Commission Implementing Regulation (EU) 2026/749 of 31 March 2026 amending Implementing Regulation (EU) 2023/2183 as regards administrative changes to the Union authorisation of the biocidal product family Evonik’s Hydrogen Peroxide Product Family
Date: 2026-03-31
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: administrative formalities, animal feedingstuffs, biocide, chemical product, decontamination, food safety, market approval, oxide, pharmaceutical product








L_202600749EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2026/749


1.4.2026







            COMMISSION IMPLEMENTING REGULATION (EU) 2026/749
of 31 March 2026
         
amending Implementing Regulation (EU) 2023/2183 as regards administrative changes to the Union authorisation of the biocidal product family ‘Evonik’s Hydrogen Peroxide Product Family’
         
(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 50(2) thereof,

Whereas:







(1)


On 18 October 2023, Commission Implementing Regulation (EU) 2023/2183 (2) granted a Union authorisation, under number EU-0028964-0000, to Evonik Operations GmbH for the making available on the market and use of the biocidal product family ‘Evonik’s Hydrogen Peroxide Product Family’. The Annex to that Implementing Regulation provides the summary of product characteristics for that biocidal product family.












(2)


On 10 July 2024 and 20 March 2025, Evonik Operations GmbH submitted to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013 (3), notifications of administrative changes to the Union authorisation for the biocidal product family ‘Evonik’s Hydrogen Peroxide Product Family’, recorded in the Register for Biocidal Products (‘Register’) under the case numbers BC-DY098630-08 and BC-ER104958-18. The notified proposed changes to that authorisation concern the removal and addition of trade names, the removal and addition of product manufacturers, changes in the names of active substance and product manufacturer and a change in the address of a product manufacturer.












(3)


On 29 July 2024 and 3 April 2025, the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, opinions (4) on the notified administrative changes to the Union authorisation for the biocidal product family ‘Evonik’s Hydrogen Peroxide Product Family’. In its opinions, the Agency concluded that the proposed changes are administrative changes as referred to in Article 50(3), point (a), of Regulation (EU) No 528/2012 and as specified in Title 1, Sections 1 and 2 of the Annex to Implementing Regulation (EU) No 354/2013, and that, after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.












(4)


On 10 April 2025, the Agency transmitted to the Commission a revised summary of product characteristics for the biocidal product family ‘Evonik’s Hydrogen Peroxide Product Family’ in all official languages of the Union, covering the administrative changes applied for, in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.












(5)


The Commission concurs with the opinion of the Agency and therefore considers it appropriate to amend the Union authorisation of the biocidal product family ‘Evonik’s Hydrogen Peroxide Product Family’ to introduce the administrative changes requested by Evonik Operations GmbH.












(6)


Except for the amendments regarding the proposed administrative changes, all other information included in the summary of product characteristics of ‘Evonik’s Hydrogen Peroxide Product Family’, as set out in the Annex to Implementing Regulation (EU) 2023/2183, remains unchanged.












(7)


In order to enhance clarity and to ease the access of users and interested parties to the consolidated version of the summary of product characteristics which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2023/2183 should be replaced in its entirety. Due to a change in the format used for the generation of the summary of product characteristics in the Register in February 2024, the summary of product characteristics in that Annex should also include some minor editorial and layout changes.












(8)


Implementing Regulation (EU) 2023/2183 should therefore be amended accordingly,





HAS ADOPTED THIS REGULATION:



Article 1
The Annex to Implementing Regulation (EU) 2023/2183 is replaced by the text set out in the Annex to this Regulation.


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, 31 March 2026.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.

(2)  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 (OJ L, 2023/2183, 19.10.2023, ELI: http://data.europa.eu/eli/reg_impl/2023/2183/oj).

(3)  Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4, ELI: http://data.europa.eu/eli/reg_impl/2013/354/oj).

(4)  ECHA opinions UAD-C-1752264-31-00/F and UAD-C-1813642-33-00/F of 29 July 2024 and 3 April 2025 on administrative changes of the Union authorisation of the biocidal product family ‘Evonik’s Hydrogen Peroxide Product family’, https://echa.europa.eu/opinions-on-union-authorisation.




ANNEX
Summary of product characteristics for a biocidal product family
Evonik’s Hydrogen Peroxide Product Family

Product type(s)

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

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
PT04: Food and feed area




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


Evonik Operations GmbH




Address


Rellinghauser Straße 1 - 11 45128 Essen DE




Authorisation number


 


EU-0028964-0000





R4BP asset number



 


EU-0028964-0000




Date of the authorisation


 


8.11.2023




Expiry date of the authorisation


 


31.10.2033




1.4.   Manufacturer(s) of the product







Name of manufacturer


Evonik Antwerpen NV




Address of manufacturer


Tijsmanstunnel West 2040 Antwerpen Belgium




Location of manufacturing sites


Evonik Antwerpen NV - Site 1 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


Evonik Operations GmbH - Site 1 Untere Kanalstr. 3 79618 Rheinfelden Germany













Name of manufacturer


Evonik Peroxid GmbH




Address of manufacturer


Industriestraße 1 9721 Weißenstein Austria




Location of manufacturing sites


Evonik Peroxid GmbH Industriestraße 1 9721 Weißenstein Austria













Name of manufacturer


Evonik Peroxide Netherlands BV




Address of manufacturer


Hettenheuvelweg 37 /39 1101 BM Amsterdam Netherlands (the)




Location of manufacturing sites


Evonik Peroxide Netherlands BV - Site 1 Oosterhorn 14 9936 HD Farmsum Netherlands (the)













Name of manufacturer


Brenntag Schweizerhall AG




Address of manufacturer


Elsässerstrasse 231 4013 Basel Switzerland




Location of manufacturing sites







Brenntag Schweizerhall AG Site 1 Route Industrielle 10 1580 Avenches Switzerland




Brenntag Schweizerhall AG Site 2 C/O Infrapark , Baselland, Rothausstrasse 61 4132 Muttenz Switzerland

















Name of manufacturer


Brenntag GmbH




Address of manufacturer


Messeallee 11 45131 Essen Germany




Location of manufacturing sites







Brenntag GmbH Site 1 Am Röhrenwerk 46 47259 Duisburg Germany




Brenntag GmbH Site 2 Boschstraße 3 08371 Glauchau Germany




Brenntag GmbH Site 3 Hannoversche Str. 40 21079 Hamburg Germany




Brenntag GmbH Site 4 Dieselstraße 5 74076 Heilbron Germany




Brenntag GmbH Site 5 Merkurstraße 47 67663 Kaiserslautern Germany




Brenntag GmbH Site 6 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







Brenntag CEE GmbH Site 1 Bahnstraße 13 2353 Guntramsdorf Austria




Brenntag CEE GmbH Site 2 Fabrikstraße 4-6 8111 Judendorf Austria




Brenntag CEE GmbH Site 3 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







Brenntag Slovakia s. r. o. Site 1 Glejovka 15 902 03 Pezinok Slovakia




Brenntag Slovakia s. r. o. Site 2 Príboj 558 976 13 Slovenská Ľupča Slovakia




Brenntag Slovakia s. r. o. Site 3 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







Brenntag S.p.A. Site 1 Via San Carlo Borromeo 24040 Levate Italy




Brenntag S.p.A. Site 2 Via Galliera 6/2 40010 Bentivoglio Italy




Brenntag S.p.A. Site 3 Via del Cimitero 6 80030 Castello di Cisterna Italy




Brenntag S.p.A. Site 4 Strada Provinciale di Bonifica 34-36 65010 Villanova di Cepagatti Italy




Brenntag S.p.A. Site 5 Via Provinciale per Bitetto 70027 Palo del Colle Italy




Brenntag S.p.A. Site 6 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







Brenntag Polska Sp. z o.o. Site 1 Józefa Bema 21 47-224 Kędzierzyn-Koźle Poland




Brenntag Polska Sp. z o.o. Site 2 Kwasowa 5 95-100 Zgierz Poland




Brenntag Polska Sp. z o.o. Site 3 Przemysłowa 2 62-080 Jankowice Poland




Brenntag Polska Sp. z o.o. Site 4 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


Brenntag Lietuva UAB Site 1 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


Brenntag Hungária Kft. Site 1 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


S.C. Brenntag S.R.L. Site 1 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


Brenntag Hrvatska d.o.o. Site 1 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


Brenntag Bulgaria EOOD Site 1 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


OQEMA S.P.A. Site 1 VIA TORTONA 73 27055 Rivanazzano Italy













Name of manufacturer


Breustedt Chemie BV




Address of manufacturer


IJsseldijk 28 7325 WZ Apeldoorn Netherlands (the)




Location of manufacturing sites


Breustedt Chemie BV Site 1 IJsseldijk 28 7325 WZ Apeldoorn Netherlands (the)













Name of manufacturer


BEAUSEIGNEUR SAS




Address of manufacturer


6, Rue André Viellard 90140 Froidefontaine France




Location of manufacturing sites


BEAUSEIGNEUR SAS Site 1 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


Staub & Co. - Silbermann GmbH Site 1 Industriestraße 3 6456 Gablingen Germany













Name of manufacturer


Möller GmbH & Co. KG




Address of manufacturer


Bürgerkamp 1 48565 Steinfurt Germany




Location of manufacturing sites


Möller GmbH & Co. KG Site 1 Bürgerkamp 1 48565 48565 Germany













Name of manufacturer


Häffner GmbH & Co. KG




Address of manufacturer


Friedrichstraße 3 71679 Asperg Germany




Location of manufacturing sites


Häffner GmbH & Co. KG Site 1 Friedrichstraße 3 71679 Asperg Germany













Name of manufacturer


Gaches Chimie




Address of manufacturer


17 avenue de la Gare 31750 Escalquens France




Location of manufacturing sites







Gaches Chimie Site 1 17 avenue de la Gare 31750 Escalquens France




Gaches Chimie Site 2 2 Chemin de la Scierie 64150 Os-Marsillon France

















Name of manufacturer


Evonik España y Portugal SA




Address of manufacturer


Afueras s/n 50784 La Zaida Spain




Location of manufacturing sites


Evonik España y Portugal SA C/ Afueras s/n. 50784 La Zaida Spain













Name of manufacturer


Amira Srl




Address of manufacturer


Via Vecchia Milanese 12 20844 Triuggio (MB) Italy




Location of manufacturing sites


Amira Srl Site 1 Via Vecchia Milanese 12 20844 Triuggio (MB) Italy













Name of manufacturer


ASiRAL Industriereiniger GmbH




Address of manufacturer


Hermann-Wehrle-Str. 15 67433 Neustadt/Weinstraße Germany




Location of manufacturing sites


ASiRAL Industriereiniger GmbH Site 1 Hermann-Wehrle-Str. 15 67433 Neustadt/Weinstraße Germany













Name of manufacturer


abcr GmbH




Address of manufacturer


Im Schlehert 10 76187 Karlsruhe Germany




Location of manufacturing sites


abcr GmbH Site 1 Im Schlehert 10 76187 Karlsruhe Germany













Name of manufacturer


Antec International Limited




Address of manufacturer


Windham Road, Chilton Industrial Estate CO1 Sudbury United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites


Antec International Limited Site 1 Windham Road, Chilton Industrial Estate CO1 Sudbury United Kingdom of Great Britain and Northern Ireland (the)













Name of manufacturer


OQEMA GmbH




Address of manufacturer


Aachener Straße 258 41061 Mönchengladbach Germany




Location of manufacturing sites


OQEMA GmbH Site 1 Gutberletstraße 17 04316 Leipzig Germany













Name of manufacturer


Brenntag Nordic AB




Address of manufacturer


Hyllie Boulvevard 34 18 TR SE-215 32 Malmö Sweden




Location of manufacturing sites


Brenntag Nordic AB Site 1 Vevgatan 2 504 64 Boras Sweden













Name of manufacturer


ECSA Chemicals SA




Address of manufacturer


Burgauerstrasse 17 9230 Flawil Switzerland




Location of manufacturing sites


ECSA Chemicals SA Site 1 Via Luigi Favre 16 6828 Balerna Switzerland













Name of manufacturer


TENSID-CHEMIE GMBH




Address of manufacturer


Heinkelstraße 32 76461 Muggensturm Germany




Location of manufacturing sites


TENSID-CHEMIE GMBH Site 1 Heinkelstraße 32 76461 Muggensturm Germany













Name of manufacturer


Carl Roth GmbH + Co. KG




Address of manufacturer


Schoemperlenstraße 3-5 76185 Karlsruhe Germany




Location of manufacturing sites


Carl Roth GmbH + Co. KG Site 1 Schoemperlenstraße 3-5 76185 Karlsruhe Germany













Name of manufacturer


Hollu Systemhygiene GmbH




Address of manufacturer


Hollu Campus 1 6170 Zirl Austria




Location of manufacturing sites


Hollu Systemhygiene GmbH Site 1 Hollu Campus 1 6170 Zirl Austria




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


Evonik Antwerpen NV Tijsmanstunnel West 2040 Antwerpen Belgium













Active substance


Hydrogen peroxide




Name of manufacturer


Evonik Operations GmbH




Address of manufacturer


Rellinghauser Straße 1-11 45128 Essen Germany




Location of manufacturing sites


Evonik Operations GmbH 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


Evonik Peroxid GmbH 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 (the)




Location of manufacturing sites


Evonik Peroxide Netherlands BV Oosterhorn 14 9936 HD Farmsum Netherlands (the)













Active substance


Hydrogen peroxide




Name of manufacturer


Evonik España y Portugal SA




Address of manufacturer


Afueras s/n 50784 La Zaida Spain




Location of manufacturing sites


Evonik España y Portugal SA C/ Afueras s/n. 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 (%)




Hydrogen peroxide


 


Active substance


7722-84-1


231-765-0


35  - 49,9  % (w/w)




2.2.   Type(s) of formulation







Formulation type(s)


SL Soluble concentrate




PART II

SECOND INFORMATION LEVEL META SPC(S)

1.   META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier







Identifier


Meta SPC: 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
PT04: Food and feed area




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 (%)




Hydrogen peroxide


 


Active substance


7722-84-1


231-765-0


35  - 49,9  % (w/w)




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







Formulation type(s)


SL Soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1







Hazard statements


H302: Harmful if swallowed.
H315: Causes skin irritation.
H318: Causes serious eye damage.
H335: May cause respiratory irritation.
H412: Harmful to aquatic life with long lasting effects.
H272: May intensify fire; oxidiser.




Precautionary statements


P261: Avoid breathing vapours.
P264: Wash hands thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P271: Use only outdoors or in a well-ventilated area.
P273: Avoid release to the environment.
P280: Wear protective gloves / eye protection / face protection..
P301+P312: IF SWALLOWED: Call a POISON CENTER / doctor / physician if you feel unwell.
P330: Rinse mouth.
P302+P352: IF ON SKIN: Wash with plenty of water/ soap.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P312: Call a POISON CENTER/ doctor/physician if you feel unwell.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310: Immediately call a POISON CENTER / doctor.
P332+P313: If skin irritation occurs: Get medical advice.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P405: Store locked up.
P501: Dispose of contents / in accordance with local requirements.
P501: Dispose of container / in accordance with local requirements.
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P220: Keep away from clothing or other combustible materials.
P370+P378: In case of fire: Use water to extinguish.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Surface disinfection by vaporised hydrogen peroxide (VHP) process







Product type


PT02: Disinfectants and algaecides not intended for direct application to humans or animals




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 use
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. 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 1 000  litres
HDPE ISO tank 20 m3





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 30 m3 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.
4.1.2.   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


Surface disinfection by vaporised hydrogen peroxide (VHP) process







Product type


PT04: Food and feed area




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 use
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
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 20 m3





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 30 m3 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


Aseptic packaging in food and feed industries







Product type


PT04: Food and feed area




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 use
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 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 20 m3





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


Disinfection of distribution system for drinking water by cleaning in place (CIP)







Product type


PT04: Food and feed area




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 use
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. 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 20 m3





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


Disinfection of non-porous hard surfaces and equipment by immersion







Product type


PT04: Food and feed area




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 use
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. 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 20 m3





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. Gloves 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


Disinfection of surfaces by cleaning in place (CIP)







Product type


PT04: Food and feed area




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 use
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. 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 20 m3





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 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




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 % (w/w)




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 % (w/w)




1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier







Identifier


Meta SPC: 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




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 (%)




Hydrogen peroxide


 


Active substance


7722-84-1


231-765-0


35  - 49,9  % (w/w)




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







Formulation type(s)


SL Soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2







Hazard statements


H302: Harmful if swallowed.
H315: Causes skin irritation.
H318: Causes serious eye damage.
H335: May cause respiratory irritation.
H412: Harmful to aquatic life with long lasting effects.
H272: May intensify fire; oxidiser.




Precautionary statements


P261: Avoid breathing vapours.
P264: Wash hands thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P271: Use only outdoors or in a well-ventilated area.
P273: Avoid release to the environment.
P280: Wear protective gloves / eye protection / face protection.
P301+P312: IF SWALLOWED: Call a POISON CENTER / doctor / physician if you feel unwell.
P330: Rinse mouth.
P302+P352: IF ON SKIN: Wash with plenty of water/ soap.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P312: Call a POISON CENTER/doctor/physician if you feel unwell.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310: Immediately call a POISON CENTER/doctor.
P332+P313: If skin irritation occurs: Get medical advice.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P405: Store locked up.
P501: Dispose of contents / in accordance with local requirements.
P501: Dispose of container / in accordance with local requirements.
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P220: Keep away from clothing or other combustible materials.
P370+P378: In case of fire: Use water to extinguish.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Aseptic packaging in food and feed industries







Product type


PT04: Food and feed area




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 use
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. 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 20 m3





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 2


Disinfection of distribution system for drinking water by cleaning in place (CIP)







Product type


PT04: Food and feed area




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 use
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 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 20 m3





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 3


Disinfection of non-porous hard surfaces and equipment by immersion







Product type


PT04: Food and feed area




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 use
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. 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
HDPE ISO tank 20 m3





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 4


Disinfection of surfaces by cleaning in place (CIP)







Product type


PT04: Food and feed area




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 use
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. 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 20 m3





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 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 % (w/w)




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 % (w/w)




1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier







Identifier


Meta SPC: 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
PT04: Food and feed area




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 (%)




Hydrogen peroxide


 


Active substance


7722-84-1


231-765-0


35  - 49,9  % (w/w)




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







Formulation type(s)


SL Soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3







Hazard statements


H302: Harmful if swallowed.
H315: Causes skin irritation.
H318: Causes serious eye damage.
H335: May cause respiratory irritation.
H412: Harmful to aquatic life with long lasting effects.
H272: May intensify fire; oxidiser.




Precautionary statements


P261: Avoid breathing vapours.
P264: Wash hands thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P271: Use only outdoors or in a well-ventilated area.
P273: Avoid release to the environment.
P280: Wear protective clothing / eye protection / face protection.
P301+P312: IF SWALLOWED: Call a POISON CENTER / doctor / physician if you feel unwell.
P330: Rinse mouth.
P302+P352: IF ON SKIN: Wash with plenty of water/ soap.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P312: Call a POISON CENTER/doctor/physician if you feel unwell.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310: Immediately call a POISON CENTER / doctor.
P332+P313: If skin irritation occurs: Get medical advice.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P405: Store locked up.
P501: Dispose of contents / in accordance with local requirements.
P501: Dispose of container / in accordance with local requirements.
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P220: Keep away from clothing or other combustible materials.
P370+P378: In case of fire: Use water to extinguish.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Laundry disinfection in closed washing machines by dosing







Product type


PT02: Disinfectants and algaecides not intended for direct application to humans or animals




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 use
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. 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 20 m3





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 2


Disinfection of distribution system for drinking water by cleaning in place (CIP)







Product type


PT04: Food and feed area




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 use
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 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 20 m3





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 3


Disinfection of non-porous hard surfaces and equipment by immersion







Product type


PT04: Food and feed area




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 use
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. 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 20 m3





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 4


Disinfection of surfaces by cleaning in place (CIP)







Product type


PT04: Food and feed area




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 use
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. 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 20 m3





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 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 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 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




Calgonit sporexalin


Market area: EU




Hollu LG DES 851


Market area: EU




Wapo 35


Market area: EU




WEICOLUB®-DES


Market area: EU




WEICOPER®-O


Market area: EU




WP 35


Market area: EU




Brennspec HP 35


Market area: EU




BEIBLEACH WP 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




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




ECSO 8670


Market area: EU




Komponente 2


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




BÜFA-Oxy WS


Market area: EU




O 33


Market area: EU




WAPERSOL® 35


Market area: EU




GRS 7325 S


Market area: EU




TH 830D


Market area: EU




KORASIL 3500-KA


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 % (w/w)




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




Wapo 50


Market area: EU




INO PEROX 50


Market area: EU




Mirasan Perox


Market area: EU




Brennspec HP 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




WAPERSOL® 50


Market area: EU




KORASIL 5000-GS


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 % (w/w)







ELI: http://data.europa.eu/eli/reg_impl/2026/749/oj
ISSN 1977-0677 (electronic edition)