Commission Implementing Regulation (EU) 2026/1159 of 28 May 2026 amending Implementing Regulation (EU) 2024/2432 as regards administrative changes to the Union authorisation for the biocidal product family Diversey Hydrogen Peroxide Product Family
Date: 2026-05-28
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, biocide, chemical product, decontamination, food safety, market approval, pharmaceutical product








L_202601159EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2026/1159


29.5.2026







            COMMISSION IMPLEMENTING REGULATION (EU) 2026/1159
of 28 May 2026
         
amending Implementing Regulation (EU) 2024/2432 as regards administrative changes to the Union authorisation for the biocidal product family ‘Diversey 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 16 September 2024, Commission Implementing Regulation (EU) 2024/2432 (2) granted a Union authorisation, under number EU-0029435-0000, to Diversey Europe Operations B.V. for the making available on the market and use of the biocidal product family Diversey Hydrogen Peroxide Product Family. The Annex to that Implementing Regulation provides the summary of product characteristics for that biocidal product family.












(2)


On 20 May 2025, Diversey Europe Operations B.V. submitted to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013 (3), a notification of administrative changes to the Union authorisation for the biocidal product family ‘Diversey Hydrogen Peroxide Product Family’, recorded in the Register for Biocidal Products (‘Register’) under case number BC-VH105986-21. The notified proposed changes to that authorisation concern the addition of three biocidal product manufacturer sites, changes to the address of the authorisation holder and the biocidal products manufacturer.












(3)


On 9 June 2025, the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, an opinion (4) on the notified administrative changes to the Union authorisation for the biocidal product family ‘Diversey Hydrogen Peroxide Product Family’. In its opinion, 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 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 9 June 2025, the Agency transmitted to the Commission a revised summary of the product characteristics for the biocidal product family ‘Diversey 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 for the biocidal product family ‘Diversey Hydrogen Peroxide Product Family’ to introduce the administrative changes requested by Diversey Europe Operations B.V.












(6)


Except for the amendments regarding the proposed administrative changes, all other information included in the summary of the product characteristics of ‘Diversey Hydrogen Peroxide Product Family’, as set out in the Annex to Implementing Regulation (EU) 2024/2432, 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 the product characteristics which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2024/2432 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) 2024/2432 should therefore be amended accordingly,





HAS ADOPTED THIS REGULATION:



Article 1
The Annex to Implementing Regulation (EU) 2024/2432 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, 28 May 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) 2024/2432 of 16 September 2024 granting a Union authorisation for the biocidal product family ‘Diversey Hydrogen Peroxide Product Family’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L, 2024/2432, 17.9.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/2432/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 Opinion No UAD-C-1826584-17-00/F of 9 June 2025 on the administrative changes of the Union authorisation of the biocidal product family ‘Diversey Hydrogen Peroxide Product Family’, https://echa.europa.eu/opinions-on-applications-for-union-authorisation.




ANNEX
Summary of product characteristics for a biocidal product family
Diversey Hydrogen Peroxide Product Family

Product type(s)

PT04: Food and feed area

Authorisation number EU-0029435-0000

R4BP asset number EU-0029435-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name







Name


Diversey Hydrogen Peroxide Product Family




1.2.   Product type(s)







Product type(s)


PT04: Food and feed area




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


Diversey Europe Operations B.V.




Address


De Corridor 4 (Regulatory team) 3621 ZB Breukelen NL




Authorisation number


 


EU-0029435-0000





R4BP asset number



 


EU-0029435-0000




Date of the authorisation


 


7 October 2024




Expiry date of the authorisation


 


31 October 2033




1.4.   Manufacturer(s) of the product







Name of manufacturer


Diversey Europe Operations B.V.




Address of manufacturer


De Corridor 4 (Regulatory team) 3621 ZB Breukelen Netherlands (the)




Location of manufacturing sites







Diversey Europe Operations B.V. site 1 Strada Statale 235 26010 Bagnolo Cremasco (CR) Italy




Diversey Europe Operations B.V. site 2 Rembrandtlaan 414 7545 ZW Enschede Netherlands (the)




Diversey Europe Operations B.V. site 3 Cotes Park Industrial Estate DE55 4PA Somercotes Alfreton United Kingdom of Great Britain and Northern Ireland (the)




Diversey Europe Operations B.V. site 4 Avenida Conde Duque 5, 7 y 9 ; Poligono Industrial La Postura 28343 Valdemoro (Madrid) Spain




Diversey Europe Operations B.V. site 5 Morschheimer Strasse 12 67292 Kirchheimbolanden Germany

















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 site 1 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


ELETTROCHIMICA VALLE STAFFORA SPA




Address of manufacturer


VIA TORTONA 73 27055 Rivanazzano Italy




Location of manufacturing sites


ELETTROCHIMICA VALLE STAFFORA SPA site 1 VIA TORTONA 73 27055 Rivanazzano Italy













Name of manufacturer


Brenntag SA




Address of manufacturer


Zone d&#39;Activités les Sauzets 07340 Andance France




Location of manufacturing sites







Brenntag SA site 1 Zone d’Activités les Sauzets 07340 Andance France




Brenntag SA site 2 12 sente des Jumelles 76710 Montville France

















Name of manufacturer


CHEPORT, spol. s r.o.




Address of manufacturer


Lhotsko 93 763 12 Vizovice Czechia




Location of manufacturing sites


CHEPORT, spol. s r.o. site 1 Lhotsko 93 763 12 Vizovice Czechia













Name of manufacturer


Brenntag Polska Sp. z o.o




Address of manufacturer


Ul. Towarowa 6 05-530 Góra Kalwaria Poland




Location of manufacturing sites


Brenntag Polska Sp. z o.o site 1 Ul. Towarowa 6 05-530 Góra Kalwaria Poland













Name of manufacturer


Evonik Peroxide Spain, S.L.U.




Address of manufacturer


C/ Afueras s/n. 50784 La Zaida Spain




Location of manufacturing sites


Evonik Peroxide Spain, S.L.U. site 1 C/ Afueras s/n. 50784 La Zaida Spain













Name of manufacturer


Solenis Sweden AB




Address of manufacturer


Högastensgatan 18 S-25232 Helsingborg Sweden




Location of manufacturing sites


Solenis Sweden AB Högastensgatan 18 S-25232 Helsingborg Sweden













Name of manufacturer


Solenis Germany GmbH & Co. KG




Address of manufacturer


Fütingsweg 20 D-47508 Krefeld Germany




Location of manufacturing sites


Solenis Germany GmbH & Co. KG Fütingsweg 20 D-47508 Krefeld Germany













Name of manufacturer


Solenis Finland Oy




Address of manufacturer


Kolmihaarankatu 7 FIN-33330 Tampere Finland




Location of manufacturing sites


Solenis Finland Oy Kolmihaarankatu 7 FIN-33330 Tampere Finland




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 site 1 Tijsmanstunnel West 2040 Antwerpen Belgium













Active substance


Hydrogen peroxide




Name of manufacturer


Evonik Operation GmbH




Address of manufacturer


Rellinghauser Straße 1-11 45128 Essen Germany




Location of manufacturing sites


Evonik Operation GmbH site 1 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 site 1 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 site 1 Oosterhorn 14 9936 HD Farmsum Netherlands (the)













Active substance


Hydrogen peroxide




Name of manufacturer


Evonik Peroxide Spain, S.L.U.




Address of manufacturer


C/ Afueras s/n. 50784 La Zaida Spain




Location of manufacturing sites


Evonik Peroxide Spain, S.L.U. site 1 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: META Divosan Spray




1.2.   Suffix to the authorisation number







Number


1-1




1.3.   Product type(s)







Product type(s)


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


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: no data
Common name: Yeasts
Development stage: no data
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 20m3





4.1.1.   Use-specific instructions for use

The aseptic filling systems are based on the principle of aseptically forming a tube from a sterilised sheet of package material, which is continuously filled with commercially sterile liquid food product and subsequently transversally sealed to form pouches, which in turn are folded into the final package shape. The packaging material are delivered to the aseptic filling machine either in the form of (sheet) reels or in the form of pre-formed packs, tubs and bottles. 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.
4.1.2.   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 .
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: no data
Common name: Yeasts
Development stage: no data
Common name: fungi
Development stage: no data




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 20m3





4.2.1.   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.
4.2.2.   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. 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.
4.2.3.   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: no data
Common name: Yeasts
Development stage: no data
Common name: fungi
Development stage: no data




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 20m3





4.3.1.   Use-specific instructions for use

For disinfection of bacteria yeasts and fungi the product should be diluted to 8,1% (w/w) hydrogen peroxide. For example, for a product containing 35% (w/w) hydrogen peroxide; add 200 ml product to 738 ml water to achieve a dilution of 8,1% (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
Immersion: Equipment in the food and feed industry is disinfected by immersion. Pre-clean the equipment. The disinfection solution should be diluted into vats (i.e. pouring or pumping the product into vats). The equipment to be disinfected is manually or automatically placed into these vats (closed baths) and taken out after a contact time of not less than 60 minutes. After the disinfection procedure is completed, equipment is rinsed with water. The disinfection 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, 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.
4.3.3.   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: no data
Common name: Yeasts
Development stage: no data
Common name: fungi
Development stage: no data




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 20m3





4.4.1.   Use-specific instructions for use

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

Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent/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.
4.4.3.   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 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)


Divosan HS 35 VT68


Market area: EU




Divosan HS 35


Market area: EU




Authorisation number


 


EU-0029435-0001 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)




1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier







Identifier


Meta SPC: META Divosan Bath




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: no data
Common name: Yeasts
Development stage: no data
Common name: Bacterial spores
Development stage: no data




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 20m3





4.1.1.   Use-specific instructions for use

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

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

No use specific first aid instructions and emergency measures to protect the environment. See general directions for use.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

No use specific instructions for safe disposal of the product and its packaging. See general directions for use.
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

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


Table 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: no data
Common name: Yeasts
Development stage: no data
Common name: fungi
Development stage: no data




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 20m3





4.2.1.   Use-specific instructions for use

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

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

No use specific first aid instructions and emergency measures to protect the environment. See general directions for use.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

No use specific instructions for safe disposal of the product and its packaging. See general directions for use.
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

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


Table 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: no data
Common name: Yeasts
Development stage: no data
Common name: fungi
Development stage: no data




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 mininutes
Frequency: Daily / if required
Temperature: room temperature




Category(ies) of users


professional




Pack sizes and packaging material


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





4.3.1.   Use-specific instructions for use

For disinfection of bacteria yeasts and fungi the product should be diluted to 8,1% (w/w) hydrogen peroxide. For example, for a product containing 35% (w/w) hydrogen peroxide: add 200 ml product to 738 ml water to achieve a dilution of 8,1% (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
Immersion:
Equipment in the food and feed industry is disinfected by immersion. Pre-clean the equipment. The disinfection solution should be diluted into vats (i.e. pouring or pumping the product into vats). The equipment to be disinfected is manually or automatically placed into these vats (closed baths) and taken out after a contact time of 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: no data
Common name: Yeasts
Development stage: no data
Common name: fungi
Development stage: no data




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 20m3





4.4.1.   Use-specific instructions for use

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

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

No use specific first aid instructions and emergency measures to protect the environment. See general directions for use.
4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

No use specific instructions for safe disposal of the product and its packaging. See general directions for use.
4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use.
5.   GENERAL DIRECTIONS FOR USE 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)


Divozon 35 VT66


Market area: EU




Divozon 35


Market area: EU




Divosan BA 35 VT66


Market area: EU




Divosan BA 35


Market area: EU




Divozon 350


Market area: EU




Divozon 350 Bath


Market area: EU




Authorisation number


 


EU-0029435-0002 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: META Divosan D




1.2.   Suffix to the authorisation number







Number


1-3




1.3.   Product type(s)







Product type(s)


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


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: no data
Common name: Yeasts
Development stage: no data
Common name: fungi
Development stage: no data




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 20m3





4.1.1.   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.
4.1.2.   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. 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.
4.1.3.   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 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: no data
Common name: Yeasts
Development stage: no data
Common name: fungi
Development stage: no data




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 20m3





4.2.1.   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.
4.2.2.   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 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.
4.2.3.   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 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: no data
Common name: Yeasts
Development stage: no data
Common name: fungi
Development stage: no data




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 20m3





4.3.1.   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.
4.3.2.   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. 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.
4.3.3.   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.
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)


Divosan D30


Market area: EU




Divosan D30 VT91


Market area: EU




Authorisation number


 


EU-0029435-0003 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)







ELI: http://data.europa.eu/eli/reg_impl/2026/1159/oj
ISSN 1977-0677 (electronic edition)