LegalizeCommission Implementing Regulation (EU) 2025/2048 of 10 October 2025 granting a Union authorisation for the biocidal product family 3025 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.
In small rooms: ≤ 80 m3, wear gloves (EN 374 or equivalent), coverall (type 6, EN 13034 or equivalent) and RPE with APF 10 (EN 12941) if 3 % in-use dilution are used.
In large rooms: > 80 m3, wear gloves (EN 374 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≤ 1 % in-use dilution is used.
In large rooms: > 80 m3, wear gloves (EN 374 or equivalent), coverall (type 6, EN 13034 or equivalent) and RPE with APF 10 (EN 12941) if ≥ 1 % in-use dilution is used.
For spraying in tanks:
Wear gloves (EN 374), coverall (type 6, EN 13034 or equivalent) and RPE APF 10 (EN 12941 or equivalent) when products with <1 % in-use dilution are used.
Wear gloves (EN 374), coverall (type 6, EN 13034 or equivalent) and RPE APF 20 (EN 12942 or equivalent) when products with 1 %-2 % in-use dilution are used.
Wear gloves (EN 374), coverall (type 6, EN 13034 or equivalent) and RPE APF 40 (EN 12942 or equivalent) when products with 3 % in-use dilution are used.
For immersion:
Application: no personal protective equipment (PPE) needed.
For CIP applications:
Application: closed system; no PPE needed.
The following secondary exposure control measure applies to all application methods:
PPE specified for the user shall also be worn by persons working in the vicinity of the application or who may otherwise be exposed to the biocidal product.
Professional users must ensure that no bystanders are present in the treatment area during application. If bystanders have to be present, the users have to ensure that those wear the same PPE as themselves.
The room shall be sealed and re-entry prevented after disinfection took place. It shall be indicated that a ventilation process after disinfection is running (information of other workers).
Re-entry is only permitted once the air concentration of the active substance has dropped below the reference value (Adverse Effect Concentration (AEC) inhalation of 0,0106 mg/m3).
Unprotected persons should be kept away from treated areas until surfaces are dry.
Regarding the personal protective equipment listed in this section, this is without prejudice to the application by employers 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.
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.
4.2. Use description
Table 2
Use # 2-11: surface disinfection in industrial production areas, wiping, mopping, spraying, immersion and circulation (CIP) clean and dirty (PT 2)
| Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
| Where relevant, an exact description of the authorised use | n/a |
| Target organism(s) (including development stage) | Common name: bacteria Common name: yeasts Common name: fungi Common name: enveloped viruses Common name: viruses |
| Field(s) of use | Indoor use Hard non-porous surface disinfection in industrial production areas by wiping of work surfaces, machines, equipment, utensils etc., by mopping of floors and walls, by spraying (tanks), by immersion, disinfection of equipment and containers by immersion in an aqueous dilution of the product, and by circulation (cleaning in place, CIP), disinfection of inner surfaces of pipes, tanks, fillers, mixers and other machines. |
| Application method(s) | Method: Surface disinfection by wiping, mopping, spraying, immersion and CIP Detailed description: n.a. |
| Application rate(s) and frequency | Application Rate: Wiping, mopping and spraying: 40 ml/m2. Use at room temperature. Disinfection with prior cleaning: Use the product with the following dilution and contact time: Bacteria & enveloped viruses: 1 % (v/v), 15 minutes; 2 % (v/v), 5 minutes. Yeasts: 1 % (v/v), 15 minutes. Fungi (mopping, wiping, spraying and immersion): 1 % (v/v), 60 minutes; 2 % (v/v), 30 minutes; Fungi (CIP): 1 % (v/v), 60 minutes; 2 % (v/v), 15 minutes. Viruses: 3 % (v/v), 60 minutes. Disinfection without prior cleaning: Use the product with the following dilution and contact time: Bacteria & enveloped viruses (mopping, wiping, spraying and immersion): 0,5 % (v/v), 2 hours; 1 % (v/v), 15 minutes; 3 % (v/v), 5 minutes; Bacteria & enveloped viruses (CIP): 1 % (v/v), 15 minutes; 3 % (v/v), 5 minutes. Yeasts: 1 % (v/v), 60 minutes; 2 % (v/v), 15 minutes; 3 % (v/v), 5 minutes. Fungi (mopping, wiping, spraying and immersion): 1 % (v/v), 2 hours; Fungi (CIP): 1 % (v/v), 60 minutes; 3 % (v/v), 15 minutes. Viruses: 3 % (v/v), 60 minutes. Immersion: up to 180 litres per disinfection bath Number and timing of application: Application frequency (CIP): 2 times a day Application frequency (wiping, mopping, spraying, immersion): 1 time a day |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | 5-30 litres canister (HDPE) 200 litres drum (HDPE) 500-1 000 litres IBC container (HDPE, embedded in steel framework) |
4.2.1. Use-specific instructions for use
For disinfection with prior cleaning: thoroughly clean and rinse the surface. Dry the surface before applying the disinfection product.
Wiping and mopping:
At the end of work-shift, the working solution is prepared by dosing the required quantity of the product into water. This is done manually by using an appropriate package size or by using a measuring cup or canister pump for correct dilution in water for the activity needed. Soak a clean dry wipe or mop in freshly prepared working solution and wipe or mop the surface until it is completely wetted. Keep the surface wet and allow to take effect for the specified contact time.
Spraying (tanks):
The working solution is prepared by dosing the required quantity of the product into water. This is done manually by using an appropriate package size or by using a measuring cup/canister pump for correct dilution in water for the activity needed. Working solution is sprayed onto the inner surface by using a standard cleaning lance (at a distance of approximately 1,5 meters to the surface) until it is completely wetted. Keep the surface wet and allow to take effect for the specified contact time.
Immersion:
The working solution is prepared by dosing the required quantity of the product into water. This is done manually by using an appropriate package size or by using a measuring cup or canister pump for correct dilution in water for the activity needed. Immerse equipment completely in working solution for the specified contact time. The disinfection bath can only be used once.
CIP:
The required quantities of product and water are pumped into the closed system by an automatic dosage system to a final concentration as needed for the respective activity. Volume of product needed to disinfect the surface depends on the size of the closed system. Circulate the working solution in the closed system for the specified contact time.
4.2.2. Use-specific risk mitigation measures
During handling of the undiluted product: Wear protective gloves (e.g. butyl rubber) compliant with the requirements of the European Standard EN 374 or equivalent, protective clothing (coveralls) (type 6, EN 13034 or equivalent) and eye/face protection (EN 166 or equivalent) and respiratory protection equipment (RPE) with Assigned Protection Factor (APF 10) (EN 12941 or equivalent).
For wiping:
In small rooms: ≤ 80 m3, wear gloves (EN 374 or equivalent) and RPE with APF 10 if (EN 12941 or equivalent) ≤ 3 % in-use dilution are used.
In large rooms: > 80 m3, wear gloves (EN 374 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≤ 3 % in-use dilution is used.
For mopping:
In small rooms: ≤ 80 m3, wear gloves (EN 374 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≤ 2 % in-use dilution are used.
In small rooms: ≤ 80 m3, wear gloves (EN 374 or equivalent), coverall (type 6, EN 13034 or equivalent) and RPE with APF 10 (EN 12941) if 3 % in-use dilution are used.
In large rooms: > 80 m3, wear gloves (EN 374 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≤ 1 % in-use dilution is used.
In large rooms: > 80 m3, wear gloves (EN 374 or equivalent), coverall (type 6, EN 13034 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≥ 1 % in-use dilution is used.
For spraying in tanks:
Wear gloves (EN 374 or equivalent), coverall (type 6, EN 13034 or equivalent) and RPE APF 10 (EN 12941 or equivalent) when products with <1 % in-use dilution are used.
Wear gloves (EN 374 or equivalent), coverall (type 6, EN 13034 or equivalent) and RPE APF 20 (EN 12942 or equivalent) when products with 1 %-2 % in-use dilution are used.
Wear gloves (EN 374 or equivalent), coverall (type 6, EN 13034 or equivalent) and RPE APF 40 (EN 12942 or equivalent) when products with 3 % in-use dilution are used.
For immersion:
Application: no personal protective equipment (PPE) needed.
For CIP applications:
Application: closed system; no PPE needed.
The following secondary exposure control measure applies to all application methods:
PPE specified for the user shall also be worn by persons working in the vicinity of the application or who may otherwise be exposed to the biocidal product.
Professional users must ensure that no bystanders are present in the treatment area during application. If bystanders have to be present, the users have to ensure that those wear the same personal protective equipment (PPE) as themselves.
The room shall be sealed and re-entry prevented after disinfection took place. It shall be indicated that a ventilation process after disinfection is running (information of other workers).
Re-entry is only permitted once the air concentration of the active substances has dropped below the reference value (Adverse Effect Concentration (AEC) inhalation of 0,0106 mg/m3).
Unprotected persons should be kept away from treated areas until surfaces are dry.
Regarding the personal protective equipment listed in this section, this is without prejudice to the application by employers 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.
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
See general directions for use.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See 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
See general directions for use.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2
5.1. Instructions for use
Please see use-specific instructions for use.
5.2. Risk mitigation measures
See use-specific risk mitigation measures.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Particulars of likely direct or indirect effects
Harmful if inhaled.
May cause an allergic skin reaction.
Causes serious eye damage.
May cause allergy or asthma symptoms or breathing difficulties if inhaled.
Corrosive to the respiratory tract.
Precautions
Avoid breathing vapours.
Environmental precautions: Do not flush into surface water.
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.
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.
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 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.
5.4. Instructions for safe disposal of the product and its packaging
Waste water emission to reprocessing plant and final release of purified liquid to STP (sewage treatment plant). Emissions to surface water, soil and groundwater via STP.
Dispose of contents/ container to an approved waste disposal plant.
Dispose of waste and residues in accordance with local authority requirements.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Conditions for safe storage, including any incompatibilities
Requirements for storage areas and containers: Store at temperature not exceeding 40 °C in the original container.
Further information on storage conditions: Keep away from heat. Keep away from direct sunlight. Keep container tightly closed. Store in a well-ventilated place.
Advice on common storage: Do not store near food, drink and feed.
Shelf-life: 24 months.
Conditions to avoid: Protect from frost, heat and sunlight.
6. OTHER INFORMATION
The full titles of the EN standards referenced in Section 4.2 ‘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)
EN ISO 12941 – Respiratory protective devices – Powered filtering devices incorporating a loose fitting respiratory interface – Requirements, testing, marking
EN 12942 – Respiratory protective devices. Powered filtering devices incorporating full face masks, half masks or quarter masks. Requirements, testing, marking
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 2
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | parmetol SL 60 | parmetol SL 60 | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0034603-0004 1-2 | EU-0034603-0004 1-2 | EU-0034603-0004 1-2 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Glutaraldehyde | 1,5-pentanedial | Active substance | Active substance | 111-30-8 | 111-30-8 | 203-856-5 | 10 % (w/w) |
| 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 | 0 ,28 % (w/w) |
ELI: http://data.europa.eu/eli/reg_impl/2025/2048/oj
ISSN 1977-0677 (electronic edition)
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