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Commission Implementing Regulation (EU) 2025/1138 of 10 June 2025 granting a Union authorisation for the biocidal product family Tevan Panox Family in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Type Implementing Regulation
Publication 2025-06-30
State In force
Text As published
Department European Commission, SANTE
Source EUR-Lex
articles 2

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.

Reform history JSON API
  • — Use of respiratory protective equipment (RPE) consistent with EN 12941 or equivalent providing a protection factor of 4 is mandatory if the product is used in rooms < 100 m3 with a ventilation of < 3 air changes per hour. At least a powered air purifying respirator with helmet, hood, or mask (TH1 or TM1), or a half mask or full mask with gas filter is required.
  • — Re-entry is only permitted once the air concentration for hydrogen peroxide has dropped below 0,9 ppm (1,25 mg/m3) or relevant lower national reference value.
  • — No access of third parties during application or treatment.
  • — Do not use near domestic animals or livestock.
  • — Animals must be kept away from treated areas until surfaces are dry.

Application – spraying – Knapsack or backpack sprayer:

  • — Spraying is only allowed in the downward or horizontal direction.
  • — The flow rate of the backpack sprayer must not exceed 0,3 l/min.
  • — Use only in rooms with a volume ≥ 1 000 m3.
  • — Provide ventilation of 3 air changes per hour (industrial ventilation or keeping windows and doors open).
  • — No access of third parties during application or treatment.
  • — Do not use near domestic animals or livestock.
  • — Animals must be kept away from treated areas until surfaces are dry.

Application – mopping and wiping:

  • — Provide ventilation of 3 air changes per hour (industrial ventilation or keeping windows and doors open).
  • — Use of respiratory protective equipment (RPE) consistent with EN 12941 or equivalent providing a protection factor of 4 is mandatory if the product is used in rooms < 1 000 m3. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with gas filter is required.
  • — Re-entry is only permitted once the air concentration for hydrogen peroxide has dropped below 0,9 ppm (1,25 mg/m3) or relevant lower national reference value.
  • — No access of third parties during application or treatment.
  • — Do not use near domestic animals or livestock.
  • — Animals must be kept away from treated areas until surfaces are dry.

Application – pouring:

  • — Pouring application should take place under feed troughs.
  • — Ensure adequate ventilation (at least 3 air changes per hour) during application.
  • — Use only in rooms with a volume ≥ 1 000 m3.
  • — No access of third parties during application or treatment.
  • — Do not use near domestic animals or livestock.
  • — Animals must be kept away from treated areas until surfaces are dry.

When means of protection are indicated, these measures are 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 EN standards.

4.5.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

If medical advice is needed, have product container or label at hand.

4.5.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Keep only in original container. Empty container completely. Keep labels on container. Dispose the container in accordance with the regulations issued by the appropriate authorities.

4.5.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Keep out of reach of children and non-target animals or pets.

4.6.   Use description

Table 6
Disinfection of surfaces in the food industry – RTU
Product type PT04: Food and feed area
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: Viruses Development stage: no data
Field(s) of use Indoor use Disinfection of surfaces in the food industry
Application method(s) Method: Manual application by pouring or spraying (trigger spray or knapsack spraying) followed by mopping or wiping. Detailed description: —
Application rate(s) and frequency Application rate: Trigger spray: 0,030 - 0,060 litre/m2 (Professional and Non-professional) Watering can: 0,19 - 1,92 litre/m2 (only Professional) Knapsack or backpack spray: 0,181 litre/m2 (only Professional) No dilution, the product is ready to use (RTU). Number and timing of application: Apply in addition to daily cleaning, this is a ready to use product; 3 applications per day shall not be exceeded. Temperature: room temperature.
Category(ies) of users Professional; general public (non-professional)
Pack sizes and packaging material 0,75 and 1 L HDPE bottle with trigger spray (stainless steel and PE) with pressure release valve. (Professional and Non-professional) 0,75 and 1 L HDPE bottle with screw cap (outer cap HDPE, inner cap PPC, with LDPE or PE foam liner as pressure release valve). (Professional and Non-professional) 5, 10 and 20 L HDPE cans with screw cap (HDPE) with inlay (PE foam) and pressure release membrane (PTFE). (professional only) 220 L HDPE drums with HDPE screw cap (with pressure release membrane). (professional only) 1 000 L HDPE IBC with HDPE screw cap (with pressure release vent) and outlet opening with butterfly valve. (professional only)
4.6.1.   Use-specific instructions

Thoroughly clean the surfaces to be disinfected.

Remove a cleaning agent, if used, with clean water.

Remove excess of water.

Pour or spray the product on the floor or surface and spread it by means of a mop or a cloth.

Make sure that the surface remains wet for at least 5 minutes.

Where gas filters (RPE) are required, training must be ensured for the users.

Comply with the instructions for use

4.6.2.   Use-specific risk mitigation measures

Application – spraying – trigger spray – professional:

  • — Spraying is only allowed in the downward or horizontal direction.
  • — Use of respiratory protective equipment (RPE) consistent with EN 12941 or equivalent providing a protection factor of 4 is mandatory if the product is used in rooms < 100 m3 with a ventilation of < 3 air changes per hour. At least a powered air purifying respirator with helmet, hood, or mask (TH1 or TM1), or a half mask or full mask with gas filter is required.
  • — Re-entry is only permitted once the air concentration for hydrogen peroxide has dropped below 0,9 ppm (1,25 mg/m3) or relevant lower national reference value.
  • — No access of third parties during application or treatment.
  • — Do not use near domestic animals or livestock.

Application – spraying – Knapsack or backpack sprayer:

  • — Spraying is only allowed in the downward or horizontal direction.
  • — The flow rate of the backpack sprayer must not exceed 0,3 l/min.
  • — Use only in rooms with a volume ≥ 1 000 m3.
  • — No access of third parties during application or treatment.
  • — Provide ventilation of 3 air changes per hour (industrial ventilation or keeping windows and doors open).

Application – mopping and wiping:

  • — Ensure adequate ventilation (at least 3 air changes per hour) during application
  • — Use of respiratory protective equipment (RPE) consistent with EN 12941 or equivalent providing a protection factor of 4 is mandatory if the product is used in rooms < 1 000 m3. At least a powered air purifying respirator with helmet, hood or mask (TH1 or TM1), or a half mask or full mask with gas filter is required.
  • — Re-entry is only permitted once the air concentration for hydrogen peroxide has dropped below 0,9 ppm (1,25 mg/m3) or relevant lower national reference value.
  • — No access of third parties during application or treatment.
  • — Do not use near domestic animals or livestock.

Application – pouring:

  • — Ensure adequate ventilation (at least 3 air changes per hour) during application.
  • — Use only in rooms with a volume ≥ 1 000 m3.
  • — No access of third parties during application or treatment.

When means of protection are indicated, these measures are 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 EN standards.

4.6.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

If medical advice is needed, have product container or label at hand.

4.6.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Keep only in original container. Empty container completely. Keep labels on container. Dispose the container in accordance with the regulations issued by the appropriate authorities.

4.6.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Keep out of reach of children and non-target animals or pets.

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 7

5.1.   Instructions for use

See use specific instructions for use.

5.2.   Risk mitigation measures

See the risk mitigation measures for specific uses.

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

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.

IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor.

IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.

IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.

Avoid release of the product to the environment.

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

Keep only in original container. Empty container completely. Keep labels on container. Dispose the container in accordance with the regulations issued by the appropriate authorities.

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

Shelf life: 24 months

Store in the original container at room temperature. Store away from light. Protect from frost.

6. OTHER INFORMATION

Professionals (including industrial, professionals) mean trained professional if this is required by national legislation.

Polyphosphoric acid (CAS: 8017-16-1) is not a substance of concern (SoC) for this Meta-SPC. It is shown due to technical limitations of the SPC editor.

The full titles of the EN standards referenced in the Risk mitigation measures are:

EN 12941 – Respiratory protective devices – Powered filtering devices incorporating a loose fitting respiratory interface

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).

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7

7.1.   Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) Trade name(s) Trade name(s) Tevan Panox 100 Tevan Panox 100 Market area: EU Market area: EU Market area: EU
Trade name(s) Trade name(s) Trade name(s) Dr. Ox (B) Dr. Ox (B) Market area: EU Market area: EU Market area: EU
Authorisation number Authorisation number Authorisation number EU-0032875-0007 1-7 EU-0032875-0007 1-7 EU-0032875-0007 1-7
Common name IUPAC name Function Function CAS number CAS number EC number Content (%)
Peracetic acid active substance active substance 79-21-0 79-21-0 201-186-8 0,0358 % (w/w)
Hydrogen peroxide dihydrogen dioxide non-active substance non-active substance 7722-84-1 7722-84-1 231-765-0 0,9948 % (w/w)
Acetic acid ethanoic acid non-active substance non-active substance 64-19-7 64-19-7 200-580-7 0,01534 %(w/w)

ELI: http://data.europa.eu/eli/reg_impl/2025/1138/oj

ISSN 1977-0677 (electronic edition)

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