LegalizeCommission Implementing Regulation (EU) 2024/2194 of 4 September 2024 amending Implementing Regulation (EU) 2020/1991 as regards administrative and minor changes to the Union authorisation for the biocidal product family perform-IPA
This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.
| Image omitted; see official source | Official Journal of the European Union | EN L series |
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| 2024/2194 | 5.9.2024 |
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 27 November 2020, a Union authorisation with authorisation number EU-0023656-0000 was granted to Schülke & Mayr GmbH for the making available on the market and use of the biocidal product family ‘perform IPA’ by Commission Implementing Regulation (EU) 2020/1991 2. The Annex to that Implementing Regulation provides the summary of product characteristics (‘SPC’) for the biocidal product family ‘perform-IPA’ in accordance with Article 22 of Regulation (EU) No 528/2012.
- (2) Commission Implementing Regulation (EU) No 354/2013 3 provides for the procedural rules for the different categories of changes referred to in Article 50(3) of Regulation (EU) No 528/2012. On receipt of an opinion from the European Chemicals Agency (‘the Agency’) on an application from an authorisation holder of a Union authorisation, seeking to change any of the information submitted for the initial application for authorisation, the Commission is to decide whether the conditions of Article 19 or, where relevant, Article 25 of Regulation (EU) No 528/2012 are still met and whether the terms and conditions of the authorisation are required to be amended.
- (3) On 20 December 2021, Schülke & Mayr GmbH submitted to the Agency a notification of administrative changes in accordance with Article 11(1) of Implementing Regulation (EU) No 354/2013, recorded in the register for biocidal products (‘the Register’) under case number BC-AB072184-64, and an application for a minor change in accordance with Article 12(1) of that Implementing Regulation, recorded in the Register under case number BC-SN072185-20, to the Union authorisation for the biocidal product family ‘perform-IPA’. In respect of the administrative changes, Schülke & Mayr GmbH notified a change in the administrative details of two of the product formulators, the addition of five product formulators, the addition of a trade name in the section meta-SPC 1 of the SPC and the removal of a claim that products can be used in clean rooms class A/B in the sections meta-SPC 1 to 6 of the SPC. Regarding the minor change, Schülke & Mayr GmbH applied for a change of the pack-size range (all for the sections meta-SPC 1 and 3 of the SPC: extension of pack size range for canisters from 5-10 L to 5-30 L, addition of 200-220 L HDPE drums and addition of 900-1000 L containers (IBC)).
- (4) On 1 February 2023, Schülke & Mayr GmbH submitted to the Agency an application for a further minor change to the Union authorisation for the biocidal product family ‘perform-IPA’ in accordance with Article 12(1) of Implementing Regulation (EU) No 354/2013, recorded in the Register under case number BC-NJ084251-38, for the addition of a claim for limited spectrum virucidal activity to all product-type 2 uses (disinfectants and algaecides not intended for direct application to humans and animals) in the sections meta-SPC 1 to 6 of the SPC.
- (5) On 11 February 2022, the Agency submitted an opinion 4 to the Commission on the notified administrative changes to the Union authorisation for the biocidal product family ‘perform-IPA’, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, together with a revised summary of the biocidal product characteristics. The opinion concludes that the proposed changes are administrative changes in accordance with 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 are still met. On 7 March 2022, the Agency transmitted to the Commission the revised summary of biocidal product characteristics of the Union authorisation for the biocidal product family ‘perform-IPA’ in all official languages of the Union covering all administrative changes applied for, in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.
- (6) On 10 October 2023, the Agency submitted its opinions 5 to the Commission on the two applications for minor changes to the Union authorisation for the biocidal product family ‘perform-IPA’, in accordance with Article 12(4) of Implementing Regulation (EU) No 354/2013, together with a revised summary of the biocidal product characteristics and a revised assessment report concluding that the proposed changes are minor changes in accordance with Article 50(3), point (b), of Regulation (EU) No 528/2012 and as specified in Title 2 of the Annex to Implementing Regulation (EU) No 354/2013, and that after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 are still met.
- (7) On 10 November 2023, the Agency transmitted to the Commission the revised summary of biocidal product characteristics of the Union authorisation for the biocidal product family ‘perform-IPA’ in all official languages of the Union covering all administrative and minor changes applied for, in accordance with Article 12(6) of Implementing Regulation (EU) No 354/2013.
- (8) The Commission concurs with the opinions of the Agency and therefore considers it appropriate to amend the Union authorisation for the biocidal product family ‘perform-IPA’ to introduce the administrative and minor changes requested by Schülke & Mayr GmbH.
- (9) Except for the amendments regarding the administrative and minor changes, all other information included in the summary of the biocidal product characteristics of ‘perform-IPA’ as set out in the Annex to Implementing Regulation (EU) 2020/1991 remains unchanged.
- (10) In order to enhance clarity and to ease the access of users and interested parties to the final consolidated version of the summary of biocidal product characteristics which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2020/1991 should be replaced in its entirety.
- (11) Implementing Regulation (EU) 2020/1991 should therefore be amended accordingly,
HAS ADOPTED THIS REGULATION:
Article 1
The Annex to Implementing Regulation (EU) 2020/1991 is replaced by the text 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, 4 September 2024.
For the Commission
The President
Ursula VON DER LEYEN
Commission Implementing Regulation (EU) 2020/1991 of 27 November 2020 granting a Union authorisation for the biocidal product family ‘perform-IPA’ (OJ L 410, 7.12.2020, p. 1; ELI: http://data.europa.eu/eli/reg_impl/2020/1991/oj).
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).
ECHA Opinion on the administrative change of the Union authorisation of the biocidal product family: perform-IPA of 11 February 2022, Opinion N° UAD-C-1560029-43-00/F, https://echa.europa.eu/opinions-on-union-authorisation.
Biocidal Products Committee (BPC) opinion on the minor change to the Union authorisation of the biocidal product family ‘perform-IPA’, 10 October 2023, ECHA/BPC/397/2023 and BPC opinion on the minor change to the Union authorisation of the biocidal product family ‘perform-IPA’, 10 October 2023, ECHA/BPC/400/2023, https://echa.europa.eu/opinions-on-union-authorisation.
ANNEX
Summary of product characteristics for a biocidal product family
perform-IPA
Product type 2 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Product type 4 - Food and feed area (Disinfectants)
Authorisation number: EU-0023656-0000
R4BP asset number: EU-0023656-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
1.1. Family name
| Name | perform-IPA |
1.2. Product type(s)
| Product type(s) | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT04 - Food and feed area (Disinfectants) |
1.3. Authorisation holder
| Name and address of the authorisation holder | Name | Schuelke & Mayr GmbH |
| Name and address of the authorisation holder | Address | Robert-Koch-Str. 2, 22851 Norderstedt Germany |
| Authorisation number | EU-0023656-0000 | EU-0023656-0000 |
| R4BP asset number | EU-0023656-0000 | EU-0023656-0000 |
| Date of the authorisation | 27 December 2020 | 27 December 2020 |
| Expiry date of the authorisation | 30 November 2030 | 30 November 2030 |
1.4. Manufacturer(s) of the biocidal products
| Name of manufacturer | Schülke & Mayr GmbH |
| Address of manufacturer | Robert-Koch-Str. 2, 22851 Norderstedt Germany |
| Location of manufacturing sites | Robert-Koch-Str. 2, 22851 Norderstedt Germany |
| --- | --- |
| Name of manufacturer | BOCHEMIE a.s. |
| Address of manufacturer | Lidická 326, 735 95 Bohumín Czech Republic |
| Location of manufacturing sites | Lidická 326, 735 95 Bohumín Czech Republic |
| --- | --- |
| Name of manufacturer | Imeco |
| Address of manufacturer | Am Sägewerk 10, 63773 Goldbach Germany |
| Location of manufacturing sites | Boschstr. 5, 63768 Hösbach Germany Neue Straße 2-4, 09471 Köningswalde Germany Am Gansberg 9, 09481 Elterlein Germany ul.Wlo'kiennicza 10, 59-800 Luban Poland |
| --- | --- |
| Name of manufacturer | Tristel Solutions Limited |
| Address of manufacturer | Lynx Business Park, Fordham Road, Snailwell, CB8 7NY Cambridgeshire United Kingdom |
| Location of manufacturing sites | Lynx Business Park, Fordham Road, Snailwell, CB8 7NY Cambridgeshire United Kingdom |
| --- | --- |
| Name of manufacturer | Techtex |
| Address of manufacturer | Units 7&8 Rhodes Bus. Park Silburn Way, M24 4NE Middleton United Kingdom |
| Location of manufacturing sites | Units 7&8 Rhodes Bus. Park Silburn Way, M24 4NE Middleton United Kingdom |
| --- | --- |
| Name of manufacturer | A.F.P. GmbH |
| Address of manufacturer | Otto Brenner Straße 16, 21337 Lüneburg Germany |
| Location of manufacturing sites | Otto Brenner Straße 16, 21337 Lüneburg Germany |
| --- | --- |
| Name of manufacturer | Innovate GmbH |
| Address of manufacturer | Gewerbegebietsstraße 30, 06618 Schönburg Germany |
| Location of manufacturing sites | Gewerbegebietsstraße 30, 06618 Schönburg Germany Keizersveld 99, 5803 AP Venray Netherlands |
| --- | --- |
| Name of manufacturer | Lysoform Dr. Hans Rosemann GmbH |
| Address of manufacturer | Kaiser-Wilhelm-Straße 133, 12247 Berlin Germany |
| Location of manufacturing sites | Kaiser-Wilhelm-Straße 133, 12247 Berlin Germany |
| --- | --- |
| Name of manufacturer | Sterisol AB |
| Address of manufacturer | Kronoängsgatan 3, 592 23 Vadstena Sweden |
| Location of manufacturing sites | Kronoängsgatan 3, 592 23 Vadstena Sweden |
| --- | --- |
| Name of manufacturer | Rudolf Dankwardt GmbH |
| Address of manufacturer | Gutenbergring 50-52, 22848 Norderstedt Germany |
| Location of manufacturing sites | Gutenbergring 50-52, 22848 Norderstedt Germany Lagerstr. 15, 19249 Jessenitz - Werk / Lübtheen Germany |
| --- | --- |
| Name of manufacturer | BIOXAL SA |
| Address of manufacturer | ZI Sud Secteur A, Route des Varennes, 71100 Chalon sur Saône France |
| Location of manufacturing sites | ZI Sud Secteur A, Route des Varennes, 71100 Chalon sur Saône France |
| --- | --- |
| Name of manufacturer | Lichtenheldt GmbH |
| Address of manufacturer | Industriestrasse 7-9, 23812 Wahlstedt Germany |
| Location of manufacturing sites | Industriestrasse 7-9, 23812 Wahlstedt Germany Justus-Liebig-Weg 1, 23812 Wahlstedt Germany |
| --- | --- |
| Name of manufacturer | NATURELLE CONSUMER PRODUCTS LTD |
| Address of manufacturer | Unit 5 Bankmore Way, East industrial Park,, BT79 ONZ Doogary, Omagh, Co. Tyrone United Kingdom |
| Location of manufacturing sites | Unit 5 Bankmore Way, East industrial Park,, BT79 ONZ Doogary, Omagh, Co. Tyrone United Kingdom |
| --- | --- |
| Name of manufacturer | Halag Chemie AG |
| Address of manufacturer | Weiernstrasse 30, 8355 Aadorf Switzerland |
| Location of manufacturing sites | Weiernstrasse 30, 8355 Aadorf Switzerland |
| --- | --- |
| Name of manufacturer | PDI (EMEA) Ltd |
| Address of manufacturer | Pywell Rd Willowbrook East Industrial Estate, NN17 5XJ Corby United Kingdom |
| Location of manufacturing sites | Pywell Rd Willowbrook East Industrial Estate, NN17 5XJ Corby United Kingdom |
1.5. Manufacturer(s) of the active substance(s)
| Active substance | Propan-2-ol |
| Name of manufacturer | Ineos Solvents Germany GmbH (formerly Sasol) |
| Address of manufacturer | Römerstraße 733, 47443 Moers Germany |
| Location of manufacturing sites | Römerstraße 733, 47443 Moers Germany Shamrockstr. 88, 44643 Herne Germany |
| --- | --- |
| Active substance | Propan-2-ol |
| Name of manufacturer | Shell Chemicals Europe B.V. |
| Address of manufacturer | Postbus 2334, 3000 CH Rotterdam Netherlands |
| Location of manufacturing sites | Shell Nederland Raffinaderij B.V., Vondelingenweg 601, 3196 KK Rotterdam-Pernis Netherlands |
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 (%) | Content (%) |
|---|---|---|---|---|---|---|
| Common name | IUPAC name | Function | CAS number | EC number | Min | Max |
| Propan-2-ol | Active Substance | 67-63-0 | 200-661-7 | 63,1 | 63,1 |
2.2. Type(s) of formulation
| Formulation(s) | Any other liquid (AL), ready-to-use Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation |
PART II
SECOND INFORMATION LEVEL - META SPC(S)
META SPC 1
1. META SPC 1 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 1 identifier
| Identifier | meta SPC 1 perform IPA liquid |
1.2. Suffix to the authorisation number
| Number | 1-1 |
1.3. Product type(s)
| Product type(s) | PT04 - Food and feed area (Disinfectants) PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
2. META SPC 1 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 1
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) | Content (%) |
|---|---|---|---|---|---|---|
| Common name | IUPAC name | Function | CAS number | EC number | Min | Max |
| Propan-2-ol | Active Substance | 67-63-0 | 200-661-7 | 63,1 | 63,1 |
2.2. Type(s) of formulation of the meta SPC 1
| Formulation(s) | Any other liquid (AL), ready-to-use |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
| Hazard statements | Highly flammable liquid and vapour. Causes serious eye irritation. May cause drowsiness or dizziness. Repeated exposure may cause skin dryness or cracking. |
| Precautionary statements | Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking. Keep container tightly closed. Ground and bond container and receiving equipment. Use explosion-proof electrical/ventilating/lighting equipment. Use non-sparking tools. Take action to prevent static discharges. Avoid breathing vapours. Avoid breathing spray. Use only outdoors or in a well-ventilated area. Wear eye protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Call a POISON CENTER or doctor if you feel unwell. If eye irritation persists:Get medical advice. If eye irritation persists:Get medical attention. In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish. Store in a well-ventilated place.Keep cool. Store locked up. Dispose of contents to /container to an approved waste disposal plant. |
4. AUTHORISED USE(S) OF THE META SPC 1
4.1. Use description
Table 1
Use # 1 – Disinfection of surfaces - spraying
| Product type | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: viruses (limited spectrum virucidal activity) Common name: - Development stage: - |
| Field(s) of use | Indoor Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas |
| Application method(s) | Method: Spraying Detailed description: Product will be sprayed directly on the surface |
| Application rate(s) and frequency | Application Rate: Ready-to-use. Do not apply more than 25 ml/m2. Dilution (%): - Number and timing of application: Disinfection after each production and cleaning process or when required according to standard operating procedure (SOP) |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | Bottle: 250-1000 ml packaging material: high-density polyethylene (HDPE), surlyn/polypropylene (PP) closure material is either: PP, polyoxymethylene (POM), low-density polyethylene (LDPE), HDPE, polyethylene (PE), ethylene-vinyl acetate (EVA), stainless steel, polybutylene terephthalate (PBT), (LD)PE, exp. polytetrafluoroethylene (PTFE), linear low density polyethylene (LLDPE), expanded PE (EXPPE), Co Polymer PP canister: 5-30 litre packaging material: HDPE. closure material is either: HDPE/LDPE Revolver BAG: 1 litre packaging material: EVA closure material: PP/Silicone/EVA drum: 200 - 220 litre packaging material: HDPE closure material is either: PP IBC: 900-1000 litre packaging material: HDPE with steel frame closure material is either: PP, HDPE |
4.1.1. Use-specific instructions for use
Spray ready-to-use product on the surface and allow to take effect at 20± 2°C for at least 1 minute (bactericidal and yeasticidal activity) or 2 minutes (limited spectrum virucidal activity).
4.1.2. Use-specific risk mitigation measures
The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.2. Use description
Table 2
Use # 2 – Disinfection of surfaces - wiping
| Product type | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: viruses (limited spectrum virucidal activity) Common name: - Development stage: - |
| Field(s) of use | Indoor Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas |
| Application method(s) | Method: Wiping Detailed description: Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on the surface. |
| Application rate(s) and frequency | Application Rate: Ready-to-use. Do not apply more than 25 ml/m2. Dilution (%): - Number and timing of application: Disinfection after each production and cleaning process or when required according to SOP. |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | Bottle: 250-1000 ml packaging material: HDPE, surlyn/PP closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP. canister: 5-30 litre packaging material: HDPE. closure material is either: HDPE/LDPE Revolver BAG: 1 litre packaging material: EVA closure material: PP/Silicone/EVA. drum: 200 - 220 litre packaging material: HDPEclosure material is either: PP IBC: 900-1000 litre packaging material: HDPE with steel frameclosure material is either: PP, HDPE |
4.2.1. Use-specific instructions for use
Spray or pour ready-to-use product on the surface and wipe afterwards or wet a wipe with the ready-to-use product by spraying or pouring and thereafter wipe the surface. Allow to take effect at 20 ± 2°C for at least 5 minutes (bactericidal, yeasticidal and limited spectrum virucidal activity).
4.2.2. Use-specific risk mitigation measures
The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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
See general directions for use.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.3. Use description
Table 3
Use # 3 – Disinfection of surfaces with food and feed contact - spraying
| Product type | PT04 - Food and feed area (Disinfectants) |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: Viruses Common name: - Development stage: - |
| Field(s) of use | Indoor Disinfection of clean non-porous surfaces in kitchens and food industry |
| Application method(s) | Method: Spraying Detailed description: Product will be sprayed directly on the surface. |
| Application rate(s) and frequency | Application Rate: Ready-to-use. Do not apply more than 25 ml/m2. Dilution (%): - Number and timing of application: Disinfection after each production and cleaning process or when required according to SOP. |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | Bottle: 250-1000 ml packaging material: HDPE, surlyn/PP closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP. canister: 5-30 litre packaging material: HDPE. closure material is either: HDPE/LDPE Revolver BAG: 1 litre packaging material: EVA closure material: PP/Silicone/EVA. drum: 200 - 220 litre packaging material: HDPEclosure material is either: PP IBC: 900-1000 litre packaging material: HDPE with steel frame closure material is either: PP, HDPE |
4.3.1. Use-specific instructions for use
Spray ready-to-use product on the surface and allow to take effect at room temperature (20± 2°C) for at least 1 (bactericidal and yeasticidal activity) or 2 minutes (virucidal activity).
4.3.2. Use-specific risk mitigation measures
The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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
See general directions for use.
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.4. Use description
Table 4
Use # 4 – Disinfection of surfaces with food and feed contact - wiping
| Product type | PT04 - Food and feed area (Disinfectants) |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: Viruses Common name: - Development stage: - |
| Field(s) of use | Indoor Disinfection of clean non-porous surfaces in kitchens and food industry |
| Application method(s) | Method: Wiping Detailed description: Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on the surface. |
| Application rate(s) and frequency | Application Rate: Ready-to-use. Do not apply more than 25 ml/m2. Dilution (%): - Number and timing of application: Disinfection after each production and cleaning process or when required according to SOP. |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | Bottle: 250-1000 ml packaging material: HDPE, surlyn/PP closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP. canister: 5-30 litre packaging material: HDPE. closure material is either: HDPE/LDPE Revolver BAG: 1 litre packaging material: EVA closure material: PP/Silicone/EVA. drum: 200 - 220 litre packaging material: HDPE closure material is either: PP IBC: 900-1000 litre packaging material: HDPE with steel frame closure material is either: PP, HDPE |
4.4.1. Use-specific instructions for use
Spray ready-to-use product on the surface and wipe afterwards or wet a wipe with the ready-to-use product by spraying or pouring and thereafter wipe the surface. Allow to take effect for at least 5 minutes at room temperature (20± 2°C).
4.4.2. Use-specific risk mitigation measures
The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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
See general directions for use.
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5. GENERAL DIRECTIONS FOR USE 6
OF THE META SPC 1
5.1. Instructions for use
Clean the surface carefully before use.
Remove excess water from the surface before disinfection, if appropriate.
Do not apply more than 25 ml/m2.
Make sure to wet surfaces completely.
Used wipes must be disposed in a closed container.
5.2. Risk mitigation measures
The product must only be applied for disinfection of small surfaces.
Ensure adequate ventilation to prevent the formation of explosive atmospheres.
Avoid contact with eyes.
Apply a funnel for refilling.
Keep out of reach of children and pets.
Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid:
In case of accident: Call a poison centre or a doctor.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
If on skin: Wash with water. If skin irritation occurs: Get medical advice.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
5.4. Instructions for safe disposal of the product and its packaging
-
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 36 months
Keep container tightly closed.
Store in a well-ventilated place.
Protect from sunlight.
Store at room temperature in the original container.
6. OTHER INFORMATION
The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
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) | perform® sterile alcohol IPA | perform® sterile alcohol IPA | Market area: EU | Market area: EU | Market area: EU | Market area: EU |
| perform® classic alcohol IPA | perform® classic alcohol IPA | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| buraton® IPA | buraton® IPA | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| perform® advanced alcohol IPA | perform® advanced alcohol IPA | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| arcana® IPA | arcana® IPA | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| clear IPA | clear IPA | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| pure IPA | pure IPA | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| disinfectant IPA | disinfectant IPA | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| Surface disinfection liquid classic | Surface disinfection liquid classic | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| sterile IPA | sterile IPA | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| mikrozid® sterile liquid | mikrozid® sterile liquid | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| Surface disinfection liquid sterile | Surface disinfection liquid sterile | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| BTS 6000 | BTS 6000 | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| Halades Alco | Halades Alco | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| Authorisation number | EU-0023656-0001 1-1 | EU-0023656-0001 1-1 | EU-0023656-0001 1-1 | EU-0023656-0001 1-1 | EU-0023656-0001 1-1 | EU-0023656-0001 1-1 |
| Common name | IUPAC name | Function | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | Active Substance | Active Substance | 67-63-0 | 200-661-7 | 63,1 |
META SPC 2
1. META SPC 2 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 2 identifier
| Identifier | meta SPC 2 perform wipes IPA |
1.2. Suffix to the authorisation number
| Number | 1-2 |
1.3. Product type(s)
| Product type(s) | PT04 - Food and feed area (Disinfectants) PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
2. META SPC 2 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 2
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) | Content (%) |
|---|---|---|---|---|---|---|
| Common name | IUPAC name | Function | CAS number | EC number | Min | Max |
| Propan-2-ol | Active Substance | 67-63-0 | 200-661-7 | 63,1 | 63,1 |
2.2. Type(s) of formulation of the meta SPC 2
| Formulation(s) | Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
| Hazard statements | Highly flammable liquid and vapour. Causes serious eye irritation. May cause drowsiness or dizziness. Repeated exposure may cause skin dryness or cracking. |
| Precautionary statements | Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking. Keep container tightly closed. Ground and bond container and receiving equipment. Use explosion-proof electrical/ventilating/lighting equipment. Use non-sparking tools. Take action to prevent static discharges. Avoid breathing vapours. Avoid breathing spray. Use only outdoors or in a well-ventilated area. Wear eye protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Call a POISON CENTER or doctor if you feel unwell. If eye irritation persists:Get medical advice. If eye irritation persists:Get medical attention. In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish. Store in a well-ventilated place.Keep cool. Store locked up. Dispose of contents to /container to an approved waste disposal plant. |
4. AUTHORISED USE(S) OF THE META SPC 2
4.1. Use description
Table 5
Use # 1 – Disinfection of surfaces - wiping
| Product type | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: viruses (limited spectrum virucidal activity) Common name: - Development stage: - |
| Field(s) of use | Indoor Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas |
| Application method(s) | Method: Wiping Detailed description: Product will be wiped directly on the surface. |
| Application rate(s) and frequency | Application Rate: Ready-to-use wipes Dilution (%): - Number and timing of application: Disinfection after each production and cleaning process or when required according to SOP. |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | Soft pack: 1-200 wipes Packaging material: LDPE/Alu/PET; LDPE/PET; biaxially oriented polypropylene (BOPP) + cast polypropylene (CPP) Pouch: 10-200 wipes Packaging material: LDPE/PET Tube: 50-200 wipes Packaging material: HDPE closure material is either PP, PE3385 |
4.1.1. Use-specific instructions for use
Thoroughly wipe the surface with the wipe and allow to take effect at 20 ± 2°C for at least 5 minutes (bactericidal, yeasticidal and limited spectrum virucidal activity).
4.1.2. Use-specific risk mitigation measures
See general directions for use.
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
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.2. Use description
Table 6
Use # 2 – Disinfection of surfaces with food and feed contact - wiping
| Product type | PT04 - Food and feed area (Disinfectants) |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: Viruses Common name: - Development stage: - |
| Field(s) of use | Indoor Disinfection of clean non-porous surfaces in kitchens and food industry |
| Application method(s) | Method: Wiping Detailed description: Product will be wiped directly on the surface. |
| Application rate(s) and frequency | Application Rate: Ready-to-use wipes Dilution (%): - Number and timing of application: Disinfection after each production and cleaning process or when required according to SOP. |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | Soft pack: 1-200 wipes Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP Pouch: 10-200 wipes Packaging material: LDPE/PET Tube: 50-200 wipes Packaging material: HDPE closure material is either PP, PE3385 |
4.2.1. Use-specific instructions for use
Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20± 2°C).
4.2.2. Use-specific risk mitigation measures
See general directions for use.
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
See general directions for use.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5. GENERAL DIRECTIONS FOR USE 7
OF THE META SPC 2
5.1. Instructions for use
Clean the surface carefully before use.
Remove excess water from the surface before disinfection, if appropriate.
Make sure to wet surfaces completely.
Used wipes must be disposed in a closed container.
5.2. Risk mitigation measures
The product must only be applied for disinfection of small surfaces.
Ensure adequate ventilation to prevent the formation of explosive atmospheres.
Avoid contact with eyes.
Keep out of reach of children and pets.
Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid:
In case of accident: Call a poison centre or a doctor.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
If on skin: Wash with water. If skin irritation occurs: Get medical advice.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
5.4. Instructions for safe disposal of the product and its packaging
-
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months
Keep container tightly closed.
Store in a well-ventilated place.
Protect from sunlight.
Store at room temperature in the original container.
6. OTHER INFORMATION
The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
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) | perform classic wipes IPA | perform classic wipes IPA | Market area: EU | Market area: EU | Market area: EU | Market area: EU |
| buraton® wipes IPA | buraton® wipes IPA | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| perform® advanced wipes IPA | perform® advanced wipes IPA | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| arcana® wipes IPA | arcana® wipes IPA | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| clear IPA wipes | clear IPA wipes | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| pure IPA wipes | pure IPA wipes | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| disinfectant IPA wipes | disinfectant IPA wipes | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| Surface disinfection wipes classic | Surface disinfection wipes classic | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| perform® sterile wipes IPA | perform® sterile wipes IPA | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| sterile IPA wipes | sterile IPA wipes | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| mikrozid® sterile wipes | mikrozid® sterile wipes | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| Surface disinfection wipes sterile | Surface disinfection wipes sterile | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| Authorisation number | EU-0023656-0002 1-2 | EU-0023656-0002 1-2 | EU-0023656-0002 1-2 | EU-0023656-0002 1-2 | EU-0023656-0002 1-2 | EU-0023656-0002 1-2 |
| Common name | IUPAC name | Function | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | Active Substance | Active Substance | 67-63-0 | 200-661-7 | 63,1 |
META SPC 3
1. META SPC 3 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 3 identifier
| Identifier | meta SPC 3 mikrozid liquid |
1.2. Suffix to the authorisation number
| Number | 1-3 |
1.3. Product type(s)
| Product type(s) | PT04 - Food and feed area (Disinfectants) PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
2. META SPC 3 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 3
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) | Content (%) |
|---|---|---|---|---|---|---|
| Common name | IUPAC name | Function | CAS number | EC number | Min | Max |
| Propan-2-ol | Active Substance | 67-63-0 | 200-661-7 | 63,1 | 63,1 |
2.2. Type(s) of formulation of the meta SPC 3
| Formulation(s) | Any other liquid (AL), ready-to-use |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
| Hazard statements | Highly flammable liquid and vapour. Causes serious eye irritation. May cause drowsiness or dizziness. Repeated exposure may cause skin dryness or cracking. |
| Precautionary statements | Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking. Keep container tightly closed. Ground and bond container and receiving equipment. Use explosion-proof electrical/ventilating/lighting equipment. Use non-sparking tools. Take action to prevent static discharges. Avoid breathing vapours. Avoid breathing spray. Use only outdoors or in a well-ventilated area. Wear eye protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Call a POISON CENTER or doctor if you feel unwell. If eye irritation persists:Get medical advice. If eye irritation persists:Get medical attention. In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish. Store in a well-ventilated place.Keep cool. Store locked up. Dispose of contents to /container to an approved waste disposal plant. |
4. AUTHORISED USE(S) OF THE META SPC 3
4.1. Use description
Table 7
Use # 1 – Disinfection of surfaces - spraying
| Product type | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria including Mycobacterium tuberculosis Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: viruses (limited spectrum virucidal activity) Common name: - Development stage: - |
| Field(s) of use | Indoor Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas |
| Application method(s) | Method: Spraying Detailed description: Product will be sprayed directly on the surface |
| Application rate(s) and frequency | Application Rate: Ready-to-use. Do not apply more than 25 ml/m2. Dilution (%): - Number and timing of application: Disinfection when required according to SOP. |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | Bottle: 250-1000 ml packaging material: HDPE, surlyn/PP closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP canister: 5-30 litre packaging material: HDPE. closure material is either: HDPE/LDPE Revolver BAG: 1 litre packaging material: EVA Closure : PP/Silicone/EVA drum: 200 - 220 litre packaging material: HDPE closure material is either: PP IBC:900-1000 litre packaging material: HDPE with steel frame closure material is either: PP, HDPE |
4.1.1. Use-specific instructions for use
Spray ready-to-use product on the surface and allow to take effect at 20± 2°C for at least 1 minute (bactericidal and yeasticidal activity) or 2 minutes (limited spectrum virucidal activity).
4.1.2. Use-specific risk mitigation measures
The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.2. Use description
Table 8
Use # 2 – Disinfection of surfaces - wiping
| Product type | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria including Mycobacterium tuberculosis Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: viruses (limited spectrum virucidal activity) Common name: - Development stage: - |
| Field(s) of use | Indoor Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas |
| Application method(s) | Method: Wiping Detailed description: Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on the surface. |
| Application rate(s) and frequency | Application Rate: Ready-to-use. Do not apply more than 25 ml/m2. Dilution (%): - Number and timing of application: Disinfection when required according to SOP. |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | Bottle: 250-1000 ml packaging material: HDPE, surlyn/PP closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP canister: 5-30 litre packaging material: HDPE. closure material is either: HDPE/LDPE Revolver BAG: 1 litre packaging material: EVA Closure : PP/Silicone/EVA drum: 200 - 220 litre packaging material: HDPE closure material is either: PP IBC:900-1000 litre packaging material: HDPE with steel frame closure material is either: PP, HDPE |
4.2.1. Use-specific instructions for use
Spray or pour ready-to-use product on the surface and wipe afterwards or wet a wipe with the ready-to-use product by spraying or pouring and thereafter wipe the surface. Allow to take effect at 20 ± 2°C for at least 5 minutes (bactericidal, yeasticidal and limited spectrum virucidal activity).
4.2.2. Use-specific risk mitigation measures
The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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
See general directions for use.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.3. Use description
Table 9
Use # 3 – Disinfection of surfaces with food and feed contact - spraying
| Product type | PT04 - Food and feed area (Disinfectants) |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria including Mycobacterium tuberculosis Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: Viruses Common name: - Development stage: - |
| Field(s) of use | Indoor Disinfection of clean non-porous surfaces in kitchens and food industry |
| Application method(s) | Method: Spraying Detailed description: Product will be sprayed directly on the surface. |
| Application rate(s) and frequency | Application Rate: Ready-to-use. Do not apply more than 25 ml/m2. Dilution (%): - Number and timing of application: Disinfection when required according to SOP. |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | Bottle: 250-1000 ml packaging material: HDPE, surlyn/PP closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP canister: 5-30 litre packaging material: HDPE. closure material is either: HDPE/LDPE Revolver BAG: 1 litre packaging material: EVA Closure : PP/Silicone/EVA drum: 200 - 220 litre packaging material: HDPE closure material is either: PP IBC: 900-1000 litre packaging material: HDPE with steel frame closure material is either: PP, HDPE |
4.3.1. Use-specific instructions for use
Spray ready-to-use product on the surface and allow to take effect at room temperature (20± 2°C) for at least 1 (bactericidal and yeasticidal activity) or 2 minutes (virucidal activity).
4.3.2. Use-specific risk mitigation measures
The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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
See general directions for use.
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.4. Use description
Table 10
Use # 4 – Disinfection of surfaces with food and feed contact - wiping
| Product type | PT04 - Food and feed area (Disinfectants) |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria including Mycobacterium tuberculosis Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: Viruses Common name: - Development stage: - |
| Field(s) of use | Indoor Disinfection of clean non-porous surfaces in kitchens and food industry |
| Application method(s) | Method: Wiping Detailed description: Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on surface. |
| Application rate(s) and frequency | Application Rate: Ready-to-use. Do not apply more than 25 ml/m2. Dilution (%): - Number and timing of application: Disinfection when required according to SOP. |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | Bottle: 250-1000 ml packaging material: HDPE, surlyn/PP closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP canister: 5-30 litre packaging material: HDPE. closure material is either: HDPE/LDPE Revolver BAG: 1 litre packaging material: EVA closure material: PP/Silicone/EVA drum: 200 - 220 litre packaging material: HDPE closure material is either: PP IBC: 900-1000 litre packaging material: HDPE with steel frame closure material is either: PP, HDPE |
4.4.1. Use-specific instructions for use
Spray or pour ready-to-use product on the surface and wipe afterwards or wet a wipe with the ready-to-use product by spraying or pouring and thereafter wipe the surface. Allow to take effect for at least 5 minutes at room temperature (20± 2°C).
4.4.2. Use-specific risk mitigation measures
The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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
See general directions for use.
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5. GENERAL DIRECTIONS FOR USE 8
OF THE META SPC 3
5.1. Instructions for use
Clean the surface carefully before use.
Remove excess water from the surface before disinfection, if appropriate.
Do not apply more than 25 ml/m2.
Make sure to wet surfaces completely.
Used wipes must be disposed in a closed container.
5.2. Risk mitigation measures
The product must only be applied for disinfection of small surfaces.
Ensure adequate ventilation to prevent the formation of explosive atmospheres.
Avoid contact with eyes.
Apply a funnel for refilling.
Keep out of reach of children and pets.
Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid:
In case of accident: Call a poison centre or a doctor.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
If on skin: Wash with water. If skin irritation occurs: Get medical advice.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
5.4. Instructions for safe disposal of the product and its packaging
-
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 36 months
Keep container tightly closed.
Store in a well-ventilated place.
Protect from sunlight.
Store at room temperature in the original container.
6. OTHER INFORMATION
The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
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) | mikrozid® classic liquid | mikrozid® classic liquid | Market area: EU | Market area: EU | Market area: EU | Market area: EU |
| mikrozid® IPA liquid | mikrozid® IPA liquid | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| Surface Disinfection liquid pure | Surface Disinfection liquid pure | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| Authorisation number | EU-0023656-0003 1-3 | EU-0023656-0003 1-3 | EU-0023656-0003 1-3 | EU-0023656-0003 1-3 | EU-0023656-0003 1-3 | EU-0023656-0003 1-3 |
| Common name | IUPAC name | Function | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | Active Substance | Active Substance | 67-63-0 | 200-661-7 | 63,1 |
META SPC 4
1. META SPC 4 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 4 identifier
| Identifier | meta SPC 4 mikrozid wipes |
1.2. Suffix to the authorisation number
| Number | 1-4 |
1.3. Product type(s)
| Product type(s) | PT04 - Food and feed area (Disinfectants) PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
2. META SPC 4 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 4
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) | Content (%) |
|---|---|---|---|---|---|---|
| Common name | IUPAC name | Function | CAS number | EC number | Min | Max |
| Propan-2-ol | Active Substance | 67-63-0 | 200-661-7 | 63,1 | 63,1 |
2.2. Type(s) of formulation of the meta SPC 4
| Formulation(s) | Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
| Hazard statements | Highly flammable liquid and vapour. Causes serious eye irritation. May cause drowsiness or dizziness. Repeated exposure may cause skin dryness or cracking. |
| Precautionary statements | Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking. Keep container tightly closed. Ground and bond container and receiving equipment. Use explosion-proof electrical/ventilating/lighting equipment. Use non-sparking tools. Take action to prevent static discharges. Avoid breathing vapours. Avoid breathing spray. Use only outdoors or in a well-ventilated area. Wear eye protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Call a POISON CENTER or doctor if you feel unwell. If eye irritation persists:Get medical advice. If eye irritation persists:Get medical attention. In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish. Store in a well-ventilated place.Keep cool. Store locked up. Dispose of contents to /container to an approved waste disposal plant. |
4. AUTHORISED USE(S) OF THE META SPC 4
4.1. Use description
Table 11
Use # 1 – Disinfection of surfaces - wiping
| Product type | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria including Mycobacterium tuberculosis Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: viruses (limited spectrum virucidal activity) Common name: - Development stage: - |
| Field(s) of use | Indoor Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas |
| Application method(s) | Method: Wiping Detailed description: Product will be wiped directly on the surface. |
| Application rate(s) and frequency | Application Rate: Ready-to-use wipes Dilution (%): - Number and timing of application: Disinfection when required according to SOP. |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | Soft pack: 1-200 wipes Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP Pouch: 10-200 wipes Packaging material: LDPE/PET Tube: 50-200 wipes Packaging material: HDPE closure material is either PP, PE3385 |
4.1.1. Use-specific instructions for use
Thoroughly wipe the surface with the wipe and allow to take effect at 20 ± 2°C for at least 5 minutes (bactericidal, yeasticidal and limited spectrum virucidal activity).
4.1.2. Use-specific risk mitigation measures
See general directions for use.
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
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.2. Use description
Table 12
Use # 2 – Disinfection of surfaces with food and feed contact - wiping
| Product type | PT04 - Food and feed area (Disinfectants) |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria including Mycobacterium tuberculosis Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: Viruses Common name: - Development stage: - |
| Field(s) of use | Indoor Disinfection of clean non-porous surfaces in kitchens and food industry |
| Application method(s) | Method: Wiping Detailed description: Product will be wiped directly on the surface. |
| Application rate(s) and frequency | Application Rate: Ready-to-use wipes Dilution (%): - Number and timing of application: Disinfection when required according to SOP. |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | Soft pack: 1-200 wipes Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP Pouch: 10-200 wipes Packaging material: LDPE/PET Tube: 50-200 wipes Packaging material: HDPE closure material is either PP, PE3385 |
4.2.1. Use-specific instructions for use
Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20± 2°C).
4.2.2. Use-specific risk mitigation measures
See general directions for use.
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
See general directions for use.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5. GENERAL DIRECTIONS FOR USE 9
OF THE META SPC 4
5.1. Instructions for use
Clean the surface carefully before use.
Remove excess water from the surface before disinfection, if appropriate.
Make sure to wet surfaces completely.
Used wipes must be disposed in a closed container.
5.2. Risk mitigation measures
The product must only be applied for disinfection of small surfaces.
Ensure adequate ventilation to prevent the formation of explosive atmospheres.
Avoid contact with eyes.
Keep out of reach of children and pets.
Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid:
In case of accident: Call a poison centre or a doctor.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
If on skin: Wash with water. If skin irritation occurs: Get medical advice.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
5.4. Instructions for safe disposal of the product and its packaging
-
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months
Keep container tightly closed.
Store in a well-ventilated place.
Protect from sunlight.
Store at room temperature in the original container.
6. OTHER INFORMATION
The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | mikrozid® classic wipes | mikrozid® classic wipes | Market area: EU | Market area: EU | Market area: EU | Market area: EU |
| mikrozid® IPA wipes | mikrozid® IPA wipes | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| surface disinfection wipes classic | surface disinfection wipes classic | Market area: EU | Market area: EU | Market area: EU | Market area: EU | |
| Authorisation number | EU-0023656-0004 1-4 | EU-0023656-0004 1-4 | EU-0023656-0004 1-4 | EU-0023656-0004 1-4 | EU-0023656-0004 1-4 | EU-0023656-0004 1-4 |
| Common name | IUPAC name | Function | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | Active Substance | Active Substance | 67-63-0 | 200-661-7 | 63,1 |
META SPC 5
1. META SPC 5 ADMINISTRATIVE INFORMATION
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