Commission Implementing Regulation (EU) 2023/1764 of 12 September 2023 granting a Union authorisation for the biocidal product family ‘Oxy’Pharm H2O2’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
Date: 2023-09-12
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, animal health, biocide, chemical product, decontamination, food safety, market approval, public health








L_2023225EN.01002101.xml










13.9.2023   


EN


Official Journal of the European Union


L 225/21








            COMMISSION IMPLEMENTING REGULATION (EU) 2023/1764
of 12 September 2023
         
granting a Union authorisation for the biocidal product family ‘Oxy’Pharm H2O2
            ’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
(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 Article 44(5), first subparagraph, thereof,

Whereas:







(1)


On 30 January 2017, OXY’PHARM submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘Oxy’Pharm H2O2’ of product-types 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-HC029658-43 in the Register for Biocidal Products.












(2)


‘Oxy’Pharm H2O2’ contains hydrogen peroxide as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2 and 4.












(3)


On 10 March 2022, 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 Agency.












(4)


On 17 October 2022, the Agency submitted to the Commission its opinion (2), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘Oxy’Pharm H2O2’ 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 ‘Oxy’Pharm H2O2’ 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 31 October 2022, 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 ‘Oxy’Pharm H2O2’.












(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-0029752-0000 is granted to OXY’PHARM for the making available on the market and use of the biocidal product family ‘Oxy’Pharm H2O2’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 3 October 2023 until 30 September 2033.


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 the Member States in accordance with the Treaties.
Done at Brussels, 12 September 2023.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1.

(2)  ECHA opinion of 14 June 2022 on the Union authorisation of ‘Oxy’Pharm H2O2
            ’ (ECHA/BPC/358/2022), https://echa.europa.eu/opinions-on-union-authorisation.




ANNEX
Summary of product characteristics for a biocidal product family
Oxy'Pharm H2O2

Product type 2 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Product type 4 - Food and feed area (Disinfectants)
Authorisation number: EU-0029752-0000
R4BP asset number: EU-0029752-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name







Name


Oxy'Pharm H2O2





1.2.   Product type(s)







Product type(s)


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
PT04 - Food and feed area (Disinfectants)




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


OXY’PHARM




Address


Rue Marcel Paul 829, 94500 Champigny-sur-Marne France




Authorisation number


EU-0029752-0000





R4BP asset number



EU-0029752-0000




Date of the authorisation


3 October 2023




Expiry date of the authorisation


30 September 2033




1.4.   Manufacturer(s) of the biocidal products







Name of manufacturer


OXY'PHARM




Address of manufacturer


Rue Marcel Paul, 829, 94500 Champigny-sur-Marne France




Location of manufacturing sites


Rue Marcel Paul, 829, 94500 Champigny-sur-Marne France




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







Active substance


Hydrogen peroxide




Name of manufacturer


Evonik Resource Efficiency GmbH




Address of manufacturer


Rellinghauser Straße 1—11, 45128 Essen Germany




Location of manufacturing sites


Evonik Industries AG / BL Active Oxygens, Untere Kanalstrasse 3, 79618 Rheinfelden Germany




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 (%)




Min


Max




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


6,0 


12,0 




Silver


 


Non-active substance


7440-22-4


231-131-3


0,0 


0,0017 




2.2.   Type(s) of formulation







Formulation(s)


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


Oxy'Pharm H2O2 6%




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 (%)




Min


Max




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


6,0 


6,0 




Silver


 


Non-active substance


7440-22-4


231-131-3


0,0017 


0,0017 




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


Causes serious eye irritation.
Harmful to aquatic life with long lasting effects.




Precautionary statements


Wash hands thoroughly after handling.
Avoid release to the environment.
Wear eye protection.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
If eye irritation persists: Get medical advice.
Dispose of contents to hazardous or special waste collection point in accordance with national regulations.
Dispose of container to hazardous or special waste collection point in accordance with national regulations.




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

4.1.   Use description


Table 1


Use # 1 – Use #1.1: Hard surface disinfection by 6% Fogging Hydrogen Peroxide (FHP)







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


-




Target organism(s) (including development stage)


Scientific name: -
Common name: Bacteria
Development stage: -
Scientific name: -
Common name: Yeasts
Development stage: -
Scientific name: -
Common name: Tuberculosis bacilli
Development stage: -
Scientific name: -
Common name: Viruses
Development stage: -
Scientific name: -
Common name: Fungi
Development stage: -




Field(s) of use


Indoor
Room disinfection with fogging hydrogen peroxide (FHP) for rooms with volumes between 4-150 m3. It involves disinfection of hard non-porous surfaces of equipment and material (excluding medical devices) present in the treated room:






—


Hospitals & clinics,










—


laboratories of research and analysis (including P3 laboratories and white rooms),










—


healthcare transport,










—


pharmaceutical industry,










—


industrial laundries,










—


dental surgery and implantology centres,










—


hotels,










—


schools,










—


day nurseries.








Application method(s)


Method: Fogging
Detailed description:
The product is a ready-to-use product that is placed in a device. That device automatically fogs the biocidal product, in the closed space/room to be disinfected, without any user or bystander present.




Application rate(s) and frequency


Application Rate:
Bactericidal, yeasticidal, fungicidal, tuberculocidal and virucidal activity: 5 ml product/m3 and 2 hours contact time. Treat a second time at 5 ml product/m3 and 2 hours contact time.
The second treatment takes place right after the first. The two treatments can be programmed in order to be carried out sequentially.
Droplet size: 1-15μM
Dilution (%): -
Number and timing of application:
Disinfect rooms and equipment as frequently as required by the hygiene protocol in place.




Category(ies) of users


Professional




Pack sizes and packaging material








1)


High density polyethylene HDPE, white (non-transparent) bottle of 1 litre with a degassing screw cap.










2)


HDPE, grey (non-transparent) single-use bottle of 2 litres.










3)


HDPE, white (non-transparent) can of 5 litres (refill packaging).










4)


HDPE, white (non-transparent) can of 20 litres.








4.1.1.   Use-specific instructions for use

Surfaces must be cleaned before disinfection. The product is ready-to-use and should be used without dilution. The product is designed for equipment such as Nocospray/Bio-sanitizer/Sanofog/Nocomax/Nocomax Easy/Glosair. Read the instructions for use before use. Use according to the following protocols:






—


Bactericidal, yeasticidal, fungicidal, tuberculocidal and virucidal activity: 5 ml product/m3 and 2 hours contact time. Treat a second time at 5 ml product/m3 and 2 hours contact time.




The second treatment takes place right after the first. The two treatments can be programmed in order to be carried out sequentially.






 


Droplet size: 1-15μM










 


Relative Humidity: 25 % - 75 %










 


Temperature: room temperature




Respect the advised contact time. The contact time starts when the required amount of product is present in the room.
The user shall always 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.
4.1.2.   Use-specific risk mitigation measures

Please refer to general directions for use of this Meta SPC.
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


First aid

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.
IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.

Likely direct or indirect effects







—


causes serious eye irritation




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

Please refer to general directions for use of this Meta SPC.
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to general directions for use of this Meta SPC.
5.   GENERAL DIRECTIONS FOR USE (1)
OF THE META SPC 1

5.1.   Instructions for use

-
5.2.   Risk mitigation measures

During the diffusion, keep the room closed and do not enter. Treatment must be conducted with no human or animals present.
All gaps present in the room (for example, window frames) from where fog may leak must be sealed before the diffusion.
Ensure that access to the fog-treated area is denied during the whole procedure with a warning sign.
No access to the treated area should be permitted until the concentration of hydrogen peroxide is ≤0,9 ppm (1,25 mg/m3) or a lower relevant national reference value.
The professional user may enter the room only in emergency situations when the hydrogen peroxide level has dropped below 36ppm (50 mg/m3) and must wear the following Personal Protective Equipment (PPE): Respiratory Protective Equipment (RPE) classified under EN 14387 or equivalent with an Assigned Protection Factor (APF) 40 (Type of RPE to be specified by the authorisation holder within the product information) and suitable protective equipment (gloves classified under European Standard EN 374 or equivalent, eye protection consistent with European Standard EN ISO 16321 or equivalent, coverall). Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards.
A measuring device should be used to ensure that the concentration of hydrogen peroxide has decreased below 0,9 ppm or a lower relevant national reference value. Unprotected persons/animals may re-enter the treated room only after the hydrogen peroxide concentration in air decreases lower than 1,25 mg/m3 (0,9 ppm) or a lower relevant national reference value.
Individual protective equipment:
Wear chemical resistant goggles consistent with European Standard EN ISO 16321 or equivalent as eye protection during mixing and loading of the product to the packaging that is directly used in the fogging device (such as Nocospray, Bio-sanitizer, Sanofog, Nocomax or Nocomax Easy).
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

At the end of the treatment, dispose of unused product and the packaging in accordance with local regulations. Used product can be flushed to the municipal sewer or disposed of to the manure deposit depending on local regulations. Avoid release to an individual wastewater treatment plant.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage







—


Shelf life: 2 years.




6.   OTHER INFORMATION

The full titles of the EN standards mentioned in section 5.2 are listed below:






 


EN 374 – Protective gloves against dangerous chemicals and micro-organisms










 


EN ISO 16321 - Eye and face protection for occupational use










 


EN 14387 - Respiratory protective devices - Gas filter(s) and combined filter(s) - Requirements, testing, marking




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)


Nocolyse


Market area: EU




 


Glosair 400


Market area: EU




Authorisation number


EU-0029752-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


6,0 




Silver


 


Non-active substance


7440-22-4


231-131-3


0,0017 




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











Trade name(s)


Nocolyse menthe


Market area: EU




 


Glosair 400 menthe


Market area: EU




Authorisation number


EU-0029752-0002 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


6,0 




Silver


 


Non-active substance


7440-22-4


231-131-3


0,0017 




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











Trade name(s)


Nocolyse nocodor


Market area: EU




 


Glosair 400 nocodor


Market area: EU




Authorisation number


EU-0029752-0003 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


6,0 




Silver


 


Non-active substance


7440-22-4


231-131-3


0,0017 





META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier







Identifier


Oxy'Pharm H2O2 12%




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 (%)




Min


Max




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


12,0 


12,0 




Silver


 


Non-active substance


7440-22-4


231-131-3


0,0017 


0,0017 




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
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.
Avoid release to the environment.
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.
Immediately call a doctor.
Dispose of contents to hazardous or special waste collection point in accordance with national regulations.
Dispose of container to hazardous or special waste collection point in accordance with national regulations.




4.   AUTHORISED USE(S) OF THE META SPC 2

4.1.   Use description


Table 2


Use # 1 – Use #2.1: Hard surface disinfection by 12% Fogging Hydrogen Peroxide (FHP)







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


-




Target organism(s) (including development stage)


Scientific name: -
Common name: Bacteria
Development stage: -
Scientific name: -
Common name: Yeasts
Development stage: -
Scientific name: -
Common name: bacterial spores
Development stage: -
Scientific name: -
Common name: Tuberculosis bacilli
Development stage: -
Scientific name: -
Common name: Viruses
Development stage: -
Scientific name: -
Common name: Fungi
Development stage: -




Field(s) of use


Indoor
Room disinfection with FHP for rooms with volumes between 4-150 m3. It involves disinfection of hard non-porous surfaces of equipment and material (excluding medical devices) present in the treated room:






—


Hospitals & clinics,










—


laboratories of research and analysis (including P3 laboratories and white rooms),










—


healthcare transport,










—


pharmaceutical industry,










—


industrial laundries,










—


dental surgery and implantology centres,










—


hotels,










—


schools,










—


day nurseries.








Application method(s)


Method: Fogging
Detailed description:
The product is a ready-to-use product that is placed in a device. That device automatically fogs the biocidal product, in the closed space/room to be disinfected, without any user or bystander present.




Application rate(s) and frequency


Application Rate:






—


Bactericidal, yeasticidal, fungicidal, sporicidal and virucidal activity: 3 ml product/m3 and 2 hours contact time. Treat a second time at 3 ml product/m3 and 2 hours contact time.










—


Tuberculocidal activity: 5 ml product/m3 and 2 hours contact time. Treat a second time at 3 ml product/m3 and 2 hours contact time.




The second treatment takes place right after the first. The two treatments can be programmed in order to be carried out sequentially.
Droplet size: 1-15 μm
Dilution (%): -
Number and timing of application:
Disinfect rooms and equipment as frequently as required by the hygiene protocol in place.




Category(ies) of users


Professional




Pack sizes and packaging material








1)


HDPE, white (non-transparent) bottle of 1 litre with a degassing screw cap.










2)


HDPE, grey (non-transparent) single-use bottle of 2 litres.










3)


HDPE, white (non-transparent) can of 5 litres (refill packaging).










4)


HDPE, white (non-transparent) can of 20 litres.








4.1.1.   Use-specific instructions for use

Surfaces must be cleaned before disinfection. The product is ready-to-use and should be used without dilution. The product is designed for equipment such as Nocospray/Bio-sanitizer/Sanofog/Nocomax/Nocomax Easy/Glosair. Read the instructions for use before use. Use according to the following protocols:






—


Bactericidal, yeasticidal, fungicidal, sporicidal and virucidal activity: 3 ml product/m3 and 2 hours contact time. Treat a second time at 3 ml product/m3 and 2 hours contact time.










—


Tuberculocidal activity: 5 ml product/m3 and 2 hours contact time. Treat a second time at 3 ml product/m3 and 2 hours contact time.




The second treatment takes place right after the first. The two treatments can be programmed in order to be carried out sequentially.






 


Droplet size: 1-15 μm










 


Relative humidity: 25% - 75%










 


Temperature: room temperature




Respect the contact time. The contact time starts when the required amount of product is present in the room.
The user shall always 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.
4.1.2.   Use-specific risk mitigation measures

Please refer to general directions for use of this Meta SPC.
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

First aid
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: IF symptoms occur 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.
Likely direct or indirect effects
-
Causes serious eye irritation
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to general directions for use of this Meta SPC.
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to general directions for use of this Meta SPC.
5.   GENERAL DIRECTIONS FOR USE (2)
OF THE META SPC 2

5.1.   Instructions for use

-
5.2.   Risk mitigation measures

During the diffusion, keep the room closed and do not enter. Treatment must be conducted with no human or animals present.
All gaps present in the room (for example, window frames) from where fog may leak must be sealed before the diffusion.
Ensure that access to the fog-treated area is denied during the whole procedure with a warning sign.
No access to the treated areas should be permitted until the concentration of hydrogen peroxide is ≤0,9 ppm (1,25 mg/m3) or a lower relevant national reference value.
The professional user may enter the room only in emergency situations when the hydrogen peroxide level has dropped below 36 ppm (50 mg/m3) and must wear the following PPE: RPE classified under EN 14387 or equivalent with APF 40 (Type of RPE to be specified by the authorisation holder within the product information) and suitable protective equipment (gloves classified under European Standard EN 374 or equivalent, eye protection consistent with European Standard EN ISO 16321 or equivalent, coverall). Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards.
A measuring device should be used to ensure that the concentration of hydrogen peroxide has decreased below 0,9 ppm or a lower relevant national reference value. Unprotected persons/animals may re-enter the treated room only after the hydrogen peroxide concentration in air decreases lower than 1,25 mg/m3 (0,9 ppm) or a lower relevant national reference value.
Individual protective equipment:
Wear chemical resistant goggles consistent with European Standard EN ISO 16321 or equivalent as eye protection during mixing and loading of the product to the packaging that is directly used in the fogging device (such as Nocospray, Bio-sanitizer, Sanofog, Nocomax or Nocomax Easy).
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

At the end of the treatment, dispose of unused product and the packaging in accordance with local regulations. Used product can be flushed to the municipal sewer or disposed of to the manure deposit depending on local regulations. Avoid release to an individual wastewater treatment plant.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage







—


Shelf life: 2 years.




6.   OTHER INFORMATION

The full titles of the EN standards referenced section 5.2 are:






 


EN ISO 16321 - Eye and face protection for occupational users










 


EN 374 – Protective gloves against dangerous chemicals and micro-organisms










 


EN 14387 - Respiratory protective devices - Gas filter(s) and combined filter(s) - Requirements, testing, marking




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)


Nocolyse One Shot


Market area: EU




 


Nocolyse +


Market area: EU




Glosair 600


Market area: EU




Authorisation number


EU-0029752-0004 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


12,0 




Silver


 


Non-active substance


7440-22-4


231-131-3


0,0017 




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











Trade name(s)


Nocolyse One Shot menthe


Market area: EU




 


Nocolyse + menthe


Market area: EU




Glosair 600 menthe


Market area: EU




Authorisation number


EU-0029752-0005 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


12,0 




Silver


 


Non-active substance


7440-22-4


231-131-3


0,0017 




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











Trade name(s)


Nocolyse One Shot nocodor


Market area: EU




 


Nocolyse + nocodor


Market area: EU




Glosair 600 nocodor


Market area: EU




Authorisation number


EU-0029752-0006 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


12,0 




Silver


 


Non-active substance


7440-22-4


231-131-3


0,0017 





META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier







Identifier


Oxy'Pharm H2O2 7.9%




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)
PT04 - Food and feed area (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 (%)




Min


Max




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


7,9 


7,9 




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


Causes serious eye irritation.




Precautionary statements


Wash hands thoroughly after handling.
Wear eye protection.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
If eye irritation persists: Get medical advice.




4.   AUTHORISED USE(S) OF THE META SPC 3

4.1.   Use description


Table 3


Use # 1 – Use #3.1: Hard surface disinfection by 7.9% Fogging Hydrogen Peroxide (FHP)







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


 




Target organism(s) (including development stage)


Scientific name: -
Common name: Bacteria
Development stage: -
Scientific name: -
Common name: yeasts
Development stage: -
Scientific name: -
Common name: Bacterial spores
Development stage:
Scientific name: -
Common name: Mycobacteria
Development stage: -
Scientific name: -
Common name: Viruses
Development stage: -
Scientific name: -
Common name: Fungi
Development stage: -




Field(s) of use


Indoor
Room disinfection with FHP for rooms with volumes between 4-150 m3. It involves disinfection of hard non-porous surfaces of equipment and material (excluding medical devices) present in the treated room:






—


Hospitals & clinics,










—


laboratories of research and analysis (including P3 laboratories and white rooms),










—


healthcare transport,










—


pharmaceutical industry,










—


industrial laundries,










—


dental surgery and implantology centres,










—


transport vehicles










—


hotels,










—


restaurants,










—


schools,










—


day nurseries,










—


veterinary clinics.








Application method(s)


Method: Fogging
Detailed description:
The product is a ready-to-use product that is placed in a device. That device automatically fogs the biocidal product, in the closed space/room to be disinfected, without any user or bystander present.




Application rate(s) and frequency


Application Rate:






—


Bactericidal, yeasticidal, fungicidal, sporicidal, and virucidal activity: 5 ml product/m3 and 2 hours contact time.










—


Mycobactericidal activity (log reduction ≥ 4): 7 ml product/m3 and 2 hours contact time.




Droplet size: 1-15 μm
Dilution (%): -
Number and timing of application:
Disinfect rooms and equipment as frequently as required by the hygiene protocol in place.




Category(ies) of users


Professional




Pack sizes and packaging material








1)


HDPE, white (non-transparent) bottle of 1 litre with a degassing screw cap.










2)


HDPE, grey (non-transparent) single-use bottle of 2 litres.










3)


HDPE, white (non-transparent) can of 5 litres (refill packaging).










4)


HDPE, white (non-transparent) can of 20 litres.








4.1.1.   Use-specific instructions for use

Surfaces must be cleaned before disinfection. The product is ready-to-use and should be used without dilution. The product is designed for equipment such as Nocospray/Bio-sanitizer/Sanofog/Nocomax/Nocomax Easy/Glosair. Read the instructions for use before use. Use according to the following protocols:






—


Bactericidal, yeasticidal, fungicidal, sporicidal, and virucidal activity: 5 ml product/m3 and 2 hours contact time.










—


Mycobactericidal activity (log reduction ≥ 4): 7 ml product/m3 and 2 hours contact time.






—


Droplet size: 1-15 μm










—


Relative humidity: 25 % - 75 %










—


Temperature: room temperature








Respect the contact time. The contact time starts when the required amount of product is present in the room.
The user shall always 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.
4.1.2.   Use-specific risk mitigation measures

Please refer to general directions for use of this Meta SPC.
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

First aid
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.
IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: If symptoms occur call a POISON CENTRE or a doctor
Likely direct or indirect effects






—


Causes severe eye irritation




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

Please refer to general directions for use of this Meta SPC.
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to general directions for use of this Meta SPC.
4.2.   Use description


Table 4


Use # 2 – Use #3.3: Hard surface disinfection by Fogging Hydrogen Peroxide (FHP)







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: -
Common name: Bacteria
Development stage: -
Scientific name: -
Common name: Yeasts
Development stage: -
Scientific name: -
Common name: Bacterial spores
Development stage: -
Scientific name: -
Common name: Mycobacteria
Development stage: -
Scientific name: -
Common name: Viruses
Development stage: -
Scientific name: -
Common name: bacteriophages
Development stage: -
Scientific name: -
Common name: Fungi
Development stage: -




Field(s) of use


Indoor
Room disinfection with FHP disinfection of hard non-porous surfaces of equipment and material present in the treated room of a size between 4-150 m3:






—


food industries,










—


central kitchens,










—


restaurants.








Application method(s)


Method: Fogging
Detailed description:
The product is a ready-to-use product that is placed in a device. That device automatically fogs the biocidal product, in the closed space/room to be disinfected, without any user or bystander present.




Application rate(s) and frequency


Application Rate:






—


Bactericidal, bacteriophagicidal, yeasticidal, fungicidal, sporicidal, and virucidal activity: 5 ml product/m3 and 2 hours contact time.










—


Mycobactericidal activity (log reduction ≥ 4): 7 ml product/m3 and 2 hours contact time.




Droplet size: 1-15 μm
Dilution (%): -
Number and timing of application:
Disinfect rooms and equipment as frequently as required by the hygiene protocol in place.




Category(ies) of users


Professional




Pack sizes and packaging material








1)


HDPE, white (non-transparent) bottle of 1litre with a degassing screw cap.










2)


HDPE, grey (non-transparent) single-use bottle of 2 litres.










3)


HDPE, white (non-transparent) can of 5 litres (refill packaging).










4)


HDPE, white (non-transparent) can of 20 litres.








4.2.1.   Use-specific instructions for use

Surfaces must be cleaned before disinfection. The product is ready-to-use and should be used without dilution. The product is designed for equipment such as Nocospray/Bio-sanitizer/Sanofog/Nocomax/Nocomax Easy/Glosair. Read the instructions for use before use. Use according to the following protocols:






—


Bactericidal, bacteriophagicidal, yeasticidal, fungicidal, sporicidal and virucidal activity: 5 ml product/m3 and 2 hours contact time.










—


Mycobactericidal activity: 7 ml product/m3 and 2 hours contact time.






—


droplet size: 1-15 μm










—


Relative humidity: 25 % - 75 %










—


Temperature: room temperature








Respect the contact time. The contact time starts when the required amount of product is present in the room. The user shall always 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.
4.2.2.   Use-specific risk mitigation measures

Please refer to general directions for use of this Meta SPC.
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

First aid
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.
IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: If symptoms occur call a POISON CENTRE or a doctor
Likely direct or indirect effects






—


Causes severe eye irritation




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

Please refer to general directions for use of this Meta SPC.
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to general directions for use of this Meta SPC.
5.   GENERAL DIRECTIONS FOR USE (3)
OF THE META SPC 3

5.1.   Instructions for use

-
5.2.   Risk mitigation measures

During the diffusion, keep the room closed and do not enter in. Treatment must be conducted with no human or animals present.
All gaps present in the room (for example, window frames) from where fog may leak must be sealed before the diffusion.
Ensure that access to the fog-treated area is denied during the whole procedure with a warning sign.
No access to the treated areas should be permitted until the concentration of hydrogen peroxide is ≤0,9 ppm (1,25 mg/m3) or a lower relevant national reference value.
The professional user may enter the room only in emergency situations when the hydrogen peroxide level has dropped below 36ppm (50 mg/m3) and must wear the following PPE: RPE classified under EN 14387 or equivalent with APF 40 (Type of RPE to be specified by the authorisation holder within the product information) and suitable protective equipment (gloves classified under European Standard EN 374 or equivalent, eye protection consistent with European Standard EN ISO 16321 or equivalent, coverall). Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards.
A measuring device should be used to ensure that the concentration of hydrogen peroxide has decreased below 0,9 ppm or a lower relevant national reference value. Unprotected persons/animals may re-enter the treated room only after the hydrogen peroxide concentration in air decreases lower than 1,25 mg/m3 (0,9 ppm) or a lower relevant national reference value.
Individual protective equipment:
Wear chemical resistant goggles consistent with European Standard EN ISO 16321 or equivalent as eye protection during mixing and loading of the product to the packaging that is directly used in the fogging device (such as Nocospray, Bio-sanitizer, Sanofog, Nocomax or Nocomax Easy).
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

At the end of the treatment, dispose of unused product and the packaging in accordance with local regulations. Used product can be flushed to the municipal sewer or disposed of to the manure deposit depending on local regulations. Avoid release to an individual wastewater treatment plant.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage







—


Shelf life: 2 years.




6.   OTHER INFORMATION

The full titles of the EN standards referenced in section 5.2 are:






 


EN ISO 16321 - Eye and face protection for occupational users










 


EN 374 – Protective gloves against chemicals and micro-organisms










 


EN 14387 - Respiratory protective devices - Gas filter(s) and combined filter(s) - Requirements, testing, marking




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)


Nocolyse Food


Market area: EU




 


Glosair 500


Market area: EU




Authorisation number


EU-0029752-0007 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


7,9 






(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.

(2)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.

(3)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.