Commission Implementing Regulation (EU) 2022/964 of 10 June 2022 granting a Union authorisation for the biocidal product family ‘SOPUROXID’ (Text with EEA relevance)
Date: 2022-06-10
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, decontamination, market approval, pharmaceutical product








L_2022166EN.01000101.xml










22.6.2022   


EN


Official Journal of the European Union


L 166/1








            COMMISSION IMPLEMENTING REGULATION (EU) 2022/964
of 10 June 2022
         
granting a Union authorisation for the biocidal product family ‘SOPUROXID’
         
(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 first subparagraph of Article 44(5) thereof,

Whereas:







(1)


On 1 September 2017, SOPURA N.V. submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘SOPUROXID’ of product-types 2, 3 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Belgium had agreed to evaluate the application. The application was recorded under case number BC-KV033704-17 in the Register for Biocidal Products.












(2)


‘SOPUROXID’ contains peracetic acid, 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.












(3)


On 27 August 2020, 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 31 March 2021, the Agency submitted to the Commission an opinion (2), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘SOPUROXID’ 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 ‘SOPUROXID’ 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 28 April 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 ‘SOPUROXID’.












(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-0026179-0000 is granted to SOPURA N.V. for the making available on the market and use of the biocidal product family ‘SOPUROXID’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 12 July 2022 until 30 June 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, 10 June 2022.


For the Commission


The President

Ursula VON DER LEYEN
            





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

(2)  ECHA opinion of 4 March 2021 on the Union authorisation of ‘SOPUROXID’ (ECHA/BPC/279/2021), https://echa.europa.eu/bpc-opinions-on-union-authorisation




ANNEX
Summary of product characteristics for a biocidal product family
SOPUROXID
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-0026179-0000
R4BP asset number: EU-0026179-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION
1.1.   Family name







Name


SOPUROXID




1.2.   Product type(s)







Product type(s)


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




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


SOPURA




Address


rue de Trazegnies 199, 6180 COURCELLES Belgium




Authorisation number


EU-0026179-0000





R4BP asset number



EU-0026179-0000




Date of the authorisation


12 July 2022




Expiry date of the authorisation


30 June 2032




1.4.   Manufacturer(s) of the biocidal products







Name of manufacturer


SOPURA N.V.




Address of manufacturer


Rue de Trazegnies 199, 6180 COURCELLES Belgium




Location of manufacturing sites


Rue de Trazegnies 199, 6180 COURCELLES Belgium













Name of manufacturer


SOPURA QUIMICA




Address of manufacturer


Poligon "La Canaleta", Avinguda Júpiter 7, 25300 TARREGA Spain




Location of manufacturing sites


Poligon "La Canaleta", Avinguda Júpiter 7, 25300 TARREGA Spain













Name of manufacturer


HYPRED SAS (KERSIA Group)




Address of manufacturer


55, Boulevard Jules Verger (BP 10180), 35803 DINARD France




Location of manufacturing sites


55, Boulevard Jules Verger (BP 10180), 35803 DINARD France
Niepruszewo, ul. Kasztanowa, 64-320 Buk Poland




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







Active substance


Peracetic acid




Name of manufacturer


SOPURA N.V.




Address of manufacturer


Rue de Trazegnies 199, 6180 COURCELLES Belgium




Location of manufacturing sites


Rue de Trazegnies 199, 6180 COURCELLES Belgium













Active substance


Peracetic acid




Name of manufacturer


SOPURA QUIMICA




Address of manufacturer


Poligon "La Canaleta", Avinguda Júpiter 7, 25300 TARREGA Spain




Location of manufacturing sites


Poligon "La Canaleta", Avinguda Júpiter 7, 25300 TARREGA Spain













Active substance


Peracetic acid




Name of manufacturer


HYPRED SAS (KERSIA Group)




Address of manufacturer


55, Boulevard Jules Verger (BP 10180), 35803 DINARD France




Location of manufacturing sites


55, Boulevard Jules Verger (BP 10180), 35803 DINARD France
Niepruszewo, ul. Kasztanowa, 64-320 Buk Poland




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




Peracetic acid


 


Active Substance


79-21-0


201-186-8


3,2 


15,0 




Sulphuric acid


 


Non-active substance


7664-93-9


231-639-5


0,2 


24,04 




Hydrogen peroxide


 


Non-active substance


7722-84-1


231-765-0


16,5 


23,5 




Acetic acid


 


Non-active substance


64-19-7


200-580-7


5,5 


16,7 




2.2.   Type(s) of formulation







Formulation(s)


SL - Soluble concentrate




PART II

SECOND INFORMATION LEVEL - META SPC(S)


META SPC 1

1.   META SPC 1 ADMINISTRATIVE INFORMATION
1.1.   Meta SPC 1 identifier







Identifier


Meta SPC1




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)
PT03 - Veterinary hygiene (Disinfectants)
PT04 - Food and feed area (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




Peracetic acid


 


Active Substance


79-21-0


201-186-8


5,0 


5,0 




Sulphuric acid


 


Non-active substance


7664-93-9


231-639-5


0,2 


24,04 




Hydrogen peroxide


 


Non-active substance


7722-84-1


231-765-0


16,5 


22,0 




Acetic acid


 


Non-active substance


64-19-7


200-580-7


5,5 


9,55 




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







Formulation(s)


SL - Soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1






Hazard statements


May intensify fire; oxidiser
May be corrosive to metals.
Harmful if swallowed. Harmful in contact with skin. Harmful if inhaled.
Causes severe skin burns and eye damage.
Causes serious eye damage.
May cause respiratory irritation.
Very toxic to aquatic life with long lasting effects.




Precautionary statements


Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.
Wear protective gloves.
Wear eye protection.
Wear face protection.
IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Immediately call a POISON CENTER/doctor.
Take any precaution to avoid mixing with combustibles.
Avoid breathing vapours.
Wash hands thoroughly after handling.
Do not eat, drink or smoke when using this product.
Use only outdoors or in a well-ventilated area.
Specific treatment (see information on this label).
Rinse mouth.
Wash contaminated clothing before reuse.
IF SWALLOWED: Call a POISON CENTER/doctor if you feel unwell.
IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
IF ON SKIN: Wash with plenty of water.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
Take off immediately all contaminated clothing. And wash it before reuse.
Store locked up.
Store in a well-ventilated place. Keep container tightly closed.
Dispose of contents to in accordance with local/regional/national/international regulations.
Wear protective clothing.
Dispose of container to in accordance with local/regional/national/international regulations.
Keep cool.
Avoid release to the environment.
Collect spillage.
IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with shower.
Avoid breathing spray.
Do not breathe spray.
Do not breathe vapours.




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


Table 1


Use # 1 – Disinfection of surfaces in industrial, public and non-medical healthcare areas - manual treatment (mopping)







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)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In Industrial, public and non-medical healthcare areas:
Disinfection of hard/non-porous surfaces by manual treatment (mopping) with prior cleaning




Application method(s)


Method: Manual treatment (mopping).
Detailed description:
Diluted product is applied by mopping with the appropriate tool (e.g. flat mop or cleaning cloths).
After application, the diluted product is drained.




Application rate(s) and frequency


Application Rate: -
Dilution (%): Against bacteria and yeasts: Non-medical healthcare areas With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) at Room Temperature in 5 min contact time. Application rate: 20 mL/m2 Use other than in HEALTHCARE With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature. Application rate: 30 mL/m2

Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.1.1.   Use-specific instructions for use

Items to be disinfected by mopping have to stay sufficiently wet during the required contact time to allow optimal disinfection.
4.1.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing and loading.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 20 is mandatory during the application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Re-entry is only permitted once the air concentrations of peracetic acid and hydrogen peroxide have dropped below the respective reference values (AEC). 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 (specified by the authorization holder).
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 2


Use # 2 – Disinfection of surfaces in industrial, public and non-medical healthcare areas. - manual treatment (spraying)







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)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In Industrial, public and non-medical healthcare areas:
Disinfection of hard/non-porous surfaces by manual treatment (spraying) with prior cleaning




Application method(s)


Method: Manual treatment (spraying)
Detailed description:
Diluted product is applied by spraying using a small spraying can




Application rate(s) and frequency


Application Rate: -
Dilution (%): Against bacteria and yeasts: Non-medical healthcare areas: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) at Room Temperature in 5 min contact time. Application rate: 20 mL/m2. Use other than in HEALTHCARE With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature. Application rate: 30 mL/m2.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.2.1.   Use-specific instructions for use

See general directions for use
4.2.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during the application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance.

                              “The treated surface should not be allowed to dry prior to rinsing.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
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.
4.3.   Use description


Table 3


Use # 3 – Clean in Place (CIP) in the pharmaceutical and cosmetic industry







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)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In pharmaceutical and cosmetic industry:
Disinfection of hard/non-porous surfaces by CIP procedures (with circulation) with prior cleaning




Application method(s)


Method: By CIP procedure
Detailed description:
Diluted product does automatically circulate from the CIP holding tanks through closed pipework and installations.
After the disinfection procedure, the vessels (pipework and tanks) are drained and rinsed with water under closed system conditions.




Application rate(s) and frequency


Application Rate: -
Dilution (%): Against bacteria and yeasts: With 0,032 % PAA (Dilution of the product at 0,64 % i.e. 640 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.3.1.   Use-specific instructions for use

See general directions for use
4.3.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing & loading phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.
Rinse the pump and disconnect it from the installation before maintenance”
4.3.3.   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.
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.3.5.   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.
4.4.   Use description


Table 4


Use # 4 – Surface disinfection in greenhouses via spraying by user with personal enclosure (in absence of plants - for general hygiene purpose only)







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)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In greenhouses:
Disinfection of hard/non-porous surfaces by spraying




Application method(s)


Method: Open system: spray treatment
Detailed description:
Diluted product is automatically applied in all directions via a spraying device
The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device)




Application rate(s) and frequency


Application Rate: Between 20 and 200 mL/m2

Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.4.1.   Use-specific instructions for use

See general directions for use.
4.4.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing & loading phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading and application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
The application should only take place with the user in a personal enclosure and no other person is present.
Rinse the pump and disconnect it from the installation before maintenance”
                           

                              “The treated surface should not be allowed to dry prior to rinsing”.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
4.4.3.   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.
4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.4.5.   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.
4.5.   Use description


Table 5


Use # 5 – Surface disinfection in greenhouses via spraying by user without personal enclosure (in absence of plants - for general hygiene purpose only)







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)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In greenhouses:
Disinfection of hard/non-porous surfaces by spraying




Application method(s)


Method: Open system: spray treatment
Detailed description:
Diluted product is automatically applied in all directions via a spraying device.




Application rate(s) and frequency


Application Rate: Between 20 and 200 mL/m2

Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.5.1.   Use-specific instructions for use
See general directions for use.
4.5.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance

                              “The treated surface should not be allowed to dry prior to rinsing”.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
4.5.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

See general directions for use.
4.5.5.   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.
4.6.   Use description


Table 6


Use # 6 – Disinfection of agriculture & horticulture equipment by soaking (in absence of plants - for general hygiene purpose only)







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)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In agriculture/horticulture areas:
Disinfection of hard/non-porous surfaces/equipment (small parts such as equipment, spare parts, tools, valves, hoses, ..) by immersion in soaking baths with prior cleaning.




Application method(s)


Method: Open system: immersion
Detailed description:
The concentrated product is pumped in a soaking bath and diluted to the desired use concentration, before immersion of items to be disinfected




Application rate(s) and frequency


Application Rate: -
Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.6.1.   Use-specific instructions for use

See general directions for use.
4.6.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase.
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post-application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance”
4.6.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

See general directions for use.
4.6.5.   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.
4.7.   Use description


Table 7


Use # 7 – Disinfection of surfaces and agriculture/horticulture equipment by spraying (in absence of plants - for general hygiene purpose only)







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)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In agriculture/horticulture areas:
Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning




Application method(s)


Method: Open system: spray treatment
Detailed description:
The diluted product is manually sprayed on the surfaces/equipment using spraying equipment. Spraying is only applied downwards and in a horizontal direction.




Application rate(s) and frequency


Application Rate: Between 20 and 200 mL/m2

Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.7.1.   Use-specific instructions for use

See general directions for use.
4.7.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 20 is mandatory during the application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.
Rinse the pump and disconnect it from the installation before maintenance”
The treated surface should not be allowed to dry prior to rinsing.
4.7.3.   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.
4.7.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.7.5.   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.
4.8.   Use description


Table 8


Use # 8 – Disinfection of surfaces and agriculture/horticulture equipment by automatic spraying (in absence of plants - for general hygiene purpose only)







Product type


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




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In agriculture/horticulture areas:
Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning




Application method(s)


Method: Spraying
Detailed description:
Diluted product is applied by spraying in an automated way
Spraying is only applied downwards and in a horizontal direction.




Application rate(s) and frequency


Application Rate: -
Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 60 min contact time
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.8.1.   Use-specific instructions for use

See general directions for use.
4.8.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.
The application is automatic and should only take place when no one is present in the treated area.
Rinse the pump and disconnect it from the installation before maintenance”
The treated surface should not be allowed to dry prior to rinsing.
4.8.3.   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.
4.8.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.8.5.   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.
4.9.   Use description


Table 9


Use # 9 – Disinfection of surfaces and agriculture/horticulture equipment by automatic spraying (closed room) (in absence of plants - for general hygiene purpose only)







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)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In agriculture/horticulture areas:
Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning




Application method(s)


Method: By spraying.
Detailed description:
Diluted product is applied by spraying in an automated way without any operator being present




Application rate(s) and frequency


Application Rate: -
Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.9.1.   Use-specific instructions for use

See general directions for use.
4.9.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing & loading phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.
The application is automatic and should only take place when no one is present in the treated area.
Rinse the pump and disconnect it from the installation before maintenance”
The treated surface should not be allowed to dry prior to rinsing.
4.9.3.   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.
4.9.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.9.5.   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.
4.10.   Use description


Table 10


Use # 10 – Disinfection of animal housing – via low-pressure spraying by user with personal enclosure







Product type


PT03 - Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


.




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Viruses
Development stage:




Field(s) of use


Indoor
In animal housing:
Disinfection of hard/non-porous surfaces by spraying with prior cleaning




Application method(s)


Method: Spraying
Detailed description:
Diluted product is automatically applied in all directions by low-pressure manual spraying via a spraying device
The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device)




Application rate(s) and frequency


Application Rate: Between 20 and 300 mL/m2

Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280  mL/100 L) in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.10.1.   Use-specific instructions for use

It has to be assured that animals are not present when treatment takes place.
4.10.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading and application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
The application should only take place with the user in a personal enclosure and no other person is present.
Rinse the pump and disconnect it from the installation before maintenance”

                              “The treated surface should not be allowed to dry prior to rinsing”.
Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
4.10.3.   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.
4.10.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.10.5.   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.
4.11.   Use description


Table 11


Use # 11 – Disinfection of animal housing via low-pressure manual spraying by user without personal enclosure







Product type


PT03 - Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


.




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Viruses
Development stage:




Field(s) of use


Indoor
In animal housing:
Disinfection of hard/non-porous surfaces by spraying with prior cleaning




Application method(s)


Method: Open system: spray treatment
Detailed description:
Diluted product is automatically applied in all directions by low-pressure automatic spraying via a spraying device




Application rate(s) and frequency


Application Rate: Between 20 and 300 mL/m2

Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 1,28 % i.e.1 280  mL/100 L) in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.11.1.   Use-specific instructions for use

It has to be assured that animals are not present when treatment takes place.
4.11.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance”

                              “The treated surface should not be allowed to dry prior to rinsing”.
Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
4.11.3.   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.
4.11.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.11.5.   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.
4.12.   Use description


Table 12


Use # 12 – Disinfection of boots in footbaths in animal housing/husbandries







Product type


PT03 - Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Viruses
Development stage:




Field(s) of use


Indoor
in animal housing/husbandries:
Disinfection of boots by dipping (not for walk-through) with prior cleaning.




Application method(s)


Method: Dipping
Detailed description:
Diluted product is put in the footbath
No rinse needed




Application rate(s) and frequency


Application Rate: -
Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280  mL/100 L) in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.12.1.   Use-specific instructions for use

See general directions for use.
4.12.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase.
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post-application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
4.12.3.   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.
4.12.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.12.5.   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.
4.13.   Use description


Table 13


Use # 13 – Disinfection of equipment by dipping







Product type


PT03 - Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


.




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Viruses
Development stage:




Field(s) of use


Indoor
Disinfection of hard/non-porous surfaces/equipment (small parts such as equipment, spare parts, tools, valves, hoses, ..) by immersion in soaking baths with prior cleaning




Application method(s)


Method: Soaking.
Detailed description:
The concentrated product is pumped in a soaking bath and diluted to the desired use concentration, before immersion of items to be disinfected




Application rate(s) and frequency


Application Rate: -
Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280  mL/100 L) in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.13.1.   Use-specific instructions for use

See general directions for use.
4.13.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase.
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post-application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance
4.13.3.   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.
4.13.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.13.5.   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.
4.14.   Use description


Table 14


Use # 14 – Disinfection in Aseptic Filling Lines (crown corks, cheese moulds and food crates) - Automated spraying closed systems







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


.




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Bacterial spores
Development stage:
Common name: Viruses
Development stage:
Common name: Bacteriophages
Development stage:




Field(s) of use


Indoor
In food and beverage industry:
Disinfection of hard/non-porous surfaces by spraying with prior cleaning




Application method(s)


Method: Spraying
Detailed description:
Diluted product is sprayed on the surfaces in an automated way without any operator being present




Application rate(s) and frequency


Application Rate: -
Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280  mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.14.1.   Use-specific instructions for use

See general directions for use.
4.14.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.
The application is automatic and should only take place when no one is present in the treated area.
Rinse the pump and disconnect it from the installation before maintenance
The treated surface should not be allowed to dry prior to rinsing.
4.14.3.   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.
4.14.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.14.5.   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.
4.15.   Use description


Table 15


Use # 15 – Disinfection of equipment in the food and beverage industry by immersion







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Bacterial spores
Development stage:
Common name: Viruses
Development stage:
Common name: Bacteriophages
Development stage:




Field(s) of use


Indoor
In food and beverage industry:
Disinfection of hard/non-porous surfaces (small parts such as equipment, spare parts, tools, valves, hoses, ..) by immersion in soaking baths with prior cleaning




Application method(s)


Method: Soaking.
Detailed description:
The concentrated product is pumped in a soaking bath and diluted to the desired use concentration, before immersion of items to be disinfected




Application rate(s) and frequency


Application Rate: -
Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280  mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.15.1.   Use-specific instructions for use

See general directions for use.
4.15.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase.
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post-application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
4.15.3.   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.
4.15.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.15.5.   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.
4.16.   Use description



Table 16



Use # 16 – Disinfection of heat and ion exchangers, membrane filters and glass and PET bottles – CIP procedures







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


.




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Bacterial spores
Development stage:
Common name: Viruses
Development stage:
Common name: Bacteriophages
Development stage:




Field(s) of use


Indoor
In food and beverage industry:
Disinfection of hard/non-porous surfaces by CIP procedures (with circulation) with prior cleaning




Application method(s)


Method: Closed system
Detailed description:
Diluted product does automatically circulate from the CIP holding tanks through closed pipework and installations.
After the disinfection procedure, the vessels (pipework and tanks) are drained and rinsed with water under closed system conditions.




Application rate(s) and frequency


Application Rate: -
Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280  mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.16.1.   Use-specific instructions for use

See general directions for use.
4.16.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing & loading phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.
Rinse the pump and disconnect it from the installation before maintenance
4.16.3.   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.
4.16.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.16.5.   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.
4.17.   Use description

Table 17


Use # 17 – Disinfection of surfaces and equipment by low pressure spraying – spraying with personal enclosure







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Bacterial spores
Development stage:
Common name: Viruses
Development stage:
Common name: bacteriophages
Development stage:




Field(s) of use


Indoor
In food industry:
Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning




Application method(s)


Method: Spraying
Detailed description:
Diluted product is automatically applied in all directions by low-pressure spraying via a spraying device
The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device).




Application rate(s) and frequency


Application Rate: Between 20 and 200 mL/m2

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280  mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.17.1.   Use-specific instructions for use

See general directions for use.
4.17.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading and application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.
The application should only take place with the user in a personal enclosure and no other person is present.
Rinse the pump and disconnect it from the installation before maintenance”
The treated surface should not be allowed to dry prior to rinsing.
4.17.3.   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.
4.17.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.17.5.   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.
4.18.   Use description


Table 18


Use # 18 – Disinfection of surfaces and equipment by low pressure spraying – spraying without personal enclosure







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Bacterial spores
Development stage:
Common name: Viruses
Development stage:
Common name: Bacteriophages
Development stage:




Field(s) of use


Indoor
In food industry:
Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning




Application method(s)


Method: Spraying
Detailed description:

Diluted product is automatically applied in all directions by low-pressure spraying via a spraying device.





Application rate(s) and frequency


Application Rate: Between 20 and 200 mL/m2

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280  mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.18.1.   Use-specific instructions for use

See general directions for use.
4.18.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.
Rinse the pump and disconnect it from the installation before maintenance
The treated surface should not be allowed to dry prior to rinsing.
4.18.3.   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.
4.18.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.18.5.   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.
4.19.   Use description


Table 19


Use # 19 – Disinfection of surfaces and equipment by low pressure spraying, manually







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


.




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Bacterial spores
Development stage:
Common name: Viruses
Development stage:
Common name: Bacteriophages
Development stage:




Field(s) of use


Indoor
In food industry:
Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning




Application method(s)


Method: Manual application - spraying.
Detailed description:
Diluted product is manually applied by low-pressure spraying, only downwards and horizontal.




Application rate(s) and frequency


Application Rate: Between 20 and 200 mL/m2

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280  mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.19.1.   Use-specific instructions for use

See general directions for use.
4.19.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 20 is mandatory during the application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.
Rinse the pump and disconnect it from the installation before maintenance”
The treated surface should not be allowed to dry prior to rinsing.
4.19.3.   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.
4.19.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.19.5.   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.
4.20.   Use description


Table 20


Use # 20 – Disinfection of surfaces and equipment by low pressure spraying, automatically







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Bacterial spores
Development stage:
Common name: Viruses
Development stage:
Common name: Bacteriophages
Development stage:




Field(s) of use


Indoor
In food industry:
Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning




Application method(s)


Method: Spraying
Detailed description:
The diluted product is sprayed on the equipment, on conveyor belt, automatically.
The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device).
Spraying is only applied downwards and in a horizontal direction.




Application rate(s) and frequency


Application Rate: Between 20 and 200 mL/m2

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280  mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.20.1.   Use-specific instructions for use

See general directions for use.
.
4.20.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
RPE are not mandatory during the application phase, on the condition that the operator remains in the control room and do not enter the treated area.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.
The application is automatic and should only take place when no one is present in the treated area.
Rinse the pump and disconnect it from the installation before maintenance”
The treated surface should not be allowed to dry prior to rinsing.
4.20.3.   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.
4.20.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.20.5.   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.
4.21.   Use description


Table 21


Use # 21 – Disinfection of surfaces and equipment by low pressure spraying – automatic spraying (closed room)







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Bacterial spores
Development stage:
Common name: Viruses
Development stage:
Common name: Bacteriophages
Development stage:




Field(s) of use


Indoor
In food industry:
Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning




Application method(s)


Method: Spraying
Detailed description:
The diluted solution is sprayed on the surfaces in an automated way without any user being present.




Application rate(s) and frequency


Application Rate: Between 20 and 200 mL/m2

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280  mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.21.1.   Use-specific instructions for use

See general directions for use.
4.21.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) is not mandatory during the application phase, on condition that the operator do not enter the treated area and remains in the control room.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.
Rinse the pump and disconnect it from the installation before maintenance”
The treated surface should not be allowed to dry prior to rinsing.
4.21.3.   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.
4.21.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.21.5.   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.
4.22.   Use description


Table 22


Use # 22 – Disinfection of inner surfaces (pipelines, tanks, vessels, …) by CIP







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Bacterial spores
Development stage:
Common name: Viruses
Development stage:
Common name: Bacteriophages
Development stage:




Field(s) of use


Indoor
In food industry:
Disinfection of hard/non-porous surfaces by CIP procedures (with circulation) with prior cleaning




Application method(s)


Method: Closed system
Detailed description:
Diluted product does automatically circulate from the CIP holding tanks through closed pipework and installations.
After the disinfection procedure, the vessels (pipework and tanks) are drained and rinsed with water under closed system conditions.




Application rate(s) and frequency


Application Rate: -
Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280  mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.22.1.   Use-specific instructions for use

See general directions for use.
4.22.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing & loading phase.
Respiratory protection:
Rinse the pump and disconnect it from the installation before maintenance”
Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.
4.22.3.   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.
4.22.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.22.5.   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.
4.23.   Use description


Table 23


Use # 23 – Disinfection of water used for rinsing of recycled items during the washing process







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In food industry:
Disinfection of water (in clean conditions) used for rinsing of recycled items = Water from drinking water quality shortly stored in tanks until use to rinse items such as bottles. The water should be disinfected to avoid recontamination and in an extent to avoid cross-contamination of inner bottle surfaces




Application method(s)


Method: Closed system
Detailed description:
Concentrated product will be pumped into a reservoir from which it is continuously dosed into the water stream.
Dilution of the product to the intended in-use concentration occurs in the water stream.
This application is a closed, automated process.




Application rate(s) and frequency


Application Rate: -
Dilution (%): Against bacteria and yeasts: With 0.008 % PAA (Dilution of the product at 0.16 % i.e. 160 mL/100 L) at Room Temperature in 15 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.23.1.   Use-specific instructions for use

See general directions for use.
4.23.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection: Not mandatory.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance”
4.23.3.   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.
4.23.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.23.5.   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









1.


All the surfaces to be disinfected must be cleaned before the disinfection procedure












2.


Disinfection cycle:






—


Products must be diluted in potable water before use.










—


Dilution rate & contact time depends on the use considered. Please refer to the description of application method related to each use.










—


Final rinsing (with potable water) is mandatory: after the disinfection procedure, treated surfaces are rinsed with water and the water is drained into the sewer system. For exceptions, please refer to the description of application method related to each use.




Only for use in areas that are inaccessible to the general public and companion animals.
No access for the general public during treatment.
Disinfection procedures by CIP: Final rinsing step (with potable water).
After the disinfection procedure, CIP vessels (pipework and tanks) are drained and rinsed with water under closed system conditions
Disinfection procedures by dipping: The bath is not intended to be re-used. Use the bath only once a day after work & replace it by a fresh solution daily.
Disinfection procedures by spraying: the surfaces to be disinfected must be wet enough in order to keep them wet during the required contact time for optimal disinfection. Then, the user should pay attention to wet surfaces completely with the disinfectant solution.
The Application Rate for spraying of diluted product must be between 20 and 30 mL/m2





5.2.   Risk mitigation measures

Dermal protection:
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 which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information).
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment


Indirect effects

The two theoretical products are oxidising agents and reactive. In case of thermal decomposition steam and oxygen will be released as decomposition products. The release of oxygen may support combustion.
Also, contact with impurities, decomposition catalysts, metallic salts, alkalis, reducing agents may lead to self-accelerated, exothermic decomposition and the formation of oxygen.
In case of decomposition of the products in confined spaces and pipers, there is a risk of overpressure and burst.

First aid measures

Ø   General advice

Move out of dangerous area.
Take care of your own personal safety.
Take off immediately all contaminated clothing.
Ø   Inhalation

Take affected persons out into the fresh air.
Possible discomfort: Irritates skin and mucous linings of the eyes and respiratory tract and cough.
If breathing difficulties occur (e.g. severe continual coughing): Keep patient half sitting with upper body raised; keep warm and in a quiet place; call a physician immediately.
Ø   Skin contact

After contact with skin, wash immediately with plenty of water.
Consult a physician.
Take off immediately all contaminated clothing.
Immediately rinse contaminated or saturated clothing with water.
Ø   Eye contact

With eye held open, thoroughly rinse immediately with plenty of water for at least 10 minutes.
Protect unharmed eye.
Continue rinsing process with eye rinsing solution.
Call ambulance (caustic burn of the eyes)
Immediate further treatment in ophthalmic hospital/ophthalmologist.
Continue rinsing eye until arrival at ophthalmic hospital.
Ø   Ingestion

Do not induce vomiting.
Danger of penetration of the lungs (danger to breathing) when swallowed or vomited, due to gas evolution and foam formation.
Only when patient fully conscious: have the mouth rinsed with water; have the patient drink plenty of water in small sips; keep patient warm and at rest.
Notify ambulance immediately (key word: acid burn).
Ø   Notes to physician

Therapy as for chemical burn.
Following inhalation:
Formation of a toxic lung oedema is possible if product continues to be inhaled despite acute irritative effect (e.g. if it is not possible to leave the danger area).
Prophylaxis of a toxic lung oedema with inhalative steroids (dosing spray, e.g. auxilosone).
If substance has been swallowed:
Aspiration hazard.
Risk of gaseous embolisms.
In case of excessive strain on the stomach due to gas evolution, insert siphon tube.
Early endoscopy in order to assess mucosa lesions in the oesophagus and stomach which may appear.
If necessary, suck away leftover substance.
Do not administer activated charcoal, since risk of release of large amounts of gas from hydrogen peroxide.

Emergency measures to protect the environment

Observe regulations on prevention of water pollution (collect, dam up, cover up).
Do not allow to run into water channels, surface water or into the ground.
Ø   Methods for cleaning up

Clean contaminated surface thoroughly; recommended cleaning agent is water.
In case of small spills, dilute product with lots of water and rinse away or absorb product with liquid-binding material, e.g. chemi-sorption, diatomaceous earth, universal binder. Do not use textiles, saw dust, combustible substances. After binding, pick up mechanically and collect in suitable containers. Dispose of absorbed material in accordance with the regulations.
Ø   Additional advice

Make safe or remove all sources of ignition.
Isolate defective containers immediately, if possible and safe to do.
Shut off leak, if possible and safe to do.
Place defective containers in waste receptacle (waste packaging receptacle) made of plastic (not metal).
Do not seal defective containers or waste receptacles airtight (danger of bursting due to product decomposition).
Product taken out should not be returned into container.
Never return spilled product into its original container for re-use (risk of decomposition).
5.4.   Instructions for safe disposal of the product and its packaging

Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains
Dispose of unused product, its packaging and all other waste, in accordance with local regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep only in the original packaging tightly closed in a cool and well-ventilated place Keep products away from direct sunlight, source of heat and ignition
The shelf life of the biocidal product is 6 months.
The products must be stored at temperatures below + 30 °C.
6.   OTHER INFORMATION
Reference values of peracetic acid and hydrogen peroxide used for the risk assessment:

PAA: AECinhal = 0,5 mg/m3


HP: AECinhal = 1,25 mg/m3

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)


SOPUROXID 5


Market area: EU




 


HyPro Biocide 5-22


Market area: EU




AGRIOXID 5


Market area: EU




TECMA CUAR HPA


Market area: EU




Authorisation number


EU-0026179-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Peracetic acid


 


Active Substance


79-21-0


201-186-8


5,0 




Sulphuric acid


 


Non-active substance


7664-93-9


231-639-5


0,2 




Hydrogen peroxide


 


Non-active substance


7722-84-1


231-765-0


22,0 




Acetic acid


 


Non-active substance


64-19-7


200-580-7


9,55 




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












Trade name(s)


SOPUROXID 5C


Market area: EU




 


DEPTIL TR 5


Market area: EU




DIS OXI-5+


Market area: EU




ANTI-GERM DES OXI-50 TC


Market area: EU




Peracid ATR +


Market area: EU




FOR-Acid TR +


Market area: EU




X-CID TR 50 +


Market area: EU




Authorisation number


EU-0026179-0002 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Peracetic acid


 


Active Substance


79-21-0


201-186-8


5,0 




Sulphuric acid


 


Non-active substance


7664-93-9


231-639-5


24,04 




Hydrogen peroxide


 


Non-active substance


7722-84-1


231-765-0


16,5 




Acetic acid


 


Non-active substance


64-19-7


200-580-7


5,8 





META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION
1.1.   Meta SPC 2 identifier







Identifier


Meta SPC2




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)
PT04 - Food and feed area (Disinfectants)
PT03 - Veterinary hygiene (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




Peracetic acid


 


Active Substance


79-21-0


201-186-8


3,2 


3,2 




Sulphuric acid


 


Non-active substance


7664-93-9


231-639-5


0,8 


1,0 




Hydrogen peroxide


 


Non-active substance


7722-84-1


231-765-0


23,5 


23,5 




Acetic acid


 


Non-active substance


64-19-7


200-580-7


6,45 


7,5 




2.2.   Type(s) of formulation of the meta SPC 2







Formulation(s)


SL - Soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2






Hazard statements


May intensify fire; oxidiser
May be corrosive to metals.
Causes severe skin burns and eye damage.
Causes serious eye damage.
May cause respiratory irritation.
Very toxic to aquatic life with long lasting effects.
Harmful if swallowed. Harmful in contact with skin.




Precautionary statements


Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.
Wear face protection.
IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Immediately call a POISON CENTER/doctor.
Wear eye protection.
Wear protective gloves.
Take any precaution to avoid mixing with combustibles.
Avoid breathing vapours.
Wash hands thoroughly after handling.
Do not eat, drink or smoke when using this product.
Use only outdoors or in a well-ventilated area.
Specific treatment (see information on this label).
Rinse mouth.
Wash contaminated clothing before reuse.
IF SWALLOWED: Call a POISON CENTER/doctor if you feel unwell.
IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
IF ON SKIN: Wash with plenty of water.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
Take off contaminated clothing. And wash it before reuse.
Store locked up.
Store in a well-ventilated place. Keep container tightly closed.
Dispose of contents to in accordance with local/regional/national/international regulations.
Wear protective clothing.
Dispose of container to in accordance with local/regional/national/international regulations.
Keep cool.
Avoid release to the environment.
Collect spillage.
IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with shower.
Avoid breathing spray.
Do not breathe spray.
Do not breathe vapours.




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


Table 24


Use # 1 – Room Disinfection by fogging - In industrial, public and non-medical healthcare areas. (pharmaceutical and cosmetic industry)







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)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Bacterial spores
Development stage:




Field(s) of use


Indoor
In industrial, public and non-medical healthcare areas:
Disinfection of hard/non-porous surfaces by fogging.




Application method(s)


Method: Fogging
Detailed description:
By fogging with the diluted product




Application rate(s) and frequency


Application Rate: -
Dilution (%): Active against bacteria (including bacterial spores) and yeasts: With 5,6 mL/m3 (Dilution of the product at 40 % i.e. 40 L/100 L i.e. 1,28 % PAA) at Room Temperature in 2h contact time (after diffusion)
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.1.1.   Use-specific instructions for use

See general directions for use.
4.1.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
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 25


Use # 2 – Room Disinfection by fogging - In agriculture & horticulture areas (in absence of plants - for general hygiene purpose only)







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)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In agriculture/horticulture areas:
Disinfection of hard/non-porous surfaces by fogging with prior cleaning




Application method(s)


Method: Fogging
Detailed description:
By fogging with the diluted product




Application rate(s) and frequency


Application Rate: -
Dilution (%): Against bacteria and yeasts: With 5,6 mL/m3 (Dilution of the product at 40 % i.e. 40 L/100 L i.e. 1,28 % PAA) at Room Temperature in 2h contact time (after diffusion)
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.2.1.   Use-specific instructions for use

See general directions for use.
4.2.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing & loading.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
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.
4.3.   Use description


Table 26


Use # 3 – Room Disinfection by fogging – In animal housing







Product type


PT03 - Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


.




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In animal housing:
Disinfection of hard/non-porous surfaces by fogging with prior cleaning




Application method(s)


Method: Fogging
Detailed description:
By fogging with the diluted product




Application rate(s) and frequency


Application Rate: -
Dilution (%): Against bacteria and yeasts: With 5,6 mL/m3 (Dilution of the product at 40 % i.e. 40 L/100 L i.e. 1,28 % PAA) at Room Temperature in 2h contact time (after diffusion)
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.3.1.   Use-specific instructions for use

See general directions for use.
4.3.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing & loading.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance.
Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
4.3.3.   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.
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.3.5.   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.
4.4.   Use description


Table 27


Use # 4 – Room Disinfection by fogging – In storage rooms with special device in storage cellar or room







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


..




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Bacterial spores
Development stage:




Field(s) of use


Indoor
In food/feed areas (storage rooms):
Disinfection of hard/non-porous surfaces by fogging.




Application method(s)


Method: Fogging
Detailed description:
By fogging with the diluted product




Application rate(s) and frequency


Application Rate: -
Dilution (%): Active against bacteria (including bacterial spores) and yeasts With 5,6 mL/m3 (Dilution of the product at 40 % i.e. 40 L/100 L i.e. 1,28 % PAA) at Room Temperature in 2h contact time (after diffusion)
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.4.1.   Use-specific instructions for use

See general directions for use.
4.4.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing & loading.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
4.4.3.   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.
4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.4.5.   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









1.


All the surfaces to be disinfected must be cleaned before the disinfection procedure.
For exceptions, please refer to the description of application method related to each use.












2.


Disinfection cycle:






—


Products must be diluted in potable water before use.










—


Dilution rate & contact time depends on the use considered. Please refer to the description of application method related to each use.










—


Final rinsing (with potable water) is mandatory: after the disinfection procedure, treated surfaces are rinsed with water and the water is drained into the sewer system. For exceptions, please refer to the description of application method related to each use.




Meta SPC2: Disinfection procedures by fogging
The product SOPUROXID 3.2 is a liquid disinfectant to be applied (after dilution at 40 %) by fogging for airborne surface disinfection and to be used indoor by professional users only.
Always check compatibility of the products with the hard/non-porous surfaces to be disinfected.
The product SOPUROXID 3.2 has been developed and demonstrated as efficacious (via efficacy studies performed according to the NF T 72 281 standard), using one device HYSPRAY, for rooms with a volume between 30 & 150 m3 (volume per application and per device) with a flow rate of 0,047 mL/min/m3.
The use of other devices is possible. They must be designed to work with PAA-based products and to ensure a fog production able to stay suspended in the air and provided that these devices meet following characteristics:






1)


Particle (medium droplet) size: between 1 and 15 μm










2)


Flow rate: 0,047 mL/min/m3











3)


Application rate: 5,6 mL/m3











4)


Room volume between 30 and 150 m3 per application and per device (i.e. diffusion time between 5 and 30 min)






—


Airborne disinfection should be done only after thorough cleaning and rinsing.




The surfaces to be disinfected should be dried before the disinfection procedure. Please pay attention to open the cupboard doors. Please check the temperature and the relative room humidity (to be set between 40 and 80 %) to obtain an optimal level for the product efficiency.






—


The room where the fogging activity takes place is tightly sealed during fogging, no user is present:




Before the start of the disinfection cycle by fogging, the treated room is sealed. All the safety tasks for the implementation of decontamination are entrusted to an user who has completed the necessary training. Among them, first step is shutting down the air handling units and closing the air intake and return, so the product is not spread in the other rooms. The door or doors to the outside of the area are then locked and, if the joints are not tight enough, they are taped to seal. An orange tape, or bright colour, is preferably chosen to attract attention and a sign "Access ban, room disinfection in progress" is put on. Only for use in areas that are inaccessible to the general public and companion animals”.






—


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. Each device or specific installation is systematically validated when it is set up.












5.2.   Risk mitigation measures

Dermal protection:
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 which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information).
+ Additional specific RMM for fogging applications:






 


Only for use in areas that are inaccessible to the general public and companion animals.






—


After disinfection product’s application by fogging & required contact time for optimal disinfection (2h), the room must be ventilated, preferably by mechanical ventilation at least for 60 min.








The duration of the ventilation period has to be established by measurement with suitable measurement equipment (specified by the authorisation holder within the product information).






—


After ventilation, re-entry in the disinfected area is only permitted after the air concentrations of peracetic acid and hydrogen peroxide have been checked and seen as dropped below the respective reference values (AEC):










—


The air concentration of PAA must have dropped to 0,5 mg/m3.




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


Indirect effects

The two products are oxidising agents and reactive. In case of thermal decomposition steam and oxygen will be released as decomposition products. The release of oxygen may support combustion.
Also, contact with impurities, decomposition catalysts, metallic salts, alkalis, reducing agents may lead to self-accelerated, exothermic decomposition and the formation of oxygen.
In case of decomposition of the products in confined spaces and pipers, there is a risk of overpressure and burst.

First aid measures

Ø   General advice

Move out of dangerous area.
Take care of your own personal safety.
Take off immediately all contaminated clothing.
Ø   Inhalation

Take affected persons out into the fresh air.
Possible discomfort: Irritates skin and mucous linings of the eyes and respiratory tract and cough.
If breathing difficulties occur (e.g. severe continual coughing): Keep patient half sitting with upper body raised; keep warm and in a quiet place; call a physician immediately.
Ø   Skin contact

After contact with skin, wash immediately with plenty of water.
Consult a physician.
Take off immediately all contaminated clothing.
Immediately rinse contaminated or saturated clothing with water.
Ø   Eye contact

With eye held open, thoroughly rinse immediately with plenty of water for at least 10 minutes.
Protect unharmed eye.
Continue rinsing process with eye rinsing solution.
Call ambulance (caustic burn of the eyes)
Immediate further treatment in ophthalmic hospital/ophthalmologist.
Continue rinsing eye until arrival at ophthalmic hospital.
Ø   Ingestion

Do not induce vomiting.
Danger of penetration of the lungs (danger to breathing) when swallowed or vomited, due to gas evolution and foam formation.
Only when patient fully conscious: have the mouth rinsed with water; have the patient drink plenty of water in small sips; keep patient warm and at rest.
Notify ambulance immediately (key word: acid burn).
Ø   Notes to physician

Therapy as for chemical burn.
Following inhalation:
Formation of a toxic lung oedema is possible if product continues to be inhaled despite acute irritative effect (e.g. if it is not possible to leave the danger area).
Prophylaxis of a toxic lung oedema with inhalative steroids (dosing spray, e.g. auxilosone).
If substance has been swallowed:
Aspiration hazard.
Risk of gaseous embolisms.
In case of excessive strain on the stomach due to gas evolution, insert siphon tube.
Early endoscopy in order to assess mucosa lesions in the oesophagus and stomach which may appear.
If necessary, suck away leftover substance.
Do not administer activated charcoal, since risk of release of large amounts of gas from hydrogen peroxide.

Emergency measures to protect the environment

Observe regulations on prevention of water pollution (collect, dam up, cover up).
Do not allow to run into water channels, surface water or into the ground.
Ø   Methods for cleaning up

Clean contaminated surface thoroughly; recommended cleaning agent is water.
In case of small spills, dilute product with lots of water and rinse away or absorb product with liquid-binding material, e.g. chemi-sorption, diatomaceous earth, universal binder. Do not use textiles, saw dust, combustible substances. After binding, pick up mechanically and collect in suitable containers. Dispose of absorbed material in accordance with the regulations.
Ø   Additional advice

Make safe or remove all sources of ignition.
Isolate defective containers immediately, if possible and safe to do.
Shut off leak, if possible and safe to do.
Place defective containers in waste receptacle (waste packaging receptacle) made of plastic (not metal).
Do not seal defective containers or waste receptacles airtight (danger of bursting due to product decomposition).
Product taken out should not be returned into container.
Never return spilled product into its original container for re-use (risk of decomposition).
5.4.   Instructions for safe disposal of the product and its packaging

Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains
Dispose of unused product, its packaging and all other waste, in accordance with local regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep only in the original packaging tightly closed in a cool and well-ventilated place Keep products away from direct sunlight, source of heat and ignition
The shelf life of the biocidal product is 6 months.
The products must be stored at temperatures below + 30 °C.
6.   OTHER INFORMATION
Reference values of peracetic acid and hydrogen peroxide used for the risk assessment:

PAA: AECinhal = 0,5 mg/m3


HP: AECinhal = 1,25 mg/m3

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)


SOPUROXID 3.2


Market area: EU




 


HyPro Biocide 3.2-23


Market area: EU




Authorisation number


EU-0026179-0003 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Peracetic acid


 


Active Substance


79-21-0


201-186-8


3,2 




Sulphuric acid


 


Non-active substance


7664-93-9


231-639-5


0,8 




Hydrogen peroxide


 


Non-active substance


7722-84-1


231-765-0


23,5 




Acetic acid


 


Non-active substance


64-19-7


200-580-7


6,45 





META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION
1.1.   Meta SPC 3 identifier







Identifier


Meta SPC3




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)
PT03 - Veterinary hygiene (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




Peracetic acid


 


Active Substance


79-21-0


201-186-8


3,2 


3,2 




Sulphuric acid


 


Non-active substance


7664-93-9


231-639-5


0,6 


1,0 




Hydrogen peroxide


 


Non-active substance


7722-84-1


231-765-0


23,5 


23,5 




Acetic acid


 


Non-active substance


64-19-7


200-580-7


5,5 


7,1 




2.2.   Type(s) of formulation of the meta SPC 3







Formulation(s)


SL - Soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3






Hazard statements


May intensify fire; oxidiser
May be corrosive to metals.
Harmful if swallowed. Harmful in contact with skin.
Causes severe skin burns and eye damage.
Causes serious eye damage.
May cause respiratory irritation.
Very toxic to aquatic life with long lasting effects.




Precautionary statements


Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.
Wear protective gloves.
Wear face protection.
Wear eye protection.
IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Immediately call a POISON CENTER/doctor.
Take any precaution to avoid mixing with combustibles.
Avoid breathing vapours.
Wash hands thoroughly after handling.
Do not eat, drink or smoke when using this product.
Use only outdoors or in a well-ventilated area.
Specific treatment (see information on this label).
Rinse mouth.
Wash contaminated clothing before reuse.
IF SWALLOWED: Call a POISON CENTER/doctor if you feel unwell.
IF ON SKIN: Wash with plenty of water.
IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
Take off immediately all contaminated clothing. And wash it before reuse.
Store locked up.
Store in a well-ventilated place. Keep container tightly closed.
Dispose of contents to in accordance with local/regional/national/international regulations.
Wear protective clothing.
Dispose of container to in accordance with local/regional/national/international regulations.
Keep cool.
Avoid release to the environment.
Collect spillage.
IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with shower.
Avoid breathing spray.
Do not breathe vapours.
Do not breathe vapours.




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


Table 28


Use # 1 – Disinfection of surfaces in industrial, public and non-medical healthcare areas. – foam application on surfaces







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)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In industrial, public and non-medical healthcare areas:
Disinfection of hard/non-porous surfaces by foaming with prior cleaning




Application method(s)


Method: Foam application
Detailed description:
By foaming via a small foaming can with the diluted product




Application rate(s) and frequency


Application Rate: -
Dilution (%): Against bacteria and yeasts: Non-medical healthcare areas With 0,048 % PAA (Dilution of the product at 1.5 % i.e. 1500 mL/100 L) at Room Temperature in 5 min contact time. Application rate: 20 mL/m2 Use other than in HEALTHCARE With 0,048 % PAA (Dilution of the product at 1.5 % i.e. 1 500  mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature. Application rate: 30 mL/m2

Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.1.1.   Use-specific instructions for use

See general directions for use.
4.1.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance”

                                          “The treated surface should not be allowed to dry prior to rinsing”.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
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 29


Use # 2 – Disinfection of surfaces and agriculture/horticulture equipment by foaming, manually (in absence of plants - for general hygiene purpose only)







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)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In agriculture/horticulture areas:
Disinfection of hard/non-porous surfaces/equipment by foaming with prior cleaning




Application method(s)


Method: Foam application
Detailed description:
By foaming via a small foaming can with the diluted product
Foaming is only applied downwards and in a horizontal direction.




Application rate(s) and frequency


Application Rate: Between 20 and 200 mL/m2

Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 1.5 % i.e. 1 500  mL/100 L) in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.2.1.   Use-specific instructions for use

See general directions for use.
4.2.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance”

                                          “The treated surface should not be allowed to dry prior to rinsing”.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
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.
4.3.   Use description


Table 30


Use # 3 – Disinfection of surfaces and agriculture/horticulture equipment by automatic foaming (in absence of plants - for general hygiene purpose only)







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)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In agriculture/horticulture areas:
Disinfection of hard/non-porous surfaces/equipment by automatic foaming with prior cleaning




Application method(s)


Method: Foam application
Detailed description:
The diluted product is foamed on the equipment in an automated way while the user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device).
Foaming is only applied downwards and in a horizontal direction.




Application rate(s) and frequency


Application Rate: -
Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 1.5 % i.e. 1 500  mL/100 L) in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.3.1.   Use-specific instructions for use

See general directions for use.
4.3.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing & loading.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
The application is automatic and should only take place when no one is present in the treated area.
Rinse the pump and disconnect it from the installation before maintenance”

                                          “The treated surface should not be allowed to dry prior to rinsing”.
4.3.3.   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.
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.3.5.   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.
4.4.   Use description


Table 31


Use # 4 – Disinfection of surfaces and agriculture/horticulture equipment by automatic foaming (closed rooms) (in absence of plants - for general hygiene purpose only)







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)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In agriculture/horticulture areas:
Disinfection of hard/non-porous surfaces/equipment by automatic foaming with prior cleaning




Application method(s)


Method: Foam application
Detailed description:
The diluted product is foamed on the surfaces in an automated way without any user being present.




Application rate(s) and frequency


Application Rate: -
Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 1.5 % i.e. 1 500  mL/100 L) in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.4.1.   Use-specific instructions for use

See general directions for use.
4.4.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing & loading.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
The application is automatic and should only take place when no one is present in the treated area.
Rinse the pump and disconnect it from the installation before maintenance”

                                          “The treated surface should not be allowed to dry prior to rinsing”.
4.4.3.   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.
4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.4.5.   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.
4.5.   Use description


Table 32


Use # 5 – Disinfection of animal houses by foaming – foaming with personal enclosure







Product type


PT03 - Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


.




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Viruses
Development stage:




Field(s) of use


Indoor
In animal housing
Disinfection of hard/non-porous surfaces by foaming with prior cleaning




Application method(s)


Method: Foam application
Detailed description:
The diluted product is automatically foamed in all directions on the surfaces/walls, via a foaming device.
The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device)




Application rate(s) and frequency


Application Rate: -
Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 2 % i.e. 2 000  mL/100 L) in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.5.1.   Use-specific instructions for use

It has to be assured that animals are not present when treatment takes place.
4.5.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading and of a factor of 10 during the application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken
The application should only take place with the user in a personal enclosure and no other person is present.
Rinse the pump and disconnect it from the installation before maintenance”

                                          “The treated surface should not be allowed to dry prior to rinsing”.
Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
4.5.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

See general directions for use.
4.5.5.   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.
4.6.   Use description


Table 33


Use # 6 – Disinfection of animal houses by foaming – foaming without personal enclosure







Product type


PT03 - Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


.




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Viruses
Development stage:




Field(s) of use


Indoor
In animal housing
Disinfection of hard/non-porous surfaces by foaming with prior cleaning




Application method(s)


Method: Foam application
Detailed description:
The diluted product is automatically foamed on the surfaces/walls, in all directions, via a foaming device.




Application rate(s) and frequency


Application Rate: -
Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 2 % i.e. 2 000  mL/100 L) in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.6.1.   Use-specific instructions for use

It has to be assured that animals are not present when treatment takes place.
4.6.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance”

                                          “The treated surface should not be allowed to dry prior to rinsing”.
Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
4.6.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

See general directions for use.
4.6.5.   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.
4.7.   Use description


Table 34


Use # 7 – Disinfection of surfaces by foaming – foaming with personal enclosure







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


.




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Bacterial spores
Development stage:
Common name: Viruses
Development stage:
Common name: Bacteriophages
Development stage:




Field(s) of use


Indoor
In food industry:
Disinfection of hard/non-porous surfaces by foaming with prior cleaning




Application method(s)


Method: Foam application
Detailed description:
The diluted product is automatically foamed on the surfaces/walls, in all directions, via a foaming device.
The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device)




Application rate(s) and frequency


Application Rate: Between 20 and 200 mL/m2

Dilution (%): Against bacteria & yeasts: With 0,048 % PAA (Dilution of the product at 1.5 % i.e. 1 500  mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature. Against bacteria (including bacterial spores), yeasts and viruses (including bacteriophages): With 0,064 % PAA (Dilution of the product at 2 % i.e. 2 000  mL/100 L) at Room Temperature in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.7.1.   Use-specific instructions for use

See general directions for use.
4.7.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.
Respiratory protection with an APF of 10 is required during the application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
The application should only take place with the user in a personal enclosure and no other person is present.
Rinse the pump and disconnect it from the installation before maintenance”

                                          “The treated surface should not be allowed to dry prior to rinsing”.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
4.7.3.   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.
4.7.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.7.5.   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.
4.8.   Use description


Table 35


Use # 8 – Disinfection of surfaces by foaming – without personal enclosure







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


.




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Bacterial spores
Development stage:
Common name: Viruses
Development stage:
Common name: Bacteriophages
Development stage:




Field(s) of use


Indoor
Indoor – In food industry:
Disinfection of hard/non-porous surfaces by foaming with prior cleaning




Application method(s)


Method: Foam application
Detailed description:
The diluted product is automatically foamed on the surfaces/walls, in all directions, via a foaming device.




Application rate(s) and frequency


Application Rate: Between 20 and 200 mL/m2

Dilution (%): Against bacteria & yeasts: With 0,048 % PAA (Dilution of the product at 1.5 % i.e. 1 500  mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature. Against bacteria (including bacterial spores), yeasts and viruses (including bacteriophages): With 0,064 % PAA (Dilution of the product at 2 % i.e. 2 000  mL/100 L) at Room Temperature in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.8.1.   Use-specific instructions for use

See general directions for use.
4.8.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance”

                                          “The treated surface should not be allowed to dry prior to rinsing”.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
4.8.3.   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.
4.8.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.8.5.   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









1.


All the surfaces to be disinfected must be cleaned before the disinfection procedure












2.


Disinfection cycle:






—


Products must be diluted in potable water before use.










—


Dilution rate & contact time depends on the use considered. Please refer to the description of application method related to each use.










—


Final rinsing (with potable water) is mandatory: after the disinfection procedure, treated surfaces are rinsed with water and the water is drained into the sewer system. For exceptions, please refer to the description of application method related to each use.





Meta SPC 3: Disinfection procedures by foaming

Only for use in areas that are inaccessible to the general public and companion animals.
No access for the general public during treatment.
The surfaces to be disinfected must be wet enough in order to keep them wet during the required contact time for optimal disinfection. Then, the user should pay attention to wet surfaces completely with the disinfectant solution.




5.2.   Risk mitigation measures

Dermal protection:
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 which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information).
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment


Indirect effects

The two products are oxidising agents and reactive. In case of thermal decomposition steam and oxygen will be released as decomposition products. The release of oxygen may support combustion.
Also, contact with impurities, decomposition catalysts, metallic salts, alkalis, reducing agents may lead to self-accelerated, exothermic decomposition and the formation of oxygen.
In case of decomposition of the products in confined spaces and pipers, there is a risk of overpressure and burst.

First aid measures

Ø   General advice

Move out of dangerous area.
Take care of your own personal safety.
Take off immediately all contaminated clothing.
Ø   Inhalation

Take affected persons out into the fresh air.
Possible discomfort: Irritates skin and mucous linings of the eyes and respiratory tract and cough.
If breathing difficulties occur (e.g. severe continual coughing): Keep patient half sitting with upper body raised; keep warm and in a quiet place; call a physician immediately.
Ø   Skin contact

After contact with skin, wash immediately with plenty of water.
Consult a physician.
Take off immediately all contaminated clothing.
Immediately rinse contaminated or saturated clothing with water.
Ø   Eye contact

With eye held open, thoroughly rinse immediately with plenty of water for at least 10 minutes.
Protect unharmed eye.
Continue rinsing process with eye rinsing solution.
Call ambulance (caustic burn of the eyes)
Immediate further treatment in ophthalmic hospital/ophthalmologist.
Continue rinsing eye until arrival at ophthalmic hospital.
Ø   Ingestion

Do not induce vomiting.
Danger of penetration of the lungs (danger to breathing) when swallowed or vomited, due to gas evolution and foam formation.
Only when patient fully conscious: have the mouth rinsed with water; have the patient drink plenty of water in small sips; keep patient warm and at rest.
Notify ambulance immediately (key word: acid burn).
Ø   Notes to physician

Therapy as for chemical burn.
Following inhalation:
Formation of a toxic lung oedema is possible if product continues to be inhaled despite acute irritative effect (e.g. if it is not possible to leave the danger area).
Prophylaxis of a toxic lung oedema with inhalative steroids (dosing spray, e.g. auxilosone).
If substance has been swallowed:
Aspiration hazard.
Risk of gaseous embolisms.
In case of excessive strain on the stomach due to gas evolution, insert siphon tube.
Early endoscopy in order to assess mucosa lesions in the oesophagus and stomach which may appear.
If necessary, suck away leftover substance.
Do not administer activated charcoal, since risk of release of large amounts of gas from hydrogen peroxide.

Emergency measures to protect the environment

Observe regulations on prevention of water pollution (collect, dam up, cover up).
Do not allow to run into water channels, surface water or into the ground.
Ø   Methods for cleaning up

Clean contaminated surface thoroughly; recommended cleaning agent is water.
In case of small spills, dilute product with lots of water and rinse away or absorb product with liquid-binding material, e.g. chemi-sorption, diatomaceous earth, universal binder. Do not use textiles, saw dust, combustible substances. After binding, pick up mechanically and collect in suitable containers. Dispose of absorbed material in accordance with the regulations.
Ø   Additional advice

Make safe or remove all sources of ignition.
Isolate defective containers immediately, if possible and safe to do.
Shut off leak, if possible and safe to do.
Place defective containers in waste receptacle (waste packaging receptacle) made of plastic (not metal).
Do not seal defective containers or waste receptacles airtight (danger of bursting due to product decomposition).
Product taken out should not be returned into container.
Never return spilled product into its original container for re-use (risk of decomposition).
5.4.   Instructions for safe disposal of the product and its packaging

Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains
Dispose of unused product, its packaging and all other waste, in accordance with local regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep only in the original packaging tightly closed in a cool and well-ventilated place Keep products away from direct sunlight, source of heat and ignition
The shelf life of the biocidal product is 6 months.
The products must be stored at temperatures below + 30 °C.
6.   OTHER INFORMATION
Reference values of peracetic acid and hydrogen peroxide used for the risk assessment:

PAA: AECinhal = 0,5 mg/m3


HP: AECinhal = 1,25 mg/m3

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)


ACIDOFOAM CF


Market area: EU




 


HyPro Biocide 3.2-23a


Market area: EU




TECHMA OXI PB


Market area: EU




Authorisation number


EU-0026179-0004 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Peracetic acid


 


Active Substance


79-21-0


201-186-8


3,2 




Sulphuric acid


 


Non-active substance


7664-93-9


231-639-5


0,8 




Hydrogen peroxide


 


Non-active substance


7722-84-1


231-765-0


23,5 




Acetic acid


 


Non-active substance


64-19-7


200-580-7


6,1 





META SPC 4

1.   META SPC 4 ADMINISTRATIVE INFORMATION
1.1.   Meta SPC 4 identifier







Identifier


Meta SPC4




1.2.   Suffix to the authorisation number







Number


1-4




1.3.   Product type(s)







Product type(s)


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




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












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Peracetic acid


 


Active Substance


79-21-0


201-186-8


15,0 


15,0 




Sulphuric acid


 


Non-active substance


7664-93-9


231-639-5


0,78 


0,78 




Hydrogen peroxide


 


Non-active substance


7722-84-1


231-765-0


22,0 


22,0 




Acetic acid


 


Non-active substance


64-19-7


200-580-7


16,7 


16,7 




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







Formulation(s)


SL - Soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4






Hazard statements


Heating may cause a fire.
May be corrosive to metals.
Harmful if swallowed. Harmful if inhaled.
Causes severe skin burns and eye damage.
Causes serious eye damage.
May cause respiratory irritation.
Very toxic to aquatic life with long lasting effects.
Flammable liquid and vapour.
Toxic in contact with skin.




Precautionary statements


Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.
Wear protective gloves.
Wear eye protection.
Wear face protection.
IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Immediately call a POISON CENTER/doctor.
Take any precaution to avoid mixing with combustibles.
Avoid breathing vapours.
Wash hands thoroughly after handling.
Do not eat, drink or smoke when using this product.
Use only outdoors or in a well-ventilated area.
Specific treatment (see information on this label).
Rinse mouth.
Wash contaminated clothing before reuse.
IF SWALLOWED: Call a POISON CENTER/doctor if you feel unwell.
IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
IF ON SKIN: Wash with plenty of water.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
Take off immediately all contaminated clothing. And wash it before reuse.
Store locked up.
Store in a well-ventilated place. Keep container tightly closed.
Dispose of contents to local/regional/national/international regulations.
Wear protective clothing.
Dispose of container to local/regional/national/international regulations.
Keep cool.
Avoid release to the environment.
Collect spillage.
IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with shower.
Do not breathe spray.
Avoid breathing spray.
Do not breathe vapours.




4.   AUTHORISED USE(S) OF THE META SPC 4
4.1.   Use description


Table 36


Use # 1 – Disinfection of surfaces in industrial, public and non-medical healthcare areas. - manual treatment (mopping)







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)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In Industrial, public and non-medical healthcare areas:
Disinfection of hard/non-porous surfaces by manual treatment (mopping) with prior cleaning




Application method(s)


Method: Manual treatment (mopping).
Detailed description:
Diluted product is applied by mopping with the appropriate tool (e.g. flat mops or cleaning cloths).
After application, the diluted product is drained.




Application rate(s) and frequency


Application Rate: -
Dilution (%): Against bacteria and yeasts: Non-medical healthcare areas With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) at Room Temperature in 5 min contact time. Application rate: 20 mL/m2. Use other than in HEALTHCARE With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature. Application rate: 30 mL/m2.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.1.1.   Use-specific instructions for use

Items to be disinfected by mopping have to stay sufficiently wet during the required contact time to allow optimal disinfection.
4.1.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 20 is mandatory during the application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance”
Re-entry is only permitted once the air concentrations of peracetic acid and hydrogen peroxide have dropped below the respective reference values (AEC). 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 (specified by authorization holder).
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
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 37


Use # 2 – Disinfection of surfaces in industrial, public and non-medical healthcare areas. - manual treatment (spraying)







Product type


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




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In Industrial, public and non-medical healthcare areas:
Disinfection of hard/non-porous surfaces by manual treatment (spraying) with prior cleaning




Application method(s)


Method: Manual treatment (spraying)
Detailed description:
Diluted product is applied by spraying using a small spraying can.




Application rate(s) and frequency


Application Rate: -
Dilution (%): Against bacteria and yeasts: Non-medical healthcare areas With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) at Room Temperature in 5 min contact time. Application rate: 20 mL/m2. Use other than in HEALTHCARE With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature. Application rate: 30 mL/m2.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.2.1.   Use-specific instructions for use

See general directions for use.
4.2.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during the application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance”

                                                   “The treated surface should not be allowed to dry prior to rinsing”.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
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.
4.3.   Use description


Table 38


Use # 3 – Clean in Place (CIP) in the pharmaceutical and cosmetic industry







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)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In pharmaceutical and cosmetic industry:
Disinfection of hard/non-porous surfaces by CIP procedures (with circulation) with prior cleaning




Application method(s)


Method: By CIP procedure
Detailed description:

Diluted product does automatically circulate from the CIP holding tanks through closed pipework and installations.


After the disinfection procedure, the vessels (pipework and tanks) are drained and rinsed with water under closed system conditions.





Application rate(s) and frequency


Application Rate: -
Dilution (%): Against bacteria & yeasts: With 0,032 % PAA (Dilution of the product at 0.2133 % i.e.213.33 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.3.1.   Use-specific instructions for use

See general directions for use.
4.3.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.
Rinse the pump and disconnect it from the installation before maintenance.
4.3.3.   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.
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.3.5.   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.
4.4.   Use description


Table 39


Use # 4 – Surface disinfection in greenhouses via spraying by user with personal enclosure (in absence of plants - for general hygiene purpose only)







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)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In greenhouses:
Disinfection of hard/non-porous surfaces by spraying with prior cleaning




Application method(s)


Method: Open system: spray treatment
Detailed description:
Diluted product is automatically applied in all directions by spraying via a spraying device
The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device)




Application rate(s) and frequency


Application Rate: Between 20 and 200 mL/m2

Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.4.1.   Use-specific instructions for use

See general directions for use.
4.4.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading and the application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
The application should only take place with the user in a personal enclosure and no other person is present.
Rinse the pump and disconnect it from the installation before maintenance”

                                                   “The treated surface should not be allowed to dry prior to rinsing”.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
4.4.3.   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.
4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.4.5.   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.
4.5.   Use description


Table 40


Use # 5 – Surface disinfection in greenhouses via spraying by user without personal enclosure (in absence of plants - for general hygiene purpose only)







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)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In greenhouses:
Disinfection of hard/non-porous surfaces by spraying with prior cleaning




Application method(s)


Method: Open system: spray treatment
Detailed description:
Diluted product is automatically applied in all directions by spraying via a spraying device.




Application rate(s) and frequency


Application Rate: Between 20 and 200 mL/m2

Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.5.1.   Use-specific instructions for use

See general directions for use.
4.5.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance”

                                                   “The treated surface should not be allowed to dry prior to rinsing”.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
4.5.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

See general directions for use.
4.5.5.   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.
4.6.   Use description


Table 41


Use # 6 – Disinfection of agriculture & horticulture equipment by soaking (in absence of plants - for general hygiene purpose only)







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)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In agriculture/horticulture areas:
Disinfection of hard/non-porous surfaces/equipment (small parts such as equipment, spare parts, tools, valves, hoses, ..) by immersion in soaking baths with prior cleaning




Application method(s)


Method: Open system: immersion
Detailed description:
The concentrated product is pumped in a soaking bath and diluted to the desired use concentration, before immersion of items to be disinfected




Application rate(s) and frequency


Application Rate: -
Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.6.1.   Use-specific instructions for use

See general directions for use.
4.6.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase.
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post-application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance”
4.6.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

See general directions for use.
4.6.5.   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.
4.7.   Use description


Table 42


Use # 7 – Disinfection of surfaces and agriculture/horticulture equipment by spraying (in absence of plants - for general hygiene purpose only)







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)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In agriculture/horticulture areas:
Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning




Application method(s)


Method: Open system: spray treatment
Detailed description:
The diluted product is manually sprayed on the surfaces/equipment using spraying equipment. Spraying is only applied downwards and in a horizontal direction.




Application rate(s) and frequency


Application Rate: Between 20 and 200 mL/m2

Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.7.1.   Use-specific instructions for use

See general directions for use.
4.7.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 20 is mandatory during the application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance

                                                   “The treated surface should not be allowed to dry prior to rinsing”.
4.7.3.   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.
4.7.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.7.5.   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.
4.8.   Use description


Table 43


Use # 8 – Disinfection of surfaces and agriculture/horticulture equipment by automatic spraying (in absence of plants - for general hygiene purpose only)







Product type


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




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In agriculture/horticulture areas:
Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning




Application method(s)


Method: Spraying
Detailed description:
Diluted product is applied by spraying in an automated way
Spraying is only applied downwards and in a horizontal direction.




Application rate(s) and frequency


Application Rate: -
Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Pack sizes and packaging material
HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.8.1.   Use-specific instructions for use

See general directions for use.
4.8.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
The application is automatic and should only take place when no one is present in the treated area.
Rinse the pump and disconnect it from the installation before maintenance”

                                                   “The treated surface should not be allowed to dry prior to rinsing”.
4.8.3.   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.
4.8.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.8.5.   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.
4.9.   Use description


Table 44


Use # 9 – Disinfection of surfaces and agriculture/horticulture equipment by automatic spraying (closed room) (in absence of plants - for general hygiene purpose only)







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)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In agriculture/horticulture areas:
Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning




Application method(s)


Method: By spraying.
Detailed description:
Diluted product is applied by spraying in an automated way without any operator being present




Application rate(s) and frequency


Application Rate: -
Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.9.1.   Use-specific instructions for use

See general directions for use.
4.9.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
The application is automatic and should only take place when no one is present in the treated area.
Rinse the pump and disconnect it from the installation before maintenance”

                                                   “The treated surface should not be allowed to dry prior to rinsing”.
4.9.3.   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.
4.9.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.9.5.   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.
4.10.   Use description


Table 45


Use # 10 – Disinfection of animal housing via low-pressure spraying by user with personal enclosure







Product type


PT03 - Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


.




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Viruses
Development stage:




Field(s) of use


Indoor
In animal housing:
Disinfection of hard/non-porous surfaces by spraying with prior cleaning




Application method(s)


Method: Spraying
Detailed description:
Diluted product is automatically applied in all directions by low-pressure manual spraying via a spraying device.
The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device)




Application rate(s) and frequency


Application Rate: Between 20 and 300 mL/m2

Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 0.42 % i.e. 426.6 mL/100 L) in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.10.1.   Use-specific instructions for use

It has to be assured that animals are not present when treatment takes place.
4.10.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading and the application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
The application is automatic and should only take place when no one is present in the treated area.
Rinse the pump and disconnect it from the installation before maintenance”

                                                   “The treated surface should not be allowed to dry prior to rinsing”.
Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
4.10.3.   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.
4.10.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.10.5.   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.
4.11.   Use description


Table 46


Use # 11 – Disinfection of animal housing via low-pressure manual spraying by user without personal enclosure







Product type


PT03 - Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


.




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Viruses
Development stage:




Field(s) of use


Indoor
In animal housing:
Disinfection of hard/non-porous surfaces by spraying with prior cleaning




Application method(s)


Method: Open system: spray treatment
Detailed description:
Diluted product is automatically applied in all directions by low-pressure automatic spraying via a spraying device.




Application rate(s) and frequency


Application Rate: Between 20 and 300 mL/m2

Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 0.42 % i.e.426.6 mL/100 L) in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.11.1.   Use-specific instructions for use

It has to be assured that animals are not present when treatment takes place.
4.11.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance”

                                                   “The treated surface should not be allowed to dry prior to rinsing”.
Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
4.11.3.   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.
4.11.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.11.5.   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.
4.12.   Use description


Table 47


Use # 12 – Disinfection of boots in footbaths in animal houses/husbandries







Product type


PT03 - Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Viruses
Development stage:




Field(s) of use


Indoor
in animal housing/husbandries:
Disinfection of boots by dipping (not for walk-through) with prior cleaning.




Application method(s)


Method: Dipping
Detailed description:
Diluted product is put in the footbath
No rinse needed




Application rate(s) and frequency


Application Rate: -
Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 0.42 % i.e. 426.6 mL/100 L) in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.12.1.   Use-specific instructions for use

See general directions for use.
4.12.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase.
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post-application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance”.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
4.12.3.   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.
4.12.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.12.5.   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.
4.13.   Use description


Table 48


Use # 13 – Disinfection of equipment by dipping







Product type


PT03 - Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


.




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Viruses
Development stage:




Field(s) of use


Indoor
Disinfection of hard/non-porous surfaces/equipment (small parts such as equipment, spare parts, tools, valves, hoses, ..) by immersion in soaking baths with prior cleaning




Application method(s)


Method: Soaking.
Detailed description:
The concentrated product is pumped in a soaking bath and diluted to the desired use concentration, before immersion of items to be disinfected




Application rate(s) and frequency


Application Rate: -
Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 0.42 % i.e. 426.6 mL/100 L) in 60 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.13.1.   Use-specific instructions for use

See general directions for use.
4.13.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase.
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post-application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance.
4.13.3.   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.
4.13.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.13.5.   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.
4.14.   Use description


Table 49


Use # 14 – Disinfection in Aseptic Filling Lines (crown corks, cheese moulds and food crates) - Automated spraying closed systems







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


.




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Bacterial spores
Development stage:
Common name: Viruses
Development stage:
Common name: Bacteriophages
Development stage:




Field(s) of use


Indoor
In food and beverage industry:
Disinfection of hard/non-porous surfaces by spraying with prior cleaning




Application method(s)


Method: Spraying
Detailed description:
Diluted product is sprayed on the surfaces in an automated way without any user being present.




Application rate(s) and frequency


Application Rate: -
Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i.e.426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.14.1.   Use-specific instructions for use

See general directions for use.
4.14.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
The application is automatic and should only take place when no one is present in the treated area.
Rinse the pump and disconnect it from the installation before maintenance”

                                                   “The treated surface should not be allowed to dry prior to rinsing”.
4.14.3.   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.
4.14.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.14.5.   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.
4.15.   Use description


Table 50


Use # 15 – Disinfection of equipment in the food and beverage industry by immersion







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Bacterial spores
Development stage:
Common name: Viruses
Development stage:
Common name: Bacteriophages
Development stage:




Field(s) of use


Indoor
In food and beverage industry:
Disinfection of hard/non-porous surfaces/equipment (small parts such as equipment, spare parts, tools, valves, hoses, ..) by immersion in soaking baths with prior cleaning




Application method(s)


Method: Soaking.
Detailed description:
The concentrated product is pumped in a soaking bath and diluted to the desired use concentration, before immersion of items to be disinfected




Application rate(s) and frequency


Application Rate: -
Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i.e.426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.15.1.   Use-specific instructions for use

See general directions for use.
4.15.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase.
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post-application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance”
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
4.15.3.   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.
4.15.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.15.5.   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.
4.16.   Use description


Table 51


Use # 16 – Disinfection of heat and ion exchangers, membrane filters and glass and PET bottles – CIP procedures







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


.




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Bacterial spores
Development stage:
Common name: Viruses
Development stage:
Common name: Bacteriophages
Development stage:




Field(s) of use


Indoor
In food and beverage industry:
Disinfection of hard/non-porous surfaces by CIP procedures (with circulation) with prior cleaning




Application method(s)


Method: Closed system
Detailed description:
Diluted product does automatically circulate from the CIP holding tanks through closed pipework and installations.
After the disinfection procedure, the vessels (pipework and tanks) are drained and rinsed with water under closed system conditions.




Application rate(s) and frequency


Application Rate: -
Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i.e.426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.16.1.   Use-specific instructions for use

See general directions for use.
4.16.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing & loading.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.
Rinse the pump and disconnect it from the installation before maintenance”
4.16.3.   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.
4.16.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.16.5.   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.
4.17.   Use description


Table 52


Use # 17 – Disinfection of surfaces and equipment by low pressure spraying – spraying with personal enclosure







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


.




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Bacterial spores
Development stage:
Common name: Viruses
Development stage:
Common name: bacteriophages
Development stage:




Field(s) of use


Indoor
In food industry:
Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning




Application method(s)


Method: Spraying
Detailed description:
Diluted product is automatically applied in all directions by low-pressure spraying via a spraying device
The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device)




Application rate(s) and frequency


Application Rate: Between 20 and 200 mL/m2

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i.e. 426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.17.1.   Use-specific instructions for use

See general directions for use.
4.17.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading and the application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
The application should only take place with the user in a personal enclosure and no other person is present.
Rinse the pump and disconnect it from the installation before maintenance”

                                                   “The treated surface should not be allowed to dry prior to rinsing”.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
4.17.3.   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.
4.17.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.17.5.   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.
4.18.   Use description


Table 53


Use # 18 – Disinfection of surfaces and equipment by low pressure spraying – spraying without personal enclosure







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Bacterial spores
Development stage:
Common name: Viruses
Development stage:
Common name: Bacteriophages
Development stage:




Field(s) of use


Indoor
In food industry:
Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning




Application method(s)


Method: Spraying
Detailed description:
Diluted product is automatically applied in all directions by low-pressure spraying via a spraying device.




Application rate(s) and frequency


Application Rate: Between 20 and 200 mL/m2

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i.e. 426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.18.1.   Use-specific instructions for use

See general directions for use.
4.18.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning
Rinse the pump and disconnect it from the installation before maintenance”

                                                   “The treated surface should not be allowed to dry prior to rinsing”.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
4.18.3.   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.
4.18.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.18.5.   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.
4.19.   Use description


Table 54


Use # 19 – Disinfection of surfaces and equipment by low pressure spraying, manually







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


.




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Bacterial spores
Development stage:
Common name: Viruses
Development stage:
Common name: Bacteriophages
Development stage:




Field(s) of use


Indoor
In food industry:
Disinfection of hard/non-porous surfaces/equipment by low-pressure spraying with prior cleaning




Application method(s)


Method: Manual application - spraying.
Detailed description:
Diluted product is manually applied by low-pressure spraying, only downwards and horizontal.




Application rate(s) and frequency


Application Rate: Between 20 and 200 mL/m2

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i.e. 426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.19.1.   Use-specific instructions for use

See general directions for use.
4.19.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 20 is mandatory during the application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.
Rinse the pump and disconnect it from the installation before maintenance”

                                                   “The treated surface should not be allowed to dry prior to rinsing”.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
4.19.3.   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.
4.19.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.19.5.   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.
4.20.   Use description


Table 55


Use # 20 – Disinfection of surfaces and equipment by low pressure spraying, automatically







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


.




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Bacterial spores
Development stage:
Common name: Viruses
Development stage:
Common name: Bacteriophages
Development stage:




Field(s) of use


Indoor
In food industry:
Disinfection of hard/non-porous surfaces/equipment by low-pressure spraying with prior cleaning




Application method(s)


Method: Spraying
Detailed description:
The diluted product is sprayed on the equipment
The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device).
Spraying is only applied downwards and in a horizontal direction.




Application rate(s) and frequency


Application Rate: Between 20 and 200 mL/m2

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i.e. 426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.20.1.   Use-specific instructions for use

See general directions for use.
4.20.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing & loading.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
RPE are not mandatory during the application phase, on the condition that the user remains in the control room and do not enter the treated area.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.
The application is automatic and should only take place when no one is present in the treated area.
Rinse the pump and disconnect it from the installation before maintenance”

                                                   “The treated surface should not be allowed to dry prior to rinsing”.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
4.20.3.   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.
4.20.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.20.5.   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.
4.21.   Use description


Table 56


Use # 21 – Disinfection of surfaces and equipment by low pressure spraying – automatic spraying (closed room)







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


.




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Bacterial spores
Development stage:
Common name: Viruses
Development stage:
Common name: Bacteriophages
Development stage:




Field(s) of use


Indoor
In food industry:
Disinfection of hard/non-porous surfaces/equipment by low-pressure spraying with prior cleaning




Application method(s)


Method: Spraying
Detailed description:
The diluted solution is sprayed on the surfaces in an automated way without any user being present.




Application rate(s) and frequency


Application Rate: Between 20 and 200 mL/m2

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i.e.426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.21.1.   Use-specific instructions for use

See general directions for use.
4.21.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing & loading.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
RPE are not mandatory during the application phase, on the condition that the user remains in the control room and do not enter the treated area.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.
Rinse the pump and disconnect it from the installation before maintenance”

                                                   “The treated surface should not be allowed to dry prior to rinsing”.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
4.21.3.   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.
4.21.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.21.5.   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.
4.22.   Use description


Table 57


Use # 22 – Disinfection of inner surfaces (pipelines, tanks, vessels, …) by CIP







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


.




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Bacterial spores
Development stage:
Common name: Viruses
Development stage:
Common name: Bacteriophages
Development stage:




Field(s) of use


Indoor
In food industry:
Disinfection of hard/non-porous surfaces by CIP procedures (with circulation) with prior cleaning




Application method(s)


Method: Closed system
Detailed description:
Diluted product does automatically circulate from the CIP holding tanks through closed pipework and installations.
After the disinfection procedure, the vessels (pipework and tanks) are drained and rinsed with water under closed system conditions.




Application rate(s) and frequency


Application Rate: -
Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i.e. 426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.22.1.   Use-specific instructions for use

See general directions for use.
4.22.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing & loading.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.
Rinse the pump and disconnect it from the installation before maintenance”
4.22.3.   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.
4.22.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.22.5.   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.
4.23.   Use description


Table 58


Use # 23 – Disinfection of water used for rinsing of recycled items during the washing process







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


.




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
In food industry:
Disinfection of water (in clean conditions) used for rinsing of recycled items = Water from drinking water quality shortly stored in tanks until use to rinse items such as bottles. The water should be disinfected to avoid recontamination and in an extent to avoid cross-contamination of inner bottle surfaces




Application method(s)


Method: Closed system
Detailed description:
Concentrated product will be pumped into a reservoir from which it is continuously dosed into the water stream.
Dilution of the product to the intended in-use concentration occurs in the water stream.
This application is a closed, automated process.




Application rate(s) and frequency


Application Rate: -
Dilution (%): Against bacteria and yeasts: With 0.008 % PAA (Dilution of the product at 0.0533 % i.e. 53.3 mL/100L) at Room Temperature in 15 min contact time.
Number and timing of application:
/




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


HDPE with screw and venting caps (weight depends on density of product):
Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000  to 1 200  kg), 1 L bottles, bulk delivery.




4.23.1.   Use-specific instructions for use

See general directions for use.
4.23.2.   Use-specific risk mitigation measures

Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing & loading.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.
Rinse the pump and disconnect it from the installation before maintenance”
4.23.3.   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.
4.23.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.23.5.   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









1.


All the surfaces to be disinfected must be cleaned before the disinfection procedure.






1.


Disinfection cycle:






—


Products must be diluted in potable water before use.










—


Dilution rate & contact time depends on the use considered. Please refer to the description of application method related to each use.










—


Final rinsing (with potable water) is mandatory: after the disinfection procedure, treated surfaces are rinsed with water and the water is drained into the sewer system. For exceptions, please refer to the description of application method related to each use.








Only for use in areas that are inaccessible to the general public and companion animals.
No access for the general public during treatment.
Disinfection procedures by CIP: Final rinsing step (with potable water).
After the disinfection procedure, CIP vessels (pipework and tanks) are drained and rinsed with water under closed system conditions
Disinfection procedures by dipping: The bath is not intended to be re-used. Use the bath only once a day after work & replace it by a fresh solution daily.
Disinfection procedures by spraying: the surfaces to be disinfected must be wet enough in order to keep them wet during the required contact time for optimal disinfection. Then, the user should pay attention to wet surfaces completely with the disinfectant solution.
The Application Rate for spraying of diluted product must be between 20 and 30 mL/m2





5.2.   Risk mitigation measures

Dermal protection:
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 which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information).
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment


Indirect effects

The two products are oxidising agents and reactive. In case of thermal decomposition steam and oxygen will be released as decomposition products. The release of oxygen may support combustion.
Also, contact with impurities, decomposition catalysts, metallic salts, alkalis, reducing agents may lead to self-accelerated, exothermic decomposition and the formation of oxygen.
In case of decomposition of the products in confined spaces and pipers, there is a risk of overpressure and burst.

First aid measures

Ø   General advice

Move out of dangerous area.
Take care of your own personal safety.
Take off immediately all contaminated clothing.
Ø   Inhalation

Take affected persons out into the fresh air.
Possible discomfort: Irritates skin and mucous linings of the eyes and respiratory tract and cough.
If breathing difficulties occur (e.g. severe continual coughing): Keep patient half sitting with upper body raised; keep warm and in a quiet place; call a physician immediately.
Ø   Skin contact

After contact with skin, wash immediately with plenty of water.
Consult a physician.
Take off immediately all contaminated clothing.
Immediately rinse contaminated or saturated clothing with water.
Ø   Eye contact

With eye held open, thoroughly rinse immediately with plenty of water for at least 10 minutes.
Protect unharmed eye.
Continue rinsing process with eye rinsing solution.
Call ambulance (caustic burn of the eyes)
Immediate further treatment in ophthalmic hospital/ophthalmologist.
Continue rinsing eye until arrival at ophthalmic hospital.
Ø   Ingestion

Do not induce vomiting.
Danger of penetration of the lungs (danger to breathing) when swallowed or vomited, due to gas evolution and foam formation.
Only when patient fully conscious: have the mouth rinsed with water; have the patient drink plenty of water in small sips; keep patient warm and at rest.
Notify ambulance immediately (key word: acid burn).
Ø   Notes to physician

Therapy as for chemical burn.
Following inhalation:
Formation of a toxic lung oedema is possible if product continues to be inhaled despite acute irritative effect (e.g. if it is not possible to leave the danger area).
Prophylaxis of a toxic lung oedema with inhalative steroids (dosing spray, e.g. auxilosone).
If substance has been swallowed:
Aspiration hazard.
Risk of gaseous embolisms.
In case of excessive strain on the stomach due to gas evolution, insert siphon tube.
Early endoscopy in order to assess mucosa lesions in the oesophagus and stomach which may appear.
If necessary, suck away leftover substance.
Do not administer activated charcoal, since risk of release of large amounts of gas from hydrogen peroxide.

Emergency measures to protect the environment

Observe regulations on prevention of water pollution (collect, dam up, cover up).
Do not allow to run into water channels, surface water or into the ground.
Ø   Methods for cleaning up

Clean contaminated surface thoroughly; recommended cleaning agent is water.
In case of small spills, dilute product with lots of water and rinse away or absorb product with liquid-binding material, e.g. chemi-sorption, diatomaceous earth, universal binder. Do not use textiles, saw dust, combustible substances. After binding, pick up mechanically and collect in suitable containers. Dispose of absorbed material in accordance with the regulations.
Ø   Additional advice

Make safe or remove all sources of ignition.
Isolate defective containers immediately, if possible and safe to do.
Shut off leak, if possible and safe to do.
Place defective containers in waste receptacle (waste packaging receptacle) made of plastic (not metal).
Do not seal defective containers or waste receptacles airtight (danger of bursting due to product decomposition).
Product taken out should not be returned into container.
Never return spilled product into its original container for re-use (risk of decomposition).
5.4.   Instructions for safe disposal of the product and its packaging

Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains
Dispose of unused product, its packaging and all other waste, in accordance with local regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep only in the original packaging tightly closed in a cool and well-ventilated place. Keep products away from direct sunlight, source of heat and ignition
The shelf life of the biocidal product is 6 months.
The products must be stored at Ambient Temperature.
6.   OTHER INFORMATION
Reference values of peracetic acid and hydrogen peroxide used for the risk assessment:

PAA: AECinhal = 0,5 mg/m3


HP: AECinhal = 1,25 mg/m3

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
7.1.   Trade name(s), authorisation number and specific composition of each individual product












Trade name(s)


SOPUROXID 15


Market area: EU




 


HORTICLEAN 15 FORT


Market area: EU




AGRIOXID 15


Market area: EU




HyPro Biocide 15-22


Market area: EU




Authorisation number


EU-0026179-0005 1-4




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Peracetic acid


 


Active Substance


79-21-0


201-186-8


15,0 




Sulphuric acid


 


Non-active substance


7664-93-9


231-639-5


0,78 




Hydrogen peroxide


 


Non-active substance


7722-84-1


231-765-0


22,0 




Acetic acid


 


Non-active substance


64-19-7


200-580-7


16,7 




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












Trade name(s)


Oxypur CS


Market area: EU




Authorisation number


EU-0026179-0006 1-4




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Peracetic acid


 


Active Substance


79-21-0


201-186-8


15,0 




Sulphuric acid


 


Non-active substance


7664-93-9


231-639-5


0,78 




Hydrogen peroxide


 


Non-active substance


7722-84-1


231-765-0


22,0 




Acetic acid


 


Non-active substance


64-19-7


200-580-7


16,7 






(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.

(4)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4.