Official Gazette Notification Text
Official TranscriptOfficial Journal EN of the European Union 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...
Official Journal EN of the European Union 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.
(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.
ELI: http://data.europa.eu/eli/reg_impl/2026/1159/oj 1/35EN OJ L, 29.5.2026
(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 2/35 ELI: http://data.europa.eu/eli/reg_impl/2026/1159/ojEN OJ L, 29.5.2026 ANNEX Summary of product characteristics for a biocidal product family Diversey Hydrogen Peroxide Product Family Product type(s) PT04: Food and feed area Authorisation numberEU-0029435-0000 R4BP asset numberEU-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)
ELI: http://data.europa.eu/eli/reg_impl/2026/1159/oj 3/35EN OJ L, 29.5.2026 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 4/35 ELI: http://data.europa.eu/eli/reg_impl/2026/1159/ojEN OJ L, 29.5.2026 Name of manufacturer Brenntag SA Address of manufacturer Zone d'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
ELI: http://data.europa.eu/eli/reg_impl/2026/1159/oj 5/35EN OJ L, 29.5.2026
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 6/35 ELI: http://data.europa.eu/eli/reg_impl/2026/1159/ojEN OJ L, 29.5.2026
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 Active 7722-84-1 231-765-0 35 - 49,9 % (w/ peroxide substance 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 Active 7722-84-1 231-765-0 35 - 49,9 % (w/ peroxide substance 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.
ELI: http://data.europa.eu/eli/reg_impl/2026/1159/oj 7/35EN OJ L, 29.5.2026 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 8/35 ELI: http://data.europa.eu/eli/reg_impl/2026/1159/ojEN OJ L, 29.5.2026
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.
ELI: http://data.europa.eu/eli/reg_impl/2026/1159/oj 9/35EN OJ L, 29.5.2026
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 10/35 ELI: http://data.europa.eu/eli/reg_impl/2026/1159/ojEN OJ L, 29.5.2026 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.
ELI: http://data.europa.eu/eli/reg_impl/2026/1159/oj 11/35EN OJ L, 29.5.2026
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.
12/35 ELI: http://data.europa.eu/eli/reg_impl/2026/1159/ojEN OJ L, 29.5.2026
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
ELI: http://data.europa.eu/eli/reg_impl/2026/1159/oj 13/35EN OJ L, 29.5.2026 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.
14/35 ELI: http://data.europa.eu/eli/reg_impl/2026/1159/ojEN OJ L, 29.5.2026
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.
ELI: http://data.europa.eu/eli/reg_impl/2026/1159/oj 15/35EN OJ L, 29.5.2026
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 Market area: EU HS 35 VT68
Divosan Market area: EU HS 35 Authorisation number EU-0029435-0001 1-1 16/35 ELI: http://data.europa.eu/eli/reg_impl/2026/1159/ojEN OJ L, 29.5.2026 Common name IUPAC name Function CAS number EC number Content (%) Hydrogen Active 7722-84-1 231-765-0 35 % (w/w) peroxide substance
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 Active 7722-84-1 231-765-0 35 - 49,9 % (w/ peroxide substance 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..
ELI: http://data.europa.eu/eli/reg_impl/2026/1159/oj 17/35EN OJ L, 29.5.2026 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 18/35 ELI: http://data.europa.eu/eli/reg_impl/2026/1159/ojEN OJ L, 29.5.2026 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.
ELI: http://data.europa.eu/eli/reg_impl/2026/1159/oj 19/35EN OJ L, 29.5.2026
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 Common name: Bacteria stage) 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 20/35 ELI: http://data.europa.eu/eli/reg_impl/2026/1159/ojEN OJ L, 29.5.2026 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.
ELI: http://data.europa.eu/eli/reg_impl/2026/1159/oj 21/35EN OJ L, 29.5.2026
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.
22/35 ELI: http://data.europa.eu/eli/reg_impl/2026/1159/ojEN OJ L, 29.5.2026
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
ELI: http://data.europa.eu/eli/reg_impl/2026/1159/oj 23/35EN OJ L, 29.5.2026 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.
24/35 ELI: http://data.europa.eu/eli/reg_impl/2026/1159/ojEN OJ L, 29.5.2026
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
ELI: http://data.europa.eu/eli/reg_impl/2026/1159/oj 25/35EN OJ L, 29.5.2026
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).
26/35 ELI: http://data.europa.eu/eli/reg_impl/2026/1159/ojEN OJ L, 29.5.2026
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 Market area: EU 35 VT66
Divozon Market area: EU 35
Divosan Market area: EU BA 35 VT66
Divosan Market area: EU BA 35
Divozon Market area: EU 350
Divozon Market area: EU 350 Bath Authorisation number EU-0029435-0002 1-2 Common name IUPAC name Function CAS number EC number Content (%) Hydrogen Active 7722-84-1 231-765-0 35 % (w/w) peroxide substance
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
ELI: http://data.europa.eu/eli/reg_impl/2026/1159/oj 27/35EN OJ L, 29.5.2026
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 Active 7722-84-1 231-765-0 35 - 49,9 % (w/ peroxide substance 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.
28/35 ELI: http://data.europa.eu/eli/reg_impl/2026/1159/ojEN OJ L, 29.5.2026 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
ELI: http://data.europa.eu/eli/reg_impl/2026/1159/oj 29/35EN OJ L, 29.5.2026
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 30/35 ELI: http://data.europa.eu/eli/reg_impl/2026/1159/ojEN OJ L, 29.5.2026 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.
ELI: http://data.europa.eu/eli/reg_impl/2026/1159/oj 31/35EN OJ L, 29.5.2026
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.
32/35 ELI: http://data.europa.eu/eli/reg_impl/2026/1159/ojEN OJ L, 29.5.2026
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.
ELI: http://data.europa.eu/eli/reg_impl/2026/1159/oj 33/35EN OJ L, 29.5.2026
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.
34/35 ELI: http://data.europa.eu/eli/reg_impl/2026/1159/ojEN OJ L, 29.5.2026
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 Market area: EU D30
Divosan Market area: EU D30 VT91 Authorisation number EU-0029435-0003 1-3 Common name IUPAC name Function CAS number EC number Content (%) Hydrogen Active 7722-84-1 231-765-0 35 % (w/w) peroxide substance
ELI: http://data.europa.eu/eli/reg_impl/2026/1159/oj 35/35