Document ID: 32020R1991
Language: ENG

<table><col/><col/><col/><col/><tbody><tr><td><p>7.12.2020&#160;&#160;&#160;</p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 410/1</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2020/1991
of 27 November 2020
granting a Union authorisation for the biocidal product family ‘perform-IPA’
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ( 1 ) , and in particular Article 44(5) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>On 19 April 2016, Schuelke &amp; Mayr GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named &#8216;perform-IPA&#8217; of product-types 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Germany had agreed to evaluate the application. The application was recorded under case number BC-AB023095-72 in the Register for Biocidal Products.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>&#8216;perform-IPA&#8217; contains propan-2-ol, as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>On 27 August 2019, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, the assessment report and the conclusions of its evaluation to the European Chemicals Agency (&#8216;the Agency&#8217;).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>On 7 April 2020, the Agency submitted to the Commission an opinion&#160;<a>(<span>2</span>)</a>, the draft summary of the biocidal product characteristics (&#8216;SPC&#8217;) of &#8216;perform-IPA&#8217; and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The opinion concludes that &#8216;perform-IPA&#8217; is a biocidal product family within the meaning of Article 3(1)(s) of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>On 27 April 2020, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for &#8216;perform-IPA&#8217;.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>According to the opinion of the Agency, as regards the non-active substance diethyl phthalate contained in &#8216;perform-IPA&#8217;, it was not possible to conclude whether it meets the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100&#160;<a>(<span>3</span>)</a> within the period for the evaluation of the application. Further examination of diethyl phthalate should therefore take place. If it is concluded that diethyl phthalate is considered as having endocrine-disrupting properties, the Commission will consider whether to cancel or amend the Union authorisation for &#8216;perform-IPA&#8217; in accordance with Article 48 of Regulation (EU) No 528/2012.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
A Union authorisation with authorisation number EU-0023656-0000 is granted to Schuelke & Mayr GmbH for the making available on the market and use of the biocidal product family ‘perform-IPA’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 27 December 2020 until 30 November 2030.
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, 27 November 2020.
For the Commission
The President
Ursula VON DER LEYEN
( 1 ) OJ L 167, 27.6.2012, p. 1 .
( 2 ) ECHA opinion of 5 March 2020 on the Union authorisation of ‘perform-IPA’ (ECHA/BPC/245/2020), https://echa.europa.eu/bpc-opinions-on-union-authorisation
( 3 ) Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council ( OJ L 301, 17.11.2017, p. 1 ).
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
<table><col/><col/><tbody><tr><td><p>Name</p></td><td><p>perform-IPA</p></td></tr></tbody></table>
1.2. Product type(s)
<table><col/><col/><tbody><tr><td><p>Product type(s)</p></td><td><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p><p>PT04 - Food and feed area (Disinfectants)</p></td></tr></tbody></table>
1.3. Authorisation holder
<table><col/><col/><col/><tbody><tr><td><p>Name and address of the authorisation holder</p></td><td><p>Name</p></td><td><p>Sch&#252;lke &amp; Mayr GmbH</p></td></tr><tr><td><p>Address</p></td><td><p>Robert-Koch-Str. 2, 22851 Norderstedt, Germany</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0023656-0000</p></td></tr><tr><td><p><span>R4BP asset number</span></p></td><td><p>EU-0023656-0000</p></td></tr><tr><td><p>Date of the authorisation</p></td><td><p>27 December 2020</p></td></tr><tr><td><p>Expiry date of the authorisation</p></td><td><p>30 November 2030</p></td></tr></tbody></table>
1.4. Manufacturer(s) of the biocidal products
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>Sch&#252;lke &amp; Mayr GmbH</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Robert-Koch-Str. 2, 22851 Norderstedt, Germany</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Robert-Koch-Str. 2, 22851 Norderstedt, Germany</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>BOCHEMIE a.s.</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Lidick&#225; 326, 735 95 Bohum&#237;n Czech Republic</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Lidick&#225; 326, 735 95 Bohum&#237;n Czech Republic</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>Imeco</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Boschstr. 5, 63768 H&#246;sbach Germany</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Boschstr. 5, 63768 H&#246;sbach Germany</p><p>Neue Stra&#223;e 2-4, 09471 K&#246;ningswalde Germany</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>Tristel Solutions Limited</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Lynx Business Park, Fordham Road, Snailwell, CB8 7NY Cambridgeshire United Kingdom</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Lynx Business Park, Fordham Road, Snailwell, CB8 7NY Cambridgeshire United Kingdom</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>Techtex</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Units 7&amp;8 Rhodes Bus. Park Silburn Way, M24 4NE Middleton United Kingdom</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Units 7&amp;8 Rhodes Bus. Park Silburn Way, M24 4NE Middleton United Kingdom</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>A.F.P. GmbH</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Otto Brenner Stra&#223;e 16, 21337 L&#252;neburg Germany</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Otto Brenner Stra&#223;e 16, 21337 L&#252;neburg Germany</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>Innovate GmbH</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Am Hohen Stein 11, 06618 Naumburg (Saale) Germany</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Am Hohen Stein 11, 06618 Naumburg (Saale) Germany</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>Lysoform Dr. Hans Rosemann GmbH</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Kaiser-Wilhelm-Stra&#223;e 133, 12247 Berlin Germany</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Kaiser-Wilhelm-Stra&#223;e 133, 12247 Berlin Germany</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>Sterisol AB</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Krono&#228;ngsgatan 3, 592 23 Vadstena Sweden</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Krono&#228;ngsgatan 3, 592 23 Vadstena Sweden</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>Rudolf Dankwardt GmbH</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Gutenbergring 50-52, 22848 Norderstedt Germany</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Gutenbergring 50-52, 22848 Norderstedt Germany</p><p>Lagerstr. 15, 19249 Jessenitz - Werk / L&#252;btheen Germany</p></td></tr></tbody></table>
1.5. Manufacturer(s) of the active substance(s)
<table><col/><col/><tbody><tr><td><p>Active substance</p></td><td><p>Propan-2-ol</p></td></tr><tr><td><p>Name of manufacturer</p></td><td><p>Ineos Solvents Germany GmbH (formerly Sasol)</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>R&#246;merstra&#223;e 733, 47443 Moers Germany</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>R&#246;merstra&#223;e 733, 47443 Moers Germany</p><p>Shamrockstr. 88, 44643 Herne Germany</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Active substance</p></td><td><p>Propan-2-ol</p></td></tr><tr><td><p>Name of manufacturer</p></td><td><p>Shell Chemicals Europe B.V.</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Postbus 2334, 3000 CH Rotterdam Netherlands</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Shell Nederland Raffinaderij B.V., Vondelingenweg 601, 3196 KK Rotterdam-Pernis Netherlands</p></td></tr></tbody></table>
2. PRODUCT FAMILY COMPOSITION AND FORMULATION
2.1. Qualitative and quantitative information on the composition of the family
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Min</p></td><td><p>Max</p></td></tr><tr><td><p>Propan-2-ol</p></td><td><p>&#160;</p></td><td><p>Active Substance</p></td><td><p>67-63-0</p></td><td><p>200-661-7</p></td><td><p>63,1</p></td><td><p>63,1</p></td></tr></tbody></table>
2.2. Type(s) of formulation
<table><col/><col/><tbody><tr><td><p>Formulation(s)</p></td><td><p>Any other liquid (AL), ready-to-use</p><p>Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation</p></td></tr></tbody></table>
PART II
SECOND INFORMATION LEVEL – META SPC(S)
META SPC 1
1. META SPC 1 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 1 identifier
<table><col/><col/><tbody><tr><td><p>Identifier</p></td><td><p>meta SPC 1 perform IPA liquid</p></td></tr></tbody></table>
1.2. Suffix to the authorisation number
<table><col/><col/><tbody><tr><td><p>Number</p></td><td><p>1-1</p></td></tr></tbody></table>
1.3. Product type(s)
<table><col/><col/><tbody><tr><td><p>Product type(s)</p></td><td><p>PT04 - Food and feed area (Disinfectants)</p><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p></td></tr></tbody></table>
2. META SPC 1 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 1
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Min</p></td><td><p>Max</p></td></tr><tr><td><p>Propan-2-ol</p></td><td><p>&#160;</p></td><td><p>Active Substance</p></td><td><p>67-63-0</p></td><td><p>200-661-7</p></td><td><p>63,1</p></td><td><p>63,1</p></td></tr></tbody></table>
2.2. Type(s) of formulation of the meta SPC 1
<table><col/><col/><tbody><tr><td><p>Formulation(s)</p></td><td><p>Any other liquid (AL), ready-to-use</p></td></tr></tbody></table>
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
<table><col/><col/><tbody><tr><td><p>Hazard statements</p></td><td><p>Highly flammable liquid and vapour.</p><p>Causes serious eye irritation.</p><p>May cause drowsiness or dizziness.</p><p>Repeated exposure may cause skin dryness or cracking.</p></td></tr><tr><td><p>Precautionary statements</p></td><td><p>Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.</p><p>Keep container tightly closed.</p><p>Ground and bond container and receiving equipment.</p><p>Use explosion-proof electrical/ventilating/lighting equipment.</p><p>Use non-sparking tools.</p><p>Take action to prevent static discharges.</p><p>Avoid breathing vapours.</p><p>Avoid breathing spray.</p><p>Use only outdoors or in a well-ventilated area.</p><p>Wear eye protection.</p><p>IF IN EYES:Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.</p><p>Call a POISON CENTER or doctor if you feel unwell.</p><p>If eye irritation persists: Get medical advice.</p><p>If eye irritation persists: Get medical attention.</p><p>In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.</p><p>Store in a well-ventilated place. Keep cool.</p><p>Store locked up.</p><p>Dispose of contents to /container to an approved waste disposal plant.</p></td></tr></tbody></table>
4. AUTHORISED USE(S) OF THE META SPC 1
4.1. Use description
Table 1. Use # 1 – Disinfection of surfaces - spraying
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: Bacteria</p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Yeast</p><p>Common name: -</p><p>Development stage: -</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Spraying</p><p>Product will be sprayed directly on the surface</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Ready-to-use. Do not apply more than 25 ml/m<span>2</span>.</p><p>Disinfection after each production and cleaning process or when required according to standard operating procedure (SOP)</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>Bottle: 250-1000 ml</p><p>packaging material: high-density polyethylene (HDPE), surlyn/polypropylene (PP)</p><p>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</p><p>canister: 5-10 L</p><p>packaging material: HDPE.</p><p>closure material is either: HDPE/LDPE</p><p>Revolver BAG: 1 L</p><p>packaging material: EVA</p><p>closure material: PP/Silicone/EVA</p></td></tr></tbody></table>
4.1.1. 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 minute.
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
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: Bacteria</p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Yeast</p><p>Common name: -</p><p>Development stage: -</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Wiping</p><p>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.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Ready-to-use. Do not apply more than 25 ml/m<span>2</span>.</p><p>Disinfection after each production and cleaning process or when required according to SOP.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>Bottle: 250-1000 ml</p><p>packaging material: HDPE, surlyn/PP</p><p>closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP.</p><p>canister: 5-10 L</p><p>packaging material: HDPE.</p><p>closure material is either: HDPE/LDPE</p><p>Revolver BAG: 1 L</p><p>packaging material: EVA</p><p>closure material: PP/Silicone/EVA.</p></td></tr></tbody></table>
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 for at least 5 minutes at room temperature (20± 2°C).
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
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT04 - Food and feed area (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: Bacteria</p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Yeast</p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Viruses</p><p>Common name: -</p><p>Development stage: -</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Spraying</p><p>Product will be sprayed directly on the surface.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Ready-to-use. Do not apply more than 25 ml/m<span>2</span>.</p><p>Disinfection after each production and cleaning process or when required according to SOP.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>Bottle: 250-1000 ml</p><p>packaging material: HDPE, surlyn/PP</p><p>closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP.</p><p>canister: 5-10 L</p><p>packaging material: HDPE.</p><p>closure material is either: HDPE/LDPE</p><p>Revolver BAG: 1 L</p><p>packaging material: EVA</p><p>closure material: PP/Silicone/EVA.</p></td></tr></tbody></table>
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
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT04 - Food and feed area (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: Bacteria</p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Yeast</p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Viruses</p><p>Common name: -</p><p>Development stage: -</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Wiping</p><p>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.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Ready-to-use. Do not apply more than 25 ml/m<span>2</span>.</p><p>Disinfection after each production and cleaning process or when required according to SOP.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>Bottle: 250-1000 ml</p><p>packaging material: HDPE, surlyn/PP</p><p>closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP.</p><p>canister: 5-10 L</p><p>packaging material: HDPE.</p><p>closure material is either: HDPE/LDPE</p><p>Revolver BAG: 1 L</p><p>packaging material: EVA</p><p>closure material: PP/Silicone/EVA.</p></td></tr></tbody></table>
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 ( 1 ) 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/m 2 .
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:
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>In case of accident: Call a poison centre or a doctor.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>IF INHALED: Remove person to fresh air and keep comfortable for breathing.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>If on skin: Wash with water. If skin irritation occurs: Get medical advice.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>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.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.</p></td></tr></tbody></table>
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/m 3 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
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>perform&#174; sterile alcohol IPA</p><p>perform&#174; classic alcohol IPA</p><p>buraton&#174; IPA</p><p>perform&#174; advanced alcohol IPA</p><p>arcana&#174; IPA</p><p>clear IPA</p><p>pure IPA</p><p>disinfectant IPA</p><p>Surface disinfection liquid classic</p><p>sterile IPA</p><p>mikrozid&#174; sterile liquid</p><p>Surface disinfection liquid sterile</p><p>BTS 6000</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0023656-0001 1-1</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Propan-2-ol</p></td><td><p>&#160;</p></td><td><p>Active Substance</p></td><td><p>67-63-0</p></td><td><p>200-661-7</p></td><td><p>63,1</p></td></tr></tbody></table>
META SPC 2
1. META SPC 2 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 2 identifier
<table><col/><col/><tbody><tr><td><p>Identifier</p></td><td><p>meta SPC 2 perform wipes IPA</p></td></tr></tbody></table>
1.2. Suffix to the authorisation number
<table><col/><col/><tbody><tr><td><p>Number</p></td><td><p>1-2</p></td></tr></tbody></table>
1.3. Product type(s)
<table><col/><col/><tbody><tr><td><p>Product type(s)</p></td><td><p>PT04 - Food and feed area (Disinfectants)</p><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p></td></tr></tbody></table>
2. META SPC 2 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 2
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Min</p></td><td><p>Max</p></td></tr><tr><td><p>Propan-2-ol</p></td><td><p>&#160;</p></td><td><p>Active Substance</p></td><td><p>67-63-0</p></td><td><p>200-661-7</p></td><td><p>63,1</p></td><td><p>63,1</p></td></tr></tbody></table>
2.2. Type(s) of formulation of the meta SPC 2
<table><col/><col/><tbody><tr><td><p>Formulation(s)</p></td><td><p>Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation</p></td></tr></tbody></table>
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
<table><col/><col/><tbody><tr><td><p>Hazard statements</p></td><td><p>Highly flammable liquid and vapour.</p><p>Causes serious eye irritation.</p><p>May cause drowsiness or dizziness.</p><p>Repeated exposure may cause skin dryness or cracking.</p></td></tr><tr><td><p>Precautionary statements</p></td><td><p>Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.</p><p>Keep container tightly closed.</p><p>Ground and bond container and receiving equipment.</p><p>Use explosion-proof electrical/ventilating/lighting equipment.</p><p>Use non-sparking tools.</p><p>Take action to prevent static discharges.</p><p>Avoid breathing vapours.</p><p>Avoid breathing spray.</p><p>Use only outdoors or in a well-ventilated area.</p><p>Wear eye protection.</p><p>IF IN EYES: Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.</p><p>Call a POISON CENTER or doctor if you feel unwell.</p><p>If eye irritation persists: Get medical advice.</p><p>If eye irritation persists: Get medical attention.</p><p>In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.</p><p>Store in a well-ventilated place. Keep cool.</p><p>Store locked up.</p><p>Dispose of contents /container to an approved waste disposal plant.</p></td></tr></tbody></table>
4. AUTHORISED USE(S) OF THE META SPC 2
4.1. Use description
Table 5. Use # 1 – Disinfection of surfaces - wiping
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: Bacteria</p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Yeast</p><p>Common name: -</p><p>Development stage: -</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Wiping</p><p>Product will be wiped directly on the surface.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Ready-to-use wipes</p><p>Disinfection after each production and cleaning process or when required according to SOP.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>Soft pack: 1-200 wipes</p><p>Packaging material: LDPE/Alu/PET; LDPE/PET; biaxially oriented polypropylene (BOPP) + cast polypropylene (CPP)</p><p>Pouch: 10-200 wipes</p><p>Packaging material: LDPE/PET</p><p>Tube: 50-200 wipes</p><p>Packaging material: HDPE</p><p>closure material is either PP, PE3385</p></td></tr></tbody></table>
4.1.1. 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).
4.1.2. 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
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT04 - Food and feed area (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: Bacteria</p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Yeast</p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Viruses</p><p>Common name: -</p><p>Development stage: -</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Wiping</p><p>Product will be wiped directly on the surface.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Ready-to-use wipes</p><p>Disinfection after each production and cleaning process or when required according to SOP.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>Soft pack: 1-200 wipes</p><p>Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP</p><p>Pouch: 10-200 wipes</p><p>Packaging material: LDPE/PET</p><p>Tube: 50-200 wipes</p><p>Packaging material: HDPE</p><p>closure material is either PP, PE3385</p></td></tr></tbody></table>
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 ( 2 ) 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:
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>In case of accident: Call a poison centre or a doctor.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>IF INHALED: Remove person to fresh air and keep comfortable for breathing.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>If on skin: Wash with water. If skin irritation occurs: Get medical advice.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>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.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.</p></td></tr></tbody></table>
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/m 3 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
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>perform classic wipes IPA</p><p>buraton&#174; wipes IPA</p><p>perform&#174; advanced wipes IPA</p><p>arcana&#174; wipes IPA</p><p>clear IPA wipes</p><p>pure IPA wipes</p><p>disinfectant IPA wipes</p><p>Surface disinfection wipes classic</p><p>perform&#174; sterile wipes IPA</p><p>sterile IPA wipes</p><p>mikrozid&#174; sterile wipes</p><p>Surface disinfection wipes sterile</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0023656-0002 1-2</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Propan-2-ol</p></td><td><p>&#160;</p></td><td><p>Active Substance</p></td><td><p>67-63-0</p></td><td><p>200-661-7</p></td><td><p>63,1</p></td></tr></tbody></table>
META SPC 3
1. META SPC 3 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 3 identifier
<table><col/><col/><tbody><tr><td><p>Identifier</p></td><td><p>meta SPC 3 mikrozid liquid</p></td></tr></tbody></table>
1.2. Suffix to the authorisation number
<table><col/><col/><tbody><tr><td><p>Number</p></td><td><p>1-3</p></td></tr></tbody></table>
1.3. Product type(s)
<table><col/><col/><tbody><tr><td><p>Product type(s)</p></td><td><p>PT04 - Food and feed area (Disinfectants)</p><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p></td></tr></tbody></table>
2. META SPC 3 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 3
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Min</p></td><td><p>Max</p></td></tr><tr><td><p>Propan-2-ol</p></td><td><p>&#160;</p></td><td><p>Active Substance</p></td><td><p>67-63-0</p></td><td><p>200-661-7</p></td><td><p>63,1</p></td><td><p>63,1</p></td></tr></tbody></table>
2.2. Type(s) of formulation of the meta SPC 3
<table><col/><col/><tbody><tr><td><p>Formulation(s)</p></td><td><p>Any other liquid (AL), ready-to-use</p></td></tr></tbody></table>
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
<table><col/><col/><tbody><tr><td><p>Hazard statements</p></td><td><p>Highly flammable liquid and vapour.</p><p>Causes serious eye irritation.</p><p>May cause drowsiness or dizziness.</p><p>Repeated exposure may cause skin dryness or cracking.</p></td></tr><tr><td><p>Precautionary statements</p></td><td><p>Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.</p><p>Keep container tightly closed.</p><p>Ground and bond container and receiving equipment.</p><p>Use explosion-proof electrical/ventilating/lighting equipment.</p><p>Use non-sparking tools.</p><p>Take action to prevent static discharges.</p><p>Avoid breathing vapours.</p><p>Avoid breathing spray.</p><p>Use only outdoors or in a well-ventilated area.</p><p>Wear eye protection.</p><p>IF IN EYES:Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.</p><p>Call a POISON CENTER or doctor if you feel unwell.</p><p>If eye irritation persists: Get medical advice.</p><p>If eye irritation persists: Get medical attention.</p><p>In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.</p><p>Store in a well-ventilated place. Keep cool.</p><p>Store locked up.</p><p>Dispose of contents /container to an approved waste disposal plant.</p></td></tr></tbody></table>
4. AUTHORISED USE(S) OF THE META SPC 3
4.1. Use description
Table 7. Use # 1 – Disinfection of surfaces - spraying
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: Bacteria including<span>Mycobacterium tuberculosis</span></p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Yeast</p><p>Common name: -</p><p>Development stage: -</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Spraying</p><p>Product will be sprayed directly on the surface</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Ready-to-use. Do not apply more than 25 ml/m<span>2</span>.</p><p>Disinfection when required according to SOP.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>Bottle: 250-1000 ml</p><p>packaging material: HDPE, surlyn/PP</p><p>closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP</p><p>canister: 5-10 L</p><p>packaging material: HDPE.</p><p>closure material is either: HDPE/LDPE</p><p>Revolver BAG: 1 L</p><p>packaging material: EVA</p><p>Closure : PP/Silicone/EVA</p></td></tr></tbody></table>
4.1.1. 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 minute.
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
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: Bacteria including<span>Mycobacterium tuberculosis</span></p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Yeast</p><p>Common name: -</p><p>Development stage: -</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Wiping</p><p>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.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Ready-to-use. Do not apply more than 25 ml/m<span>2</span>.</p><p>Disinfection when required according to SOP.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>Bottle: 250-1000 ml</p><p>packaging material: HDPE, surlyn/PP</p><p>closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP</p><p>canister: 5-10 L</p><p>packaging material: HDPE.</p><p>closure material is either: HDPE/LDPE</p><p>Revolver BAG: 1 L</p><p>packaging material: EVA</p><p>Closure : PP/Silicone/EVA</p></td></tr></tbody></table>
4.2.1. Use-specific instructions for use
Spray or pour rready-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).
4.2.2. 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
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT04 - Food and feed area (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: Bacteria including<span>Mycobacterium tuberculosis</span></p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Yeast</p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Viruses</p><p>Common name: -</p><p>Development stage: -</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Spraying</p><p>Product will be sprayed directly on the surface.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Ready-to-use. Do not apply more than 25 ml/m<span>2</span>.</p><p>Disinfection when required according to SOP.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>Bottle: 250-1000 ml</p><p>packaging material: HDPE, surlyn/PP</p><p>closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP</p><p>canister: 5-10 L</p><p>packaging material: HDPE.</p><p>closure material is either: HDPE/LDPE</p><p>Revolver BAG: 1 L</p><p>packaging material: EVA</p><p>Closure : PP/Silicone/EVA</p></td></tr></tbody></table>
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
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT04 - Food and feed area (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: Bacteria including<span>Mycobacterium tuberculosis</span></p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Yeast</p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Viruses</p><p>Common name: -</p><p>Development stage: -</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Wiping</p><p>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.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Ready-to-use. Do not apply more than 25 ml/m<span>2</span>.</p><p>Disinfection when required according to SOP.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>Bottle: 250-1000 ml</p><p>packaging material: HDPE, surlyn/PP</p><p>closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP</p><p>canister: 5-10 L</p><p>packaging material: HDPE.</p><p>closure material is either: HDPE/LDPE</p><p>Revolver BAG: 1 L</p><p>packaging material: EVA</p><p>closure material: PP/Silicone/EVA</p></td></tr></tbody></table>
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 ( 3 ) 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/m 2 .
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:
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>In case of accident: Call a poison centre or a doctor.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>IF INHALED: Remove person to fresh air and keep comfortable for breathing.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>If on skin: Wash with water. If skin irritation occurs: Get medical advice.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>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.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.</p></td></tr></tbody></table>
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/m 3 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
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>mikrozid&#174; classic liquid</p><p>mikrozid&#174; IPA liquid</p><p>Surface Disinfection liquid pure</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0023656-0003 1-3</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Propan-2-ol</p></td><td><p>&#160;</p></td><td><p>Active Substance</p></td><td><p>67-63-0</p></td><td><p>200-661-7</p></td><td><p>63,1</p></td></tr></tbody></table>
META SPC 4
1. META SPC 4 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 4 identifier
<table><col/><col/><tbody><tr><td><p>Identifier</p></td><td><p>meta SPC 4 mikrozid wipes</p></td></tr></tbody></table>
1.2. Suffix to the authorisation number
<table><col/><col/><tbody><tr><td><p>Number</p></td><td><p>1-4</p></td></tr></tbody></table>
1.3. Product type(s)
<table><col/><col/><tbody><tr><td><p>Product type(s)</p></td><td><p>PT04 - Food and feed area (Disinfectants)</p><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p></td></tr></tbody></table>
2. META SPC 4 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 4
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Min</p></td><td><p>Max</p></td></tr><tr><td><p>Propan-2-ol</p></td><td><p>&#160;</p></td><td><p>Active Substance</p></td><td><p>67-63-0</p></td><td><p>200-661-7</p></td><td><p>63,1</p></td><td><p>63,1</p></td></tr></tbody></table>
2.2. Type(s) of formulation of the meta SPC 4
<table><col/><col/><tbody><tr><td><p>Formulation(s)</p></td><td><p>Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation</p></td></tr></tbody></table>
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
<table><col/><col/><tbody><tr><td><p>Hazard statements</p></td><td><p>Highly flammable liquid and vapour.</p><p>Causes serious eye irritation.</p><p>May cause drowsiness or dizziness.</p><p>Repeated exposure may cause skin dryness or cracking.</p></td></tr><tr><td><p>Precautionary statements</p></td><td><p>Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.</p><p>Keep container tightly closed.</p><p>Ground and bond container and receiving equipment.</p><p>Use explosion-proof electrical/ventilating/lighting equipment.</p><p>Use non-sparking tools.</p><p>Take action to prevent static discharges.</p><p>Avoid breathing vapours.</p><p>Avoid breathing spray.</p><p>Use only outdoors or in a well-ventilated area.</p><p>Wear eye protection.</p><p>IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.</p><p>Call a POISON CENTER or doctor if you feel unwell.</p><p>If eye irritation persists: Get medical advice.</p><p>If eye irritation persists: Get medical attention.</p><p>In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.</p><p>Store in a well-ventilated place. Keep cool.</p><p>Store locked up.</p><p>Dispose of contents /container to an approved waste disposal plant.</p></td></tr></tbody></table>
4. AUTHORISED USE(S) OF THE META SPC 4
4.1. Use description
Table 11. Use # 1 – Disinfection of surfaces - wiping
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: Bacteria including<span>Mycobacterium tuberculosis</span></p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Yeast</p><p>Common name: -</p><p>Development stage: -</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Wiping</p><p>Product will be wiped directly on the surface.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Ready-to-use wipes</p><p>Disinfection when required according to SOP.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>Soft pack: 1-200 wipes</p><p>Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP</p><p>Pouch: 10-200 wipes</p><p>Packaging material: LDPE/PET</p><p>Tube: 50-200 wipes</p><p>Packaging material: HDPE</p><p>closure material is either PP, PE3385</p></td></tr></tbody></table>
4.1.1. 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).
4.1.2. 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
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT04 - Food and feed area (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: Bacteria including<span>Mycobacterium tuberculosis</span></p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Yeast</p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Viruses</p><p>Common name: -</p><p>Development stage: -</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Wiping</p><p>Product will be wiped directly on the surface.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Ready-to-use wipes</p><p>Disinfection when required according to SOP.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>Soft pack: 1-200 wipes</p><p>Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP</p><p>Pouch: 10-200 wipes</p><p>Packaging material: LDPE/PET</p><p>Tube: 50-200 wipes</p><p>Packaging material: HDPE</p><p>closure material is either PP, PE3385</p></td></tr></tbody></table>
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 ( 4 ) 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:
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>In case of accident: Call a poison centre or a doctor.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>IF INHALED: Remove person to fresh air and keep comfortable for breathing.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>If on skin: Wash with water. If skin irritation occurs: Get medical advice.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>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.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.</p></td></tr></tbody></table>
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/m 3 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
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>mikrozid&#174; classic wipes</p><p>mikrozid&#174; IPA wipes</p><p>surface disinfection wipes classic</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0023656-0004 1-4</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Propan-2-ol</p></td><td><p>&#160;</p></td><td><p>Active Substance</p></td><td><p>67-63-0</p></td><td><p>200-661-7</p></td><td><p>63,1</p></td></tr></tbody></table>
META SPC 5
1. META SPC 5 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 5 identifier
<table><col/><col/><tbody><tr><td><p>Identifier</p></td><td><p>meta SPC 5 kodan wipes IPA pro</p></td></tr></tbody></table>
1.2. Suffix to the authorisation number
<table><col/><col/><tbody><tr><td><p>Number</p></td><td><p>1-5</p></td></tr></tbody></table>
1.3. Product type(s)
<table><col/><col/><tbody><tr><td><p>Product type(s)</p></td><td><p>PT04 - Food and feed area (Disinfectants)</p><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p></td></tr></tbody></table>
2. META SPC 5 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 5
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Min</p></td><td><p>Max</p></td></tr><tr><td><p>Propan-2-ol</p></td><td><p>&#160;</p></td><td><p>Active Substance</p></td><td><p>67-63-0</p></td><td><p>200-661-7</p></td><td><p>63,1</p></td><td><p>63,1</p></td></tr></tbody></table>
2.2. Type(s) of formulation of the meta SPC 5
<table><col/><col/><tbody><tr><td><p>Formulation(s)</p></td><td><p>Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation</p></td></tr></tbody></table>
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
<table><col/><col/><tbody><tr><td><p>Hazard statements</p></td><td><p>Highly flammable liquid and vapour.</p><p>Causes serious eye irritation.</p><p>May cause drowsiness or dizziness.</p><p>Repeated exposure may cause skin dryness or cracking.</p></td></tr><tr><td><p>Precautionary statements</p></td><td><p>Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.</p><p>Keep container tightly closed.</p><p>Ground and bond container and receiving equipment.</p><p>Use explosion-proof electrical/ventilating/lighting equipment.</p><p>Use non-sparking tools.</p><p>Take action to prevent static discharges.</p><p>Avoid breathing vapours.</p><p>Avoid breathing spray.</p><p>Use only outdoors or in a well-ventilated area.</p><p>Wear eye protection.</p><p>IF IN EYES: Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.</p><p>Call a POISON CENTER or doctor if you feel unwell.</p><p>If eye irritation persists: Get medical advice.</p><p>If eye irritation persists: Get medical attention.</p><p>In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.</p><p>Store in a well-ventilated place. Keep cool.</p><p>Store locked up.</p><p>Dispose of contents /container to an approved waste disposal plant.</p></td></tr></tbody></table>
4. AUTHORISED USE(S) OF THE META SPC 5
4.1. Use description
Table 13. Use # 1 – Disinfection of surfaces - wiping
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: Bacteria including<span>Mycobacterium tuberculosis</span></p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Yeast</p><p>Common name: -</p><p>Development stage: -</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Wiping</p><p>Product will be wiped directly on the surface.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Ready-to-use wipes</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>Soft pack: 1-200 wipes</p><p>Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP</p><p>Pouch: 10-200 wipes</p><p>Packaging material: LDPE/PET</p><p>Tube: 50-200 wipes</p><p>Packaging material: HDPE</p><p>closure material is either PP, PE3385</p></td></tr></tbody></table>
4.1.1. 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).
4.1.2. 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 14. Use # 2 – disinfection of surfaces with food and feed contact - wiping
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT04 - Food and feed area (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: Bacteria including<span>Mycobacterium tuberculosis</span></p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Yeast</p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Viruses</p><p>Common name: -</p><p>Development stage: -</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Wiping</p><p>Product will be wiped directly on the surface.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Ready-to-use wipes</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>Soft pack: 1-200 wipes</p><p>Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP</p><p>Pouch: 10-200 wipes</p><p>Packaging material: LDPE/PET</p><p>Tube: 50-200 wipes</p><p>Packaging material: HDPE</p><p>closure material is either PP, PE3385</p></td></tr></tbody></table>
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 ( 5 ) OF THE META SPC 5
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:
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>In case of accident: Call a poison centre or a doctor.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>IF INHALED: Remove person to fresh air and keep comfortable for breathing.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>If on skin: Wash with water. If skin irritation occurs: Get medical advice.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>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.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.</p></td></tr></tbody></table>
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/m 3 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 5
7.1. Trade name(s), authorisation number and specific composition of each individual product
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>kodan&#174; wipes pure</p><p>sch&#252;lke&#174; classic wipes</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0023656-0005 1-5</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Propan-2-ol</p></td><td><p>&#160;</p></td><td><p>Active Substance</p></td><td><p>67-63-0</p></td><td><p>200-661-7</p></td><td><p>63,1</p></td></tr></tbody></table>
META SPC 6
1. META SPC 6 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 6 identifier
<table><col/><col/><tbody><tr><td><p>Identifier</p></td><td><p>meta SPC 6 kodan wipes IPA</p></td></tr></tbody></table>
1.2. Suffix to the authorisation number
<table><col/><col/><tbody><tr><td><p>Number</p></td><td><p>1-6</p></td></tr></tbody></table>
1.3. Product type(s)
<table><col/><col/><tbody><tr><td><p>Product type(s)</p></td><td><p>PT04 - Food and feed area (Disinfectants)</p><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p></td></tr></tbody></table>
2. META SPC 6 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 6
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Min</p></td><td><p>Max</p></td></tr><tr><td><p>Propan-2-ol</p></td><td><p>&#160;</p></td><td><p>Active Substance</p></td><td><p>67-63-0</p></td><td><p>200-661-7</p></td><td><p>63,1</p></td><td><p>63,1</p></td></tr></tbody></table>
2.2. Type(s) of formulation of the meta SPC 6
<table><col/><col/><tbody><tr><td><p>Formulation(s)</p></td><td><p>Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation</p></td></tr></tbody></table>
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6
<table><col/><col/><tbody><tr><td><p>Hazard statements</p></td><td><p>Highly flammable liquid and vapour.</p><p>Causes serious eye irritation.</p><p>May cause drowsiness or dizziness.</p><p>Repeated exposure may cause skin dryness or cracking.</p></td></tr><tr><td><p>Precautionary statements</p></td><td><p>If medical advice is needed, have product container or label at hand.</p><p>Keep out of reach of children.</p><p>Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.</p><p>Keep container tightly closed.</p><p>Ground and bond container and receiving equipment.</p><p>Use explosion-proof electrical/ventilating/lighting equipment.</p><p>Use non-sparking tools.</p><p>Take action to prevent static discharges.</p><p>Avoid breathing vapours.</p><p>Avoid breathing spray.</p><p>Use only outdoors or in a well-ventilated area.</p><p>IF INHALED: Remove person to fresh air and keep comfortable for breathing.</p><p>IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.</p><p>Call a POISON CENTER or doctor if you feel unwell.</p><p>If eye irritation persists: Get medical advice.</p><p>If eye irritation persists: Get medical attention.</p><p>In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.</p><p>Store in a well-ventilated place. Keep cool.</p><p>Store locked up.</p><p>Dispose of contents /container to an approved waste disposal plant.</p></td></tr></tbody></table>
4. AUTHORISED USE(S) OF THE META SPC 6
4.1. Use description
Table 15. Use # 1 – Disinfection of surfaces - wiping
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: Bacteria including<span>Mycobacterium tuberculosis</span></p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Yeast</p><p>Common name: -</p><p>Development stage: -</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Wiping</p><p>Product will be wiped directly on the surface.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Ready-to-use wipes</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p><p>Professional</p><p>General public (non-professional)</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>Soft pack: 1-200 wipes</p><p>Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP</p><p>Pouch: 10-200 wipes</p><p>Packaging material: LDPE/PET</p><p>Tube: 50-200 wipes</p><p>Packaging material: HDPE</p><p>closure material is either PP, PE3385</p></td></tr></tbody></table>
4.1.1. 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).
4.1.2. 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 16. Use # 2 – Disinfection of surfaces with food and feed contact - wiping
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT04 - Food and feed area (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: Bacteria including<span>Mycobacterium tuberculosis</span></p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Yeast</p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Viruses</p><p>Common name: -</p><p>Development stage: -</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Wiping</p><p>Product will be wiped directly on the surface.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Ready-to-use wipes</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p><p>Professional</p><p>General public (non-professional)</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>Soft pack: 1-200 wipes</p><p>Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP</p><p>Pouch: 10-200 wipes</p><p>Packaging material: LDPE/PET</p><p>Tube: 50-200 wipes</p><p>Packaging material: HDPE</p><p>closure material is either PP, PE3385</p></td></tr></tbody></table>
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 ( 6 ) OF THE META SPC 6
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 the 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:
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>In case of accident: Call a poison centre or a doctor.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>IF INHALED: Remove person to fresh air and keep comfortable for breathing.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>If on skin: Wash with water. If skin irritation occurs: Get medical advice.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>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.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.</p></td></tr></tbody></table>
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/m 3 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 6
7.1. Trade name(s), authorisation number and specific composition of each individual product
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>sch&#252;lke Hygiene-T&#252;cher</p><p>SOS Desinfizierende Feuchtt&#252;cher</p><p>SOS Hygiene-T&#252;cher</p><p>kodan&#174; clean comfort wipes</p><p>sch&#252;lke clean comfort wipes</p><p>Hygiene-T&#252;cher</p><p>Desinfizierende Feuchtt&#252;cher</p><p>Desinfektionst&#252;cher</p><p>clean comfort wipes</p><p>disinfecting wipes</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0023656-0006 1-6</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Propan-2-ol</p></td><td><p>&#160;</p></td><td><p>Active Substance</p></td><td><p>67-63-0</p></td><td><p>200-661-7</p></td><td><p>63,1</p></td></tr></tbody></table>
META SPC 7
1. META SPC 7 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 7 identifier
<table><col/><col/><tbody><tr><td><p>Identifier</p></td><td><p>meta SPC 7 AntiLy SD</p></td></tr></tbody></table>
1.2. Suffix to the authorisation number
<table><col/><col/><tbody><tr><td><p>Number</p></td><td><p>1-7</p></td></tr></tbody></table>
1.3. Product type(s)
<table><col/><col/><tbody><tr><td><p>Product type(s)</p></td><td><p>PT04 - Food and feed area (Disinfectants)</p><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p></td></tr></tbody></table>
2. META SPC 7 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 7
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Min</p></td><td><p>Max</p></td></tr><tr><td><p>Propan-2-ol</p></td><td><p>&#160;</p></td><td><p>Active Substance</p></td><td><p>67-63-0</p></td><td><p>200-661-7</p></td><td><p>63,1</p></td><td><p>63,1</p></td></tr></tbody></table>
2.2. Type(s) of formulation of the meta SPC 7
<table><col/><col/><tbody><tr><td><p>Formulation(s)</p></td><td><p>Any other liquid (AL), ready-to-use</p></td></tr></tbody></table>
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7
<table><col/><col/><tbody><tr><td><p>Hazard statements</p></td><td><p>Highly flammable liquid and vapour.</p><p>Causes serious eye irritation.</p><p>May cause drowsiness or dizziness.</p><p>Repeated exposure may cause skin dryness or cracking.</p></td></tr><tr><td><p>Precautionary statements</p></td><td><p>Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.</p><p>Keep container tightly closed.</p><p>Ground and bond container and receiving equipment.</p><p>Use explosion-proof electrical/ventilating/lighting equipment.</p><p>Use non-sparking tools.</p><p>Take action to prevent static discharges.</p><p>Avoid breathing vapours.</p><p>Avoid breathing spray.</p><p>Use only outdoors or in a well-ventilated area.</p><p>Wear eye protection.</p><p>IF IN EYES: Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.</p><p>Call a POISON CENTER or doctor if you feel unwell.</p><p>If eye irritation persists: Get medical advice.</p><p>If eye irritation persists: Get medical attention.</p><p>In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.</p><p>Store in a well-ventilated place. Keep cool.</p><p>Store locked up.</p><p>Dispose of contents /container to an approved waste disposal plant.</p></td></tr></tbody></table>
4. AUTHORISED USE(S) OF THE META SPC 7
4.1. Use description
Table 17. Use # 1 – Disinfection of surfaces - spraying
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: Bacteria</p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Yeast</p><p>Common name: -</p><p>Development stage: -</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Spraying</p><p>Product will be sprayed directly on the surface.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Ready-to-use. Do not apply more than 25 ml/m<span>2</span>.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>Bottle: 125-1000 ml</p><p>packaging material: HDPE</p><p>Clack cap material: PP; Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel); Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)</p></td></tr></tbody></table>
4.1.1. Use-specific instructions for use
Spray ready-to-use product onto the surfaces and allow to take effect for at least 1 minute at room temperature(20±2 °C).
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 18. Use # 2 – Disinfection of surfaces - wiping
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: Bacteria</p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Yeast</p><p>Common name: -</p><p>Development stage: -</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Wiping</p><p>Product is applied on wipes by pouring, spraying or soaking and the surface is thoroughly wiped with the soaked wipe afterwards (wet-wiping).</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Ready-to-use. Do not apply more than 25 ml/m<span>2</span>.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>Bottle: 125-1000 ml</p><p>packaging material: HDPE</p><p>Clack cap material: PP</p><p>Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel);</p><p>Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)</p><p>Canister: 5-30 L</p><p>packaging material: HDPE</p><p>closure material: HDPE</p></td></tr></tbody></table>
4.2.1. Use-specific instructions for use
Apply the ready-to-use product on wipes by pouring, spraying or soaking and wipe the surface thoroughly with the wet wipe (wet-wiping). Allow to take effect for at least 5 minutes at room temperature (20±2 °C).
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 19. Use # 3 – Disinfection of surfaces with food and feed contact - spraying
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT04 - Food and feed area (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: Bacteria</p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Yeast</p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Viruses</p><p>Common name: -</p><p>Development stage: -</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Spraying</p><p>Product will be sprayed directly on the surface.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Ready-to-use. Do not apply more than 25 ml/m<span>2</span>.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>Bottle: 125-1000 ml</p><p>packaging material: HDPE</p><p>Clack cap material: PP</p><p>Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)</p><p>Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)</p></td></tr></tbody></table>
4.3.1. Use-specific instructions for use
Spray ready-to-use product onto 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 20. Use # 4 – Disinfection of surfaces with food and feed contact - wiping
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT04 - Food and feed area (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: Bacteria</p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Yeast</p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Viruses</p><p>Common name: -</p><p>Development stage: -</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Wiping</p><p>Product is applied on wipes by pouring, spraying or soaking and the surface is thoroughly wiped with the soaked wipe afterwards (wet-wiping).</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Ready-to-use. Do not apply more than 25 ml/m<span>2</span>.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>Bottle: 125-1000 ml</p><p>packaging material: HDPE</p><p>Clack cap material: PP</p><p>Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)</p><p>Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)</p><p>Canister: 5-30 L</p><p>packaging material: HDPE</p><p>closure material: HDPE</p></td></tr></tbody></table>
4.4.1. Use-specific instructions for use
Apply the ready-to-use product on wipes by pouring, spraying or soaking and wipe the surface thoroughly with the wet wipe (wet-wiping). 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 ( 7 ) OF THE META SPC 7
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/m 2 .
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:
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>In case of accident: Call a poison centre or a doctor.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>IF INHALED: Remove person to fresh air and keep comfortable for breathing.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>If on skin: Wash with water. If skin irritation occurs: Get medical advice.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>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.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.</p></td></tr></tbody></table>
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/m 3 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 7
7.1. Trade name(s), authorisation number and specific composition of each individual product
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>AntiLy 5</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0023656-0007 1-7</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Propan-2-ol</p></td><td><p>&#160;</p></td><td><p>Active Substance</p></td><td><p>67-63-0</p></td><td><p>200-661-7</p></td><td><p>63,1</p></td></tr></tbody></table>
7.2. Trade name(s), authorisation number and specific composition of each individual product
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>AntiLy 6</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0023656-0008 1-7</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Propan-2-ol</p></td><td><p>&#160;</p></td><td><p>Active Substance</p></td><td><p>67-63-0</p></td><td><p>200-661-7</p></td><td><p>63,1</p></td></tr></tbody></table>
META SPC 8
1. META SPC 8 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 8 identifier
<table><col/><col/><tbody><tr><td><p>Identifier</p></td><td><p>meta SPC 8 AntiLy SD wipes</p></td></tr></tbody></table>
1.2. Suffix to the authorisation number
<table><col/><col/><tbody><tr><td><p>Number</p></td><td><p>1-8</p></td></tr></tbody></table>
1.3. Product type(s)
<table><col/><col/><tbody><tr><td><p>Product type(s)</p></td><td><p>PT04 - Food and feed area (Disinfectants)</p><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p></td></tr></tbody></table>
2. META SPC 8 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 8
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Min</p></td><td><p>Max</p></td></tr><tr><td><p>Propan-2-ol</p></td><td><p>&#160;</p></td><td><p>Active Substance</p></td><td><p>67-63-0</p></td><td><p>200-661-7</p></td><td><p>63,1</p></td><td><p>63,1</p></td></tr></tbody></table>
2.2. Type(s) of formulation of the meta SPC 8
<table><col/><col/><tbody><tr><td><p>Formulation(s)</p></td><td><p>Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation</p></td></tr></tbody></table>
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8
<table><col/><col/><tbody><tr><td><p>Hazard statements</p></td><td><p>Highly flammable liquid and vapour.</p><p>Causes serious eye irritation.</p><p>May cause drowsiness or dizziness.</p><p>Repeated exposure may cause skin dryness or cracking.</p></td></tr><tr><td><p>Precautionary statements</p></td><td><p>Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.</p><p>Keep container tightly closed.</p><p>Ground and bond container and receiving equipment.</p><p>Use explosion-proof electrical/ventilating/lighting equipment.</p><p>Use non-sparking tools.</p><p>Take action to prevent static discharges.</p><p>Avoid breathing vapours.</p><p>Avoid breathing spray.</p><p>Use only outdoors or in a well-ventilated area.</p><p>Wear eye protection.</p><p>IF IN EYES: Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.</p><p>Call a POISON CENTER or doctor if you feel unwell.</p><p>If eye irritation persists: Get medical advice.</p><p>If eye irritation persists: Get medical attention.</p><p>In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.</p><p>Store in a well-ventilated place. Keep cool.</p><p>Store locked up.</p><p>Dispose of contents /container to an approved waste disposal plant.</p></td></tr></tbody></table>
4. AUTHORISED USE(S) OF THE META SPC 8
4.1. Use description
Table 21. Use # 1 – Disinfection of surfaces - wiping
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: Bacteria</p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Yeast</p><p>Common name: -</p><p>Development stage: -</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Wiping</p><p>Product will be wiped directly on the surface.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Ready-to-use wipes</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>Can: 100-150 wipes</p><p>Packaging: HDPE</p><p>Closure material: HDPE</p><p>Pack: 100-150 wipes</p><p>Packaging: PET/PE</p></td></tr></tbody></table>
4.1.1. 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).
4.1.2. 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 22. Use # 2 – Disinfection of surfaces with food and feed contact - wiping
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT04 - Food and feed area (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: Bacteria</p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Yeast</p><p>Common name: -</p><p>Development stage: -</p><p>Scientific name: Viruses</p><p>Common name: -</p><p>Development stage: -</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Wiping</p><p>Product will be wiped directly on the surface.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Ready-to-use wipes</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>Can: 100-150 wipes</p><p>Packaging: HDPE</p><p>Closure material: HDPE</p><p>Pack: 100-150 wipes</p><p>Packaging: PET/PE</p></td></tr></tbody></table>
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 ( 8 ) OF THE META SPC 8
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:
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>In case of accident: Call a poison centre or a doctor.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>IF INHALED: Remove person to fresh air and keep comfortable for breathing.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>If on skin: Wash with water. If skin irritation occurs: Get medical advice.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>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.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.</p></td></tr></tbody></table>
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/m 3 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 8
7.1. Trade name(s), authorisation number and specific composition of each individual product
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>AntiLy 5 wipes</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0023656-0009 1-8</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Propan-2-ol</p></td><td><p>&#160;</p></td><td><p>Active Substance</p></td><td><p>67-63-0</p></td><td><p>200-661-7</p></td><td><p>63,1</p></td></tr></tbody></table>
7.2. Trade name(s), authorisation number and specific composition of each individual product
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>AntiLy 6 wipes</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0023656-0010 1-8</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Propan-2-ol</p></td><td><p>&#160;</p></td><td><p>Active Substance</p></td><td><p>67-63-0</p></td><td><p>200-661-7</p></td><td><p>63,1</p></td></tr></tbody></table>
<note>
( 1 ) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.
( 2 ) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.
( 3 ) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.
( 4 ) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4.
( 5 ) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 5.
( 6 ) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 6.
( 7 ) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 7.
( 8 ) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 8.
</note>