LegalizeCommission Implementing Regulation (EU) 2025/263 of 10 February 2025 granting a Union authorisation for the biocidal product family Ecolab CMIT-MIT BPF in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.
| Product type | PT11: Preservatives for liquid-cooling and processing systems |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: no data Common name: bacteria Development stage: no data Scientific name: no data Common name: yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Scientific name: no data Common name: algae Development stage: no data Scientific name: no data Common name: Legionella pneumophila Development stage: no data Scientific name: no data Common name: biofilm Development stage: no data |
| Field(s) of use | indoor use outdoor use Preservation of fluids in cooling systems with discharge to the municipal sewer in: Open recirculating cooling systems, Closed cooling system. Preservation of processing liquids in: Pasteurizers and sterilizers, Air washers and scrubbers. |
| Application method(s) | Method: closed system Detailed description: Feed the product via a closed feed system. Product applied via automated process with use of pumps or injection. Product can be added whilst the process is in operation. |
| Application rate(s) and frequency | Application rate: Maintenance: Bacteria 34-69 ppm product (1,5-3 mg as/l (active substance per liter)) Legionella 17-69 ppm product (0,75-3 mg as/l) Biofilm 69 ppm product (3 mg as/l) Curative: Bacteria 137 ppm product 6 hours contact time (6 mg as/l) Legionella 33-137 ppm product 6 hours contact time (1,5-6 mg as/l) Yeast and fungi 69-137 ppm product 6 hours contact time (3-6 mg as/l) Algae 33-137 ppm product 6 hours contact time (1,5-6 mg as/l) - Number and timing of application: Maintenance frequency: once per day to once per week. Curative: this may be implemented when control is lost or when monitoring data suggests that curative implementation is required, however this should not be more than once every two months in cases of heavy fouling. |
| Category(ies) of users | industrial ; professional |
| Pack sizes and packaging material | 20-100 kg opaque polyethylene pails 50-500 kg opaque polyethylene drums 1 000 -2 000 kg opaque polyethylene IBCs |
4.1.1. Use-specific instructions
The product should be slug-fed to recirculating cooling and process water in such a way to achieve maximum dispersion and exposure to the areas of the system with the highest level of microorganisms.
The product should be added to the system according to the size of the system, for example to achieve a 100 ppm concentration in a 10 000 liter system 1 000 ml (1 liter) of product will need to be added.
The interval between two doses depends on the system’s hydraulic retention time and removal of the active substance by degradation and blow-down. The product may accumulate in preserved fluids when dosed too often. It is the responsibility of the end-user to determine the effective dose on-site (e.g. by chemical or microbiological tests) for the specific location/system to ensure that the system is efficacious under the use conditions. If needed, consult the authorisation holder (as specified in the label).
4.1.2. Use-specific risk mitigation measures
Wear compatible Personal Protective Equipment:
Wear protective chemical resistant gloves meeting the requirements of European Standard EN ISO 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).
Wear a protective coverall type 6, consistent with the European Standard EN 13034 or equivalent.
The use of eye protection according to the European Standard EN ISO166 or equivalent during handling of the product is mandatory.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
The use is restricted to small cooling systems with a maximum blowdown of 2 m3/h. Waste water must be discharged to the municipal sewer or purified in an on-site industrial sewage treatment plant including a biological treatment step.
The product can only be applied when the cooling towers are equipped with drift eliminators that reduce drift with at least 99%.
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
Please refer to the general direction for use
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Please refer to the 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
Please refer to the general directions for use
4.2. Use description
Table 2
Use 3.2 Slimicide in the pulp and paper industry (Preservatives)
| Product type | PT12: Slimicides |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: no data Common name: bacteria Development stage: no data Scientific name: no data Common name: yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Scientific name: no data Common name: biofilm Development stage: no data |
| Field(s) of use | indoor use For use as a slimicide in the pulp and paper industry, de-inking process, wet end / white water, pulp including during machine shut-down. Thick stock (including broke, blend, machine chests as well as the recycled pulp). White water, cloudy water and clear water. Thin stock. Control of Microbiologically Induced Corrosion (MIC) and biofouling of deaerators and filters. Control of slime growth in additives specifically intended to be used in the paper production process. |
| Application method(s) | Method: closed system Detailed description: Feed the product via a closed feed system. Product applied via automated process with use of pumps or injection. Product can be added whilst the process is in operation. |
| Application rate(s) and frequency | Application rate: Additives used in paper production Maintenance: Bacteria 17-137 ppm product (0,75-6 mg as/l(active substance per liter)) Yeast 34-137 ppm product (1,5-6 mg as/l) Curative: Bacteria 17-137 ppm product 24 hours contact time (0,75-6 mg as/l) Yeast and fungi 68-137 ppm product 6 hours contact time (3-6 mg as/l) Paper machine system (including wet end, white water and pulp) Maintenance: Bacteria and yeast 9-137 ppm product (0,38-6 mg as/l) Biofilm 69-137 ppm product (3-6 mg as/l) Curative: Bacteria 69-137 ppm product 24 hours contact time (3-6 mg as/l) Yeast 9-137 ppm product 24 hours contact time (0,38-6 mg as/l) Fungi 137 ppm product 6 hours contact time (6 mg as/l) - Number and timing of application: For pulp and paper industry, feed on an intermittent (slug) basis: Additives used in paper production and Paper machine system (including wet end, white water and pulp) Maintenance frequency: four times daily to once per week. Curative: In cases of heavy fouling this may be implemented when control is lost or when monitoring data suggests that curative implementation is required, however this should not be more than once every two months. |
| Category(ies) of users | industrial ; professional |
| Pack sizes and packaging material | 20-100 kg opaque polyethylene pails 50-500 kg opaque polyethylene drums 1 000 -2 000 kg opaque polyethylene IBCs |
4.2.1. Use-specific instructions
Feed the product on an intermittent basis to provide preservation of acceptable (low level) microbial counts in the paper machine system. Feed the product in the wet-end intermittently in the machine chest or similar stock chest or to additives used in paper production. Alone, it should never be used in the short loop but back in the system.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. The interval between two doses also depends on the system’s hydraulic retention time and removal of the active substance by e.g. degradation and dilution. The product may accumulate in processing fluids when dosed too often. It is the responsibility of the end-user to determine the effective dose on-site (e.g. by chemical or microbiological tests) for the specific location/system to ensure that the system is efficacious under the use conditions. If needed, consult the authorisation holder (as specified in the label).
The product should be added based on the volume of the system, for example to achieve a 100 ppm concentration in a 10 000 liter system 1 000 ml (1 liter) of product will need to be added.
4.2.2. Use-specific risk mitigation measures
Human Health:
Wear compatible Personal Protective Equipment (PPE)
Wear protective chemical resistant gloves meeting the requirements of European Standard EN ISO 374 or equivalent during product handling phase (glove material to be specified by the uthorisation holder within the product information).
Wear a protective coverall type 6, consistent with the European Standard EN 13034 or equivalent.
The use of eye protection according to the European Standard EN ISO 166 or equivalent during handling of the product is mandatory.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
Environment:
Application is only allowed in paper factories that comply to the Industrial Emission directive 2010/75/EU where wastewater is purified in an on-site industrial sewage treatment plant including a biological treatment step in accordance with the Best Available Techniques (BAT) as prescribed in the BAT reference document (BREF) for the production of pulp, paper and board. the effluent must be diluted at least 200 times. Paper factories that are exempted from the Industrial Emission Directive must discharge to the municipal sewer.
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Please refer to the General directions for use.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Please refer to the general directions for use.
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Please refer to the general directions for use.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 3
5.1. Instructions for use
Resistance management procedures shall be adopted in use as follows:
- — products shall always be used in accordance with label recommendations
- — elimination of microbial growth shall be attempted by using application rates demonstrated to be efficacious
- — levels of effectiveness shall be monitored and instances of reduced effectiveness shall be investigated for possible evidence of resistance.
In commercial use, CMIT/MIT is often used in combination or rotation with other biocides in various applications. Microbial resistance to CMIT/MIT can be avoided by switching or alternating biocides or using combinations with other actives.
All workers and individuals handling the product shall be trained, have access to the Safety Data Sheets (SDS) and Technical Data Sheets (TDS).
5.2. Risk mitigation measures
Refer to use-specific risk mitigation measures
Organisational risk management measures:
- — Loading should be restricted to automated processes.
- — Workers involved in performing repairs or cleaning activities should rinse the system before opening and cleaning.
- — Eye wash station and safety shower are necessary.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Refer to Sections 4.1.3 and 4.2.3 ‘Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment’.
Protection of first-aiders: Wear adequate personal protective equipment.
First aid instructions:
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. If skin irritation or rash occur: Get medical advice.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
Environmental precautions:
In the event of a spill, prevent material from entering sewers or waterways. Do not allow material to contaminate ground water system. Prevent product from entering drains. If drains, streams, soil or sewers become contaminated, notify local authority. Spilled product may pose a risk to the aquatic ecosystem if released.
Methods and materials for containment and cleaning up:
SMALL SPILLS: Dike and absorb with inert material (e.g. dry earth, sand), shovel all contaminated solids into a pail or drum and then treat with enough deactivation solution to wet the solids thoroughly. Let these containers stand open for 48 hours to prevent pressure build up and then seal for disposal. Equipment containing residues should be decontaminated before carrying out maintenance or repair work or using for other service. Contaminated surfaces should be swabbed with deactivation solution, wait for the reaction to subside and rinse thoroughly with clean water.
LARGE SPILLS: Soak up with inert absorbent material. Transfer contaminated material to suitable containers for disposal. Contaminated surfaces should be swabbed with deactivation solution, let stand for 30 minutes and rinse thoroughly with clean water.
DO NOT add deactivation solution to the waste container to deactivate the absorbed material.
-
- DEACTIVATION SOLUTION - prepare fresh a solution of 5% Sodium bicarbonate and 5% Sodium hypochlorite in water. Use a ratio of 10 volumes decontamination solution per estimated volume of residual spill. Contact an approved waste hauler for disposal of contaminated recovered material. Dispose of material in compliance with regulations indicated in Safety Data Sheet.
5.4. Instructions for safe disposal of the product and its packaging
Dispose of in accordance with the European Directives on waste and hazardous waste. Waste codes should be assigned by the user, preferably in discussion with the waste disposal authorities.
The product must not be released to soil, water courses or any kind of sewer. Where possible recycling is preferred to disposal. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility.
Contaminated packaging: Dispose of as unused product. Empty containers should be taken to an approved waste handling site. Do not re-use empty containers.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf life: 24 months.
Do not store above ambient storage temperature (25°C).
Keep container tightly closed. Store in suitable labelled containers.
6. OTHER INFORMATION
The full titles of the EN standards referenced in sections “Use-specific risk mitigation measures” are:
EN ISO 374 - Protective gloves against dangerous chemicals and micro-organisms
EN ISO 166 – Personal eye protection standard
EN 13034 - Protective clothing against liquid chemicals - Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6 and Type PB equipment)
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
With respect to the “Category (ies) of users” note: “Professionals (including industrial users)” means trained professionals if this is required by national legislation.
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | NALCO® BACTOLYSE 74824 | NALCO® BACTOLYSE 74824 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | NALCO® 74824 | NALCO® 74824 | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0032881-0004 1-3 | EU-0032881-0004 1-3 | EU-0032881-0004 1-3 | ||
| Common name | IUPAC name | Function | Function | CAS number | 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 | active substance | 55965-84-9 | 55965-84-9 | 7,51 % (w/w) |
ELI: http://data.europa.eu/eli/reg_impl/2025/263/oj
ISSN 1977-0677 (electronic edition)
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