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)

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

(1)  

OJ L 167, 27.6.2012, p. 1

.

(2)  ECHA opinion of 13 October 2021 on the Union authorisation of ‘INTEROX Biocidal Product Family 1’ (ECHA/BPC/295/2021), https://echa.europa.eu/bpc-opinions-on-union-authorisation

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

1.2.   

Product type(s)

1.3.   

Authorisation holder

1.4.   

Manufacturer(s) of the biocidal products

1.5.   

Manufacturer(s) of the active substance(s)

2.   

PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1.   

Qualitative and quantitative information on the composition of the family

2.2.   

Type(s) of formulation

PART II

SECOND INFORMATION LEVEL - META SPC(S)

META SPC 1

1.   

META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 1 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   

META SPC 1 COMPOSITION

2.1.   

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

2.2.   

Type(s) of formulation of the meta SPC 1

3.   

HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

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

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 m

3

.

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/m

3

 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

 (1)

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/m

3

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

META SPC 2

1.   

META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 2 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   

META SPC 2 COMPOSITION

2.1.   

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

2.2.   

Type(s) of formulation of the meta SPC 2

3.   

HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

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

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 m

3

.

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/m

3

 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)

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/m

3

).

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/m

3

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

 (2)

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/m

3

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

7.2.   

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

META SPC 3

1.   

META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 3 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   

META SPC 3 COMPOSITION

2.1.   

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

2.2.   

Type(s) of formulation of the meta SPC 3

3.   

HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

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

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 m

3

.

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/m

3

 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)

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/m

3

).

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/m

3

 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

 (3)

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/m

3

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

7.2.   

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

META SPC 4

1.   

META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 4 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   

META SPC 4 COMPOSITION

2.1.   

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

2.2.   

Type(s) of formulation of the meta SPC 4

3.   

HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

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)

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

 (4)

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/m

3

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

META SPC 5

1.   

META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 5 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   

META SPC 5 COMPOSITION

2.1.   

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

2.2.   

Type(s) of formulation of the meta SPC 5

3.   

HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

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)

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.

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

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)

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.

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.

4.2.3.   

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 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/m

3

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

7.2.   

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

7.3.   

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

7.4.   

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

7.5.   

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

META SPC 6

1.   

META SPC 6 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 6 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   

META SPC 6 COMPOSITION

2.1.   

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

2.2.   

Type(s) of formulation of the meta SPC 6

3.   

HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6

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

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

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

 (6)

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/m

3

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

META SPC 7

1.   

META SPC 7 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 7 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   

META SPC 7 COMPOSITION

2.1.   

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

2.2.   

Type(s) of formulation of the meta SPC 7

3.   

HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7

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

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

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

 (7)

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/m

3

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

META SPC 8

1.   

META SPC 8 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 8 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   

META SPC 8 COMPOSITION

2.1.   

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

2.2.   

Type(s) of formulation of the meta SPC 8

3.   

HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8

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

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

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

 (8)

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/m

3

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

META SPC 9

1.   

META SPC 9 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 9 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   

META SPC 9 COMPOSITION

2.1.   

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

2.2.   

Type(s) of formulation of the meta SPC 9

3.   

HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9

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

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 /m

2

 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.