Commission Implementing Regulation (EU) 2022/1232 of 13 July 2022 granting a Union authorisation for the biocidal product family ‘INTEROX Biocidal Product Family 1’ (Text with EEA relevance)

• 1. In case of maintenance of the aseptic packaging plant (e.g. manual cleaning, technical incidents or repair) appropriate PPE (respiratory protective equipment, chemical protective gloves, chemical protective coverall (at least type 6), eye protection) is required. The type of RPE and the filter type (code letter, colour) are to be specified by the authorisation holder within the product information. Glove material to be specified by the authorisation holder within the product information

Aerosolised or vaporised application should be use only in closed aseptic packaging machines with no emission to water and negligible emission to air. Hydrogen peroxide emission to air should be controlled by the machine e.g. with catalytic treatment or through a gas scrubber.

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 8. Use # 2 – Disinfection of closed areas in aseptic packaging machines by aerosolised and vaporised hydrogen peroxide (VHP)

Product type	PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use	Not relevant
Target organism(s) (including development stage)	Common name: Bacterial Spores Development stage:
Field(s) of use	Indoor Industrial use - food and feed area. Disinfection of non-porous surfaces.
Application method(s)	Method: - Detailed description: Automated vaporisation or aerosolization in closed areas in aseptic filling machines.
Application rate(s) and frequency	Application Rate: Undiluted product (35 % w/w hydrogen peroxide) is used. 100 – 800 mL product consumed per machine in one disinfection cycle. Dilution (%): Number and timing of application: Frequency – as required by user, typically once every 24 hours.
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE packaging: 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L (IBC). Approved grades of HDPE.

4.2.1.   Use-specific instructions for use

Use an automated loading system.

Automated disinfection of closed areas in aseptic filling machines.

Flash evaporation 130-250 °C or aerosolization (room temperature) of undiluted product using automated equipment integrated to the packaging machine. From 100 to 800 mL product required for one disinfection cycle. Minimum contact time 7 minutes starting from beginning of application.

Disinfection performance of each packaging machine should be validated using biological and chemical indicators.

Follow machine operating instructions for disinfection period, volume of disinfectant extraction of hydrogen peroxide and re-entry. Prevent entry during disinfection process.

4.2.2.   Use-specific risk mitigation measures

During operation, ensure adequate ventilation along the machines (LEV) and in the industrial halls (technical ventilation).

During manual maintenance tasks, ensure adequate ventilation inside the machine (LEV) before opening the doors of the aseptic area.

	1.	The product shall only be transferred in closed pipes after mixing and loading. Open product and waste water flows are not allowed.
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	2.	Workplace release measurements with suitable measurement equipment shall be performed upon implementation of the aseptic packaging plant, at regular intervals (annual intervals recommended) and after any change in relevant boundary conditions. The national regulations for workplace measurements have to be followed.
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	3.	In case of maintenance of the aseptic packaging plant (e.g. manual cleaning, technical incidents or repair) appropriate PPE (respiratory protective equipment, chemical protective gloves, chemical protective coverall (at least type 6), eye protection) is required. The type of RPE and the filter type (code letter, colour) are to be specified by the authorisation holder within the product information. Glove material to be specified by the authorisation holder within the product information.

Use only in closed aseptic packaging machines with no emission to water and negligible emission to air. Hydrogen peroxide emission to air should be controlled by the machine e.g. with catalytic treatment or through a gas scrubber.

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 ⁷

OF THE META SPC 5

5.1.   Instructions for use

-

5.2.   Risk mitigation measures

The use of eye protection during handling of the product is mandatory.

Wear face shield where splashing is possible.

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 adverse effects:

• — In case of inhalation: Breathing difficulties, cough, pulmonary oedema, nausea, vomiting.

• — In case of skin contact: Redness, swelling of tissue, skin irritation.

• — In case of eye contact: Redness, lachrymation, swelling of tissue, severe burns.

• — In case of ingestion: Nausea, abdominal pain, bloody vomiting, diarrhoea, suffocation, cough, severe shortness of breath, severe burns of the mouth and throat, as well as a danger of perforation of the oesophagus and the stomach. Risk of respiratory disorder.

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 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.

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.

Emergency measures to protect environment in case of accident:

• — Environmental precautions:

Should not be released into the environment. If the product contaminates rivers and lakes or drains inform respective authorities.

• — Methods and materials for containment and cleaning up:

Dilute with plenty of water. Dam up. Do not mix waste streams during collection. Soak up with inert absorbent material. Keep in properly labelled containers. Keep in suitable, closed containers for disposal. Never return spills in original containers for re-use.

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

Do not allow undiluted product to enter the sewer. Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains. Only pass on empty containers/packaging for recycling. Disposal of packaging should at all times comply with the waste disposal legislation and any regional local authority requirements.

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

Storage: Hydrogen peroxide should be stored in properly designed bulk storage tanks or in original vented container in upright position away from incompatible products. Use only approved materials of construction for equipment or approved packs. Store in a cool, ventilated area and protect from damage and direct sunlight. Do not store at temperatures above 40°C. Keep away from combustible materials and sources of ignition and heat.

Shelf-life: 12 months in HDPE packs at ambient temperature.

6. OTHER INFORMATION

Please be aware of the European reference value of 1.25 mg/m³ for the active substance hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for this product.

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)	INTEROX AG Spray 35	INTEROX AG Spray 35	Market area: EU	Market area: EU	Market area: EU	Market area: EU
Authorisation number	EU-0027468-0007 1-5	EU-0027468-0007 1-5	EU-0027468-0007 1-5	EU-0027468-0007 1-5	EU-0027468-0007 1-5	EU-0027468-0007 1-5
Common name	IUPAC name	Function	Function	CAS number	EC number	Content (%)
Hydrogen peroxide		Active Substance	Active Substance	7722-84-1	231-765-0	35,7

7.2.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)	INTEROX AG Spray 35S	INTEROX AG Spray 35S	Market area: EU	Market area: EU	Market area: EU	Market area: EU
Authorisation number	EU-0027468-0008 1-5	EU-0027468-0008 1-5	EU-0027468-0008 1-5	EU-0027468-0008 1-5	EU-0027468-0008 1-5	EU-0027468-0008 1-5
Common name	IUPAC name	Function	Function	CAS number	EC number	Content (%)
Hydrogen peroxide		Active Substance	Active Substance	7722-84-1	231-765-0	35,7

7.3.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)	INTEROX AG Bath 35S	INTEROX AG Bath 35S	Market area: EU	Market area: EU	Market area: EU	Market area: EU
Authorisation number	EU-0027468-0009 1-5	EU-0027468-0009 1-5	EU-0027468-0009 1-5	EU-0027468-0009 1-5	EU-0027468-0009 1-5	EU-0027468-0009 1-5
Common name	IUPAC name	Function	Function	CAS number	EC number	Content (%)
Hydrogen peroxide		Active Substance	Active Substance	7722-84-1	231-765-0	35,7

7.4.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)	INTEROX AG Bath 35	INTEROX AG Bath 35	Market area: EU	Market area: EU	Market area: EU	Market area: EU
Authorisation number	EU-0027468-0010 1-5	EU-0027468-0010 1-5	EU-0027468-0010 1-5	EU-0027468-0010 1-5	EU-0027468-0010 1-5	EU-0027468-0010 1-5
Common name	IUPAC name	Function	Function	CAS number	EC number	Content (%)
Hydrogen peroxide		Active Substance	Active Substance	7722-84-1	231-765-0	35,7

7.5.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)	INTEROX AG Dual 35	INTEROX AG Dual 35	Market area: EU	Market area: EU	Market area: EU	Market area: EU
Authorisation number	EU-0027468-0011 1-5	EU-0027468-0011 1-5	EU-0027468-0011 1-5	EU-0027468-0011 1-5	EU-0027468-0011 1-5	EU-0027468-0011 1-5
Common name	IUPAC name	Function	Function	CAS number	EC number	Content (%)
Hydrogen peroxide		Active Substance	Active Substance	7722-84-1	231-765-0	35,7

META SPC 6

1. META SPC 6 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 6 identifier

Identifier	Meta SPC 6

1.2.   Suffix to the authorisation number

Number	1-6

1.3.   Product type(s)

Product type(s)	PT04 - Food and feed area (Disinfectants)

2. META SPC 6 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 6

Common name	IUPAC name	Function	CAS number	EC number	Content (%)	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Hydrogen peroxide		Active Substance	7722-84-1	231-765-0	35,0	35,7

2.2.   Type(s) of formulation of the meta SPC 6

Formulation(s)	SL - Soluble concentrate

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6

Hazard statements	May intensify fire; oxidiser Harmful if swallowed. Causes skin irritation. Causes serious eye damage. May cause respiratory irritation. Harmful to aquatic life with long lasting effects.
Precautionary statements	Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking. Keep away from clothing and other combustible materials. Avoid breathing vapours. Wash hands thoroughly after handling. Do no eat, drink or smoke when using this product. Use only outdoors or in a well-ventilated area. Avoid release to the environment. Wear protective gloves. Wear protective clothing. Wear eye protection. Wear face protection. IF SWALLOWED:Call a POISON CENTER/doctor if you feel unwell. IF ON SKIN:Wash with plenty of water. IF INHALED:Remove person to fresh air and keep comfortable for breathing. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor. Rinse mouth. If skin irritation occurs:Get medical advice. If skin irritation occurs:Get medical attention. Take off contaminated clothing.And wash it before reuse. In case of fire:Use water to extinguish. Store in a well-ventilated place.Keep container tightly closed. Store locked up. Dispose of contents to ….in accordance with all local, regional, national and international regulations.. Dispose of container to in accordance with local/regional/national/international regulation.

4. AUTHORISED USE(S) OF THE META SPC 6

4.1.   Use description

Table 9. Use # 1 – Disinfection of distribution and storage systems for drinking water

Product type	PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use	Not relevant
Target organism(s) (including development stage)	Common name: Bacteria Development stage: Common name: Fungi/yeasts Development stage: Common name: Viruses Development stage: Common name: Bacterial Spores Development stage:
Field(s) of use	Indoor Industrial use - drinking water systems for human and animals drinking water. Disinfection of non-porous surfaces.
Application method(s)	Method: - Detailed description: Flooding of pipes Automated spraying (CIP)
Application rate(s) and frequency	Application Rate: Use concentration 13% w/w hydrogen peroxide. Dilution (%): Number and timing of application: Apply at room temperature. Frequency: once per week. Use following installation, maintenance or cleaning.
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE packaging: 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L (IBC). Approved grades of HDPE.

4.1.1.   Use-specific instructions for use

Use an automated loading system.

Dilute the product to reach the needed hydrogen peroxide concentration stated below.

Effective hydrogen peroxide (w/w) concentration and contact time:

Bactericidal – 13%, 10 min

Yeasticidal and fungicidal – 13%, 15 min

Sporicidal – 13 %, 60 min

Virucidal – 13%, 30 min

All claimed microbes - 13%, 60 min

Each product label should give information on how the dilution should be made, e.g. to reach 13% (w/w) hydrogen peroxide concentration:

A product with 35 % hydrogen peroxide concentration: The product should be diluted to 39% w/v (390 g or 340 mL of product, add water up to 1L).

Apply diluted product at room temperature on pre-cleaned surfaces. Add as aqueous solution to pipes as needed for flooding. Spray application to tanks until run-off. Surface need to be wet with disinfectant for the allocated contact time.

4.1.2.   Use-specific risk mitigation measures

CIP and automated spraying:

The processes must be fully automated and enclosed with no exposure in the case of tanks or piping systems.

The use is limited to distribution and storage systems with volume ≤ 15 000 L. Rinse well with potable water.

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 10. Use # 2 – Surface disinfection in food and feed processing by liquid application

Product type	PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use	Disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food or feed for humans and animals.
Target organism(s) (including development stage)	Common name: Bacteria Development stage: Common name: Fungi/yeasts Development stage: Common name: Viruses Development stage: Common name: Bacterial Spores Development stage:
Field(s) of use	Indoor Industrial use - food & feed area. Disinfection of non-porous surfaces.
Application method(s)	Method: - Detailed description: Automated spraying on surfaces Cleaning-in-Place (CIP) Immersion of equipment and utensils
Application rate(s) and frequency	Application Rate: Use concentration 13% w/w hydrogen peroxide. Dilution (%): Number and timing of application: — CIP (cleaning-in-place): volume of diluted product needed to fill the system to be disinfected — Automated spraying: 50 – 100 mL diluted product/m2 — Immersion: make solution and dip items As required by user - up to 1 or 2 times per day, often once per week. Apply at room temperature.
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE packaging: 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L (IBC). Approved grades of HDPE.

4.2.1.   Use-specific instructions for use

Disinfection of pre-cleaned, non-porous surfaces such as tables, floors, walls, machinery, equipment and utensils in food & feed areas in production, transport, storage or preparation and handling. CIP (cleaning in place) disinfection (terminal disinfection after cleaning) – pipes, tanks, mixer, other machine which comes into contact with food. Soaking of pre-cleaned items – dishes, cutlery, equipment, small machinery, machine items, crates, boxes.

Use an automated loading system for CIP and automated spraying.

Dilute the product to reach the needed hydrogen peroxide concentration stated below.

Effective hydrogen peroxide (w/w) concentration and contact time:

Bactericidal, yeasticidal, fungicidal – 13%, 15 min

Sporicidal – 13 %, 60 min

Virucidal – 13%, 30 min

All claimed microbes - 13%, 60 min

Each product label should give information on how the dilution should be made, e.g. to reach 13% (w/w) hydrogen peroxide concentration:

A product with 35% hydrogen peroxide concentration: The product should be diluted to 39% w/v (390 g or 340 mL of product, add water up to 1L).

Apply at room temperature.

Precleaning of surfaces required before using disinfectants.

Dosing

—   Automated spraying 50 – 100 mL/m2

Surface need to be wet with disinfectant for the allocated contact time. Rinse well with potable water and allow to drain or dry with hot air.

4.2.2.   Use-specific risk mitigation measures

CIP:

The processes must be fully automated and enclosed with no exposure in the case of tanks or piping systems.

Automated spraying:

In the case of automated spraying of surfaces such as conveyors or other fixed installations workers must leave the room before processing.

Disinfection can only be processed after the end of a shift with all workers having left the room. The process must be started from outside the room. Warning notices indicating that entry is denied and temporary barriers must be placed on all entries.

Air concentrations must be monitored to ensure that no leakage occurs during operations. For re-entry, the undercut of AECinhalation of 1.25 mg/m3 shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period).

Immersion:

The use of eye protection during handling of the product is mandatory.

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).

A protective coverall (at least type 6, EN 13034) shall be worn in loading.

For stationary processes, a local exhaust ventilation (LEV) with a capture efficiency of at least 85% shall be specified.

If no LEV, use respiratory protective equipment (RPE) providing a protection factor of 20 in loading and 5 for immersion.

After use, immersion baths must be emptied or covered to prevent further evaporation.

The waste water from breweries should not be discharged direct to surface water after simple on-site treatment. The waste water from breweries should be discharged to the sewer connected to the sewage treatment plant (STP).

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 ⁸

OF THE META SPC 6

5.1.   Instructions for use

-

5.2.   Risk mitigation measures

The use of eye protection during handling of the product is mandatory.

Wear face shield where splashing is possible.

Ensure adequate ventilation during the application.

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 adverse effects:

• — In case of inhalation: Breathing difficulties, cough, pulmonary oedema, nausea, vomiting.

• — In case of skin contact: Redness, swelling of tissue, skin irritation.

• — In case of eye contact: Redness, lachrymation, swelling of tissue, severe burns.

• — In case of ingestion: Nausea, abdominal pain, bloody vomiting, diarrhoea, suffocation, cough, severe shortness of breath, severe burns of the mouth and throat, as well as a danger of perforation of the oesophagus and the stomach. Risk of respiratory disorder.

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 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.

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.

Emergency measures to protect environment in case of accident:

• — Environmental precautions:

Should not be released into the environment. If the product contaminates rivers and lakes or drains inform respective authorities.

• — Methods and materials for containment and cleaning up:

Dilute with plenty of water. Dam up. Do not mix waste streams during collection. Soak up with inert absorbent material. Keep in properly labelled containers. Keep in suitable, closed containers for disposal. Never return spills in original containers for re-use.

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

Do not allow undiluted product to enter the sewer. Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains. Only pass on empty containers/packaging for recycling. Disposal of packaging should at all times comply with the waste disposal legislation and any regional local authority requirements.

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

Storage: Hydrogen peroxide should be stored in properly designed bulk storage tanks or in original vented container in upright position away from incompatible products. Use only approved materials of construction for equipment or approved packs. Store in a cool, ventilated area and protect from damage and direct sunlight. Do not store at temperatures above 40°C. Keep away from combustible materials and sources of ignition and heat.

Shelf-life: 12 months in HDPE packs at ambient temperature.

6. OTHER INFORMATION

Please be aware of the European reference value of 1.25 mg/m³ for the active substance hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for this product.

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)	INTEROX FCC 35	INTEROX FCC 35	Market area: EU	Market area: EU	Market area: EU	Market area: EU
Authorisation number	EU-0027468-0012 1-6	EU-0027468-0012 1-6	EU-0027468-0012 1-6	EU-0027468-0012 1-6	EU-0027468-0012 1-6	EU-0027468-0012 1-6
Common name	IUPAC name	Function	Function	CAS number	EC number	Content (%)
Hydrogen peroxide		Active Substance	Active Substance	7722-84-1	231-765-0	35,7

META SPC 7

1. META SPC 7 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 7 identifier

Identifier	Meta SPC 7

1.2.   Suffix to the authorisation number

Number	1-7

1.3.   Product type(s)

Product type(s)	PT04 - Food and feed area (Disinfectants)

2. META SPC 7 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 7

Common name	IUPAC name	Function	CAS number	EC number	Content (%)	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Hydrogen peroxide		Active Substance	7722-84-1	231-765-0	49,0	49,9

2.2.   Type(s) of formulation of the meta SPC 7

Formulation(s)	SL - Soluble concentrate

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7

Hazard statements	May intensify fire; oxidiser Harmful if swallowed. Causes severe skin burns and eye damage. May cause respiratory irritation. Harmful to aquatic life with long lasting effects.
Precautionary statements	Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking. Keep away from clothing and other combustible materials. Do not breathe vapours. Wash hands thoroughly after handling. Do no eat, drink or smoke when using this product. Use only outdoors or in a well-ventilated area. Avoid release to the environment. Wear protective gloves. Wear protective clothing. Wear eye protection. Wear face protection. IF SWALLOWED:Call a POISON CENTER/doctor if you feel unwell. IF SWALLOWED:Rinse mouth.Do NOT induce vomiting. IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water. IF INHALED:Remove person to fresh air and keep comfortable for breathing. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor. Wash contaminated clothing before reuse. In case of fire:Use water to extinguish. Store in a well-ventilated place.Keep container tightly closed. Store locked up. Dispose of contents to ….in accordance with all local, regional, national and international regulations.. Dispose of container to in accordance with local/regional/national/international regulation.

4. AUTHORISED USE(S) OF THE META SPC 7

4.1.   Use description

Table 11. Use # 1 – Disinfection of distribution and storage systems for drinking water

Product type	PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use	Not relevant
Target organism(s) (including development stage)	Common name: Bacteria Development stage: Common name: Fungi/yeasts Development stage: Common name: Viruses Development stage: Common name: Bacterial Spores Development stage:
Field(s) of use	Indoor Industrial use - drinking water systems for human and animals drinking water. Disinfection of non-porous surfaces.
Application method(s)	Method: - Detailed description: Flooding of pipes Automated spraying (CIP)
Application rate(s) and frequency	Application Rate: Use concentration 13% w/w hydrogen peroxide. Dilution (%): Number and timing of application: Apply at room temperature. Frequency: once per week. Use following installation, maintenance or cleaning.
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE packaging: 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L (IBC). Approved grades of HDPE.

4.1.1.   Use-specific instructions for use

Use an automated loading system.

Dilute the product to reach the needed hydrogen peroxide concentration stated below.

Effective hydrogen peroxide (w/w) concentration and contact time:

Bactericidal – 13%, 10 min

Yeasticidal and fungicidal – 13%, 15 min

Sporicidal – 13 %, 60 min

Virucidal – 13%, 30 min

All claimed microbes - 13%, 60 min

Each product label should give information on how the dilution should be made, e.g. to reach 13% (w/w) hydrogen peroxide concentration:

A product with 50% hydrogen peroxide concentration: The product should be diluted to 28% w/v (280 g or 230 mL of product, add water up to 1L).

Apply diluted product at room temperature on pre-cleaned surfaces. Add as aqueous solution to pipes as needed for flooding. Spray application to tanks until run-off. Surface need to be wet with disinfectant for the allocated contact time.

4.1.2.   Use-specific risk mitigation measures

CIP and automated spraying:

The processes must be fully automated and enclosed with no exposure in the case of tanks or piping systems.

The use is limited to distribution and storage systems with volume ≤ 15 000 L. Rinse well with potable water.

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 12. Use # 2 – Surface disinfection in food and feed processing by liquid application

Product type	PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use	Disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food or feed for humans and animals.
Target organism(s) (including development stage)	Common name: Bacteria Development stage: Common name: Fungi/yeasts Development stage: Common name: Viruses Development stage: Common name: Bacterial Spores Development stage:
Field(s) of use	Indoor Industrial use - food & feed area. Disinfection of non-porous surfaces.
Application method(s)	Method: - Detailed description: Automated spraying on surfaces Cleaning-in-Place (CIP) Immersion of equipment and utensils
Application rate(s) and frequency	Application Rate: Use concentration 13% w/w hydrogen peroxide. Dilution (%): Number and timing of application: — CIP (cleaning-in-place): volume of diluted product needed to fill the system to be disinfected — Automated spraying: 50 – 100 mL diluted product/m2 — Immersion: make solution and dip items As required by user - up to 1 or 2 times per day, often once per week. Apply at room temperature.
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE packaging: 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L (IBC). Approved grades of HDPE.

4.2.1.   Use-specific instructions for use

Disinfection of pre-cleaned, non-porous surfaces such as tables, floors, walls, machinery, equipment and utensils in food & feed areas in production, transport, storage or preparation and handling. CIP (cleaning in place) disinfection (terminal disinfection after cleaning) – pipes, tanks, mixer, other machine which comes into contact with food. Soaking of pre-cleaned items – dishes, cutlery, equipment, small machinery, machine items, crates, boxes.

Use an automated loading system for CIP and automated spraying.

Dilute the product to reach the needed hydrogen peroxide concentration stated below.

Effective hydrogen peroxide (w/w) concentration and contact time:

Bactericidal, yeasticidal, fungicidal – 13%, 15 min

Sporicidal – 13%, 60 min

Virucidal – 13%, 30 min

All claimed microbes - 13%, 60 min

Each product label should give information on how the dilution should be made, e.g. to reach 13% (w/w) hydrogen peroxide concentration:

A product with 50% hydrogen peroxide concentration: The product should be diluted to 28% w/v (280 g or 230 mL of product, add water up to 1L).

Apply at room temperature.

Precleaning of surfaces required before using disinfectants.

Dosing

—   Automated spraying 50 – 100 mL/m2

Surface need to be wet with disinfectant for the allocated contact time.

Rinse well with potable water and allow to drain or dry with hot air.

4.2.2.   Use-specific risk mitigation measures

CIP:

The processes must be fully automated and enclosed with no exposure in the case of tanks or piping systems.

Automated spraying:

In the case of automated spraying of surfaces such as conveyors or other fixed installations workers must leave the room before processing.

Disinfection can only be processed after the end of a shift with all workers having left the room. The process must be started from outside the room. Warning notices indicating that entry is denied and temporary barriers must be placed on all entries.

Air concentrations must be monitored to ensure that no leakage occurs during operations and levels are safe before entering the area. For re-entry, the undercut of AECinhalation of 1.25 mg/m3 shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period).

Immersion:

The use of eye protection during handling of the product is mandatory.

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).

A protective coverall (at least type 6, EN 13034) shall be worn in loading.

For stationary processes, a local exhaust ventilation (LEV) with a capture efficiency of at least 85% shall be specified.

If no LEV, use respiratory protective equipment (RPE) providing a protection factor of 20 in loading and 5 for immersion.

After use, immersion baths must be emptied or covered to prevent further evaporation.

The waste water from breweries should not be discharged direct to surface water after simple on-site treatment. The waste water from breweries should be discharged to the sewer connected to the sewage treatment plant (STP).

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 ⁹

OF THE META SPC 7

5.1.   Instructions for use

-

5.2.   Risk mitigation measures

The use of eye protection during handling of the product is mandatory.

Wear face shield where splashing is possible.

Ensure adequate ventilation during the application.

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 adverse effects:

• — In case of inhalation: Breathing difficulties, cough, pulmonary oedema, nausea, vomiting.

• — In case of skin contact: Redness, swelling of tissue, skin irritation.

• — In case of eye contact: Redness, lachrymation, swelling of tissue, severe burns.

• — In case of ingestion: Nausea, abdominal pain, bloody vomiting, diarrhoea, suffocation, cough, severe shortness of breath, severe burns of the mouth and throat, as well as a danger of perforation of the oesophagus and the stomach. Risk of respiratory disorder.

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 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.

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.

Emergency measures to protect environment in case of accident:

• — Environmental precautions:

Should not be released into the environment. If the product contaminates rivers and lakes or drains inform respective authorities.

• — Methods and materials for containment and cleaning up:

Dilute with plenty of water. Dam up. Do not mix waste streams during collection. Soak up with inert absorbent material. Keep in properly labelled containers. Keep in suitable, closed containers for disposal. Never return spills in original containers for re-use.

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

Do not allow undiluted product to enter the sewer. Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains. Only pass on empty containers/packaging for recycling. Disposal of packaging should at all times comply with the waste disposal legislation and any regional local authority requirements.

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

Storage: Hydrogen peroxide should be stored in properly designed bulk storage tanks or in original vented container in upright position away from incompatible products. Use only approved materials of construction for equipment or approved packs. Store in a cool, ventilated area and protect from damage and direct sunlight. Do not store at temperatures above 40°C. Keep away from combustible materials and sources of ignition and heat.

Shelf-life: 12 months in HDPE packs at ambient temperature.

6. OTHER INFORMATION

Please be aware of the European reference value of 1.25 mg/m³ for the active substance hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for this product.

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)	INTEROX FCC 50	INTEROX FCC 50	Market area: EU	Market area: EU	Market area: EU	Market area: EU
Authorisation number	EU-0027468-0013 1-7	EU-0027468-0013 1-7	EU-0027468-0013 1-7	EU-0027468-0013 1-7	EU-0027468-0013 1-7	EU-0027468-0013 1-7
Common name	IUPAC name	Function	Function	CAS number	EC number	Content (%)
Hydrogen peroxide		Active Substance	Active Substance	7722-84-1	231-765-0	49,9

META SPC 8

1. META SPC 8 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 8 identifier

Identifier	Meta SPC 8

1.2.   Suffix to the authorisation number

Number	1-8

1.3.   Product type(s)

Product type(s)	PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT03 - Veterinary hygiene (Disinfectants)

2. META SPC 8 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 8

Common name	IUPAC name	Function	CAS number	EC number	Content (%)	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Hydrogen peroxide		Active Substance	7722-84-1	231-765-0	35,0	35,7

2.2.   Type(s) of formulation of the meta SPC 8

Formulation(s)	SL - Soluble concentrate

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8

Hazard statements	May intensify fire; oxidiser Harmful if swallowed. Causes skin irritation. Causes serious eye damage. May cause respiratory irritation. Harmful to aquatic life with long lasting effects.
Precautionary statements	Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking. Keep away from clothing and other combustible materials. Avoid breathing vapours. Avoid breathing spray. Wash hands thoroughly after handling. Do no eat, drink or smoke when using this product. Use only outdoors or in a well-ventilated area. Avoid release to the environment. Wear protective gloves. Wear protective clothing. Wear eye protection. Wear face protection. IF SWALLOWED:Call a POISON CENTER/doctor if you feel unwell. IF ON SKIN:Wash with plenty of water. IF INHALED:Remove person to fresh air and keep comfortable for breathing. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor. Rinse mouth. If skin irritation occurs:Get medical advice. If skin irritation occurs:Get medical attention. Take off contaminated clothing.And wash it before reuse. In case of fire:Use water to extinguish. Store in a well-ventilated place.Keep container tightly closed. Store locked up. Dispose of contents to ….in accordance with all local, regional, national and international regulations.. Dispose of container to in accordance with local/regional/national/international regulation.

4. AUTHORISED USE(S) OF THE META SPC 8

4.1.   Use description

Table 13. Use # 1 – Surface disinfection by liquid application in industrial and institutional areas

Product type	PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use	Not relevant
Target organism(s) (including development stage)	Common name: Bacteria Development stage: Common name: Fungi/yeasts Development stage: Common name: Viruses Development stage: Common name: Bacterial spores Development stage:
Field(s) of use	Indoor Industrial or institutional use. Disinfection of non-porous surfaces.
Application method(s)	Method: - Detailed description: Automated spraying on surfaces Cleaning-in-Place (CIP) Immersion of equipment and utensils
Application rate(s) and frequency	Application Rate: Use concentration 13% w/w hydrogen peroxide. Dilution (%): Number and timing of application: — CIP (cleaning-in-place): volume of diluted product needed to fill the disinfected system — Automated spraying: 50 -100 mL diluted product/m2 — Immersion: make solution and dip items Frequency - as required by the user. Apply at room temperature.
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE packaging: 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L (IBC). Approved grades of HDPE.

4.1.1.   Use-specific instructions for use

Use an automated loading system for CIP and automated spraying.

Dilute the product to reach the needed hydrogen peroxide concentration stated below.

Effective hydrogen peroxide concentration (w/w) and contact time:

Bactericidal - 13 %, 10 min

Sporicidal – 13%, 60 min

Yeasticidal and fungicidal – 13%, 15 min

Virucidal – 13%, 30 min

All claimed microbes - 13%, 60 min

Each product label should give information on how the dilution should be made, e.g. to reach 13% (w/w) hydrogen peroxide concentration:

A product with 35% hydrogen peroxide concentration: The product should be diluted to 39% w/v (390 g or 340 mL of product, add water up to 1L).

Precleaning of surfaces required before using disinfectants.

Automated spraying of diluted product 50 -100 mL /m2 on non-porous surfaces. Surface needs to stay wet for the allocated contact time.

Immerse instruments in diluted product for the allocated contact time. Allow to drain and dry.

4.1.2.   Use-specific risk mitigation measures

CIP:

The processes must be fully automated and enclosed with no exposure in the case of tanks or piping systems.

Automated spraying:

In the case of automated spraying of surfaces such as conveyors or other fixed installations workers must leave the room before processing.

Disinfection can only be processed after the end of a shift with all workers having left the room. The process must be started from outside the room. Warning notices indicating that entry is denied and temporary barriers must be placed on all entries.

Air concentrations must be monitored to ensure that no leakage occurs during operations. For re-entry, the undercut of AECinhalation of 1.25 mg/m3 shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period).

Immersion:

The use of eye protection during handling of the product is mandatory.

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).

A protective coverall (at least type 6, EN 13034) shall be worn in loading.

For stationary processes, a local exhaust ventilation (LEV) with a capture efficiency of at least 85% shall be specified.

If no LEV, use respiratory protective equipment (RPE) providing a protection factor of 20 in loading and 5 for immersion.

After use, immersion baths must be emptied or covered to prevent further evaporation.

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 14. Use # 2 – Disinfection of surfaces associated with animal housing by spraying

Product type	PT03 - Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	Not relevant
Target organism(s) (including development stage)	Common name: Bacteria Development stage: Common name: Fungi/yeasts Development stage: Common name: Viruses Development stage:
Field(s) of use	Indoor Disinfection of non-porous materials and surfaces associated with the housing of animals.
Application method(s)	Method: - Detailed description: Spraying with automated or manual equipment
Application rate(s) and frequency	Application Rate: Use concentration 9.5-13 % w/w hydrogen peroxide. Dilution (%): Number and timing of application: Spraying: 50 -100 mL diluted product/m2. Frequency depends on life-cycle of animals - as required by user.
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE packaging: 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L (IBC). Approved grades of HDPE.

4.2.1.   Use-specific instructions for use

Dilute the product to reach the needed hydrogen peroxide concentration stated below.

Effective hydrogen peroxide concentration (w/w) and contact time:

Bactericidal and yeasticidal - 9.5%, 30 min

Fungicidal – 13%, 60 min

Virucidal – 13%, 30 min

All claimed microbes - 13%, 60 min

Each product label should give information on how the dilution should be made, e.g. to reach 13% (w/w) hydrogen peroxide concentration:

A product with 35% hydrogen peroxide concentration: The product should be diluted to 39% w/v (390 g or 340 mL of product, add water up to 1L).

Remove animals from spaces to be disinfected. Precleaning of surfaces required before using disinfectants.

Spray diluted product 50 -100 mL /m2 on non-porous surfaces. Surface needs to stay wet for the allocated contact time. Allow to drain and dry.

4.2.2.   Use-specific risk mitigation measures

Automated spraying systems:

During the operation worker must leave the area and access must be denied by appropriate barriers or locked doors. After operation efficient ventilation (10 ACH) must be used to reach a safe level. During this period access must also be denied. Air concentrations must be monitored to ensure that no leakage occurs during operations. For re-entry, the undercut of AECinhalation of 1.25 mg/m3 shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period).

For manual spraying:

The use of eye protection during handling of the product is mandatory.

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).

A protective coverall (at least type 6, EN 13034) shall be worn.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a half/full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information).

Only operators wearing the specified RPE should be present while spraying or fumigating.

The operator must walk backward towards the exit while spraying the surfaces so always walking away from sprayed areas.

Efficient ventilation (10 ACH) must be used during spraying and access must be denied by appropriate barriers and notices. Also after operation efficient ventilation (10 ACH) must be used to reach a safe level. During this period access must also be denied. Air concentrations must be monitored to ensure that no leakage occurs during operations. For re-entry, the undercut of AECinhalation of 1.25 mg/m3 shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period).

No secondary exposure is expected because of rapid decomposition of hydrogen peroxide.

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 ¹⁰

OF THE META SPC 8

5.1.   Instructions for use

-

5.2.   Risk mitigation measures

The use of eye protection during handling of the product is mandatory.

Wear face shield where splashing is possible.

Ensure adequate ventilation during the application.

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 adverse effects:

• — In case of inhalation: Breathing difficulties, cough, pulmonary oedema, nausea, vomiting.

• — In case of skin contact: Redness, swelling of tissue, skin irritation.

• — In case of eye contact: Redness, lachrymation, swelling of tissue, severe burns.

• — In case of ingestion: Nausea, abdominal pain, bloody vomiting, diarrhoea, suffocation, cough, severe shortness of breath, severe burns of the mouth and throat, as well as a danger of perforation of the oesophagus and the stomach. Risk of respiratory disorder.

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 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.

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.

Emergency measures to protect environment in case of accident:

• — Environmental precautions:

Should not be released into the environment. If the product contaminates rivers and lakes or drains inform respective authorities.

• — Methods and materials for containment and cleaning up:

Dilute with plenty of water. Dam up. Do not mix waste streams during collection. Soak up with inert absorbent material. Keep in properly labelled containers. Keep in suitable, closed containers for disposal. Never return spills in original containers for re-use.

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

Do not allow undiluted product to enter the sewer. Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains. Only pass on empty containers/packaging for recycling. Disposal of packaging should at all times comply with the waste disposal legislation and any regional local authority requirements.

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

Storage: Hydrogen peroxide should be stored in properly designed bulk storage tanks or in original vented container in upright position away from incompatible products. Use only approved materials of construction for equipment or approved packs. Store in a cool, ventilated area and protect from damage and direct sunlight. Do not store at temperatures above 40°C. Keep away from combustible materials and sources of ignition and heat.

Shelf-life: 12 months in HDPE packs at ambient temperature.

6. OTHER INFORMATION

Please be aware of the European reference value of 1.25 mg/m³ for the active substance hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for this product.

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)	INTEROX BT 35	INTEROX BT 35	Market area: EU	Market area: EU	Market area: EU	Market area: EU
Authorisation number	EU-0027468-0014 1-8	EU-0027468-0014 1-8	EU-0027468-0014 1-8	EU-0027468-0014 1-8	EU-0027468-0014 1-8	EU-0027468-0014 1-8
Common name	IUPAC name	Function	Function	CAS number	EC number	Content (%)
Hydrogen peroxide		Active Substance	Active Substance	7722-84-1	231-765-0	35,7

META SPC 9

1. META SPC 9 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 9 identifier

Identifier	Meta SPC 9

1.2.   Suffix to the authorisation number

Number	1-9

1.3.   Product type(s)

Product type(s)	PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT03 - Veterinary hygiene (Disinfectants)

2. META SPC 9 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 9

Common name	IUPAC name	Function	CAS number	EC number	Content (%)	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Hydrogen peroxide		Active Substance	7722-84-1	231-765-0	49,0	49,9

2.2.   Type(s) of formulation of the meta SPC 9

Formulation(s)	SL - Soluble concentrate

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9

Hazard statements	May intensify fire; oxidiser Harmful if swallowed. Causes severe skin burns and eye damage. May cause respiratory irritation. Harmful to aquatic life with long lasting effects.
Precautionary statements	Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking. Keep away from clothing and other combustible materials. Do not breathe vapours. Do not breathe spray. Wash hands thoroughly after handling. Do no eat, drink or smoke when using this product. Use only outdoors or in a well-ventilated area. Avoid release to the environment. Wear protective gloves. Wear protective clothing. Wear eye protection. Wear face protection. IF SWALLOWED:Call a POISON CENTER/doctor if you feel unwell. IF SWALLOWED:Rinse mouth.Do NOT induce vomiting. IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water. IF INHALED:Remove person to fresh air and keep comfortable for breathing. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor. Wash contaminated clothing before reuse. In case of fire:Use water to extinguish. Store in a well-ventilated place.Keep container tightly closed. Store locked up. Dispose of contents to ….in accordance with all local, regional, national and international regulations.. Dispose of container to in accordance with local/regional/national/international regulation.

4. AUTHORISED USE(S) OF THE META SPC 9

4.1.   Use description

Table 15. Use # 1 – Surface disinfection by liquid application in industrial and institutional areas

Product type	PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use	Not relevant
Target organism(s) (including development stage)	Common name: Bacteria Development stage: Common name: Fungi/yeasts Development stage: Common name: Viruses Development stage: Common name: Bacterial spores Development stage:
Field(s) of use	Indoor Industrial or institutional use. Disinfection of non-porous surfaces.
Application method(s)	Method: - Detailed description: Automated spraying on surfaces Cleaning-in-Place (CIP) Immersion of equipment and utensils
Application rate(s) and frequency	Application Rate: Use concentration 13% w/w hydrogen peroxide. Dilution (%): Number and timing of application: — CIP (cleaning-in-place): volume of diluted product needed to fill the disinfected system — Automated spraying: 50 -100 mL diluted product/m2 — Immersion: make solution and dip items Frequency - as required by the user. Apply at room temperature.
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE packaging: 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L (IBC). Approved grades of HDPE.

4.1.1.   Use-specific instructions for use

Use an automated loading system for CIP and automated spraying.

Dilute the product to reach the needed hydrogen peroxide concentration stated below.

Effective hydrogen peroxide concentration (w/w) and contact time:

Bactericidal - 13%, 10 min

Sporicidal – 13%, 60 min

Yeasticidal and fungicidal – 13%, 15 min

Virucidal – 13%, 30 min

All claimed microbes - 13%, 60 min

Each product label should give information on how the dilution should be made, e.g. to reach 13% (w/w) hydrogen peroxide concentration:

A product with 50% hydrogen peroxide concentration: The product should be diluted to 28% w/v (280 g or 230 mL of product, add water up to 1 L).

Precleaning of surfaces required before using disinfectants.

Automated spraying of diluted product 50 -100 mL /m² on non-porous surfaces. Surface needs to stay wet for the allocated contact time.

Immerse instruments in diluted product for the allocated contact time. Allow to drain and dry.

4.1.2.   Use-specific risk mitigation measures

CIP:

The processes must be fully automated and enclosed with no exposure in the case of tanks or piping systems.

Automated spraying:

In the case of automated spraying of surfaces such as conveyors or other fixed installations workers must leave the room before processing.

Disinfection can only be processed after the end of a shift with all workers having left the room. The process must be started from outside the room. Warning notices indicating that entry is denied and temporary barriers must be placed on all entries.

Air concentrations must be monitored to ensure that no leakage occurs during operations. For re-entry, the undercut of AECinhalation of 1.25 mg/m3 shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period).

Immersion:

The use of eye protection during handling of the product is mandatory.

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).

A protective coverall (at least type 6, EN 13034) shall be worn in loading.

For stationary processes, a local exhaust ventilation (LEV) with a capture efficiency of at least 85% shall be specified.

If no LEV, use respiratory protective equipment (RPE) providing a protection factor of 20 in loading and 5 for immersion.

After use, immersion baths must be emptied or covered to prevent further evaporation.

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 16. Use # 2 – Disinfection of surfaces associated with animal housing by spraying

Product type	PT03 - Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	Not relevant.
Target organism(s) (including development stage)	Common name: Bacteria Development stage: Common name: Fungi/yeasts Development stage: Common name: Viruses Development stage:
Field(s) of use	Indoor Disinfection of non-porous materials and surfaces associated with the housing of animals.
Application method(s)	Method: - Detailed description: Spraying with automated or manual equipment
Application rate(s) and frequency	Application Rate: Use concentration 9.5-13 % w/w hydrogen peroxide. Dilution (%): Number and timing of application: Spraying: 50 -100 mL diluted product/m2 Frequency depends on life-cycle of animals - as required by user.
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE packaging: 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L (IBC). Approved grades of HDPE.

4.2.1.   Use-specific instructions for use

Dilute the product to reach the needed hydrogen peroxide concentration stated below.

Effective hydrogen peroxide concentration (w/w) and contact time:

Bactericidal and yeasticidal - 9.5%, 30 min

Fungicidal – 13%, 60 min

Virucidal – 13%, 30 min

All claimed microbes - 13%, 60 min

Each product label should give information on how the dilution should be made, e.g. to reach 13% (w/w) hydrogen peroxide concentration:

A product with 50% hydrogen peroxide concentration: The product should be diluted to 28% w/v (280 g or 230 mL of product, add water up to 1L).

Remove animals from spaces to be disinfected. Precleaning of surfaces required before using disinfectants.

Spray diluted product 50 -100 mL /m2 on non-porous surfaces. Surface needs to stay wet for the allocated contact time. Allow to drain and dry.

4.2.2.   Use-specific risk mitigation measures

Automated spraying systems:

During the operation worker must leave the area and access must be denied by appropriate barriers or locked doors. After operation efficient ventilation (10 ACH) must be used to reach a safe level. During this period access must also be denied. Air concentrations must be monitored to ensure that no leakage occurs during operations. For re-entry, the undercut of AECinhalation of 1.25 mg/m3 shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period).

For manual spraying:

The use of eye protection during handling of the product is mandatory.

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).

A protective coverall (at least type 6, EN 13034) shall be worn.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a half/full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information).

Only operators wearing the specified RPE should be present while spraying or fumigating.

The operator must walk backward towards the exit while spraying the surfaces so always walking away from sprayed areas.

Efficient ventilation (10 ACH) must be used during spraying and access must be denied by appropriate barriers and notices, Also after operation efficient ventilation (10 ACH) must be used to reach a safe level. During this period access must also be denied. Air concentrations must be monitored to ensure that no leakage occurs during operations. For re-entry, the undercut of AECinhalation of 1.25 mg/m3 shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period).

No secondary exposure is expected because of rapid decomposition of hydrogen peroxide.

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 ¹¹

OF THE META SPC 9

5.1.   Instructions for use

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5.2.   Risk mitigation measures

The use of eye protection during handling of the product is mandatory.

Wear face shield where splashing is possible.