Commission Implementing Regulation (EU) 2023/2183 of 18 October 2023 granting a Union authorisation for the biocidal product family Evonik’s Hydrogen Peroxide Product Family in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Date: 2023-10-18
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, decontamination, market approval








L_202302183EN.000101.fmx.xml












Official Journal of the European Union


EN
Series L













2023/2183


19.10.2023







            COMMISSION IMPLEMENTING REGULATION (EU) 2023/2183
of 18 October 2023
         
granting a Union authorisation for the biocidal product family ‘Evonik’s Hydrogen Peroxide Product Family’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

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


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

Whereas:







(1)


On 20 January 2017, Evonik Operations GmbH submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for a Union authorisation of a biocidal product family named ‘Evonik’s Hydrogen Peroxide Product Family’ of product-types 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-UE029056-42 in the Register for Biocidal Products.












(2)


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












(3)


On 7 January 2022, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.












(4)


On 5 July 2022, the Agency submitted to the Commission its opinion (2), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘Evonik’s Hydrogen Peroxide Product Family’ 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 ‘Evonik’s Hydrogen Peroxide Product Family’ 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 19 July 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.












(7)


The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Evonik’s Hydrogen Peroxide Product Family’.












(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-0028964-0000 is granted to Evonik Operations GmbH for the making available on the market and use of the biocidal product family ‘Evonik’s Hydrogen Peroxide Product Family’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 8 November 2023 until 31 October 2033.


Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 October 2023.


For the Commission


The President

Ursula VON DER LEYEN
            





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

(2)  ECHA opinion of 14 June 2022 on the Union authorisation of ‘Evonik’s Hydrogen Peroxide Product Family’ (ECHA/BPC/343/2022), https://echa.europa.eu/bpc-opinions-on-union-authorisation




ANNEX
Summary of product characteristics for a biocidal product family

Evonik’s Hydrogen Peroxide Product Family


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


Product type 4 – Food and feed area (Disinfectants)


Authorisation number: EU-0028964-0000


R4BP asset number: EU-0028964-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name







Name


Evonik’s Hydrogen Peroxide Product Family




1.2.   Product type(s)







Product type(s)


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




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


Evonik Operations GmbH




Address


Rellinghauser Straße 1-11, 45128 Essen Germany




Authorisation number


EU-0028964-0000





R4BP asset number



EU-0028964-0000




Date of the authorisation


8 November 2023




Expiry date of the authorisation


31 October 2033




1.4.   Manufacturer(s) of the biocidal products







Name of manufacturer


Evonik Antwerpen NV




Address of manufacturer


Tijsmanstunnel West, 2040 Antwerpen Belgium




Location of manufacturing sites


Tijsmanstunnel West, 2040 Antwerpen Belgium













Name of manufacturer


Evonik Operations GmbH




Address of manufacturer


Rellinghauser Straße 1-11, 45128 Essen Germany




Location of manufacturing sites


Untere Kanalstr. 3, 79618 Rheinfelden Germany













Name of manufacturer


Evonik Peroxid GmbH




Address of manufacturer


Industriestraße 1, 9721 Weißenstein Austria




Location of manufacturing sites


Industriestraße 1, 9721 Weißenstein Austria













Name of manufacturer


Evonik Peroxide Netherlands BV




Address of manufacturer


Hettenheuvelweg 37/39, 1101 BM Amsterdam Netherlands




Location of manufacturing sites


Oosterhorn 14, 9936 HD Farmsum Netherlands













Name of manufacturer


Brenntag Schweizerhall AG




Address of manufacturer


Elsässerstrasse 231, 4013 Basel Switzerland




Location of manufacturing sites







Route Industrielle 10, 1580 Avenches Switzerland




C/O Infrapark, Baselland, Rothausstrasse 61, 4132 Muttenz Switzerland

















Name of manufacturer


Brenntag Nordic A/S




Address of manufacturer


Borupvang 5B, DK-2750 Ballerup Denmark




Location of manufacturing sites


Strandgade 35, 7100 Vejle Denmark













Name of manufacturer


Brenntag GmbH




Address of manufacturer


Messeallee 11, 45131 Essen Germany




Location of manufacturing sites







Am Röhrenwerk 46, 47259 Duisburg Germany




Boschstraße 3, 08371 Glauchau Germany




Hannoversche Str. 40, 21079 Hamburg Germany




Dieselstraße 5, 74076 Heilbron Germany




Merkurstraße 47, 67663 Kaiserslautern Germany




Am Fieseler Werk 9, 34253 Lohfelden Germany

















Name of manufacturer


Brenntag CEE GmbH




Address of manufacturer


Linke Wienzeile 152, 1060 Wien Austria




Location of manufacturing sites







Bahnstraße 13, 2353 Guntramsdorf Austria




Fabrikstraße 4-6, 8111 Judendorf Austria




Rubensstraße 48, 4050 Traun Austria

















Name of manufacturer


Brenntag Slovakia s. r. o.




Address of manufacturer


Glejovka, 902 03 Pezinok Slovakia




Location of manufacturing sites







Glejovka 15, 902 03 Pezinok Slovakia




Príboj 558, 976 13 Slovenská Ľupča Slovakia




Južná Trieda 72, 042 85 Košice Slovakia

















Name of manufacturer


Brenntag S.p.A.




Address of manufacturer


Via Cusago, 150/4, 20153 Milano Italy




Location of manufacturing sites







Via San Carlo Borromeo, 24040 Levate Italy




Via Galliera 6/2, 40010 Bentivoglio Italy




Via del Cimitero 6, 80030 Castello di Cisterna Italy




Strada Provinciale di Bonifica 34-36, 65010 Villanova di Cepagatti Italy




Via Provinciale per Bitetto, 70027 Palo del Colle Italy




Via Paduni, 03012 Anagni Italy

















Name of manufacturer


Brenntag Polska Sp. z o.o.




Address of manufacturer


Józefa Bema 21, 47-224 Kędzierzyn-Koźle Poland




Location of manufacturing sites







Józefa Bema 21, 47-224 Kędzierzyn-Koźle Poland




Kwasowa 5, 95-100 Zgierz Poland




Przemysłowa 2, 62-080 Jankowice Poland




Towarowa 9, 05-530 Góra Kalwaria Poland

















Name of manufacturer


Brenntag Lietuva UAB




Address of manufacturer


Palemono g. 171D, 52107 Kaunas Lithuania




Location of manufacturing sites


Palemono g. 171D, 52107 Kaunas Lithuania













Name of manufacturer


Brenntag Hungária Kft.




Address of manufacturer


Bányalég u. 45, 1225 Budapest Hungary




Location of manufacturing sites


Bányalég u. 45, 1225 Budapest Hungary













Name of manufacturer


S.C. Brenntag S.R.L.




Address of manufacturer


Garii Street 1, 077040 Chiajna Romania




Location of manufacturing sites


Garii Street 1, 077040 Chiajna Romania













Name of manufacturer


Brenntag Hrvatska d.o.o.




Address of manufacturer


Radnička cesta 173p, 10000 Zagreb Croatia




Location of manufacturing sites


Radnička cesta 173p, 10000 Zagreb Croatia













Name of manufacturer


Brenntag Bulgaria EOOD




Address of manufacturer


j.k. Drujba 2, ul. Obikolna 21, et. 1, 1582 Sofia Bulgaria




Location of manufacturing sites


j.k. Drujba 2, ul. Obikolna 21, et. 1, 1582 Sofia Bulgaria













Name of manufacturer


OQEMA S.P.A.




Address of manufacturer


Via Roggia Bartolomea 7, 20090 Assago Italy




Location of manufacturing sites


VIA TORTONA 73, 27055 Rivanazzano Italy













Name of manufacturer


Breustedt Chemie BV




Address of manufacturer


IJsseldijk 28, 7325 WZ Apeldoorn Netherlands




Location of manufacturing sites


IJsseldijk 28, 7325 WZ Apeldoorn Netherlands













Name of manufacturer


BEAUSEIGNEUR SAS




Address of manufacturer


6, Rue André Viellard, 90140 Froidefontaine France




Location of manufacturing sites


6, Rue André Viellard, 90140 Froidefontaine France













Name of manufacturer


Staub & Co. – Silbermann GmbH




Address of manufacturer


Ostendstraße 124, 90482 Nürnberg Germany




Location of manufacturing sites


Industriestraße 3, 6456 Gablingen Germany













Name of manufacturer


Möller GmbH & Co. KG




Address of manufacturer


Bürgerkamp 1, 48565 Steinfurt Germany




Location of manufacturing sites


Bürgerkamp 1, 48565 48565 Germany













Name of manufacturer


Häffner GmbH & Co. KG




Address of manufacturer


Friedrichstraße 3, 71679 Asperg Germany




Location of manufacturing sites


Friedrichstraße 3, 71679 Asperg Germany













Name of manufacturer


Evonik Peroxide Spain, S.L.U.




Address of manufacturer


C/Afueras s/h., 50784 La Zaida Spain




Location of manufacturing sites


C/Afueras s/h., 50784 La Zaida Spain













Name of manufacturer


Gaches Chimie




Address of manufacturer


17 avenue de la Gare, 31750 Escalquens France




Location of manufacturing sites







17 avenue de la Gare, 31750 Escalquens France




2 Chemin de la Scierie, 64150 Os-Marsillon France








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







Active substance


Hydrogen peroxide




Name of manufacturer


Evonik Antwerpen NV




Address of manufacturer


Tijsmanstunnel West, 2040 Antwerpen Belgium




Location of manufacturing sites


Tijsmanstunnel West, 2040 Antwerpen Belgium













Active substance


Hydrogen peroxide




Name of manufacturer


Evonik Operation GmbH




Address of manufacturer


Rellinghauser Straße 1-11, 45128 Essen Germany




Location of manufacturing sites


Untere Kanalstr. 3, 79618 Rheinfelden Germany













Active substance


Hydrogen peroxide




Name of manufacturer


Evonik Peroxid GmbH




Address of manufacturer


Industriestraße 1, 9721 Weißenstein Austria




Location of manufacturing sites


Industriestraße 1, 9721 Weißenstein Austria













Active substance


Hydrogen peroxide




Name of manufacturer


Evonik Peroxide Netherlands BV




Address of manufacturer


Hettenheuvelweg 37/39, 1101 BM Amsterdam Netherlands




Location of manufacturing sites


Oosterhorn 14, 9936 HD Farmsum Netherlands













Active substance


Hydrogen peroxide




Name of manufacturer


Evonik Peroxide Spain, S.L.U.




Address of manufacturer


C/Afueras s/h., 50784 La Zaida Spain




Location of manufacturing sites


C/Afueras s/h., 50784 La Zaida Spain




2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

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












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


35,0 


49,9 




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


OXTERIL® Group 1




1.2.   Suffix to the authorisation number







Number


1-1




1.3.   Product type(s)







Product type(s)


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




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


35,0


49,9




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


Harmful if swallowed.
Causes skin irritation.
Causes serious eye damage.
May cause respiratory irritation.
Harmful to aquatic life with long lasting effects.
May intensify fire; oxidiser




Precautionary statements


Avoid breathing vapours.
Wash hands thoroughly after handling.
Do no eat, drink or smoke when using this product.
Use only outdoors or in a well-ventilated area.
Avoid release to the environment.
Wear protective gloves/eye protection/face protection..
IF SWALLOWED:Call a POISON CENTER/doctor/physician if you feel unwell.
Rinse mouth.
IF ON SKIN:Wash with plenty of water/soap.
IF INHALED:Remove person to fresh air and keep comfortable for breathing.
Call a POISON CENTER/doctor/physician if you feel unwell.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Immediately call a POISON CENTER/doctor.
If skin irritation occurs:Get medical advice.
Store in a well-ventilated place.Keep container tightly closed.
Store locked up.
Dispose of contents to/in accordance with local requirements.
Dispose of container to/in accordance with local requirements.
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
Keep away from clothing and other combustible materials.
In case of fire:Use water to extinguish.




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

4.1.   Use description


Table 1


Use # 1 – Surface disinfection by vaporised hydrogen peroxide (VHP) process







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
Disinfection of dry surfaces and equipment in hospital rooms, laboratories and other enclosed spaces, which do not come in contact with food and feed.




Application method(s)


Method: Vaporisation
Detailed description:
Automated disinfection with Vaporised Hydrogen Peroxide, generated with the aid of a VHP generator.
Main specifications of a VHP generator
Diffusion principle: vaporisation, disinfection with gaseous hydrogen peroxide
Room Volume: 30 – 150 m3

Product concentration: 3 120  mg/m3. Relative humidity: 40 – 80 %
Temperature: room temperature




Application rate(s) and frequency


Application Rate: The ready to use product should be applied in a hydrogen peroxide concentration of 1 092  mg/m3 (780 ppm) by the VHP generator.
Dilution (%): not applicable
Number and timing of application:
Contact time: at least 4 hours
Frequency: daily/if required
Maximum 3 times per day




Category(ies) of users


Professional




Pack sizes and packaging material


High density polyethylene (HDPE) bottle 1, 5 litres
HDPE jerry can 10, 20, 30, 60 litres
HDPE drum 200 litres
HDPE container 1000 litres
HDPE ISO tank 20m3





4.1.1.   Use-specific instructions for use

The area to disinfect is prepared for decontamination by removing standing liquid and by wiping down any visible dirt. Clean the area before disinfection. Cupboard doors should be opened, surfaces should be dried and wet areas (such as sinks) should be disinfected with suitable alternative products.
Specially trained professionals replace the cap of the sealed packaging with a special cap that has a degassing valve and a fast connector. The fast connector is connected to a pipe that connects to the VHP generator. Seal the enclosed space or room and make sure that access to the vapour-treated area is denied during the whole procedure.
Room volume ranging from 30m3 to 150 m3.
Diffusion speed can vary from 1,5 to 20 g product/minute.
Starting temperature of 20 °C, ± 2 °C.
Relative humidity between 40 and 80 %.
During the disinfection cycle the VHP generator adjusts the hydrogen peroxide concentration up to the effective levels of 1092 mg/m3 (780 ppm) and keeps it at this level for at least 4 hours. Concentration of hydrogen peroxide is monitored during the disinfection. After disinfection the aeration of the sealed area is required to reduce the concentration of hydrogen peroxide below 1,25 mg/m3 or a lower relevant national reference value before entering the area. This step can be quick but can also last several hours resulting in a total decontamination cycle of 5 – 8 hours.
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. In the event that there are methods available for chemically monitoring the active substance in the air or on surfaces, chemical validation should be performed besides biological validation, for example with test strips or with a device that measures ppm hydrogen peroxide in the air.
When it concerns a ‘standard room’ for which a protocol is available, the validation may be limited to only a chemical validation.
4.1.2.   Use-specific risk mitigation measures

Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal products, chemical resistant gloves classified under European Standard EN 374 or equivalent, face shield and Respiratory Protective Equipment (RPE) (Assigned Protection Factor (APF) = 10) during mixing and loading. Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC.
No access to the treated area is permitted during treatment. During aeration and before permitting re-entry to the treated area it should be checked that the concentration of hydrogen peroxide is below 1,25 mg/m3 or a lower relevant national reference value, using for example test strips. During the operation of the VHP generator or in the event of malfunctions, entry to the room is only possible if wearing chemical protective suits and RPE (APF = 10), when the concentration of hydrogen peroxide is at or below 12,5 mg/m3. Observe label instructions.
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

No use specific 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

No use specific 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

No use specific instructions 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 – Surface disinfection by vaporised hydrogen peroxide (VHP) 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
Disinfection of dry surfaces in food and feed areas and other enclosed spaces.




Application method(s)


Method: Vaporisation
Detailed description:
Automated disinfection with Vaporised Hydrogen Peroxide, generated with the aid of a VHP generator.
Main specifications of a VHP generator
Diffusion principle: vaporisation, disinfection with gaseous hydrogen peroxide.
Room Volume 30 – 150 m3

Product concentration: 3 120  mg/m3

Relative humidity: 40 – 80 %
Temperature: room temperature




Application rate(s) and frequency


Application Rate: The ready to use product should be applied in a hydrogen peroxide concentration of 1 092  mg/m3 (780 ppm) by the VHP generator
Dilution (%):
Number and timing of application:
Contact time: at least 4 hours
Frequency: daily/if required
Maximum 3 times per day




Category(ies) of users


Professional




Pack sizes and packaging material


HDPE bottle 1, 5 litres
HDPE jerry can 10, 20, 30, 60 litres
HDPE drum 200 litres
HDPE container 1 000  litres
HDPE ISO tank 20m3





4.2.1.   Use-specific instructions for use

The area to disinfect is prepared for decontamination by removing standing liquid and by wiping down any visible dirt. Clean the area before disinfection. Cupboard doors should be opened, surfaces should be dried and wet areas (such as sinks) should be disinfected with suitable alternative products.
Specially trained professionals replace the cap of the sealed packaging with a special cap that has a degassing valve and a fast connector. The fast connector is connected to a pipe that connects to the VHP generator. Seal the enclosed space or room and make sure that access to the vapour-treated area is denied during the whole procedure.
Room volume ranging from 30m3 to 150 m3.
Diffusion speed can vary from 1,5 to 20 g product/minute.
Starting temperature of 20 °C, ± 2 °C.
Relative humidity between 40 and 80 %.
During the disinfection cycle the VHP generator adjusts the hydrogen peroxide concentration up to the effective levels of 1 092 mg/m3 (780 ppm) and keeps it at this level for at least 4 hours. Concentration of hydrogen peroxide is monitored during the disinfection. After disinfection the aeration of the sealed area is required to reduce the concentration of hydrogen peroxide below 1,25 mg/m3 or a lower relevant national reference value before entering the area. This step can be quick but can also last several hours resulting in a total decontamination cycle of 5 – 8 hours.
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. In the event that there are methods available for chemically monitoring the active substance in the air or on surfaces, chemical validation should be performed besides biological validation, for example with test strips or with a device that measures ppm hydrogen peroxide in the air.
When it concerns a ‘standard room’ for which a protocol is available, the validation may be limited to only a chemical validation.
4.2.2.   Use-specific risk mitigation measures

Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal products, chemical resistant gloves classified under European Standard EN 374 or equivalent, face shield and RPE (APF = 10) during mixing and loading. Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC.
No access to the treated area is permitted during treatment. During aeration and before permitting re-entry to the treated area it should be checked that the concentration of hydrogen peroxide is below 1,25 mg/m3 or a lower relevant national reference value, using for example test strips. During the operation of the VHP generator or in the event of malfunctions entry to the room is only possible by wearing chemical protective suits and RPE (APF = 10), when the concentration of hydrogen peroxide is at or below 12,5 mg/m3. Observe label instructions.
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

No use specific 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

No use specific 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

No use specific instructions 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 – Aseptic packaging in food and feed industries







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: Bacterial spores




Field(s) of use


Indoor
Disinfection of food packaging material in closed aseptic packaging systems by sprayed or nebulised product.




Application method(s)


Method: Nebulising
Detailed description:
Automated spraying or nebulising in closed systems.




Application rate(s) and frequency


Application Rate: In-use concentration: 35 % (w/w) hydrogen peroxide. Product concentration in hot air: 10,83 g/kg
Dilution (%): For disinfection of bacteria, yeasts and bacterial spores the product should be diluted to 35 % (w/w) hydrogen peroxide. For example, for a product containing 49,9 % (w/w) hydrogen peroxide: add 700 ml product to 357 ml water to achieve a dilution of 35 % (w/w) hydrogen peroxide.
Number and timing of application:
Automated chemo-thermal disinfectant processes.
Temperature: ≥ 100 °C
Contact time: at least 5,5 seconds




Category(ies) of users


Professional




Pack sizes and packaging material


HDPE bottle 1, 5 litres
HDPE jerry can 10, 20, 30, 60 litres
HDPE drum 200 litres
HDPE container 1 000  litres
HDPE ISO tank 20m3





4.3.1.   Use-specific instructions for use

The aseptic filling systems are based on the principle of aseptically forming a tube from a sterilised sheet of package material, which is continuously filled with commercially sterile liquid food product and subsequently transversally sealed to form pouches, which in turn are folded into the final package shape. The packaging material are delivered to the aseptic filling machine either in the form of (sheet) reels or in the form of pre-formed packs, tubs and bottles. Then, 35 % (w/w) hydrogen peroxide is sprayed or nebulised to the packaging material gradually via a nozzle. After that, several stages follow to evaporate any excess hydrogen peroxide with sterile hot air.
Depending on the size of the receptacle, an amount of 0,1 – 1 mL of 35 % (w/w) hydrogen peroxide is sprayed or nebulised gradually via a nozzle.
Temperature: ≥ 100 °C
Contact time: at least 5,5 seconds.
For example, for a product containing 49,9 % (w/w) hydrogen peroxide; add 700 ml product to 357 ml water to achieve a dilution of 35 % (w/w) hydrogen peroxide.
The user shall always carry out a microbiological validation of the disinfection, after which a protocol for disinfection of this packaging/system can be made and used thereafter.
4.3.2.   Use-specific risk mitigation measures

Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal products, chemical resistant gloves classified under European Standard EN 374 or equivalent, face shield and RPE (APF = 10) when handling concentrated solutions during mixing and loading; chemical resistant gloves classified under European Standard EN 374 or equivalent, protective clothing chemically resistant to the biocidal products, and chemical resistant goggles consistent with European Standard EN 16321 or equivalent face shield during application. During maintenance work, wear chemical resistant gloves classified under EN 374 or equivalent, protective clothing chemically resistant to the biocidal products, chemical resistant goggles consistent with EN 16321 or equivalent face shield and RPE (APF = 4) and spray water for approximately 10 seconds before opening the machine. The instructions for use of the re-filling station specify that the loading operations must take place in a cool and ventilated place. Gloves and coverall material to be specified by the authorisation holder within the product information. Observe label instructions. See section 6 for the full titles of the EN standards.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC.
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

No use specific 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

No use specific 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

No use specific instructions 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 – Disinfection of distribution system for drinking water by cleaning in place (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: Fungi
Development stage:




Field(s) of use


Indoor
Disinfection of distributing and storing installations for drinking water




Application method(s)


Method: CIP (Cleaning in place)
Detailed description:
Disinfecting the interior surfaces of closed systems by CIP




Application rate(s) and frequency


Application Rate: 4,7 % (w/w) hydrogen peroxide.
Dilution (%): For disinfection of bacteria, yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide. For example, in case of a 35 %(w/w) hydrogen peroxide product: add 114 ml product to 819 ml water. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
Number and timing of application:
Contact time: at least 3 hours
Frequency: Daily/if required
Temperature: room temperature




Category(ies) of users


Professional




Pack sizes and packaging material


HDPE bottle 1, 5 litres
HDPE jerry can 10, 20, 30, 60 litres
HDPE drum 200 litres
HDPE container 1 000  litres
HDPE ISO tank 20m3





4.4.1.   Use-specific instructions for use

CIP (Cleaning in place): Clean before disinfection (Remove all deposits and dirt by a pre-flush or pre-scrape, and when necessary, a pre-soak treatment). Circulate the diluted product through the system under conditions of increased turbulence and flow velocity. After 3 hours contact time, pipelines and tanks are rinsed with water before refilled with drinking water. For disinfection of bacteria, yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide: add 114 ml product to 819 ml water to achieve a dilution of 4,7 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
4.4.2.   Use-specific risk mitigation measures

Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent/face shield, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent. and RPE (APF = 10) during mixing and loading. Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC.
Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 air changes per hour (ACH)). Observe label instructions.
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

No use specific 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

No use specific 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

No use specific instructions 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 – Disinfection of non-porous hard surfaces and equipment 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: Fungi
Development stage:




Field(s) of use


Indoor
Equipment in both food and drink industries, large scale catering kitchens and large scale canteens.




Application method(s)


Method: Open system: immersion
Detailed description:
Manual immersion of equipment in closed baths. Automated immersion of equipment in closed baths.




Application rate(s) and frequency


Application Rate: 8,1 % (w/w) hydrogen peroxide.
Dilution (%): For disinfection of bacteria, yeasts and fungi the product should be diluted to 8,1 % (w/w) hydrogen peroxide. For example, in case of a 35 %(w/w) hydrogen peroxide product: add 200 ml product to 738 ml water. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
Number and timing of application:
Contact time: 60 minutes
Frequency: Daily/if required
Temperature: room temperature




Category(ies) of users


Professional




Pack sizes and packaging material


HDPE bottle 1, 5 litres
HDPE jerry can 10, 20, 30, 60 litres
HDPE drum 200 litres
HDPE container 1 000  litres
HDPE ISO tank 20m3





4.5.1.   Use-specific instructions for use

For disinfection of bacteria yeasts and fungi the product should be diluted to 8,1 % (w/w) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide; add 200 ml product to 738 ml water to achieve a dilution of 8,1 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
Immersion: Equipment in the food and feed industry is disinfected by immersion. Pre-clean the equipment. The disinfection solution should be diluted into vats (i.e. pouring or pumping the product into vats). The equipment to be disinfected is manually or automatically placed into these vats (closed baths) and taken out after a contact time of not less than 60 minutes. After the disinfection procedure is completed, equipment is rinsed with water. The disinfection solution in the immersion/dipping bath should be replaced after each disinfection cycle.
4.5.2.   Use-specific risk mitigation measures

Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent, face shield and RPE (APF = 10) during mixing and loading and application. Glove and coverall material to be specified by the authorisation holder within the product information. No access of other worker to the room is permitted during disinfection without wearing adequate PPE and RPE as described above. See section 6 for the full titles of the EN standards.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC
Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 ACH). Dipping bath has to be placed in a separated room. For use only in areas inaccessible to the general public. Professional users without PPE and RPE (APF = 10) are not allowed to enter the disinfection room. Keep the bath closed during disinfection, only open to load and discharge.
Observe label instructions.
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

No use specific 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

No use specific 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

No use specific instructions 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 surfaces by cleaning in place (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: Fungi
Development stage:




Field(s) of use


Indoor
Disinfection of food contact inner surfaces of pipe work and tank systems in food and feed industry




Application method(s)


Method: Cleaning in Place (CIP)
Detailed description:
Disinfecting the interior surfaces of closed systems by Cleaning In Place (CIP).




Application rate(s) and frequency


Application Rate: 4,7 % (w/w) hydrogen peroxide.
Dilution (%): For disinfection of bacteria, yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide. For example, in case of a 35 %(w/w) hydrogen peroxide product: add 114 ml product to 819 ml water. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
Number and timing of application:
Contact time: at least 3 hours
Frequency: Daily/if required
Temperature: room temperature




Category(ies) of users


Professional




Pack sizes and packaging material


HDPE bottle 1, 5 litres
HDPE jerry can 10, 20, 30, 60 litres
HDPE drum 200 litres
HDPE container 1 000  litres
HDPE ISO tank 20m3





4.6.1.   Use-specific instructions for use

Clean prior to disinfection. The inner surfaces of pipe work and tank systems are disinfected by CIP process. For disinfection of bacteria yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide; add 114 ml product to 819 ml water to achieve a dilution of 4,7 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
The process is carried out by circulating the disinfection solution through the system under conditions of increased turbulence and flow velocity. The application is automated and a closed process. After 3 hours contact time, pipelines and tanks are rinsed with water under closed system conditions as well.
4.6.2.   Use-specific risk mitigation measures

Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent/face shield, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent and RPE (APF = 10) during mixing and loading. Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC.
Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 ACH). Observe label instructions.
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

No use specific 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

No use specific 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

No use specific instructions 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

See use specific instructions for each use.
5.2.   Risk mitigation measures

See use specific risk mitigation measures for each use.
Observe label instructions.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment


First aid instructions

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing.
If symptoms: Call 112/ambulance for medical assistance.
If no symptoms: Call a POISON CENTRE or a doctor.

Accidental release measures

Large spillage: Collect product in suitable containers (for example made of plastic) using appropriate equipment (for example liquid pump) for disposal. Never return spills in original containers for re-use. Keep away from flammable and incompatible substances. Rinse away any residue with plenty of water. Dispose of absorbed material in accordance with the applicable environmental regulations.
Small spillage: Dilute product with lots of water and rinse away or absorb with liquid-binding material (for example diatomaceous earth or universal binder). Pick up mechanically and collect in suitable containers. Clean contaminated surface thoroughly. Pack and label wastes like the product. Do not detach label from the delivery containers prior to disposal.
5.4.   Instructions for safe disposal of the product and its packaging

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to municipal sewer depending on local requirements.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage


Advice on protection against fire and explosion:






 


Store away from direct sunlight and heat sources.










 


Store away from sources of ignition – No smoking.










 


Store away from flammable substances.










 


Store away from incompatible substances.





Storage:







 


Temperature requirement- during storage maximum 40 °C and protect from frost.










 


Store in clean, dry and well-ventilated places.










 


Transport and store container in upright position only.










 


Always close container tightly after removal of product.










 


Avoid leakage and residues of the product on the containers.





Advice on common storage:







 


Do not store together with alkalis, reductants, metallic salts (risk of decomposition).










 


Do not store together with organic solvents (risk of explosion).





Shelf-life:

24 months
6.   OTHER INFORMATION

The full titles of the EN standards referenced in the “Use-specific mitigation measures” sections are:






 


EN 16321 – Eye and face protection for occupational users










 


EN 374 – Protective gloves against chemicals and micro-organisms




The Council Directive referenced in the “Use-specific mitigation measures” sections is: Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998[RMJ1], p. 11).
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)


OXTERIL® 350 SPRAY


Market area: EU




 


BIS OKSAN


Market area: EU




Halades DI


Market area: EU




DEPTIL 350 SPRAY


Market area: EU




OXY-DES Food


Market area: EU




Amira Hydrogen Peroxide


Market area: EU




Asiral Des O


Market area: EU




OXTERIL® 350 VHP


Market area: EU




PERSYNT® 350 VHP


Market area: EU




Authorisation number


EU-0028964-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


35,0 




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











Trade name(s)


OXTERIL® 350 SPRAY S


Market area: EU




 


DES O HR


Market area: EU




Authorisation number


EU-0028964-0002 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


35,0 





META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier







Identifier


OXTERIL® Group 2




1.2.   Suffix to the authorisation number







Number


1-2




1.3.   Product type(s)







Product type(s)


PT04 – Food and feed area (Disinfectants)




2.   META SPC 2 COMPOSITION

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












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


35,0


49,9




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


Harmful if swallowed.
Causes skin irritation.
Causes serious eye damage.
May cause respiratory irritation.
Harmful to aquatic life with long lasting effects.
May intensify fire; oxidiser




Precautionary statements


Avoid breathing vapours.
Wash hands thoroughly after handling.
Do no eat, drink or smoke when using this product.
Use only outdoors or in a well-ventilated area.
Avoid release to the environment.
Wear protective gloves/eye protection/face protection..
IF SWALLOWED:Call a POISON CENTER/doctor/physician if you feel unwell.
Rinse mouth.
IF ON SKIN:Wash with plenty of water/soap.
IF INHALED:Remove person to fresh air and keep comfortable for breathing.
Call a POISON CENTER/doctor/physician if you feel unwell.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Immediately call a POISON CENTER/doctor.
If skin irritation occurs:Get medical advice.
Store in a well-ventilated place.Keep container tightly closed.
Store locked up.
Dispose of contents to/in accordance with local requirements.
Dispose of container to/in accordance with local requirements.
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
Keep away from clothing and other combustible materials.
In case of fire:Use water to extinguish.




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

4.1.   Use description


Table 7


Use # 1 – Aseptic packaging in food and feed industries







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
Disinfection of food and feed packaging material in closed aseptic packaging systems by dipping, spraying or nebulising




Application method(s)


Method: Dipping, nebulising and spraying
Detailed description:
Automated dipping in closed systems
Automated nebulising and spraying in closed systems




Application rate(s) and frequency


Application Rate: In-use concentration: 35 % (w/w) hydrogen peroxide.
Dilution (%): For disinfection of bacteria, yeasts and bacterial spores, the product should be diluted to 35 % (w/w) hydrogen peroxide. For example, for a product containing 49,9 % (w/w) hydrogen peroxide; add 700 ml product to 357 ml water to achieve a dilution of 35 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
Number and timing of application:
automated chemo-thermal disinfection processes. In-use concentration: 35 % (w/w) hydrogen peroxide
Spraying or nebulizing:
Temperature: ≥ 100 °C
Contact time: at least 5,5 seconds
Dipping:
Temperature: ≥ 80 °C
Contact time: at least 2,5 seconds




Category(ies) of users


Professional




Pack sizes and packaging material


HDPE bottle 1, 5 litres
HDPE jerry can 10, 20, 30, 60 litres
HDPE drum 200 litres
HDPE container 1 000  litres
HDPE ISO tank 20m3





4.1.1.   Use-specific instructions for use

The aseptic filling systems are based on the principle of aseptically forming a tube from a sterilised sheet of package material, which is continuously filled with commercially sterile liquid food product and subsequently transversally sealed to form pouches, which in turn are folded into the final package shape. The packaging material are delivered to the aseptic filling machine either in the form of (sheet) reels or in the form of pre-formed packs, tubs and bottles. The packaging material in the form of (sheet) reels passes through a deep bath filled with 35 % (w/w) hydrogen peroxide by dipping. The pre-formed packs, tubs and bottles are sprayed or fogged with 35 % (w/w) hydrogen peroxide stepwise via a nozzle. After that, several stages follow to evaporate any excess hydrogen peroxide with sterile hot air.
Depending on the size of the receptacle, an amount of 0,1 – 1 mL of 35 % (w/w) hydrogen peroxide is sprayed or nebulized gradually via a nozzle.
Temperature: ≥ 100 °C
Contact time: at least 5,5 seconds
The packaging material in the form of (sheet) reels passes through a deep bath filled with 35 % (w/w) hydrogen peroxide by dipping.
Temperature: ≥ 80 °C
Contact time: at least 2,5 seconds
For example, for a product containing 49,9 % (w/w) hydrogen peroxide; add 700 ml product to 357 ml water to achieve a dilution of 35 % (w/w) hydrogen peroxide.
The user shall always carry out a microbiological validation of the disinfection, after which a protocol for disinfection of this packaging/system can be made and used thereafter.
4.1.2.   Use-specific risk mitigation measures

Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal products, chemical resistant gloves classified under European Standard EN 374 or equivalent, face shield and RPE (APF = 10) when handling concentrated solutions during mixing and loading; chemical resistant gloves classified under European Standard EN 374 or equivalent, protective clothing chemically resistant to the biocidal products, and chemical resistant goggles consistent with European Standard EN 16321 or equivalent face shield during application. During maintenance work, wear chemical resistant gloves classified under EN 374 or equivalent, protective clothing chemically resistant to the biocidal products, chemical resistant goggles consistent with EN 16321 or equivalent face shield and RPE (APF = 4) and spray water for approximately 10 seconds before opening the machine. The instructions for use of the re-filling station specify that the loading operations must take place in a cool and ventilated place. Gloves and coverall material to be specified by the authorisation holder within the product information. Observe label instructions. See section 6 for the full titles of the EN standards.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC.
The instructions for use of the re-filling station specify that the loading operations must take place in a cool and ventilated place. Observe label instructions.
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

No use specific 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

No use specific 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

No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use.
4.2.   Use description


Table 8


Use # 2 – Disinfection of distribution system for drinking water by cleaning in place (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: Fungi
Development stage:




Field(s) of use


Indoor
Cleaning and disinfection of distributing and storing installations for drinking water




Application method(s)


Method: CIP (Cleaning in place)
Detailed description:
Disinfecting the interior surfaces of closed systems by CIP




Application rate(s) and frequency


Application Rate: 4,7 % (w/w) hydrogen peroxide
Dilution (%): For disinfection of bacteria, yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide. For example, in case of a 35 %(w/w) hydrogen peroxide product: add 114 ml product to 819 ml water. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
Number and timing of application:
Contact time: at least 3 hours
Frequency: Daily/if required
Temperature: room temperature




Category(ies) of users


Professional




Pack sizes and packaging material


HDPE bottle 1, 5 litres
HDPE jerry can 10, 20, 30, 60 litres
HDPE drum 200 litres
HDPE container 1 000  litres
HDPE ISO tank 20m3





4.2.1.   Use-specific instructions for use

CIP (Cleaning in place): Clean prior to disinfection. Circulate the diluted product through the system under conditions of increased turbulence and flow velocity. After 3 hours contact time, pipelines and tanks are rinsed with water before refilled with drinking water. For disinfection of bacteria, yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide: add 114 ml product to 819 ml water to achieve a dilution of 4,7 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
4.2.2.   Use-specific risk mitigation measures

Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent/face shield, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent and RPE (APF = 10) during mixing and loading. Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 ACH). Observe label instructions. Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC
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

No use specific 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

No use specific 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

No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use.
4.3.   Use description


Table 9


Use # 3 – Disinfection of non-porous hard surfaces and equipment 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: Fungi
Development stage:




Field(s) of use


Indoor
Equipment in both food and drink industries, large scale catering kitchens and large scale canteens.




Application method(s)


Method: Open system: immersion
Detailed description:
Manual immersion of equipment in closed baths. Automated immersion of equipment in closed baths.




Application rate(s) and frequency


Application Rate: 8,1 % (w/w) hydrogen peroxide.
Dilution (%): For disinfection of bacteria, yeasts and fungi the product should be diluted to 8,1 % (w/w) hydrogen peroxide. For example, in case of a 35 %(w/w) hydrogen peroxide product: add 200 ml product to 738 ml water. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
Number and timing of application:
Contact time: at least 60 min
Frequency: Daily/if required
Temperature: room temperature




Category(ies) of users


Professional




Pack sizes and packaging material


HDPE bottle 1, 5 litres
HDPE jerry can 10, 20, 30, 60 litres
HDPE drum 200 litres
HDPE container 1 000  litres
HISO tank 20m3





4.3.1.   Use-specific instructions for use

For disinfection of bacteria yeasts and fungi the product should be diluted to 8,1 % (w/w) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide: add 200 ml product to 738 ml water to achieve a dilution of 8,1 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
Immersion:
Equipment in the food and feed industry is disinfected by immersion. Pre-clean the equipment. The disinfection solution should be diluted into vats (i.e. pouring or pumping the product into vats). The equipment to be disinfected is manually or automatically placed into these vats (closed baths) and taken out after a contact time of at least 60 minutes. After the disinfection procedure is completed, equipment is rinsed with water. The disinfection solution in the immersion/dipping bath should be replaced after each disinfection cycle.
4.3.2.   Use-specific risk mitigation measures

Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent/face shield, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent and RPE (APF = 10) during mixing and loading and application. Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC. No access of other worker to the room is permitted during disinfection without wearing adequate PPE and RPE as described above.
Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 ACH). Dipping bath has to be placed in a separate room. For use only in areas inaccessible to the general public. Professional users without PPE and RPE (APF = 10) are not allowed to enter the disinfection room. Keep the bath closed during disinfection, only open to load and discharge.
Observe label instructions.
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

No use specific 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

No use specific 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

No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use.
4.4.   Use description


Table 10


Use # 4 – Disinfection of surfaces by cleaning in place (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: Fungi
Development stage:




Field(s) of use


Indoor
Disinfection of food contact inner surfaces of pipe work and tank systems in food and feed industry




Application method(s)


Method: Cleaning in Place (CIP)
Detailed description:
Disinfecting the interior surfaces of closed systems by Cleaning In Place (CIP).




Application rate(s) and frequency


Application Rate: 4,7 % (w/w) hydrogen peroxide.
Dilution (%): For disinfection of bacteria, yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide. For example, in case of a 35 %(w/w) hydrogen peroxide product: add 114 ml product to 819 ml water. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
Number and timing of application:
Contact time: at least 3 hours
Frequency: Daily/if required
Temperature: room temperature




Category(ies) of users


Professional




Pack sizes and packaging material


HDPE bottle 1, 5 litres
HDPE jerry can 10, 20, 30, 60 litres
HDPE drum 200 litres
HDPE container 1 000  litres
HDPE ISO tank 20m3





4.4.1.   Use-specific instructions for use

Clean prior to disinfection. For disinfection of bacteria yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide; add 114 ml product to 819 ml water to achieve a dilution of 4,7 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
The process is carried out by circulating the disinfection solution through the system under conditions of increased turbulence and flow velocity. The application is automated and a closed process. After 3 hours contact time, pipelines and tanks are rinsed with water under closed system conditions as well.
4.4.2.   Use-specific risk mitigation measures

Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent, face shield and RPE (APF = 10) during mixing and loading. Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC.
Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 ACH).
Observe label instructions
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

No use specific 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

No use specific 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

No use specific instructions 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

See use specific instructions for each use.
5.2.   Risk mitigation measures

See use specific risk mitigation measures for each use.
Observe label instructions.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment


First aid instructions

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing.
If symptoms: Call 112/ambulance for medical assistance.
If no symptoms: Call a POISON CENTRE or a doctor.

Accidental release measures

Large spillage: Collect product in suitable containers (e.g. made of plastic) using appropriate equipment (e.g. liquid pump) for disposal. Never return spills in original containers for re-use. Keep away from flammable and incompatible substances. Rinse away any residue with plenty of water. Dispose of absorbed material in accordance with the applicable environmental regulations.
Small spillage: Dilute product with lots of water and rinse away or absorb with liquid-binding material (e.g. diatomaceous earth or universal binder). Pick up mechanically and collect in suitable containers. Clean contaminated surface thoroughly. Pack and label wastes like the product. Do not detach label from the delivery containers prior to disposal
5.4.   Instructions for safe disposal of the product and its packaging

At the end of the treatment, dispose of unused product and the packaging in accordance with local requirements. Used product can be flushed to municipal sewer depending on local requirements.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage


Advice on protection against fire and explosion:






 


Store away from direct sunlight and heat sources.










 


Store away from sources of ignition – No smoking.










 


Store away from flammable substances.










 


Store away from incompatible substances.





Storage:

Temperature requirement- during storage maximum 40 °C and protect from frost.
Store in clean, dry and well-ventilated places.
Transport and store container in upright position only.
Always close container tightly after removal of product.
Avoid leakage and residues of the product on the containers.

Advice on common storage:

Do not store together with alkalis, reductants, metallic salts (risk of decomposition).
Do not store together with organic solvents (risk of explosion).

Shelf-life:







 



24 months





6.   OTHER INFORMATION

The full titles of the EN standards referenced in the “Use-specific mitigation measures” sections are:
EN 16321 – Eye and face protection for occupational users
EN 374 – Protective gloves against chemicals and micro-organisms
The Council Directive referenced in the “Use-specific mitigation measures” sections is: Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998[RMJ1], p. 11).
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)


OXTERIL® 350 BATH


Market area: EU




 


DES-H2O2 35


Market area: EU




Authorisation number


EU-0028964-0003 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


35,0 




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











Trade name(s)


OXTERIL® 350 COMBI


Market area: EU




 


SPECIJAL PT


Market area: EU




Brennspec HP 35 aseptic


Market area: EU




Climax HPO Aseptisk


Market area: EU




OXTERIL® 350 LRD


Market area: EU




Authorisation number


EU-0028964-0004 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


35,0 





META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier







Identifier


CLARMARIN® Group 1




1.2.   Suffix to the authorisation number







Number


1-3




1.3.   Product type(s)







Product type(s)


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




2.   META SPC 3 COMPOSITION

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












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


35,0 


49,9 




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


Harmful if swallowed.
Causes skin irritation.
Causes serious eye damage.
May cause respiratory irritation.
Harmful to aquatic life with long lasting effects.
May intensify fire; oxidiser




Precautionary statements


Avoid breathing vapours.
Wash hands thoroughly after handling.
Do no eat, drink or smoke when using this product.
Use only outdoors or in a well-ventilated area.
Avoid release to the environment.
Wear protective clothing/eye protection/face protection.
IF SWALLOWED:Call a POISON CENTER/doctor/physician if you feel unwell.
Rinse mouth.
IF ON SKIN:Wash with plenty of water/soap.
IF INHALED:Remove person to fresh air and keep comfortable for breathing.
Call a POISON CENTER/doctor/physician if you feel unwell.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Immediately call a POISON CENTER/doctor.
If skin irritation occurs:Get medical advice.
Store in a well-ventilated place.Keep container tightly closed.
Store locked up.
Dispose of contents to/in accordance with local requirements.
Dispose of container to/in accordance with local requirements.
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
Keep away from clothing and other combustible materials.
In case of fire:Use water to extinguish.




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

4.1.   Use description


Table 11


Use # 1 – Laundry disinfection in closed washing machines by dosing







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: Viruses
Development stage:
Common name: Fungi
Development stage:




Field(s) of use


Indoor
Laundry disinfection in washing machines.




Application method(s)


Method: Loading (dosing)
Detailed description:
The product is automatically dosed into the closed washing machine during the washing process (main wash).




Application rate(s) and frequency


Application Rate: 0,019 – 0,029 % (w/w) hydrogen peroxide.
Dilution (%): The biocidal products are diluted accordingly in order to achieve an in-use concentration in the range of 0,019 – 0,029 % (w/w). For example, in the case of 35 % (w/w) hydrogen peroxide product: 0,5 ml or 0,75 ml concentrate add water up to 1 litre to achieve 0,019 % (w/w) or 0,029 % (w/w). For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
Number and timing of application:
Frequency: Daily/if required
Bacteria, yeasts, fungi: In use concentration 0,019 % (w/w) hydrogen peroxide in the wash solution.
Alkaline buffering agent: 0,6 ml/l BEIPUR ANP.
Contact time: 10 minutes
Temperature: 70 °C
Viruses: In use concentration 0,029 % (w/w) hydrogen peroxide in the wash solution.
Alkaline buffering agent: 0,6 ml/l BEIPUR ANP
Contact time: 10 minutes
Temperature: 80 °C
Cloth: liquid ratio = 1:4




Category(ies) of users


Professional




Pack sizes and packaging material


HDPE bottle 1, 5 litres
HDPE jerry can 10, 20, 30, 60 litres
HDPE drum 200 litres
HDPE container 1 000  litres
HDPE ISO tank 20m3





4.1.1.   Use-specific instructions for use

The product and alkaline buffering agent (BEIPUR ANP) are automatically dosed into the closed washing machine during the washing process. The dosing of both components, i.e. the biocidal product and the alkaline buffering agent BEIPUR ANP, is realised via two separate pipes and dosing stations. Biocidal product and alkaline buffering agent should not be mixed prior the dosing into the washing machine. Treatment Interval – daily/if required (0,5 hours/day).
4.1.2.   Use-specific risk mitigation measures

Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent, face shield and RPE (APF = 10) during mixing and loading. Glove and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC.
Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 ACH). Observe label instructions.
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

No use specific 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

No use specific 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

No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use.
4.2.   Use description


Table 12


Use # 2 – Disinfection of distribution system for drinking water by cleaning in place (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: Fungi
Development stage:




Field(s) of use


Indoor
Disinfection of distributing and storing installations for drinking water.




Application method(s)


Method: CIP (Cleaning in place) in closed systems
Detailed description:
Disinfecting the interior surfaces of closed systems by CIP




Application rate(s) and frequency


Application Rate: 4,7 % (w/w) hydrogen peroxide
Dilution (%): For disinfection of bacteria, yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide. For example, in the case of a product containing 35 % (w/w) hydrogen peroxide: add 114 ml product to 819 ml water to achieve a dilution of 4,7 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
Number and timing of application:
Contact time: at least 3 hours
Frequency: Daily/if required
Temperature: room temperature




Category(ies) of users


Professional




Pack sizes and packaging material


HDPE bottle 1, 5 litres
HDPE jerry can 10, 20, 30, 60 litres
HDPE drum 200 litres
HDPE container 1 000  litres
HDPE ISO tank 20m3





4.2.1.   Use-specific instructions for use

CIP (Cleaning in place): Clean prior to disinfection. Circulate the diluted product through the system under conditions of increased turbulence and flow velocity. After 3 hours contact time, pipelines and tanks are rinsed with water before refilled with drinking water. For disinfection of bacteria, yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide.
For example, for a product containing 35 % (w/w) hydrogen peroxide: add 114 ml product to 819 ml water to achieve a dilution of 4,7 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
4.2.2.   Use-specific risk mitigation measures

Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent, face shield and RPE (APF = 10) during mixing and loading. See section 6 for the full titles of the EN standards.
Glove and coverall material to be specified by the authorisation holder within the product information.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC.
Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 ACH). Observe label instructions.
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

No use specific 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

No use specific 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

No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use.
4.3.   Use description


Table 13


Use # 3 – Disinfection of non-porous hard surfaces and equipment 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: Fungi
Development stage:




Field(s) of use


Indoor
Equipment in both food and drink industries, large scale catering kitchens and large scale canteens.




Application method(s)


Method: Open system: immersion
Detailed description:
Manual immersion of equipment in closed baths. Automated immersion of equipment in closed baths.




Application rate(s) and frequency


Application Rate: 8,1 % (w/w) hydrogen peroxide.
Dilution (%): For disinfection of bacteria, yeasts and fungi the product should be diluted to 8,1 % (w/w) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide: add 200 ml product to 738 ml water to achieve a dilution of 8,1 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
Number and timing of application:
Contact time: 60 minutes
Frequency: Daily/if required
Temperature: room temperature




Category(ies) of users


Professional




Pack sizes and packaging material


HDPE bottle 1, 5 litres
HDPE jerry can 10, 20, 30, 60 litres
HDPE drum 200 litres
HDPE container 1 000  litres
HDPE ISO tank 20m3





4.3.1.   Use-specific instructions for use

For disinfection of bacteria yeasts and fungi the product should be diluted to 8,1 % (w/w) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide: add 200 ml product to 738 ml water to achieve a dilution of 8,1 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
Immersion: Equipment in the food and feed industry is disinfected by immersion. Pre-clean the equipment. The disinfection solution should be diluted into vats (i.e. pouring or pumping the product into vats). The equipment to be disinfected is manually or automatically placed into these vats (closed baths) and taken out after a contact time of not less than 60 minutes. After the disinfection procedure is completed, equipment is rinsed with water. The disinfection of the immersion/dipping bath should be replaced after each disinfection cycle.
4.3.2.   Use-specific risk mitigation measures

Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent, face shield and RPE (APF = 10) during mixing and loading and application. Glove and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC. No access to the room is permitted during disinfection without wearing adequate PPE and RPE as described above.
Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 ACH). Dipping bath has to be placed in a separate room. For use only in areas inaccessible to the general public. Professional users without PPE and RPE (APF = 10) are not allowed to enter the disinfection room. Keep the bath closed during disinfection, only open to load and discharge.
Observe label instructions.
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

No use specific 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

No use specific 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

No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use.
4.4.   Use description


Table 14


Use # 4 – Disinfection of surfaces by cleaning in place (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: Fungi
Development stage:




Field(s) of use


Indoor
Disinfection of food contact inner surfaces of pipe work and tank systems in food and feed industry.




Application method(s)


Method: CIP in closed systems
Detailed description:
Disinfecting the interior surfaces of closed systems by Cleaning In Place (CIP).




Application rate(s) and frequency


Application Rate: 4,7 % (w/w) hydrogen peroxide.
Dilution (%): For disinfection of bacteria, yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide: add 114 ml product to 819 ml water to achieve a dilution of 4,7 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
Number and timing of application:
Contact time: at least 3 hours
Frequency: Daily/if required
Temperature: room temperature




Category(ies) of users


Professional




Pack sizes and packaging material


HDPE bottle 1, 5 litres
HDPE jerry can 10, 20, 30, 60 litres
HDPE drum 200 litres
HDPE container 1 000  litres
HDPE ISO tank 20m3





4.4.1.   Use-specific instructions for use

Clean prior to disinfection. The inner surfaces of pipe work and tank systems are disinfected by CIP process. For disinfection of bacteria yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide: add 114 ml product to 819 ml water to achieve a dilution of 4,7 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
The process is carried out by circulating the disinfection solution through the system under conditions of increased turbulence and flow velocity. The application is automated and a closed process. After 3 hours contact time, pipelines and tanks are rinsed with water under closed system conditions as well.
4.4.2.   Use-specific risk mitigation measures

Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent, face shield and RPE (APF = 10) during mixing and loading. See section 6 for the full titles of the EN standards.
Glove and coverall material to be specified by the authorisation holder within the product information.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC.
Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 ACH). Observe label instructions
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

No use specific 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

No use specific 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

No use specific instructions 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

See use specific instructions for each use.
5.2.   Risk mitigation measures

See use specific risk mitigation measures for each use.
Observe label instructions.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment


First aid instructions

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing.
If symptoms: Call 112/ambulance for medical assistance.
If no symptoms: Call a POISON CENTRE or a doctor.

Accidental release measures

Large spillage: Collect product in suitable containers (for example made of plastic) using appropriate equipment (for exampl liquid pump) for disposal. Never return spills in original containers for re-use. Keep away from flammable and incompatible substances. Rinse away any residue with plenty of water. Dispose of absorbed material in accordance with the applicable environmental regulations.
Small spillage: Dilute product with lots of water and rinse away or absorb with liquid-binding material (for example diatomaceous earth or universal binder). Pick up mechanically and collect in suitable containers. Clean contaminated surface thoroughly. Pack and label wastes like the product. Do not detach label from the delivery containers prior to disposal
5.4.   Instructions for safe disposal of the product and its packaging

At the end of the treatment, dispose of unused product and the packaging in accordance with local requirements. Used product can be flushed to municipal sewer depending on local requirements.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage


Advice on protection against fire and explosion

Store away from direct sunlight and heat sources.
Store away from sources of ignition – No smoking.
Store away from flammable substances.
Store away from incompatible substances.

Storage

Temperature requirement- during storage maximum 40 °C and protect from frost.
Store in clean, dry and well- ventilated places.
Transport and store container in upright position only.
Always close container tightly after removal of product.
Avoid leakage and residues of the product on the containers.

Advice on common storage

Do not store together with alkalis, reductants, metallic salts (risk of decomposition).
Do not store together with organic solvents (risk of explosion).

Shelf-life:

24 months
6.   OTHER INFORMATION

The full titles of the EN standards referenced in the “Use-specific mitigation measures” sections are:






 


EN 16321 – Eye and face protection for occupational users










 


EN 374 – Protective gloves against chemicals and micro-organisms




The Council Directive referenced in the “Use-specific mitigation measures” sections is: Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998[RMJ1], p. 11).
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)


CLARMARIN® 350


Market area: EU




 


Wapo 35 Biozid


Market area: EU




580 Wasseraufbereitungsmittel


Market area: EU




Biozid 5


Market area: EU




Calgonit sporexalin


Market area: EU




Coolcid 5


Market area: EU




Ferrocid 8590


Market area: EU




Hollu LG DES 851


Market area: EU




Hydrokwix 35


Market area: EU




Kurita G-6250


Market area: EU




Neudod M-B 35


Market area: EU




Optidos W 35


Market area: EU




Trdes


Market area: EU




Wapo 35


Market area: EU




Waterdos RST 08


Market area: EU




WEICOLUB®-DES


Market area: EU




WEICOPER®-O


Market area: EU




WP 35


Market area: EU




OXY-DES


Market area: EU




Brennspec HP 35


Market area: EU




BEIBLEACH WP 35


Market area: EU




Waperox 35


Market area: EU




SANITER LP


Market area: EU




OXY 50


Market area: EU




OXY 50 PLUS


Market area: EU




STERIL 130


Market area: EU




OXY 50 DM


Market area: EU




PEROXISOL


Market area: EU




DEWA-OX


Market area: EU




PEROGENO 130


Market area: EU




EUROXY 50 AG SUPER


Market area: EU




EUROGENO


Market area: EU




OXICLEAN 2510/A


Market area: EU




OXICLEAN 3000/A


Market area: EU




AGRISAN 40


Market area: EU




OXICLEAN 10


Market area: EU




ENERSAN 2510A


Market area: EU




ANTIFERMENTATIVO K


Market area: EU




ANTIFERMENTATIVO K 100


Market area: EU




ACQUA


Market area: EU




SBIANCANTE K


Market area: EU




OSSIDANTE ATTIVO


Market area: EU




UNYRAIN


Market area: EU




LAUNDRY 05


Market area: EU




SYSTEMIC PROFESSIONAL M4 DES


Market area: EU




LAUNDRY 05 D


Market area: EU




RAPIDES OXY


Market area: EU




DES-H 35


Market area: EU




SYSTEM PROTEX 4


Market area: EU




SCHWEGO® fix W 8112


Market area: EU




ECSO 8670


Market area: EU




CARELA AKTIVATOR


Market area: EU




Komponente 2


Market area: EU




CARELA CARBOCLEAN


Market area: EU




CARELA HYDRODES


Market area: EU




CARELA PEROXSIL


Market area: EU




GENO-perox


Market area: EU




GENO-perox Spray


Market area: EU




SANOLIFE HO


Market area: EU




E-FLOW DETERGENTE SP01


Market area: EU




CANDOR STERIL B


Market area: EU




OXY 70 DM


Market area: EU




BLUOXIRAPID


Market area: EU




ALFA-O-DUE


Market area: EU




BAR-O-DUE


Market area: EU




OXY ONE


Market area: EU




OXI 50 DM


Market area: EU




Idroxan WT


Market area: EU




Waterdos LST 08


Market area: EU




BÜFA-Oxy WS


Market area: EU




O 33


Market area: EU




Authorisation number


EU-0028964-0005 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


35,0 




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











Trade name(s)


CLARMARIN® 500


Market area: EU




 


Wapo 50 Biozid


Market area: EU




Desbest


Market area: EU




ROTIE-Clean


Market area: EU




Systematic


Market area: EU




Systemclean


Market area: EU




Wapo 50


Market area: EU




INO PEROX 50


Market area: EU




Mirasan Perox


Market area: EU




Brennspec HP 50


Market area: EU




Waperox 50


Market area: EU




INTERCLEAN® TW


Market area: EU




DES-H 50


Market area: EU




Sanivet TM AQUA


Market area: EU




OXINEUTRO


Market area: EU




Vet-Ox


Market area: EU




Authorisation number


EU-0028964-0006 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


49,9 






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

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

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



ELI: http://data.europa.eu/eli/reg_impl/2023/2183/oj
ISSN 1977-0677 (electronic edition)