)
Butyl carbitol 2-(2-butoxye Non-active 112-34-5 203-961-6 87,9 - 89,2 % (w/
thoxy)ethanol substance 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.
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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 Preservation of de-watered crude oil and refined products (middle
authorised use and light distillate fuels) with a maximum water content of 2 %
Target organism(s) (including development Scientific name: Bacteria
stage) Common name: bacteria
Development stage: vegetative cells
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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.
ELI: http://data.europa.eu/eli/reg_impl/2025/2218/oj 15/18EN
OJ L, 3.11.2025
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.
16/18 ELI: http://data.europa.eu/eli/reg_impl/2025/2218/ojEN
OJ L, 3.11.2025
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.
ELI: http://data.europa.eu/eli/reg_impl/2025/2218/oj 17/18EN
OJ L, 3.11.2025
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
-
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 Market area: EU
HP 120
Biocide
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 Active 55965-84-9 11,3 % (w/w)
of 5-chloro- substance
2-methyl-2h-
isothiazol-
3-one
and 2-methyl-
2h-isothiazol-
3-one (3:1)
Butyl carbitol 2-(2-butoxye Non-active 112-34-5 203-961-6 88,7 % (w/w)
thoxy)ethanol substance
18/18 ELI: http://data.europa.eu/eli/reg_impl/2025/2218/oj