LegalizeCommission Implementing Regulation (EU) 2023/2183 of 18 October 2023 granting a Union authorisation for the biocidal product family Evonik’s Hydrogen Peroxide Product Family in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Article 1
A Union authorisation with authorisation number EU-0028964-0000 is granted to Evonik Operations GmbH for the making available on the market and use of the biocidal product family ‘Evonik’s Hydrogen Peroxide Product Family’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 8 November 2023 until 31 October 2033.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX
Summary of product characteristics for a biocidal product family
Evonik’s Hydrogen Peroxide Product Family
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
Authorisation number EU-0028964-0000
R4BP asset number EU-0028964-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
1.1. Family name
| Name | Evonik’s Hydrogen Peroxide Product Family |
1.2. Product type(s)
| Product type(s) | PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area |
1.3. Authorisation holder
| Name and address of the authorisation holder | Name | Evonik Operations GmbH |
| Name and address of the authorisation holder | Address | Rellinghauser Straße 1 - 11 45128 Essen DE |
| Authorisation number | EU-0028964-0000 | |
| R4BP asset number | EU-0028964-0000 | |
| Date of the authorisation | 8.11.2023 | |
| Expiry date of the authorisation | 31.10.2033 |
1.4. Manufacturer(s) of the product
| Name of manufacturer | Evonik Antwerpen NV |
| Address of manufacturer | Tijsmanstunnel West 2040 Antwerpen Belgium |
| Location of manufacturing sites | Evonik Antwerpen NV - Site 1 Tijsmanstunnel West 2040 Antwerpen Belgium |
| --- | --- |
| Name of manufacturer | Evonik Operations GmbH |
| Address of manufacturer | Rellinghauser Straße 1-11 45128 Essen Germany |
| Location of manufacturing sites | Evonik Operations GmbH - Site 1 Untere Kanalstr. 3 79618 Rheinfelden Germany |
| --- | --- |
| Name of manufacturer | Evonik Peroxid GmbH |
| Address of manufacturer | Industriestraße 1 9721 Weißenstein Austria |
| Location of manufacturing sites | Evonik Peroxid GmbH Industriestraße 1 9721 Weißenstein Austria |
| --- | --- |
| Name of manufacturer | Evonik Peroxide Netherlands BV |
| Address of manufacturer | Hettenheuvelweg 37 /39 1101 BM Amsterdam Netherlands (the) |
| Location of manufacturing sites | Evonik Peroxide Netherlands BV - Site 1 Oosterhorn 14 9936 HD Farmsum Netherlands (the) |
| --- | --- |
| Name of manufacturer | Brenntag Schweizerhall AG |
| Address of manufacturer | Elsässerstrasse 231 4013 Basel Switzerland |
| Location of manufacturing sites | Brenntag Schweizerhall AG Site 1 Route Industrielle 10 1580 Avenches Switzerland Brenntag Schweizerhall AG Site 2 C/O Infrapark , Baselland, Rothausstrasse 61 4132 Muttenz Switzerland |
| --- | --- |
| Name of manufacturer | Brenntag GmbH |
| Address of manufacturer | Messeallee 11 45131 Essen Germany |
| Location of manufacturing sites | Brenntag GmbH Site 1 Am Röhrenwerk 46 47259 Duisburg Germany Brenntag GmbH Site 2 Boschstraße 3 08371 Glauchau Germany Brenntag GmbH Site 3 Hannoversche Str. 40 21079 Hamburg Germany Brenntag GmbH Site 4 Dieselstraße 5 74076 Heilbron Germany Brenntag GmbH Site 5 Merkurstraße 47 67663 Kaiserslautern Germany Brenntag GmbH Site 6 Am Fieseler Werk 9 34253 Lohfelden Germany |
| --- | --- |
| Name of manufacturer | Brenntag CEE GmbH |
| Address of manufacturer | Linke Wienzeile 152 1060 Wien Austria |
| Location of manufacturing sites | Brenntag CEE GmbH Site 1 Bahnstraße 13 2353 Guntramsdorf Austria Brenntag CEE GmbH Site 2 Fabrikstraße 4-6 8111 Judendorf Austria Brenntag CEE GmbH Site 3 Rubensstraße 48 4050 Traun Austria |
| --- | --- |
| Name of manufacturer | Brenntag Slovakia s. r. o. |
| Address of manufacturer | Glejovka 902 03 Pezinok Slovakia |
| Location of manufacturing sites | Brenntag Slovakia s. r. o. Site 1 Glejovka 15 902 03 Pezinok Slovakia Brenntag Slovakia s. r. o. Site 2 Príboj 558 976 13 Slovenská Ľupča Slovakia Brenntag Slovakia s. r. o. Site 3 Južná Trieda 72 042 85 Košice Slovakia |
| --- | --- |
| Name of manufacturer | Brenntag S.p.A. |
| Address of manufacturer | Via Cusago, 150/4 20153 Milano Italy |
| Location of manufacturing sites | Brenntag S.p.A. Site 1 Via San Carlo Borromeo 24040 Levate Italy Brenntag S.p.A. Site 2 Via Galliera 6/2 40010 Bentivoglio Italy Brenntag S.p.A. Site 3 Via del Cimitero 6 80030 Castello di Cisterna Italy Brenntag S.p.A. Site 4 Strada Provinciale di Bonifica 34-36 65010 Villanova di Cepagatti Italy Brenntag S.p.A. Site 5 Via Provinciale per Bitetto 70027 Palo del Colle Italy Brenntag S.p.A. Site 6 Via Paduni 03012 Anagni Italy |
| --- | --- |
| Name of manufacturer | Brenntag Polska Sp. z o.o. |
| Address of manufacturer | Józefa Bema 21 47-224 Kędzierzyn-Koźle Poland |
| Location of manufacturing sites | Brenntag Polska Sp. z o.o. Site 1 Józefa Bema 21 47-224 Kędzierzyn-Koźle Poland Brenntag Polska Sp. z o.o. Site 2 Kwasowa 5 95-100 Zgierz Poland Brenntag Polska Sp. z o.o. Site 3 Przemysłowa 2 62-080 Jankowice Poland Brenntag Polska Sp. z o.o. Site 4 Towarowa 9 05-530 Góra Kalwaria Poland |
| --- | --- |
| Name of manufacturer | Brenntag Lietuva UAB |
| Address of manufacturer | Palemono g. 171D 52107 Kaunas Lithuania |
| Location of manufacturing sites | Brenntag Lietuva UAB Site 1 Palemono g. 171D 52107 Kaunas Lithuania |
| --- | --- |
| Name of manufacturer | Brenntag Hungária Kft. |
| Address of manufacturer | Bányalég u. 45 1225 Budapest Hungary |
| Location of manufacturing sites | Brenntag Hungária Kft. Site 1 Bányalég u. 45 1225 Budapest Hungary |
| --- | --- |
| Name of manufacturer | S.C. Brenntag S.R.L. |
| Address of manufacturer | Garii Street 1 077040 Chiajna Romania |
| Location of manufacturing sites | S.C. Brenntag S.R.L. Site 1 Garii Street 1 077040 Chiajna Romania |
| --- | --- |
| Name of manufacturer | Brenntag Hrvatska d.o.o. |
| Address of manufacturer | Radnička cesta 173p 10000 Zagreb Croatia |
| Location of manufacturing sites | Brenntag Hrvatska d.o.o. Site 1 Radnička cesta 173p 10000 Zagreb Croatia |
| --- | --- |
| Name of manufacturer | Brenntag Bulgaria EOOD |
| Address of manufacturer | j.k. Drujba 2, ul. Obikolna 21, et. 1 1582 Sofia Bulgaria |
| Location of manufacturing sites | Brenntag Bulgaria EOOD Site 1 j.k. Drujba 2, ul. Obikolna 21, et. 1 1582 Sofia Bulgaria |
| --- | --- |
| Name of manufacturer | OQEMA S.P.A. |
| Address of manufacturer | Via Roggia Bartolomea 7 20090 Assago Italy |
| Location of manufacturing sites | OQEMA S.P.A. Site 1 VIA TORTONA 73 27055 Rivanazzano Italy |
| --- | --- |
| Name of manufacturer | Breustedt Chemie BV |
| Address of manufacturer | IJsseldijk 28 7325 WZ Apeldoorn Netherlands (the) |
| Location of manufacturing sites | Breustedt Chemie BV Site 1 IJsseldijk 28 7325 WZ Apeldoorn Netherlands (the) |
| --- | --- |
| Name of manufacturer | BEAUSEIGNEUR SAS |
| Address of manufacturer | 6, Rue André Viellard 90140 Froidefontaine France |
| Location of manufacturing sites | BEAUSEIGNEUR SAS Site 1 6, Rue André Viellard 90140 Froidefontaine France |
| --- | --- |
| Name of manufacturer | Staub & Co. - Silbermann GmbH |
| Address of manufacturer | Ostendstraße 124 90482 Nürnberg Germany |
| Location of manufacturing sites | Staub & Co. - Silbermann GmbH Site 1 Industriestraße 3 6456 Gablingen Germany |
| --- | --- |
| Name of manufacturer | Möller GmbH & Co. KG |
| Address of manufacturer | Bürgerkamp 1 48565 Steinfurt Germany |
| Location of manufacturing sites | Möller GmbH & Co. KG Site 1 Bürgerkamp 1 48565 48565 Germany |
| --- | --- |
| Name of manufacturer | Häffner GmbH & Co. KG |
| Address of manufacturer | Friedrichstraße 3 71679 Asperg Germany |
| Location of manufacturing sites | Häffner GmbH & Co. KG Site 1 Friedrichstraße 3 71679 Asperg Germany |
| --- | --- |
| Name of manufacturer | Gaches Chimie |
| Address of manufacturer | 17 avenue de la Gare 31750 Escalquens France |
| Location of manufacturing sites | Gaches Chimie Site 1 17 avenue de la Gare 31750 Escalquens France Gaches Chimie Site 2 2 Chemin de la Scierie 64150 Os-Marsillon France |
| --- | --- |
| Name of manufacturer | Evonik España y Portugal SA |
| Address of manufacturer | Afueras s/n 50784 La Zaida Spain |
| Location of manufacturing sites | Evonik España y Portugal SA C/ Afueras s/n. 50784 La Zaida Spain |
| --- | --- |
| Name of manufacturer | Amira Srl |
| Address of manufacturer | Via Vecchia Milanese 12 20844 Triuggio (MB) Italy |
| Location of manufacturing sites | Amira Srl Site 1 Via Vecchia Milanese 12 20844 Triuggio (MB) Italy |
| --- | --- |
| Name of manufacturer | ASiRAL Industriereiniger GmbH |
| Address of manufacturer | Hermann-Wehrle-Str. 15 67433 Neustadt/Weinstraße Germany |
| Location of manufacturing sites | ASiRAL Industriereiniger GmbH Site 1 Hermann-Wehrle-Str. 15 67433 Neustadt/Weinstraße Germany |
| --- | --- |
| Name of manufacturer | abcr GmbH |
| Address of manufacturer | Im Schlehert 10 76187 Karlsruhe Germany |
| Location of manufacturing sites | abcr GmbH Site 1 Im Schlehert 10 76187 Karlsruhe Germany |
| --- | --- |
| Name of manufacturer | Antec International Limited |
| Address of manufacturer | Windham Road, Chilton Industrial Estate CO1 Sudbury United Kingdom of Great Britain and Northern Ireland (the) |
| Location of manufacturing sites | Antec International Limited Site 1 Windham Road, Chilton Industrial Estate CO1 Sudbury United Kingdom of Great Britain and Northern Ireland (the) |
| --- | --- |
| Name of manufacturer | OQEMA GmbH |
| Address of manufacturer | Aachener Straße 258 41061 Mönchengladbach Germany |
| Location of manufacturing sites | OQEMA GmbH Site 1 Gutberletstraße 17 04316 Leipzig Germany |
| --- | --- |
| Name of manufacturer | Brenntag Nordic AB |
| Address of manufacturer | Hyllie Boulvevard 34 18 TR SE-215 32 Malmö Sweden |
| Location of manufacturing sites | Brenntag Nordic AB Site 1 Vevgatan 2 504 64 Boras Sweden |
| --- | --- |
| Name of manufacturer | ECSA Chemicals SA |
| Address of manufacturer | Burgauerstrasse 17 9230 Flawil Switzerland |
| Location of manufacturing sites | ECSA Chemicals SA Site 1 Via Luigi Favre 16 6828 Balerna Switzerland |
| --- | --- |
| Name of manufacturer | TENSID-CHEMIE GMBH |
| Address of manufacturer | Heinkelstraße 32 76461 Muggensturm Germany |
| Location of manufacturing sites | TENSID-CHEMIE GMBH Site 1 Heinkelstraße 32 76461 Muggensturm Germany |
| --- | --- |
| Name of manufacturer | Carl Roth GmbH + Co. KG |
| Address of manufacturer | Schoemperlenstraße 3-5 76185 Karlsruhe Germany |
| Location of manufacturing sites | Carl Roth GmbH + Co. KG Site 1 Schoemperlenstraße 3-5 76185 Karlsruhe Germany |
| --- | --- |
| Name of manufacturer | Hollu Systemhygiene GmbH |
| Address of manufacturer | Hollu Campus 1 6170 Zirl Austria |
| Location of manufacturing sites | Hollu Systemhygiene GmbH Site 1 Hollu Campus 1 6170 Zirl Austria |
1.5. Manufacturer(s) of the active substance(s)
| Active substance | Hydrogen peroxide |
| Name of manufacturer | Evonik Antwerpen NV |
| Address of manufacturer | Tijsmanstunnel West 2040 Antwerpen Belgium |
| Location of manufacturing sites | Evonik Antwerpen NV Tijsmanstunnel West 2040 Antwerpen Belgium |
| --- | --- |
| Active substance | Hydrogen peroxide |
| Name of manufacturer | Evonik Operations GmbH |
| Address of manufacturer | Rellinghauser Straße 1-11 45128 Essen Germany |
| Location of manufacturing sites | Evonik Operations GmbH Untere Kanalstr. 3 79618 Rheinfelden Germany |
| --- | --- |
| Active substance | Hydrogen peroxide |
| Name of manufacturer | Evonik Peroxid GmbH |
| Address of manufacturer | Industriestraße 1 9721 Weißenstein Austria |
| Location of manufacturing sites | Evonik Peroxid GmbH Industriestraße 1 9721 Weißenstein Austria |
| --- | --- |
| Active substance | Hydrogen peroxide |
| Name of manufacturer | Evonik Peroxide Netherlands BV |
| Address of manufacturer | Hettenheuvelweg 37 /39 1101 BM Amsterdam Netherlands (the) |
| Location of manufacturing sites | Evonik Peroxide Netherlands BV Oosterhorn 14 9936 HD Farmsum Netherlands (the) |
| --- | --- |
| Active substance | Hydrogen peroxide |
| Name of manufacturer | Evonik España y Portugal SA |
| Address of manufacturer | Afueras s/n 50784 La Zaida Spain |
| Location of manufacturing sites | Evonik España y Portugal SA C/ Afueras s/n. 50784 La Zaida Spain |
2. PRODUCT FAMILY COMPOSITION AND FORMULATION
2.1. Qualitative and quantitative information on the composition of the family
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
|---|---|---|---|---|---|
| Hydrogen peroxide | Active substance | 7722-84-1 | 231-765-0 | 35 - 49,9 % (w/w) |
2.2. Type(s) of formulation
| Formulation type(s) | SL Soluble concentrate |
PART II
SECOND INFORMATION LEVEL META SPC(S)
1. META SPC 1 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 1 identifier
| Identifier | Meta SPC: OXTERIL® Group 1 |
1.2. Suffix to the authorisation number
| Number | 1-1 |
1.3. Product type(s)
| Product type(s) | PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area |
2. META SPC 1 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 1
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
|---|---|---|---|---|---|
| Hydrogen peroxide | Active substance | 7722-84-1 | 231-765-0 | 35 - 49,9 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 1
| Formulation type(s) | SL Soluble concentrate |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
| Hazard statements | H302: Harmful if swallowed. H315: Causes skin irritation. H318: Causes serious eye damage. H335: May cause respiratory irritation. H412: Harmful to aquatic life with long lasting effects. H272: May intensify fire; oxidiser. |
| Precautionary statements | P261: Avoid breathing vapours. P264: Wash hands thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P280: Wear protective gloves / eye protection / face protection.. P301+P312: IF SWALLOWED: Call a POISON CENTER / doctor / physician if you feel unwell. P330: Rinse mouth. P302+P352: IF ON SKIN: Wash with plenty of water/ soap. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P312: Call a POISON CENTER/ doctor/physician if you feel unwell. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER / doctor. P332+P313: If skin irritation occurs: Get medical advice. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P405: Store locked up. P501: Dispose of contents / in accordance with local requirements. P501: Dispose of container / in accordance with local requirements. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P220: Keep away from clothing or other combustible materials. P370+P378: In case of fire: Use water to extinguish. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Surface disinfection by vaporised hydrogen peroxide (VHP) process
| Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Common name: bacteria Development stage: - Common name: yeasts Development stage: - |
| Field(s) of use | indoor use Disinfection of dry surfaces and equipment in hospital rooms, laboratories and other enclosed spaces, which do not come in contact with food and feed. |
| Application method(s) | Method: Vaporisation Detailed description: Automated disinfection with Vaporised Hydrogen Peroxide, generated with the aid of a VHP generator. Main specifications of a VHP generator: Diffusion principle: vaporisation, disinfection with gaseous hydrogen peroxide. Room Volume: 30 - 150 m3. Product concentration: 3 120 mg/m3. Relative humidity: 40 - 80 %. Temperature: room temperature. |
| Application rate(s) and frequency | Application Rate: The ready to use product should be applied in a hydrogen peroxide concentration of 1 092 mg/m3 (780 ppm) by the VHP generator. not applicable Number and timing of application: Contact time: at least 4 hours Frequency: daily /if required Maximum 3 times per day |
| Category(ies) of users | professional |
| Pack sizes and packaging material | High density polyethylene (HDPE) bottle 1, 5 litres HDPE jerry can 10, 20, 30, 60 litres HDPE drum 200 litres HDPE container 1 000 litres HDPE ISO tank 20 m3 |
4.1.1. Use-specific instructions for use
The area to disinfect is prepared for decontamination by removing standing liquid and by wiping down any visible dirt. Clean the area before disinfection. Cupboard doors should be opened, surfaces should be dried and wet areas (such as sinks) should be disinfected with suitable alternative products.
Specially trained professionals replace the cap of the sealed packaging with a special cap that has a degassing valve and a fast connector. The fast connector is connected to a pipe that connects to the VHP generator. Seal the enclosed space or room and make sure that access to the vapour-treated area is denied during the whole procedure.
Room volume ranging from 30 m3 to 150 m3.
Diffusion speed can vary from 1,5 to 20 g product /minute.
Starting temperature of 20 °C, ± 2 °C.
Relative humidity between 40 and 80 %.
During the disinfection cycle the VHP generator adjusts the hydrogen peroxide concentration up to the effective levels of 1 092 mg/m3 (780 ppm) and keeps it at this level for at least 4 hours. Concentration of hydrogen peroxide is monitored during the disinfection. After disinfection the aeration of the sealed area is required to reduce the concentration of hydrogen peroxide below 1,25 mg/m3 or a lower relevant national reference value before entering the area. This step can be quick but can also last several hours resulting in a total decontamination cycle of 5 - 8 hours.
The user shall always carry out a microbiological validation of the disinfection in the rooms to be disinfected (or in a suitable ‘standard room’, if applicable) with the devices to be used, after which a protocol for disinfection of these rooms can be made and used thereafter. In the event that there are methods available for chemically monitoring the active substance in the air or on surfaces, chemical validation should be performed besides biological validation, for example with test strips or with a device that measures ppm hydrogen peroxide in the air.
When it concerns a ‘standard room’ for which a protocol is available, the validation may be limited to only a chemical validation.
4.1.2. Use-specific risk mitigation measures
Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal products, chemical resistant gloves classified under European Standard EN 374 or equivalent, face shield and Respiratory Protective Equipment (RPE) (Assigned Protection Factor (APF) = 10) during mixing and loading. Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC.
No access to the treated area is permitted during treatment. During aeration and before permitting re-entry to the treated area it should be checked that the concentration of hydrogen peroxide is below 1,25 mg/m3 or a lower relevant national reference value, using for example test strips. During the operation of the VHP generator or in the event of malfunctions, entry to the room is only possible if wearing chemical protective suits and RPE (APF = 10), when the concentration of hydrogen peroxide is at or below 12,5 mg/m3. Observe label instructions.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
No use specific first aid instructions and emergency measures to protect the environment.See General directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
No use specific instructions for safe disposal of the product and its packaging. See General directions for use.
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See General directions for use.
4.2. Use description
Table 2
Surface disinfection by vaporised hydrogen peroxide (VHP) process
| Product type | PT04: Food and feed area |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Common name: bacteria Development stage: - Common name: yeasts Development stage: - |
| Field(s) of use | indoor use Disinfection of dry surfaces in food and feed areas and other enclosed spaces. |
| Application method(s) | Method: Vaporisation Detailed description: Automated disinfection with Vaporised Hydrogen Peroxide, generated with the aid of a VHP generator. Main specifications of a VHP generator: Diffusion principle: vaporisation, disinfection with gaseous hydrogen peroxide. Room Volume 30 - 150 m3 . Product concentration: 3 120 mg/m3 . Relative humidity: 40 - 80 %. Temperature: room temperature. |
| Application rate(s) and frequency | Application Rate: The ready to use product should be applied in a hydrogen peroxide concentration of 1 092 mg/m3 (780 ppm) by the VHP generator Number and timing of application: Contact time: at least 4 hours Frequency: daily /if required Maximum 3 times per day |
| Category(ies) of users | professional |
| Pack sizes and packaging material | HDPE bottle 1, 5 litres HDPE jerry can 10, 20, 30, 60 litres HDPE drum 200 litres HDPE container 1 000 litres HDPE ISO tank 20 m3 |
4.2.1. Use-specific instructions for use
The area to disinfect is prepared for decontamination by removing standing liquid and by wiping down any visible dirt. Clean the area before disinfection. Cupboard doors should be opened, surfaces should be dried and wet areas (such as sinks) should be disinfected with suitable alternative products.
Specially trained professionals replace the cap of the sealed packaging with a special cap that has a degassing valve and a fast connector. The fast connector is connected to a pipe that connects to the VHP generator. Seal the enclosed space or room and make sure that access to the vapour-treated area is denied during the whole procedure.
Room volume ranging from 30 m3 to 150 m3.
Diffusion speed can vary from 1,5 to 20 g product /minute.
Starting temperature of 20 °C, ± 2 °C.
Relative humidity between 40 and 80 %.
During the disinfection cycle the VHP generator adjusts the hydrogen peroxide concentration up to the effective levels of 1 092 mg/m3 (780 ppm) and keeps it at this level for at least 4 hours. Concentration of hydrogen peroxide is monitored during the disinfection. After disinfection the aeration of the sealed area is required to reduce the concentration of hydrogen peroxide below 1,25 mg/m3 or a lower relevant national reference value before entering the area. This step can be quick but can also last several hours resulting in a total decontamination cycle of 5 - 8 hours.
The user shall always carry out a microbiological validation of the disinfection in the rooms to be disinfected (or in a suitable ‘standard room’, if applicable) with the devices to be used, after which a protocol for disinfection of these rooms can be made and used thereafter. In the event that there are methods available for chemically monitoring the active substance in the air or on surfaces, chemical validation should be performed besides biological validation, for example with test strips or with a device that measures ppm hydrogen peroxide in the air.
When it concerns a ‘standard room’ for which a protocol is available, the validation may be limited to only a chemical validation.
4.2.2. Use-specific risk mitigation measures
Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal products, chemical resistant gloves classified under European Standard EN 374 or equivalent, face shield and RPE (APF = 10) during mixing and loading. Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC .
No access to the treated area is permitted during treatment. During aeration and before permitting re-entry to the treated area it should be checked that the concentration of hydrogen peroxide is below 1,25 mg/m3 or a lower relevant national reference value, using for example test strips. During the operation of the VHP generator or in the event of malfunctions entry to the room is only possible by wearing chemical protective suits and RPE (APF=10), when the concentration of hydrogen peroxide is at or below 12,5 mg/m3. Observe label instructions.
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
No use specific first aid instructions and emergency measures to protect the environment. See general directions for use.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
No use specific instructions for safe disposal of the product and its packaging. See general directions for use.
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use.
4.3. Use description
Table 3
Aseptic packaging in food and feed industries
| Product type | PT04: Food and feed area |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Common name: bacteria Development stage: - Common name: yeasts Development stage: - Common name: Bacterial spores Development stage: Bacterial spores |
| Field(s) of use | indoor use Disinfection of food packaging material in closed aseptic packaging systems by sprayed or nebulised product. |
| Application method(s) | Method: Nebulising Detailed description: Automated spraying or nebulising in closed systems. |
| Application rate(s) and frequency | Application Rate: In-use concentration: 35 % (w/w) hydrogen peroxide. Product concentration in hot air: 10,83 g/kg For disinfection of bacteria, yeasts and bacterial spores the product should be diluted to 35 % (w/w) hydrogen peroxide. For example, for a product containing 49,9 % (w/w) hydrogen peroxide: add 700 ml product to 357 ml water to achieve a dilution of 35 % (w/w) hydrogen peroxide. Number and timing of application: Automated chemo-thermal disinfectant processes. Temperature: ≥ 100 °C Contact time: at least 5,5 seconds |
| Category(ies) of users | professional |
| Pack sizes and packaging material | HDPE bottle 1, 5 litres HDPE jerry can 10, 20, 30, 60 litres HDPE drum 200 litres HDPE container 1 000 litres HDPE ISO tank 20 m3 |
4.3.1. Use-specific instructions for use
The aseptic filling systems are based on the principle of aseptically forming a tube from a sterilised sheet of package material, which is continuously filled with commercially sterile liquid food product and subsequently transversally sealed to form pouches, which in turn are folded into the final package shape. The packaging material are delivered to the aseptic filling machine either in the form of (sheet) reels or in the form of pre-formed packs, tubs and bottles. Then, 35 % (w/w) hydrogen peroxide is sprayed or nebulised to the packaging material gradually via a nozzle. After that, several stages follow to evaporate any excess hydrogen peroxide with sterile hot air.
Depending on the size of the receptacle, an amount of 0,1 - 1 mL of 35 % (w/w) hydrogen peroxide is sprayed or nebulised gradually via a nozzle.
Temperature: ≥ 100 °C
Contact time: at least 5,5 seconds.
For example, for a product containing 49,9 % (w/w) hydrogen peroxide: add 700 ml product to 357 ml water to achieve a dilution of 35 % (w/w) hydrogen peroxide.
The user shall always carry out a microbiological validation of the disinfection, after which a protocol for disinfection of this packaging / system can be made and used thereafter.
4.3.2. Use-specific risk mitigation measures
Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal products, chemical resistant gloves classified under European Standard EN 374 or equivalent, face shield and RPE (APF = 10) when handling concentrated solutions during mixing and loading; chemical resistant gloves classified under European Standard EN 374 or equivalent, protective clothing chemically resistant to the biocidal products, and chemical resistant goggles consistent with European Standard EN 16321 or equivalent face shield during application. During maintenance work, wear chemical resistant gloves classified under EN 374 or equivalent, protective clothing chemically resistant to the biocidal products, chemical resistant goggles consistent with EN 16321 or equivalent face shield and RPE (APF = 4) and spray water for approximately 10 seconds before opening the machine. The instructions for use of the re-filling station specify that the loading operations must take place in a cool and ventilated place. Gloves and coverall material to be specified by the authorisation holder within the product information. Observe label instructions. See section 6 for the full titles of the EN standards.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC.
4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
No use specific first aid instructions and emergency measures to protect the environment. See general directions for use.
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
No use specific instructions for safe disposal of the product and its packaging. See general directions for use.
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use.
4.4. Use description
Table 4
Disinfection of distribution system for drinking water by cleaning in place (CIP)
| Product type | PT04: Food and feed area |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Common name: bacteria Development stage: - Common name: yeasts Development stage: - Common name: fungi Development stage: - |
| Field(s) of use | indoor use Disinfection of distributing and storing installations for drinking water |
| Application method(s) | Method: CIP (Cleaning in place) Detailed description: Disinfecting the interior surfaces of closed systems by CIP |
| Application rate(s) and frequency | Application Rate: 4,7 % (w/w) hydrogen peroxide. For disinfection of bacteria, yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide. For example, in case of a 35 %(w/w) hydrogen peroxide product: add 114 ml product to 819 ml water. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. Number and timing of application: Contact time: at least 3 hours Frequency: Daily / if required Temperature: room temperature |
| Category(ies) of users | professional |
| Pack sizes and packaging material | HDPE bottle 1, 5 litres HDPE jerry can 10, 20, 30, 60 litres HDPE drum 200 litres HDPE container 1 000 litres HDPE ISO tank 20 m3 |
4.4.1. Use-specific instructions for use
CIP (Cleaning in place): Clean before disinfection (Remove all deposits and dirt by a pre-flush or pre-scrape, and when necessary, a pre-soak treatment). Circulate the diluted product through the system under conditions of increased turbulence and flow velocity. After 3 hours contact time, pipelines and tanks are rinsed with water before refilled with drinking water. For disinfection of bacteria, yeasts and fungi the product should be diluted to 4,7 % (w/w ) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide: add 114 ml product to 819 ml water to achieve a dilution of 4,7 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
4.4.2. Use-specific risk mitigation measures
Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent/face shield, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent. and RPE (APF = 10) during mixing and loading. Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC.
Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 air changes per hour (ACH)). Observe label instructions.
4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
No use specific first aid instructions and emergency measures to protect the environment. See general directions for use.
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
No use specific instructions for safe disposal of the product and its packaging. See general directions for use.
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use.
4.5. Use description
Table 5
Disinfection of non-porous hard surfaces and equipment by immersion
| Product type | PT04: Food and feed area |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Common name: bacteria Development stage: - Common name: yeasts Development stage: - Common name: fungi Development stage: - |
| Field(s) of use | indoor use Equipment in both food and drink industries, large scale catering kitchens and large scale canteens. |
| Application method(s) | Method: open system: immersion Detailed description: Manual immersion of equipment in closed baths. Automated immersion of equipment in closed baths. |
| Application rate(s) and frequency | Application Rate: 8,1 % (w/w) hydrogen peroxide. For disinfection of bacteria, yeasts and fungi the product should be diluted to 8,1 % (w/w) hydrogen peroxide. For example, in case of a 35 %(w/w) hydrogen peroxide product: add 200 ml product to 738 ml water. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. Number and timing of application: Contact time: 60 minutes Frequency: Daily / if required Temperature: room temperature |
| Category(ies) of users | professional |
| Pack sizes and packaging material | HDPE bottle 1, 5 litres HDPE jerry can 10, 20, 30, 60 litres HDPE drum 200 litres HDPE container 1 000 litres HDPE ISO tank 20 m3 |
4.5.1. Use-specific instructions for use
For disinfection of bacteria yeasts and fungi the product should be diluted to 8,1 % (w/w) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide: add 200 ml product to 738 ml water to achieve a dilution of 8,1 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
Immersion: Equipment in the food and feed industry is disinfected by immersion. Pre-clean the equipment. The disinfection solution should be diluted into vats (i.e. pouring or pumping the product into vats). The equipment to be disinfected is manually or automatically placed into these vats (closed baths) and taken out after a contact time of not less than 60 minutes. After the disinfection procedure is completed, equipment is rinsed with water. The disinfection solution in the immersion/dipping bath should be replaced after each disinfection cycle.
4.5.2. Use-specific risk mitigation measures
Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent, face shield and RPE (APF = 10) during mixing and loading and application. Gloves and coverall material to be specified by the authorisation holder within the product information. No access of other worker to the room is permitted during disinfection without wearing adequate PPE and RPE as described above. See section 6 for the full titles of the EN standards.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC.
Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 ACH). Dipping bath has to be placed in a separated room. For use only in areas inaccessible to the general public. Professional users without PPE and RPE (APF = 10) are not allowed to enter the disinfection room. Keep the bath closed during disinfection, only open to load and discharge.
Observe label instructions.
4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
No use specific first aid instructions and emergency measures to protect the environment. See general directions for use.
4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
No use specific instructions for safe disposal of the product and its packaging. See general directions for use.
4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use.
4.6. Use description
Table 6
Disinfection of surfaces by cleaning in place (CIP)
| Product type | PT04: Food and feed area |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Common name: bacteria Development stage: - Common name: yeasts Development stage: - Common name: fungi Development stage: - |
| Field(s) of use | indoor use Disinfection of food contact inner surfaces of pipe work and tank systems in food and feed industry |
| Application method(s) | Method: Cleaning in Place (CIP) Detailed description: Disinfecting the interior surfaces of closed systems by Cleaning In Place (CIP). |
| Application rate(s) and frequency | Application Rate: 4,7 % (w/w) hydrogen peroxide. For disinfection of bacteria, yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide. For example, in case of a 35 %(w/w) hydrogen peroxide product: add 114 ml product to 819 ml water. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. Number and timing of application: Contact time: at least 3 hours Frequency: Daily / if required Temperature: room temperature |
| Category(ies) of users | professional |
| Pack sizes and packaging material | HDPE bottle 1, 5 litres HDPE jerry can 10, 20, 30, 60 litres HDPE drum 200 litres HDPE container 1 000 litres HDPE ISO tank 20 m3 |
4.6.1. Use-specific instructions for use
Clean prior to disinfection. The inner surfaces of pipe work and tank systems are disinfected by CIP process. For disinfection of bacteria yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide; add 114 ml product to 819 ml water to achieve a dilution of 4,7 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
The process is carried out by circulating the disinfection solution through the system under conditions of increased turbulence and flow velocity. The application is automated and a closed process. After 3 hours contact time, pipelines and tanks are rinsed with water under closed system conditions as well.
4.6.2. Use-specific risk mitigation measures
Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent/face shield, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent and RPE (APF = 10) during mixing and loading. Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC.
Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 ACH). Observe label instructions.
4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
No use specific first aid instructions and emergency measures to protect the environment. See general directions for use.
4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
No use specific instructions for safe disposal of the product and its packaging. See general directions for use.
4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1
5.1. Instructions for use
See use specific instructions for each use.
5.2. Risk mitigation measures
See use specific risk mitigation measures for each use.
Observe label instructions.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid instructions
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing.
If symptoms: Call 112/ambulance for medical assistance.
If no symptoms: Call a POISON CENTRE or a doctor.
Accidental release measures
Large spillage: Collect product in suitable containers (for example made of plastic) using appropriate equipment (for example liquid pump) for disposal. Never return spills in original containers for re-use. Keep away from flammable and incompatible substances. Rinse away any residue with plenty of water. Dispose of absorbed material in accordance with the applicable environmental regulations.
Small spillage: Dilute product with lots of water and rinse away or absorb with liquid-binding material (for example diatomaceous earth or universal binder). Pick up mechanically and collect in suitable containers. Clean contaminated surface thoroughly. Pack and label wastes like the product. Do not detach label from the delivery containers prior to disposal.
5.4. Instructions for safe disposal of the product and its packaging
At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to municipal sewer depending on local requirements.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Advice on protection against fire and explosion:
Store away from direct sunlight and heat sources.
Store away from sources of ignition - No smoking.
Store away from flammable substances.
Store away from incompatible substances.
Storage:
Temperature requirement- during storage maximum 40 °C and protect from frost.
Store in clean, dry and well-ventilated places.
Transport and store container in upright position only.
Always close container tightly after removal of product.
Avoid leakage and residues of the product on the containers.
Advice on common storage:
Do not store together with alkalis, reductants, metallic salts (risk of decomposition).
Do not store together with organic solvents (risk of explosion).
Shelf-life:
24 months
6. OTHER INFORMATION
The full titles of the EN standards referenced in the ‘Use-specific mitigation measures’ sections are:
EN 16321 - Eye and face protection for occupational users
EN 374 - Protective gloves against chemicals and micro-organisms
The Council Directive referenced in the ‘Use-specific mitigation measures’ sections is: Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998[RMJ1], p. 11).
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | OXTERIL® 350 SPRAY | OXTERIL® 350 SPRAY | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | BIS OKSAN | BIS OKSAN | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Halades DI | Halades DI | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | DEPTIL 350 SPRAY | DEPTIL 350 SPRAY | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Amira Hydrogen Peroxide | Amira Hydrogen Peroxide | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Asiral Des O | Asiral Des O | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | OXTERIL® 350 VHP | OXTERIL® 350 VHP | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PERSYNT® 350 VHP | PERSYNT® 350 VHP | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0028964-0001 1-1 | EU-0028964-0001 1-1 | EU-0028964-0001 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Hydrogen peroxide | Active substance | Active substance | 7722-84-1 | 7722-84-1 | 231-765-0 | 35 % (w/w) |
7.2. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | OXTERIL® 350 SPRAY S | OXTERIL® 350 SPRAY S | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | DES O HR | DES O HR | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0028964-0002 1-1 | EU-0028964-0002 1-1 | EU-0028964-0002 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Hydrogen peroxide | Active substance | Active substance | 7722-84-1 | 7722-84-1 | 231-765-0 | 35 % (w/w) |
1. META SPC 2 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 2 identifier
| Identifier | Meta SPC: OXTERIL® Group 2 |
1.2. Suffix to the authorisation number
| Number | 1-2 |
1.3. Product type(s)
| Product type(s) | PT04: Food and feed area |
2. META SPC 2 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 2
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
|---|---|---|---|---|---|
| Hydrogen peroxide | Active substance | 7722-84-1 | 231-765-0 | 35 - 49,9 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 2
| Formulation type(s) | SL Soluble concentrate |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
| Hazard statements | H302: Harmful if swallowed. H315: Causes skin irritation. H318: Causes serious eye damage. H335: May cause respiratory irritation. H412: Harmful to aquatic life with long lasting effects. H272: May intensify fire; oxidiser. |
| Precautionary statements | P261: Avoid breathing vapours. P264: Wash hands thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P280: Wear protective gloves / eye protection / face protection. P301+P312: IF SWALLOWED: Call a POISON CENTER / doctor / physician if you feel unwell. P330: Rinse mouth. P302+P352: IF ON SKIN: Wash with plenty of water/ soap. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P312: Call a POISON CENTER/doctor/physician if you feel unwell. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER/doctor. P332+P313: If skin irritation occurs: Get medical advice. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P405: Store locked up. P501: Dispose of contents / in accordance with local requirements. P501: Dispose of container / in accordance with local requirements. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P220: Keep away from clothing or other combustible materials. P370+P378: In case of fire: Use water to extinguish. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Aseptic packaging in food and feed industries
| Product type | PT04: Food and feed area |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Common name: bacteria Development stage: - Common name: yeasts Development stage: - Common name: Bacterial spores Development stage: Bacterial spores |
| Field(s) of use | indoor use Disinfection of food and feed packaging material in closed aseptic packaging systems by dipping, spraying or nebulising |
| Application method(s) | Method: Dipping, nebulising and spraying Detailed description: Automated dipping in closed systems. Automated nebulising and spraying in closed systems. |
| Application rate(s) and frequency | Application Rate: In-use concentration: 35% (w/w) hydrogen peroxide. For disinfection of bacteria, yeasts and bacterial spores, the product should be diluted to 35 % (w/w) hydrogen peroxide. For example, for a product containing 49,9 % (w/w) hydrogen peroxide; add 700 ml product to 357 ml water to achieve a dilution of 35 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. Number and timing of application: Automated chemo-thermal disinfection processes. In-use concentration: 35% (w/w) hydrogen peroxide Spraying or nebulizing: Temperature: ≥100°C Contact time: at least 5,5 seconds Dipping: Temperature: ≥80°C Contact time: at least 2,5 seconds |
| Category(ies) of users | professional |
| Pack sizes and packaging material | HDPE bottle 1, 5 litres HDPE jerry can 10, 20, 30, 60 litres HDPE drum 200 litres HDPE container 1 000 litres HDPE ISO tank 20 m3 |
4.1.1. Use-specific instructions for use
The aseptic filling systems are based on the principle of aseptically forming a tube from a sterilised sheet of package material, which is continuously filled with commercially sterile liquid food product and subsequently transversally sealed to form pouches, which in turn are folded into the final package shape. The packaging material are delivered to the aseptic filling machine either in the form of (sheet) reels or in the form of pre-formed packs, tubs and bottles. The packaging material in the form of (sheet) reels passes through a deep bath filled with 35 % (w/w) hydrogen peroxide by dipping. The pre-formed packs, tubs and bottles are sprayed or fogged with 35 % (w/w) hydrogen peroxide stepwise via a nozzle. After that, several stages follow to evaporate any excess hydrogen peroxide with sterile hot air.
Depending on the size of the receptacle, an amount of 0,1 - 1 mL of 35 % (w/w) hydrogen peroxide is sprayed or nebulized gradually via a nozzle.
Temperature: ≥ 100 °C
Contact time: at least 5,5 seconds
The packaging material in the form of (sheet) reels passes through a deep bath filled with 35 % (w/w) hydrogen peroxide by dipping.
Temperature: ≥ 80 °C
Contact time: at least 2,5 seconds
For example, for a product containing 49,9 % (w/w) hydrogen peroxide; add 700 ml product to 357 ml water to achieve a dilution of 35 % (w/w) hydrogen peroxide.
The user shall always carry out a microbiological validation of the disinfection, after which a protocol for disinfection of this packaging / system can be made and used thereafter.
4.1.2. Use-specific risk mitigation measures
Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal products, chemical resistant gloves classified under European Standard EN 374 or equivalent, face shield and RPE (APF = 10) when handling concentrated solutions during mixing and loading; chemical resistant gloves classified under European Standard EN 374 or equivalent, protective clothing chemically resistant to the biocidal products, and chemical resistant goggles consistent with European Standard EN 16321 or equivalent face shield during application.
During maintenance work, wear chemical resistant gloves classified under EN 374 or equivalent, protective clothing chemically resistant to the biocidal products, chemical resistant goggles consistent with EN 16321 or equivalent face shield and RPE (APF = 4) and spray water for approximately 10 seconds before opening the machine. The instructions for use of the re-filling station specify that the loading operations must take place in a cool and ventilated place. Gloves and coverall material to be specified by the authorisation holder within the product information. Observe label instructions. See section 6 for the full titles of the EN standards.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC.
The instructions for use of the re-filling station specify that the loading operations must take place in a cool and ventilated place. Observe label instructions.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
No use specific first aid instructions and emergency measures to protect the environment. See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
No use specific instructions for safe disposal of the product and its packaging. See general directions for use.
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use.
4.2. Use description
Table 2
Disinfection of distribution system for drinking water by cleaning in place (CIP)
| Product type | PT04: Food and feed area |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Common name: bacteria Development stage: - Common name: yeasts Development stage: - Common name: fungi Development stage: - |
| Field(s) of use | indoor use Cleaning and disinfection of distributing and storing installations for drinking water |
| Application method(s) | Method: CIP (Cleaning in place) Detailed description: Disinfecting the interior surfaces of closed systems by CIP |
| Application rate(s) and frequency | Application Rate: 4,7 % (w/w) hydrogen peroxide For disinfection of bacteria, yeasts and fungi the product should be diluted to 4,7 % (w/w) hydrogen peroxide. For example, in case of a 35 % (w/w) hydrogen peroxide product: add 114 ml product to 819 ml water. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. Number and timing of application: Contact time: at least 3 hours Frequency: Daily / if required Temperature: room temperature |
| Category(ies) of users | professional |
| Pack sizes and packaging material | HDPE bottle 1, 5 litres HDPE jerry can 10, 20, 30, 60 litres HDPE drum 200 litres HDPE container 1 000 litres HDPE ISO tank 20 m3 |
4.2.1. Use-specific instructions for use
CIP (Cleaning in place): Clean prior to disinfection. Circulate the diluted product through the system under conditions of increased turbulence and flow velocity. After 3 hours contact time, pipelines and tanks are rinsed with water before refilled with drinking water. For disinfection of bacteria,yeasts and fungi the product should be diluted to 4,7 % (w/w ) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide: add 114 ml product to 819 ml water to achieve a dilution of 4,7 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
4.2.2. Use-specific risk mitigation measures
Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent/face shield, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent and RPE (APF = 10) during mixing and loading. Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 ACH). Observe label instructions. Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC.
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
No use specific first aid instructions and emergency measures to protect the environment. See general directions for use.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
No use specific instructions for safe disposal of the product and its packaging. See general directions for use.
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use.
4.3. Use description
Table 3
Disinfection of non-porous hard surfaces and equipment by immersion
| Product type | PT04: Food and feed area |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Common name: bacteria Development stage: - Common name: yeasts Development stage: - Common name: fungi Development stage: - |
| Field(s) of use | indoor use Equipment in both food and drink industries, large scale catering kitchens and large scale canteens. |
| Application method(s) | Method: open system: immersion Detailed description: Manual immersion of equipment in closed baths. Automated immersion of equipment in closed baths. |
| Application rate(s) and frequency | Application Rate: 8,1 % (w/w) hydrogen peroxide. For disinfection of bacteria, yeasts and fungi the product should be diluted to 8,1 % (w/w) hydrogen peroxide. For example, in case of a 35 %(w/w) hydrogen peroxide product: add 200 ml product to 738 ml water. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. Number and timing of application: Contact time: at least 60 min Frequency: Daily / if required Temperature: room temperature |
| Category(ies) of users | professional |
| Pack sizes and packaging material | HDPE bottle 1, 5 litres HDPE jerry can 10, 20, 30, 60 litres HDPE drum 200 litres HDPE container 1 000 litres HDPE ISO tank 20 m3 |
4.3.1. Use-specific instructions for use
For disinfection of bacteria yeasts and fungi the product should be diluted to 8,1 % (w/w) hydrogen peroxide. For example, for a product containing 35 % (w/w) hydrogen peroxide: add 200 ml product to 738 ml water to achieve a dilution of 8,1 % (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
Immersion:
Equipment in the food and feed industry is disinfected by immersion. Pre-clean the equipment. The disinfection solution should be diluted into vats (i.e. pouring or pumping the product into vats). The equipment to be disinfected is manually or automatically placed into these vats (closed baths) and taken out after a contact time of at least 60 minutes. After the disinfection procedure is completed, equipment is rinsed with water. The disinfection solution in the immersion/dipping bath should be replaced after each disinfection cycle.
4.3.2. Use-specific risk mitigation measures
Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent/face shield, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent and RPE (APF = 10) during mixing and loading and application. Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC.
No access of other worker to the room is permitted during disinfection without wearing adequate PPE and RPE as described above.
Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 ACH).
Dipping bath has to be placed in a separate room. For use only in areas inaccessible to the general public. Professional users without PPE and RPE (APF = 10) are not allowed to enter the disinfection room. Keep the bath closed during disinfection, only open to load and discharge.
Observe label instructions.
4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
No use specific first aid instructions and emergency measures to protect the environment. See general directions for use.
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
No use specific instructions for safe disposal of the product and its packaging. See general directions for use.
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use.
4.4. Use description
Table 4
Disinfection of surfaces by cleaning in place (CIP)
Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.
This text is published under EUR-Lex's own terms of reuse, not a Legalize or public-domain licence.
EUR-Lex
Creative Commons Attribution 4.0 International (CC BY 4.0)
© European Union, https://eur-lex.europa.eu — Source: EUR-Lex (Publications Office of the European Union). Reused under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Only EU legislation published in the printed Official Journal of the European Union is deemed authentic; consolidated texts are reproduced here for documentation purposes and have been reformatted to Markdown.