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)

19.7.2022	EN	Official Journal of the European Union	L 190/7

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ¹, and in particular the Article 44(5), first subparagraph, thereof,

Whereas:

• (1) On 25 January 2017, Solvay Chemicals International S.A. submitted an application, in accordance with Article 43(1) of Regulation (EU) No 528/2012, for authorisation of a biocidal product family named ‘INTEROX Biocidal Product Family 1’ of product-types 2, 3 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Finland had agreed to evaluate the application. The application was recorded under case number BC-WX029254-02 in the Register for Biocidal Products.

• (2) ‘INTEROX Biocidal Product Family 1’ contains hydrogen peroxide as the active substance, which is included in the Union list of approved active substance referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2, 3 and 4.

• (3) On 21 April 2021, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

• (4) On 4 November 2021, the Agency submitted to the Commission an opinion ², including the draft summary of the biocidal product characteristics (‘SPC’) of ‘INTEROX Biocidal Product Family 1’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.

• (5) The opinion concludes that ‘INTEROX Biocidal Product Family 1’ is a ‘biocidal product family’ within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.

• (6) On 16 November 2021, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

• (7) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘INTEROX Biocidal Product Family 1’.

• (8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on biocidal products,

HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation with authorisation number EU-0027468-0000 is granted to Solvay Chemicals International S.A. for the making available on the market and use of the biocidal product family ‘INTEROX Biocidal Product Family 1’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union Authorisation is valid from 8 August 2022 to 31 July 2032.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 13 July 2022.

For the Commission

The President

Ursula VON DER LEYEN

ANNEX

Summary of product characteristics for a biocidal product family

Interox Biocidal Product Family 1

Product type 2 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Product type 3 - Veterinary hygiene (Disinfectants)

Product type 4 - Food and feed area (Disinfectants)

Authorisation number: EU-0027468-0000

R4BP asset number: EU-0027468-0000

PART I

FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION

1.1.   Family name

Name	Interox Biocidal Product Family 1

1.2.   Product type(s)

Product type(s)	PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT03 - Veterinary hygiene (Disinfectants) PT04 - Food and feed area (Disinfectants)

1.3.   Authorisation holder

Name and address of the authorisation holder	Name	SOLVAY CHEMICALS INTERNATIONAL
Name and address of the authorisation holder	Address	RUE DE RANSBEEK 310, B-1120 BRUXELLES Belgium
Authorisation number	EU-0027468-0000	EU-0027468-0000
R4BP asset number	EU-0027468-0000	EU-0027468-0000
Date of the authorisation	8 August 2022	8 August 2022
Expiry date of the authorisation	31 July 2032	31 July 2032

1.4.   Manufacturer(s) of the biocidal products

Name of manufacturer	Solvay Interox Limited
Address of manufacturer	Baronet Road, Solvay House, WA4 6HA Warrington United Kingdom
Location of manufacturing sites	Solvay Interox Limited, Baronet Road, Solvay House, WA4 6HA Warrington United Kingdom
---	---
Name of manufacturer	Solvay Chemicals Finland Oy
Address of manufacturer	YRJONOJANTIE 2, 45910 VOIKKAA Finland
Location of manufacturing sites	Solvay Chemicals Finland Oy, YRJONOJANTIE 2, 45910 VOIKKAA Finland
---	---
Name of manufacturer	Solvay Chemicals GmbH Germany
Address of manufacturer	KOETHENSCHE STRASSE 1-3, 06406 DE BERNBURG Germany
Location of manufacturing sites	Solvay Chemicals GmbH Germany, KOETHENSCHE STRASSE 1-3, 06406 DE BERNBURG Germany
---	---
Name of manufacturer	Solvay Chemie BV Netherlands
Address of manufacturer	SCHEPERSWEG, 1, 6049 CV HERTEN Netherlands
Location of manufacturing sites	Solvay Chemie BV Netherlands, SCHEPERSWEG, 1, 6049 CV HERTEN Netherlands
---	---
Name of manufacturer	Solvay Chimica Italia SpA Italy
Address of manufacturer	VIA PIAVE, 6 Rosignano SOLVAY, LI 57013 Rosignano Italy
Location of manufacturing sites	Solvay Chimica Italia SpA Italy, VIA PIAVE, 6 Rosignano SOLVAY, LI 57013 Rosignano Italy
---	---
Name of manufacturer	Solvay Chimie SA Belgium
Address of manufacturer	Rue de Ransbeek 310, 1120 BE Brussels Belgium
Location of manufacturing sites	Solvay Chimie SA Belgium, RUE SOLVAY, 39, 5190 BE JEMEPPE-SUR-SAMBRE Belgium Solvay Chimie SA Belgium, SCHELDELAAN 600 – HAVEN 725, 2040 BE Antwerp Belgium
---	---
Name of manufacturer	Solvay Interox Produtos Peroxidados SA
Address of manufacturer	RUA ENG. CLEMENT DUMOULIN, 2625-106 POVOA DE SANTA IRIA Portugal
Location of manufacturing sites	Solvay Interox Produtos Peroxidados SA, RUA ENG. CLEMENT DUMOULIN, 2625-106 POVOA DE SANTA IRIA Portugal

1.5.   Manufacturer(s) of the active substance(s)

Active substance	Hydrogen peroxide
Name of manufacturer	Solvay Interox Limited
Address of manufacturer	Baronet Road, Solvay House, WA4 6HA Warrington United Kingdom
Location of manufacturing sites	Solvay Interox Limited, Baronet Road, Solvay House, WA4 6HA Warrington United Kingdom
---	---
Active substance	Hydrogen peroxide
Name of manufacturer	Solvay Chemicals Finland Oy
Address of manufacturer	YRJONOJANTIE 2, 45910 VOIKKAA Finland
Location of manufacturing sites	Solvay Chemicals Finland Oy, YRJONOJANTIE 2, 45910 VOIKKAA Finland
---	---
Active substance	Hydrogen peroxide
Name of manufacturer	Solvay Chemicals GmbH Germany
Address of manufacturer	KOETHENSCHE STRASSE 1-3, 06406 BERNBURG Germany
Location of manufacturing sites	Solvay Chemicals GmbH Germany, KOETHENSCHE STRASSE 1-3, 06406 BERNBURG Germany
---	---
Active substance	Hydrogen peroxide
Name of manufacturer	Solvay Chimica Italia SpA Italy
Address of manufacturer	VIA PIAVE, 6 ROSIGNANO SOLVAY, LI 57013 ROSIGNANO Italy
Location of manufacturing sites	Solvay Chimica Italia SpA Italy, VIA PIAVE, 6 ROSIGNANO SOLVAY, LI 57013 ROSIGNANO Italy
---	---
Active substance	Hydrogen peroxide
Name of manufacturer	Solvay Chimie SA Belgium
Address of manufacturer	Rue de Ransbeek 310, 1120 Brussels Belgium
Location of manufacturing sites	Solvay Chimie SA Belgium, RUE SOLVAY 39, 5190 BE JEMEPPE-SUR-SAMBRE Belgium Solvay Chimie SA Belgium, SCHELDELAAN 600 – HAVEN 725, 2040 BE Antwerp Belgium
---	---
Active substance	Hydrogen peroxide
Name of manufacturer	Solvay Interox Produtos Peroxidados SA
Address of manufacturer	RUA ENG. CLEMENT DUMOULIN, 2625-106 POVOA DE SANTA IRIA Portugal
Location of manufacturing sites	Solvay Interox Produtos Peroxidados SA, RUA ENG. CLEMENT DUMOULIN, 2625-106 POVOA DE SANTA IRIA Portugal

2. PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the family

Common name	IUPAC name	Function	CAS number	EC number	Content (%)	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Hydrogen peroxide		Active Substance	7722-84-1	231-765-0	13,0	49,9

2.2.   Type(s) of formulation

Formulation(s)	SL - Soluble concentrate AL - Any other liquid

PART II

SECOND INFORMATION LEVEL - META SPC(S)

META SPC 1

1. META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier

Identifier	Meta SPC 1

1.2.   Suffix to the authorisation number

Number	1-1

1.3.   Product type(s)

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

2. META SPC 1 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 1

Common name	IUPAC name	Function	CAS number	EC number	Content (%)	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Hydrogen peroxide		Active Substance	7722-84-1	231-765-0	13,0	13,5

2.2.   Type(s) of formulation of the meta SPC 1

Formulation(s)	AL - Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements	May intensify fire; oxidiser Causes serious eye damage.
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. Wear eye protection. 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. In case of fire:Use water to extinguish. Dispose of contents to in accordance with local/regional/national/international regulation. Dispose of container to in accordance with local/regional/national/international regulation.

4. AUTHORISED USE(S) OF THE META SPC 1

4.1.   Use description

Table 1. Use # 1 – Surface disinfection of closed spaces by aerosolised hydrogen peroxide

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: Viruses Development stage: Common name: Fungi/yeasts Development stage: Common name: Bacterial spores Development stage:
Field(s) of use	Indoor Indoor, closed spaces. Industrial/pharmaceutical industry or cosmetics industry, for example clean rooms. Medical - healthcare facilities, hospitals and emergency vehicles. Institutional. Disinfection of non-porous surfaces
Application method(s)	Method: - Detailed description: Automated, non-directed aerosolization (e.g. fogging or spraying)
Application rate(s) and frequency	Application Rate: 13% hydrogen peroxide (undiluted product) applied via aerosolization in closed rooms. Dilution (%): Number and timing of application: Frequency - as required by user, for example up to 3 times per day. Treatment time depends on machine type, size of room or area of surfaces to be disinfected. Apply at room temperature.
Category(ies) of users	Professional
Pack sizes and packaging material	Pack sizes (L): 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L Packaging material: Approved grades of HDPE.

4.1.1.   Use-specific instructions for use

Use an automated loading system.

13% (w/w) hydrogen peroxide (undiluted product) is applied via aerosolization by automated device in a sealed room. Rooms may be dehumidified to achieve higher hydrogen peroxide concentrations on surfaces.

Remove barriers that may hinder aerosolized product from reaching the surfaces to be disinfected.

The disinfected surfaces should be non-porous and cleaned before application of the product. The product is not intended to be used on surfaces that may come into contact with food or feeding stuffs.

The user should carry out a microbiological validation of the disinfection in the rooms to be disinfected (or in a suitable "standard room", if applicable) with the devices to be used, after which a protocol for disinfection of these rooms can be made and used thereafter. Each device or specific installation is systematically validated when it is set up. The optimal operating conditions are validated on site (temperature, hygrometry, product to be used, diffusion time, extraction time, etc.). Besides biological validation chemical validation should be performed.

Efficacy of room disinfection was demonstrated according to norm NF T 72-281 by nebulization of 1 g of hydrogen peroxide per cubic meter of room volume in 22 min followed by 180 min contact time at room temperature.

Volume of disinfected space should be 30 - 150 m³.

Median particle size should be <0.5 μm in aerosols used for disinfection

Prevent entry during disinfection process

4.1.2.   Use-specific risk mitigation measures

Surfaces in the treatment area must be clean and dry prior to application.

Seal the treatment enclosure (e.g. with tape) to ensure that hydrogen peroxide levels outside the enclosure are kept at acceptable health and safety levels.

Ensure all personnel have vacated the treatment enclosure prior to application. Remove all plants, animals, beverages and food. Re-entry is only permitted once the air concentration has dropped below the reference value (1.25 mg/m3). After the application, the room must be ventilated, preferably by mechanical ventilation. The duration of the ventilation period has to be established by measurement with suitable measurement equipment. In case of the room has to be entered when the hydrogen peroxide concentration is still above 1.25 mg/m³ it is only allowed by wearing appropriate PPE including SCBA (Self Contained Breathing Apparatus).

Place warning signs on all entrances to the treatment enclosure.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

5. GENERAL DIRECTIONS FOR USE ³

OF THE META SPC 1

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: If symptoms occur 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 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 1

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

Trade name(s)	INTEROX SG 12	INTEROX SG 12	Market area: EU	Market area: EU	Market area: EU	Market area: EU
Authorisation number	EU-0027468-0001 1-1	EU-0027468-0001 1-1	EU-0027468-0001 1-1	EU-0027468-0001 1-1	EU-0027468-0001 1-1	EU-0027468-0001 1-1
Common name	IUPAC name	Function	Function	CAS number	EC number	Content (%)
Hydrogen peroxide		Active Substance	Active Substance	7722-84-1	231-765-0	13,5

META SPC 2

1. META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

Identifier	Meta SPC 2

1.2.   Suffix to the authorisation number

Number	1-2

1.3.   Product type(s)

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

2. META SPC 2 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 2

Common name	IUPAC name	Function	CAS number	EC number	Content (%)	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 2

Formulation(s)	AL - Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

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 2

4.1.   Use description

Table 2. Use # 1 – Surface disinfection of closed spaces by aerosolised hydrogen peroxide

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 Indoor, closed spaces Industrial – pharmaceutical industry or cosmetics industry, for example clean rooms. Medical– healthcare facilities, hospitals, emergency vehicles. Institutional. Disinfection of non-porous surfaces.
Application method(s)	Method: - Detailed description: Automated, non-directed aerosolization (e.g. fogging or spraying)
Application rate(s) and frequency	Application Rate: 35% hydrogen peroxide (undiluted product) applied via aerosolization in closed rooms. Dilution (%): Number and timing of application: Frequency - as required by user, for example up to 3 times per day. Treatment time depends on machine type, size of room or area of surfaces to be disinfected. Apply at room temperature.
Category(ies) of users	Professional
Pack sizes and packaging material	Pack sizes (L): 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L Packaging material: Approved grades of HDPE.

4.1.1.   Use-specific instructions for use

Use an automated loading system.

35% (w/w) hydrogen peroxide (undiluted product) is applied via aerosolization by automated device in a sealed room. Rooms may be dehumidified to achieve higher hydrogen peroxide concentrations on surfaces.

Remove barriers that may hinder aerosolized product from reaching the surfaces to be disinfected.

The disinfected surfaces should be non-porous and cleaned before application of the product. The product is not intended to be used on surfaces that may come into contact with food or feeding stuffs.

The user should carry out a microbiological validation of the disinfection in the rooms to be disinfected (or in a suitable "standard room", if applicable) with the devices to be used, after which a protocol for disinfection of these rooms can be made and used thereafter. Each device or specific installation is systematically validated when it is set up. The optimal operating conditions are validated on site (temperature, hygrometry, product to be used, diffusion time, extraction time, etc.). Besides biological validation chemical validation should be performed.

Efficacy of room disinfection was demonstrated according to norm NF T 72-281 by nebulization of 1 g of hydrogen peroxide per cubic meter of room volume in 22 min followed by 180 min contact time at room temperature.

Volume of disinfected space should be 30 - 150 m³.

Median particle size should be <0.5 μm in aerosols used for disinfection.

Prevent entry during disinfection process.

4.1.2.   Use-specific risk mitigation measures

Surfaces in the treatment area must be clean and dry prior to application.

Seal the treatment enclosure (e.g. with tape) to ensure that hydrogen peroxide levels outside the enclosure are kept at acceptable health and safety levels.

Ensure all personnel have vacated the treatment enclosure prior to application. Remove all plants, animals, beverages and food. Re-entry is only permitted once the air concentration has dropped below the reference value (1.25 mg/m3). After the application, the room must be ventilated, preferably by mechanical ventilation. The duration of the ventilation period has to be established by measurement with suitable measurement equipment. In case the room has to be entered when the hydrogen peroxide concentration is still above 1.25 mg/m³ it is only allowed by wearing appropriate PPE including SCBA (Self Contained Breathing Apparatus).

Place warning signs on all entrances to the treatment enclosure.

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 3. Use # 2 – Surface disinfection of enclosures in filling isolators by aerosolised or vaporised hydrogen peroxide (VHP)

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: bacterial spores Development stage: Common name: Fungi/yeasts Development stage: Common name: Viruses Development stage:
Field(s) of use	Indoor Indoor. Industrial – aseptic chambers in aseptic filling applied in pharmaceutical or cosmetics industry. Disinfection of non-porous surfaces.
Application method(s)	Method: - Detailed description: Automated, non-directed aerosolization (e.g. fogging or spraying, flash evaporation)
Application rate(s) and frequency	Application Rate: 35% hydrogen peroxide (undiluted product) applied via flash evaporation or aerosolization in filling isolators. Dilution (%): Number and timing of application: Frequency – as required by user, for example 1 or 2 times per day/week.
Category(ies) of users	Professional
Pack sizes and packaging material	Pack sizes (L): 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L. Packaging material: Approved grades of HDPE

4.2.1.   Use-specific instructions for use

Use an automated loading system.

35% (w/w) hydrogen peroxide (undiluted product) is applied via flash evaporation or aerosolization by automated device connected to an filling isolator. Filling isolators may be dehumidified to achieve higher hydrogen peroxide concentrations on surfaces.

The disinfected surfaces should be non-porous and cleaned before application of the product. The product is not intended to be used on surfaces that may come into contact with food or feeding stuffs.

The user should carry out a microbiological validation of the disinfection in the enclosures to be disinfected with the devices to be used, after which a protocol for disinfection of these enclosures can be made and used thereafter. Each device or specific installation is systematically validated when it is set up. The optimal operating conditions are validated on site (temperature, hygrometry, product to be used, diffusion time, extraction time, etc.). Besides biological validation chemical validation should be performed.

Efficacy of use against bacterial spores was demonstrated by flash evaporation of hydrogen peroxide at a rate of 0.35 g/m3/min for 51 min (18 g hydrogen peroxide / m3 / treatment).

Volume of disinfected enclosure should be 15 - 150 m3.

Median particle size should be <0.5 μm in aerosols used for disinfection.

Prevent entry during disinfection process.

4.2.2.   Use-specific risk mitigation measures

Surfaces in the treatment area must be clean and dry prior to application.

Seal the treatment enclosure (e.g. with tape) to ensure that hydrogen peroxide levels outside the enclosure are kept at acceptable health and safety levels.

Ensure all personnel have vacated the treatment enclosure prior to application. Remove all plants, animals, beverages and food. Re-entry is only permitted once the air concentration has dropped below the reference value (1.25 mg/m³).

After the application, the room must be ventilated, preferably by mechanical ventilation. The duration of the ventilation period has to be established by measurement with suitable measurement equipment. In case the room has to be entered when the hydrogen peroxide concentration is still above 1.25 mg/m³ it is only allowed by wearing appropriate PPE including SCBA (Self Contained Breathing Apparatus).

Place warning signs on all entrances to the treatment enclosure.

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 ⁴

OF THE META SPC 2

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 2

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

Trade name(s)	INTEROX SG 35	INTEROX SG 35	Market area: EU	Market area: EU	Market area: EU	Market area: EU
Authorisation number	EU-0027468-0002 1-2	EU-0027468-0002 1-2	EU-0027468-0002 1-2	EU-0027468-0002 1-2	EU-0027468-0002 1-2	EU-0027468-0002 1-2
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 SG 35 PLUS	INTEROX SG 35 PLUS	Market area: EU	Market area: EU	Market area: EU	Market area: EU
Authorisation number	EU-0027468-0003 1-2	EU-0027468-0003 1-2	EU-0027468-0003 1-2	EU-0027468-0003 1-2	EU-0027468-0003 1-2	EU-0027468-0003 1-2
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 3

1. META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier

Identifier	Meta SPC 3

1.2.   Suffix to the authorisation number

Number	1-3

1.3.   Product type(s)

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

2. META SPC 3 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 3

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 3

Formulation(s)	AL - Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

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 3

4.1.   Use description

Table 4. Use # 1 – Surface disinfection of closed spaces by aerosolised hydrogen peroxide

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 Indoor, closed spaces. Industrial – pharmaceutical industry or cosmetics industry, for example clean rooms. Medical– healthcare facilities, hospitals, emergency vehicles. Institutional. Disinfection of non-porous surfaces.
Application method(s)	Method: - Detailed description: Automated, non-directed aerosolization (e.g. fogging or spraying).
Application rate(s) and frequency	Application Rate: 49% hydrogen peroxide (undiluted product) applied via aerosolization in closed rooms. Dilution (%): Number and timing of application: Frequency - as required by user, for example up to 3 times per day. Treatment time depends on machine type, size of room or area of surfaces to be disinfected. Apply at room temperature.
Category(ies) of users	Professional
Pack sizes and packaging material	Pack sizes (L): 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L Packaging material: Approved grades of HDPE.

4.1.1.   Use-specific instructions for use

Use an automated loading system.

49% (w/w) hydrogen peroxide (undiluted product) is applied via aerosolization by automated device in a sealed room. Rooms may be dehumidified to achieve higher hydrogen peroxide concentrations on surfaces.

Remove barriers that may hinder aerosolized product from reaching the surfaces to be disinfected.

The disinfected surfaces should be non-porous and cleaned before application of the product. The product is not intended to be used on surfaces that may come into contact with food or feeding stuffs.

The user should carry out a microbiological validation of the disinfection in the rooms to be disinfected (or in a suitable "standard room", if applicable) with the devices to be used, after which a protocol for disinfection of these rooms can be made and used thereafter. Each device or specific installation is systematically validated when it is set up. The optimal operating conditions are validated on site (temperature, hygrometry, product to be used, diffusion time, extraction time, etc.). Besides biological validation chemical validation should be performed.

Efficacy of room disinfection was demonstrated according to norm NF T 72-281by nebulization of 1 g of hydrogen peroxide per cubic meter of room volume in 22 min followed by 180 min contact time at room temperature.

Volume of disinfected space should be 30 - 150 m³.

Median particle size should be <0.5 μm in aerosols used for disinfection.

Prevent entry during disinfection process.

4.1.2.   Use-specific risk mitigation measures

Surfaces in the treatment area must be clean and dry prior to application.

Seal the treatment enclosure (e.g. with tape) to ensure that hydrogen peroxide levels outside the enclosure are kept at acceptable health and safety levels.

Ensure all personnel have vacated the treatment enclosure prior to application. Remove all plants, animals, beverages and food. Re-entry is only permitted once the air concentration has dropped below the reference value (1.25 mg/m3). After the application, the room must be ventilated, preferably by mechanical ventilation. The duration of the ventilation period has to be established by measurement with suitable measurement equipment. In case the room has to be entered when the hydrogen peroxide concentration is still above 1.25 mg/m³ it is only allowed by wearing appropriate PPE including SCBA (Self Contained Breathing Apparatus).

Place warning signs on all entrances to the treatment enclosure.

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 5. Use # 2 – Surface disinfection of enclosures in filling isolators by aerosolised or vaporised hydrogen peroxide (VHP)

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: bacterial spores Development stage: Common name: Fungi/yeasts Development stage: Common name: Viruses Development stage:
Field(s) of use	Indoor Indoor. Industrial – aseptic chambers in aseptic filling applied in pharmaceutical or cosmetics industry. Disinfection of non-porous surfaces.
Application method(s)	Method: - Detailed description: Automated, non-directed aerosolization (e.g. fogging or spraying, flash evaporation)
Application rate(s) and frequency	Application Rate: 49% hydrogen peroxide (undiluted product) applied via flash evaporation or aerosolization in filling isolators. Dilution (%): Number and timing of application: Frequency – as required by user, for example 1 or 2 times per day/week.
Category(ies) of users	Professional
Pack sizes and packaging material	Pack sizes (L): 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L. Packaging material: Approved grades of HDPE.

4.2.1.   Use-specific instructions for use

Use an automated loading system.

49% (w/w) hydrogen peroxide (undiluted product) is applied via flash evaporation or aerosolization by automated device connected to an filling isolator. Filling isolators may be dehumidified to achieve higher hydrogen peroxide concentrations on surfaces.

The disinfected surfaces should be non-porous and cleaned before application of the product. The product is not intended to be used on surfaces that may come into contact with food or feeding stuffs.

The user should carry out a microbiological validation of the disinfection in the enclosures to be disinfected with the devices to be used, after which a protocol for disinfection of these enclosures can be made and used thereafter. Each device or specific installation is systematically validated when it is set up. The optimal operating conditions are validated on site (temperature, hygrometry, product to be used, diffusion time, extraction time, etc.). Besides biological validation chemical validation should be performed.

Efficacy of use against bacterial spores was demonstrated by flash evaporation of hydrogen peroxide at a rate of 0.35 g/m3/min for 51 min (18 g hydrogen peroxide / m3 / treatment).

Volume of disinfected enclosure should be 15 - 150 m3.

Median particle size should be <0.5 μm in aerosols used for disinfection.

Prevent entry during disinfection process.

4.2.2.   Use-specific risk mitigation measures

Surfaces in the treatment area must be clean and dry prior to application.

Seal the treatment enclosure (e.g. with tape) to ensure that hydrogen peroxide levels outside the enclosure are kept at acceptable health and safety levels.

Ensure all personnel have vacated the treatment enclosure prior to application. Remove all plants, animals, beverages and food. Re-entry is only permitted once the air concentration has dropped below the reference value (1.25 mg/m³).

After the application, the room must be ventilated, preferably by mechanical ventilation. The duration of the ventilation period has to be established by measurement with suitable measurement equipment. In case the room has to be entered when the hydrogen peroxide concentration is still above 1.25 mg/m³ it is only allowed by wearing appropriate PPE including SCBA (Self Contained Breathing Apparatus).

Place warning signs on all entrances to the treatment enclosure.

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 ⁵

OF THE META SPC 3

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 3

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

Trade name(s)	Interox SG 50	Interox SG 50	Market area: EU	Market area: EU	Market area: EU	Market area: EU
Authorisation number	EU-0027468-0004 1-3	EU-0027468-0004 1-3	EU-0027468-0004 1-3	EU-0027468-0004 1-3	EU-0027468-0004 1-3	EU-0027468-0004 1-3
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

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

Trade name(s)	INTEROX SG 50 PLUS	INTEROX SG 50 PLUS	Market area: EU	Market area: EU	Market area: EU	Market area: EU
Authorisation number	EU-0027468-0005 1-3	EU-0027468-0005 1-3	EU-0027468-0005 1-3	EU-0027468-0005 1-3	EU-0027468-0005 1-3	EU-0027468-0005 1-3
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 4

1. META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier

Identifier	Meta SPC 4

1.2.   Suffix to the authorisation number

Number	1-4

1.3.   Product type(s)

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

2. META SPC 4 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 4

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	25,0	25,7

2.2.   Type(s) of formulation of the meta SPC 4

Formulation(s)	AL - Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

Hazard statements	May intensify fire; oxidiser Harmful if swallowed. Causes serious eye damage. 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. Wash hands thoroughly after handling. Do no eat, drink or smoke when using this product. Avoid release to the environment. Wear eye protection. IF SWALLOWED:Call a POISON CENTER/doctor if you feel unwell. 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/doctor. Rinse mouth. 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 4

4.1.   Use description

Table 6. Use # 1 – Disinfection of polyethylene terephthalate food packages by 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 food package material.
Application method(s)	Method: - Detailed description: Automated vaporization in aseptic filling machines
Application rate(s) and frequency	Application Rate: Undiluted product (25 % w/w hydrogen peroxide) vaporized 400 g/h/packaging machine. Dilution (%): Number and timing of application: Number and timing of applications as required by user. Machines typically operate up to 120 hours per week.
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.

Use undiluted product (25 % w/w hydrogen peroxide) to disinfect polyethylene terephthalate food packages used in aseptic packaging in food industry..

Follow machine operating instructions for disinfection period, extraction of hydrogen peroxide and re-entry. Prevent entry during disinfection process. Efficacy was demonstrated with a packaging machine running at 12 480 bottles per hour with a production consumption rate of 400 g/h.

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

After sterilisation, blow-dry the packaging with hot sterile air.

4.1.2.   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.
---	---	---
	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.
---	---	---
	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.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

5. GENERAL DIRECTIONS FOR USE ⁶

OF THE META SPC 4

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: If symptoms occur 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 4

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

Trade name(s)	INTEROX AG Spray 25S	INTEROX AG Spray 25S	Market area: EU	Market area: EU	Market area: EU	Market area: EU
Authorisation number	EU-0027468-0006 1-4	EU-0027468-0006 1-4	EU-0027468-0006 1-4	EU-0027468-0006 1-4	EU-0027468-0006 1-4	EU-0027468-0006 1-4
Common name	IUPAC name	Function	Function	CAS number	EC number	Content (%)
Hydrogen peroxide		Active Substance	Active Substance	7722-84-1	231-765-0	25,7

META SPC 5

1. META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 5 identifier

Identifier	Meta SPC 5

1.2.   Suffix to the authorisation number

Number	1-5

1.3.   Product type(s)

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

2. META SPC 5 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 5

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 5

Formulation(s)	AL - Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

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 5

4.1.   Use description

Table 7. Use # 1 – Disinfection of food packaging material (aseptic packaging) by immersion or aerosolised or 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 food package material.
Application method(s)	Method: - Detailed description: Automated immersion of packaging material into bath of heated product in aseptic filling machine. Automated vaporisation or aerosolisation of product in sealed area in aseptic filling machine.
Application rate(s) and frequency	Application Rate: Undiluted product (35 % w/w hydrogen peroxide) is used. Product consumption in vapour and aerosol applications 0.1 – 1 mL per second per packaging line while the machine is operating. Dilution (%): Number and timing of application: Number and timing of applications as required by user. Machines typically operate up to 120 hours per week.
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.

Immersion: immerse clean packaging material in undiluted product according to packaging machine operating instruction Disinfection efficacy is determined by immersion time and temperature and packaging material.

Efficacy was demonstrated by immersion of carton food packages in 80 °C bath for 2.5 s.

If concentration of hydrogen peroxide in the bath drops to less than 32% during operation, replace solution with fresh product.

Vaporization: vaporize and apply undiluted product to clean packaging material according to packaging machine operating instructions. Product vaporized at 100-250 °C. Efficacy was demonstrated with polyethylene terephthalate packages flushed with 100 °C air containing 1.1% (w/w) of product for 5.5 s.

After sterilisation, blow-dry the packaging with hot sterile air.

Suitable packaging materials included paperboard, polyethylene terephthalate, polystyrene and aluminium.

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

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

4.1.2.   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.

• 1. 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.