# L_2021216EN.01006501.xml

| 18.6.2021 | EN | Official Journal of the European Union | L 216/65 |
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18.6.2021

EN

Official Journal of the European Union

L 216/65

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COMMISSION IMPLEMENTING REGULATION (EU) 2021/978

of 10 June 2021

granting a Union authorisation for the biocidal product family “Lyso IPA Surface Disinfection”

(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 the first subparagraph of Article 44(5) thereof,

Whereas:

| (1) | On 22 June 2016, Schuelke & Mayr GmbH submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for authorisation of the same biocidal product family, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named “Lyso IPA Surface Disinfection”, of product-types 2 and 4, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-GX025200-35 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference product family “perform-IPA”, recorded in the Register under case number BC-AB023095-72. |
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(1)

On 22 June 2016, Schuelke & Mayr GmbH submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for authorisation of the same biocidal product family, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named “Lyso IPA Surface Disinfection”, of product-types 2 and 4, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-GX025200-35 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference product family “perform-IPA”, recorded in the Register under case number BC-AB023095-72.

| (2) | The same biocidal product family “Lyso IPA Surface Disinfection” 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. |
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(2)

The same biocidal product family “Lyso IPA Surface Disinfection” 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.

| (3) | On 12 May 2020, the Agency submitted to the Commission an opinion (3) and the draft summary of the biocidal product characteristics (‘SPC’) of “Lyso IPA Surface Disinfection” in accordance with Article 6(1) and (2) of Implementing Regulation (EU) No 414/2013. |
| --- | --- |

(3)

On 12 May 2020, the Agency submitted to the Commission an opinion (3) and the draft summary of the biocidal product characteristics (‘SPC’) of “Lyso IPA Surface Disinfection” in accordance with Article 6(1) and (2) of Implementing Regulation (EU) No 414/2013.

| (4) | The opinion concludes that “Lyso IPA Surface Disinfection” is a biocidal product family within the meaning of Article 3(1)(s) of Regulation (EU) No 528/2012, that the proposed differences between the same biocidal product family and the related reference biocidal product family are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 (4), that “Lyso IPA Surface Disinfection” is eligible for Union authorisation in accordance with Article 42(1) of Regulation (EU) No 528/2012, and that based on the assessment of the related reference “perform-IPA” product family and subject to compliance with the draft SPC, the same biocidal product family meets the conditions laid down in Article 19(1) and (6) of Regulation (EU) No 528/2012. |
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(4)

The opinion concludes that “Lyso IPA Surface Disinfection” is a biocidal product family within the meaning of Article 3(1)(s) of Regulation (EU) No 528/2012, that the proposed differences between the same biocidal product family and the related reference biocidal product family are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 (4), that “Lyso IPA Surface Disinfection” is eligible for Union authorisation in accordance with Article 42(1) of Regulation (EU) No 528/2012, and that based on the assessment of the related reference “perform-IPA” product family and subject to compliance with the draft SPC, the same biocidal product family meets the conditions laid down in Article 19(1) and (6) of Regulation (EU) No 528/2012.

| (5) | On 6 November 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. |
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(5)

On 6 November 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.

| (6) | The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same biocidal product family “Lyso IPA Surface Disinfection”. |
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(6)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same biocidal product family “Lyso IPA Surface Disinfection”.

| (7) | The same biocidal product family “Lyso IPA Surface Disinfection” contains the non-active substance diethyl phthalate, for which 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 (5) within the period for the evaluation of the application for the related reference biocidal product family. 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 “Lyso IPA Surface Disinfection” in accordance with Article 48 of Regulation (EU) No 528/2012. |
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(7)

The same biocidal product family “Lyso IPA Surface Disinfection” contains the non-active substance diethyl phthalate, for which 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 (5) within the period for the evaluation of the application for the related reference biocidal product family. 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 “Lyso IPA Surface Disinfection” in accordance with Article 48 of Regulation (EU) No 528/2012.

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
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(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation with authorisation number EU-0023860-0000 is granted to Schuelke & Mayr GmbH for the making available on the market and use of the same biocidal product family “Lyso IPA Surface Disinfection” in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 8 July 2021 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, 10 June 2021.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 167, 27.6.2012, p. 1.

1

(2)  Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4).

2

(3)  ECHA opinion of 11 May 2020 on the Union authorisation of the same biocidal product family “Lyso IPA Surface Disinfection”, https://echa.europa.eu/en/opinions-on-union-authorisation

3

(4)  Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4).

4

(5)  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).

5

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ANNEX

Summary of product characteristics for a biocidal product family

Lyso IPA Surface Disinfection

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-0023860-0000

R4BP asset number: EU-0023860-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

| Name | Lyso IPA Surface Disinfection |
| --- | --- |

Name

Lyso IPA Surface Disinfection

1.2.   Product type(s)

| Product type(s) | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 – Food and feed area (Disinfectants)

1.3.   Authorisation holder

| Name and address of the authorisation holder | Name | Schülke & Mayr GmbH |
| --- | --- | --- |
| Address | Robert-Koch-Str. 2, 22851, Norderstedt, Germany |
| Authorisation number | EU-0023860-0000 |
| R4BP asset number | EU-0023860-0000 |
| Date of the authorisation | 8 July 2021 |
| Expiry date of the authorisation | 30 November 2030 |

Name and address of the authorisation holder

Name

Schülke & Mayr GmbH

Address

Robert-Koch-Str. 2, 22851, Norderstedt, Germany

Authorisation number

EU-0023860-0000

R4BP asset number

EU-0023860-0000

Date of the authorisation

8 July 2021

Expiry date of the authorisation

30 November 2030

1.4.   Manufacturer(s) of the biocidal products

| Name of manufacturer | Schülke & Mayr GmbH |
| --- | --- |
| Address of manufacturer | Robert-Koch-Str. 2, 22851 Norderstedt Germany |
| Location of manufacturing sites | Robert-Koch-Str. 2, 22851 Norderstedt Germany |

Name of manufacturer

Schülke & Mayr GmbH

Address of manufacturer

Robert-Koch-Str. 2, 22851 Norderstedt Germany

Location of manufacturing sites

Robert-Koch-Str. 2, 22851 Norderstedt Germany

| Name of manufacturer | BOCHEMIE a.s. |
| --- | --- |
| Address of manufacturer | Lidická 326, 735 95 Bohumín Czech Republic |
| Location of manufacturing sites | Lidická 326, 735 95 Bohumín Czech Republic |

Name of manufacturer

BOCHEMIE a.s.

Address of manufacturer

Lidická 326, 735 95 Bohumín Czech Republic

Location of manufacturing sites

Lidická 326, 735 95 Bohumín Czech Republic

| Name of manufacturer | Imeco |
| --- | --- |
| Address of manufacturer | Boschstr. 5, 63768 Hösbach Germany |
| Location of manufacturing sites | Boschstr. 5, 63768 Hösbach Germany
  Neue Straße 2-4, 09471 Köningswalde Germany |

Name of manufacturer

Imeco

Address of manufacturer

Boschstr. 5, 63768 Hösbach Germany

Location of manufacturing sites

Boschstr. 5, 63768 Hösbach Germany

Neue Straße 2-4, 09471 Köningswalde Germany

| Name of manufacturer | Tristel Solutions Limited |
| --- | --- |
| Address of manufacturer | Lynx Business Park, Fordham Road, Snailwell, CB8 7NY Cambridgeshire United Kingdom |
| Location of manufacturing sites | Lynx Business Park, Fordham Road, Snailwell, CB8 7NY Cambridgeshire United Kingdom |

Name of manufacturer

Tristel Solutions Limited

Address of manufacturer

Lynx Business Park, Fordham Road, Snailwell, CB8 7NY Cambridgeshire United Kingdom

Location of manufacturing sites

Lynx Business Park, Fordham Road, Snailwell, CB8 7NY Cambridgeshire United Kingdom

| Name of manufacturer | Techtex |
| --- | --- |
| Address of manufacturer | Units 7&8 Rhodes Bus. Park Silburn Way, M24 4NE Middleton United Kingdom |
| Location of manufacturing sites | Units 7&8 Rhodes Bus. Park Silburn Way, M24 4NE Middleton United Kingdom |

Name of manufacturer

Techtex

Address of manufacturer

Units 7&8 Rhodes Bus. Park Silburn Way, M24 4NE Middleton United Kingdom

Location of manufacturing sites

Units 7&8 Rhodes Bus. Park Silburn Way, M24 4NE Middleton United Kingdom

| Name of manufacturer | A.F.P. GmbH |
| --- | --- |
| Address of manufacturer | Otto Brenner Straße 16, 21337 Lüneburg Germany |
| Location of manufacturing sites | Otto Brenner Straße 16, 21337 Lüneburg Germany |

Name of manufacturer

A.F.P. GmbH

Address of manufacturer

Otto Brenner Straße 16, 21337 Lüneburg Germany

Location of manufacturing sites

Otto Brenner Straße 16, 21337 Lüneburg Germany

| Name of manufacturer | Innovate GmbH |
| --- | --- |
| Address of manufacturer | Am Hohen Stein 11, 06618 Naumbourg (Saale) Germany |
| Location of manufacturing sites | Am Hohen Stein 11, 06618 Naumbourg (Saale) Germany |

Name of manufacturer

Innovate GmbH

Address of manufacturer

Am Hohen Stein 11, 06618 Naumbourg (Saale) Germany

Location of manufacturing sites

Am Hohen Stein 11, 06618 Naumbourg (Saale) Germany

| Name of manufacturer | Lysoform Dr. Hans Rosemann GmbH |
| --- | --- |
| Address of manufacturer | Kaiser-Wilhelm-Straße 133, 12247 Berlin Germany |
| Location of manufacturing sites | Kaiser-Wilhelm-Straße 133, 12247 Berlin Germany |

Name of manufacturer

Lysoform Dr. Hans Rosemann GmbH

Address of manufacturer

Kaiser-Wilhelm-Straße 133, 12247 Berlin Germany

Location of manufacturing sites

Kaiser-Wilhelm-Straße 133, 12247 Berlin Germany

| Name of manufacturer | Sterisol AB |
| --- | --- |
| Address of manufacturer | Kronoängsgatan 3, 592 23 Vadstena Sweden |
| Location of manufacturing sites | Kronoängsgatan 3, 592 23 Vadstena Sweden |

Name of manufacturer

Sterisol AB

Address of manufacturer

Kronoängsgatan 3, 592 23 Vadstena Sweden

Location of manufacturing sites

Kronoängsgatan 3, 592 23 Vadstena Sweden

| Name of manufacturer | Rudolf Dankwardt GmbH |
| --- | --- |
| Address of manufacturer | Gutenbergring 50-52, 22848 Norderstedt Germany |
| Location of manufacturing sites | Gutenbergring 50-52, 22848 Norderstedt Germany
  Lagerstr. 15, 19249 Jessenitz - Werk/Lübtheen Germany |

Name of manufacturer

Rudolf Dankwardt GmbH

Address of manufacturer

Gutenbergring 50-52, 22848 Norderstedt Germany

Location of manufacturing sites

Gutenbergring 50-52, 22848 Norderstedt Germany

Lagerstr. 15, 19249 Jessenitz - Werk/Lübtheen Germany

1.5.   Manufacturer(s) of the active substance(s)

| Active substance | Propan-2-ol |
| --- | --- |
| Name of manufacturer | Ineos Solvents Germany GmbH (formerly Sasol) |
| Address of manufacturer | Römerstraße 733, 47443 Moers Germany |
| Location of manufacturing sites | Römerstraße 733, 47443 Moers Germany
  Shamrockstr. 88, 44643 Herne Germany |

Active substance

Propan-2-ol

Name of manufacturer

Ineos Solvents Germany GmbH (formerly Sasol)

Address of manufacturer

Römerstraße 733, 47443 Moers Germany

Location of manufacturing sites

Römerstraße 733, 47443 Moers Germany

Shamrockstr. 88, 44643 Herne Germany

| Active substance | Propan-2-ol |
| --- | --- |
| Name of manufacturer | Shell Chemicals Europe B.V. |
| Address of manufacturer | Postbus 2334, 3000 CH Rotterdam Netherlands |
| Location of manufacturing sites | Shell Nederland Raffinaderij B.V., Vondelingenweg 601, 3196 KK Rotterdam-Pernis Netherlands |

Active substance

Propan-2-ol

Name of manufacturer

Shell Chemicals Europe B.V.

Address of manufacturer

Postbus 2334, 3000 CH Rotterdam Netherlands

Location of manufacturing sites

Shell Nederland Raffinaderij B.V., Vondelingenweg 601, 3196 KK Rotterdam-Pernis Netherlands

2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the family

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,1 | 63,1 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,1

63,1

2.2.   Type(s) of formulation

| Formulation(s) | Any other liquid (AL), ready-to-use
  Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation |
| --- | --- |

Formulation(s)

Any other liquid (AL), ready-to-use

Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation

PART II

SECOND INFORMATION LEVEL – META SPC(S)

META SPC 1

1.   META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier

| Identifier | meta-SPC1 |
| --- | --- |

Identifier

meta-SPC1

1.2.   Suffix to the authorisation number

| Number | 1-1 |
| --- | --- |

Number

1-1

1.3.   Product type(s)

| Product type(s) | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 – Food and feed area (Disinfectants)

2.   META SPC 1 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 1

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,1 | 63,1 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,1

63,1

2.2.   Type(s) of formulation of the meta SPC 1

| Formulation(s) | Any other liquid (AL), ready-to-use |
| --- | --- |

Formulation(s)

Any other liquid (AL), ready-to-use

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

| Hazard statements | Highly flammable liquid and vapour.
  Causes serious eye irritation.
  May cause drowsiness or dizziness.
  Repeated exposure may cause skin dryness or cracking. |
| --- | --- |
| Precautionary statements | Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
  Keep container tightly closed.
  Ground and bond container and receiving equipment.
  Use explosion-proof electrical/ventilating/lighting equipment.
  Use non-sparking tools.
  Take action to prevent static discharges.
  Avoid breathing vapours.
  Avoid breathing spray.
  Use only outdoors or in a well-ventilated area.
  Wear eye protection.
  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
  Call a POISON CENTER or doctor if you feel unwell.
  If eye irritation persists: Get medical advice.
  If eye irritation persists: Get medical attention.
  In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
  Store in a well-ventilated place. Keep cool.
  Store locked up.
  Dispose of contents/container to an approved waste disposal plant. |

Hazard statements

Highly flammable liquid and vapour.

Causes serious eye irritation.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

Keep container tightly closed.

Ground and bond container and receiving equipment.

Use explosion-proof electrical/ventilating/lighting equipment.

Use non-sparking tools.

Take action to prevent static discharges.

Avoid breathing vapours.

Avoid breathing spray.

Use only outdoors or in a well-ventilated area.

Wear eye protection.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

Call a POISON CENTER or doctor if you feel unwell.

If eye irritation persists: Get medical advice.

If eye irritation persists: Get medical attention.

In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.

Store in a well-ventilated place. Keep cool.

Store locked up.

Dispose of contents/container to an approved waste disposal plant.

4.   AUTHORISED USE(S) OF THE META SPC 1

4.1.   Use description

Table 1. Use # 1 – Disinfection of surfaces – spraying

| Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  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) |
| Application method(s) | Spraying
  Product will be sprayed directly on the surface |
| Application rate(s) and frequency | Ready-to-use. Do not apply more than 25 ml/m2.
  Disinfection after each production and cleaning process or when required according to standard operating procedure (SOP) |
| Category(ies) of users | Industrial
  Professional |
| Pack sizes and packaging material | Bottle: 250-1000 ml
  packaging material: high-density polyethylene (HDPE), surlyn/polypropylene (PP)
  closure material is either: PP, polyoxymethylene (POM), low-density polyethylene (LDPE), HDPE, polyethylene (PE), ethylene-vinyl acetate (EVA), stainless steel, polybutylene terephthalate (PBT), (LD)PE, exp. polytetrafluoroethylene (PTFE), linear low density polyethylene (LLDPE), expanded PE (EXPPE), Co Polymer PP
  canister: 5-10 L
  packaging material: HDPE.
  closure material is either: HDPE/LDPE
  Revolver BAG: 1 L
  packaging material: EVA
  closure material: PP/Silicone/EVA |

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Field(s) of use

Indoor

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)

Application method(s)

Spraying

Product will be sprayed directly on the surface

Application rate(s) and frequency

Ready-to-use. Do not apply more than 25 ml/m2.

Disinfection after each production and cleaning process or when required according to standard operating procedure (SOP)

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Bottle: 250-1000 ml

packaging material: high-density polyethylene (HDPE), surlyn/polypropylene (PP)

closure material is either: PP, polyoxymethylene (POM), low-density polyethylene (LDPE), HDPE, polyethylene (PE), ethylene-vinyl acetate (EVA), stainless steel, polybutylene terephthalate (PBT), (LD)PE, exp. polytetrafluoroethylene (PTFE), linear low density polyethylene (LLDPE), expanded PE (EXPPE), Co Polymer PP

canister: 5-10 L

packaging material: HDPE.

closure material is either: HDPE/LDPE

Revolver BAG: 1 L

packaging material: EVA

closure material: PP/Silicone/EVA

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

| Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  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) |
| Application method(s) | Wiping
  Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on the surface. |
| Application rate(s) and frequency | Ready-to-use. Do not apply more than 25 ml/m2.
  Disinfection after each production and cleaning process or when required according to SOP. |
| Category(ies) of users | Industrial
  Professional |
| Pack sizes and packaging material | Bottle: 250-1000 ml
  packaging material: HDPE, surlyn/PP
  closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP.
  canister: 5-10 L
  packaging material: HDPE.
  closure material is either: HDPE/LDPE
  Revolver BAG: 1 L
  packaging material: EVA
  closure material: PP/Silicone/EVA. |

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Field(s) of use

Indoor

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)

Application method(s)

Wiping

Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on the surface.

Application rate(s) and frequency

Ready-to-use. Do not apply more than 25 ml/m2.

Disinfection after each production and cleaning process or when required according to SOP.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Bottle: 250-1000 ml

packaging material: HDPE, surlyn/PP

closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP.

canister: 5-10 L

packaging material: HDPE.

closure material is either: HDPE/LDPE

Revolver BAG: 1 L

packaging material: EVA

closure material: PP/Silicone/EVA.

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

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: -
  Scientific name: Viruses
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B) |
| Application method(s) | Spraying
  Product will be sprayed directly on the surface. |
| Application rate(s) and frequency | Ready-to-use. Do not apply more than 25 ml/m2.
  Disinfection after each production and cleaning process or when required according to SOP. |
| Category(ies) of users | Industrial
  Professional |
| Pack sizes and packaging material | Bottle: 250-1000 ml
  packaging material: HDPE, surlyn/PP
  closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP.
  canister: 5-10 L
  packaging material: HDPE.
  closure material is either: HDPE/LDPE
  Revolver BAG: 1 L
  packaging material: EVA
  closure material: PP/Silicone/EVA. |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: Viruses

Common name: -

Development stage: -

Field(s) of use

Indoor

Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)

Application method(s)

Spraying

Product will be sprayed directly on the surface.

Application rate(s) and frequency

Ready-to-use. Do not apply more than 25 ml/m2.

Disinfection after each production and cleaning process or when required according to SOP.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Bottle: 250-1000 ml

packaging material: HDPE, surlyn/PP

closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP.

canister: 5-10 L

packaging material: HDPE.

closure material is either: HDPE/LDPE

Revolver BAG: 1 L

packaging material: EVA

closure material: PP/Silicone/EVA.

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 minute (bactericidal and yeasticidal activity) or 2 minutes (virucidal activity).

4.3.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.

4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

-

4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.4.   Use description

Table 4. Use # 4 – Disinfection of surfaces with food and feed contact – wiping

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: -
  Scientific name: Viruses
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B) |
| Application method(s) | Wiping
  Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on the surface. |
| Application rate(s) and frequency | Ready-to-use. Do not apply more than 25 ml/m2.
  Disinfection after each production and cleaning process or when required according to SOP. |
| Category(ies) of users | Industrial
  Professional |
| Pack sizes and packaging material | Bottle: 250-1000 ml
  packaging material: HDPE, surlyn/PP
  closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP.
  canister: 5-10 L
  packaging material: HDPE.
  closure material is either: HDPE/LDPE
  Revolver BAG: 1 L
  packaging material: EVA
  closure material: PP/Silicone/EVA. |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: Viruses

Common name: -

Development stage: -

Field(s) of use

Indoor

Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)

Application method(s)

Wiping

Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on the surface.

Application rate(s) and frequency

Ready-to-use. Do not apply more than 25 ml/m2.

Disinfection after each production and cleaning process or when required according to SOP.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Bottle: 250-1000 ml

packaging material: HDPE, surlyn/PP

closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP.

canister: 5-10 L

packaging material: HDPE.

closure material is either: HDPE/LDPE

Revolver BAG: 1 L

packaging material: EVA

closure material: PP/Silicone/EVA.

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/m2.

Make sure to wet surfaces completely.

Used wipes must be disposed in a closed container.

5.2.   Risk mitigation measures

The product must only be applied for disinfection of small surfaces.

Ensure adequate ventilation to prevent the formation of explosive atmospheres.

Avoid contact with eyes.

Apply a funnel for refilling.

Keep out of reach of children and pets.

Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid:

| | In case of accident: Call a poison centre or a doctor. |
| --- | --- |

In case of accident: Call a poison centre or a doctor.

| | IF INHALED: Remove person to fresh air and keep comfortable for breathing. |
| --- | --- |

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

| | If on skin: Wash with water. If skin irritation occurs: Get medical advice. |
| --- | --- |

If on skin: Wash with water. If skin irritation occurs: Get medical advice.

| | IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. |
| --- | --- |

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

| | IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell. |
| --- | --- |

IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.

5.4.   Instructions for safe disposal of the product and its packaging

-

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 36 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   OTHER INFORMATION

The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | Schülke® 6 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0023860-0001 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,1 |

Trade name(s)

Schülke® 6

Market area: EU

Authorisation number

EU-0023860-0001 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,1

META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

| Identifier | meta-SPC 2 |
| --- | --- |

Identifier

meta-SPC 2

1.2.   Suffix to the authorisation number

| Number | 1-2 |
| --- | --- |

Number

1-2

1.3.   Product type(s)

| Product type(s) | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 – Food and feed area (Disinfectants)

2.   META SPC 2 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 2

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,1 | 63,1 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,1

63,1

2.2.   Type(s) of formulation of the meta SPC 2

| Formulation(s) | Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation |
| --- | --- |

Formulation(s)

Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

| Hazard statements | Highly flammable liquid and vapour.
  Causes serious eye irritation.
  May cause drowsiness or dizziness.
  Repeated exposure may cause skin dryness or cracking. |
| --- | --- |
| Precautionary statements | Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
  Keep container tightly closed.
  Ground and bond container and receiving equipment.
  Use explosion-proof electrical/ventilating/lighting equipment.
  Use non-sparking tools.
  Take action to prevent static discharges.
  Avoid breathing vapours.
  Avoid breathing spray.
  Use only outdoors or in a well-ventilated area.
  Wear eye protection.
  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
  Call a POISON CENTER or doctor if you feel unwell.
  If eye irritation persists: Get medical advice.
  If eye irritation persists: Get medical attention.
  In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
  Store in a well-ventilated place. Keep cool.
  Store locked up.
  Dispose of contents/container to an approved waste disposal plant. |

Hazard statements

Highly flammable liquid and vapour.

Causes serious eye irritation.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

Keep container tightly closed.

Ground and bond container and receiving equipment.

Use explosion-proof electrical/ventilating/lighting equipment.

Use non-sparking tools.

Take action to prevent static discharges.

Avoid breathing vapours.

Avoid breathing spray.

Use only outdoors or in a well-ventilated area.

Wear eye protection.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

Call a POISON CENTER or doctor if you feel unwell.

If eye irritation persists: Get medical advice.

If eye irritation persists: Get medical attention.

In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.

Store in a well-ventilated place. Keep cool.

Store locked up.

Dispose of contents/container to an approved waste disposal plant.

4.   AUTHORISED USE(S) OF THE META SPC 2

4.1.   Use description

Table 5. Use # 1 – Disinfection of surfaces – wiping

| Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  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) |
| Application method(s) | Wiping
  Product will be wiped directly on the surface. |
| Application rate(s) and frequency | Ready-to-use wipes
  Disinfection after each production and cleaning process or when required according to SOP. |
| Category(ies) of users | Industrial
  Professional |
| Pack sizes and packaging material | Soft pack: 1-200 wipes
  Packaging material: LDPE/Alu/PET; LDPE/PET; biaxially oriented polypropylene (BOPP) + cast polypropylene (CPP)
  Pouch: 10-200 wipes
  Packaging material: LDPE/PET
  Tub: 50-200 wipes
  Packaging material: HDPE
  Closure material is either PP, PE3385 |

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Field(s) of use

Indoor

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)

Application method(s)

Wiping

Product will be wiped directly on the surface.

Application rate(s) and frequency

Ready-to-use wipes

Disinfection after each production and cleaning process or when required according to SOP.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Soft pack: 1-200 wipes

Packaging material: LDPE/Alu/PET; LDPE/PET; biaxially oriented polypropylene (BOPP) + cast polypropylene (CPP)

Pouch: 10-200 wipes

Packaging material: LDPE/PET

Tub: 50-200 wipes

Packaging material: HDPE

Closure material is either PP, PE3385

4.1.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect 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

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: -
  Scientific name: Viruses
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B) |
| Application method(s) | Wiping
  Product will be wiped directly on the surface. |
| Application rate(s) and frequency | Ready-to-use wipes
  Disinfection after each production and cleaning process or when required according to SOP. |
| Category(ies) of users | Industrial
  Professional |
| Pack sizes and packaging material | Soft pack: 1-200 wipes
  Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
  Pouch: 10-200 wipes
  Packaging material: LDPE/PET
  Tub: 50-200 wipes
  Packaging material: HDPE
  closure material is either PP, PE3385 |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: Viruses

Common name: -

Development stage: -

Field(s) of use

Indoor

Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)

Application method(s)

Wiping

Product will be wiped directly on the surface.

Application rate(s) and frequency

Ready-to-use wipes

Disinfection after each production and cleaning process or when required according to SOP.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Soft pack: 1-200 wipes

Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP

Pouch: 10-200 wipes

Packaging material: LDPE/PET

Tub: 50-200 wipes

Packaging material: HDPE

closure material is either PP, PE3385

4.2.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C).

4.2.2.   Use-specific risk mitigation measures

See general directions for use.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

-

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (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:

| | In case of accident: Call a poison centre or a doctor. |
| --- | --- |

In case of accident: Call a poison centre or a doctor.

| | IF INHALED: Remove person to fresh air and keep comfortable for breathing. |
| --- | --- |

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

| | If on skin: Wash with water. If skin irritation occurs: Get medical advice. |
| --- | --- |

If on skin: Wash with water. If skin irritation occurs: Get medical advice.

| | IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. |
| --- | --- |

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

| | IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell. |
| --- | --- |

IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.

5.4.   Instructions for safe disposal of the product and its packaging

-

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   OTHER INFORMATION

The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | Schülke® 7 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0023860-0002 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,1 |

Trade name(s)

Schülke® 7

Market area: EU

Authorisation number

EU-0023860-0002 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,1

META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier

| Identifier | meta-SPC 3 |
| --- | --- |

Identifier

meta-SPC 3

1.2.   Suffix to the authorisation number

| Number | 1-3 |
| --- | --- |

Number

1-3

1.3.   Product type(s)

| Product type(s) | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 – Food and feed area (Disinfectants)

2.   META SPC 3 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 3

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,1 | 63,1 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,1

63,1

2.2.   Type(s) of formulation of the meta SPC 3

| Formulation(s) | Any other liquid (AL), ready-to-use |
| --- | --- |

Formulation(s)

Any other liquid (AL), ready-to-use

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

| Hazard statements | Highly flammable liquid and vapour.
  Causes serious eye irritation.
  May cause drowsiness or dizziness.
  Repeated exposure may cause skin dryness or cracking. |
| --- | --- |
| Precautionary statements | Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
  Keep container tightly closed.
  Ground and bond container and receiving equipment.
  Use explosion-proof electrical/ventilating/lighting equipment.
  Use non-sparking tools.
  Take action to prevent static discharges.
  Avoid breathing vapours.
  Avoid breathing spray.
  Use only outdoors or in a well-ventilated area.
  Wear eye protection.
  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
  Call a POISON CENTER or doctor if you feel unwell.
  If eye irritation persists: Get medical advice.
  If eye irritation persists: Get medical attention.
  In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
  Store in a well-ventilated place. Keep cool.
  Store locked up.
  Dispose of contents/container to an approved waste disposal plant. |

Hazard statements

Highly flammable liquid and vapour.

Causes serious eye irritation.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

Keep container tightly closed.

Ground and bond container and receiving equipment.

Use explosion-proof electrical/ventilating/lighting equipment.

Use non-sparking tools.

Take action to prevent static discharges.

Avoid breathing vapours.

Avoid breathing spray.

Use only outdoors or in a well-ventilated area.

Wear eye protection.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

Call a POISON CENTER or doctor if you feel unwell.

If eye irritation persists: Get medical advice.

If eye irritation persists: Get medical attention.

In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.

Store in a well-ventilated place. Keep cool.

Store locked up.

Dispose of contents/container to an approved waste disposal plant.

4.   AUTHORISED USE(S) OF THE META SPC 3

4.1.   Use description

Table 7. Use # 1 – disinfection of surfaces – spraying

| Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria including Mycobacterium tuberculosis
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  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) |
| Application method(s) | Spraying
  Product will be sprayed directly on the surface |
| Application rate(s) and frequency | Ready-to-use. Do not apply more than 25 ml/m2.
  Disinfection when required according to SOP. |
| Category(ies) of users | Industrial
  Professional |
| Pack sizes and packaging material | Bottle: 250-1000 ml
  packaging material: HDPE, surlyn/PP
  closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP
  canister: 5-10 L
  packaging material: HDPE.
  closure material is either: HDPE/LDPE
  Revolver BAG: 1 L
  packaging material: EVA
  Closure: PP/Silicone/EVA |

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria including Mycobacterium tuberculosis

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Field(s) of use

Indoor

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)

Application method(s)

Spraying

Product will be sprayed directly on the surface

Application rate(s) and frequency

Ready-to-use. Do not apply more than 25 ml/m2.

Disinfection when required according to SOP.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Bottle: 250-1000 ml

packaging material: HDPE, surlyn/PP

closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP

canister: 5-10 L

packaging material: HDPE.

closure material is either: HDPE/LDPE

Revolver BAG: 1 L

packaging material: EVA

Closure: PP/Silicone/EVA

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

| Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria including Mycobacterium tuberculosis
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  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) |
| Application method(s) | Wiping
  Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on the surface. |
| Application rate(s) and frequency | Ready-to-use. Do not apply more than 25 ml/m2.
  Disinfection when required according to SOP. |
| Category(ies) of users | Industrial
  Professional |
| Pack sizes and packaging material | Bottle: 250-1000 ml
  packaging material: HDPE, surlyn/PP
  closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP
  canister: 5-10 L
  packaging material: HDPE.
  closure material is either: HDPE/LDPE
  Revolver BAG: 1 L
  packaging material: EVA
  Closure: PP/Silicone/EVA |

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria including Mycobacterium tuberculosis

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Field(s) of use

Indoor

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)

Application method(s)

Wiping

Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on the surface.

Application rate(s) and frequency

Ready-to-use. Do not apply more than 25 ml/m2.

Disinfection when required according to SOP.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Bottle: 250-1000 ml

packaging material: HDPE, surlyn/PP

closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP

canister: 5-10 L

packaging material: HDPE.

closure material is either: HDPE/LDPE

Revolver BAG: 1 L

packaging material: EVA

Closure: PP/Silicone/EVA

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 9. Use # 3 – Disinfection of surfaces with food and feed contact – spraying

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria including Mycobacterium tuberculosis
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: -
  Scientific name: Viruses
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B) |
| Application method(s) | Spraying
  Product will be sprayed directly on the surface. |
| Application rate(s) and frequency | Ready-to-use. Do not apply more than 25 ml/m2.
  Disinfection when required according to SOP. |
| Category(ies) of users | Industrial
  Professional |
| Pack sizes and packaging material | Bottle: 250-1000 ml
  packaging material: HDPE, surlyn/PP
  closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP
  canister: 5-10 L
  packaging material: HDPE.
  closure material is either: HDPE/LDPE
  Revolver BAG: 1 L
  packaging material: EVA
  Closure: PP/Silicone/EVA |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria including Mycobacterium tuberculosis

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: Viruses

Common name: -

Development stage: -

Field(s) of use

Indoor

Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)

Application method(s)

Spraying

Product will be sprayed directly on the surface.

Application rate(s) and frequency

Ready-to-use. Do not apply more than 25 ml/m2.

Disinfection when required according to SOP.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Bottle: 250-1000 ml

packaging material: HDPE, surlyn/PP

closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP

canister: 5-10 L

packaging material: HDPE.

closure material is either: HDPE/LDPE

Revolver BAG: 1 L

packaging material: EVA

Closure: PP/Silicone/EVA

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 minute (bactericidal and yeasticidal activity) or 2 minutes (virucidal activity).

4.3.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures:

Wear eye protection during handling of the product.

4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

-

4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use

4.4.   Use description

Table 10. Use # 4 – Disinfection of surfaces with food and feed contact – wiping

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria including Mycobacterium tuberculosis
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: -
  Scientific name: Viruses
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B) |
| Application method(s) | Wiping
  Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on surface. |
| Application rate(s) and frequency | Ready-to-use. Do not apply more than 25 ml/m2.
  Disinfection when required according to SOP. |
| Category(ies) of users | Industrial
  Professional |
| Pack sizes and packaging material | Bottle: 250-1000 ml
  packaging material: HDPE, surlyn/PP
  closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP
  canister: 5-10 L
  packaging material: HDPE.
  closure material is either: HDPE/LDPE
  Revolver BAG: 1 L
  packaging material: EVA
  Closure: PP/Silicone/EVA |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria including Mycobacterium tuberculosis

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: Viruses

Common name: -

Development stage: -

Field(s) of use

Indoor

Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)

Application method(s)

Wiping

Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on surface.

Application rate(s) and frequency

Ready-to-use. Do not apply more than 25 ml/m2.

Disinfection when required according to SOP.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Bottle: 250-1000 ml

packaging material: HDPE, surlyn/PP

closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP

canister: 5-10 L

packaging material: HDPE.

closure material is either: HDPE/LDPE

Revolver BAG: 1 L

packaging material: EVA

Closure: PP/Silicone/EVA

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/m2.

Make sure to wet surfaces completely.

Used wipes must be disposed in a closed container.

5.2.   Risk mitigation measures

The product must only be applied for disinfection of small surfaces.

Ensure adequate ventilation to prevent the formation of explosive atmospheres.

Avoid contact with eyes.

Apply a funnel for refilling.

Keep out of reach of children and pets.

Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid:

| | In case of accident: Call a poison centre or a doctor. |
| --- | --- |

In case of accident: Call a poison centre or a doctor.

| | IF INHALED: Remove person to fresh air and keep comfortable for breathing. |
| --- | --- |

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

| | If on skin: Wash with water. If skin irritation occurs: Get medical advice. |
| --- | --- |

If on skin: Wash with water. If skin irritation occurs: Get medical advice.

| | IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. |
| --- | --- |

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

| | IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell. |
| --- | --- |

IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.

5.4.   Instructions for safe disposal of the product and its packaging

-

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 36 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   OTHER INFORMATION

The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | Schülke® 8 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0023860-0003 1-3 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,1 |

Trade name(s)

Schülke® 8

Market area: EU

Authorisation number

EU-0023860-0003 1-3

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,1

META SPC 4

1.   META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier

| Identifier | meta-SPC 4 |
| --- | --- |

Identifier

meta-SPC 4

1.2.   Suffix to the authorisation number

| Number | 1-4 |
| --- | --- |

Number

1-4

1.3.   Product type(s)

| Product type(s) | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 – Food and feed area (Disinfectants)

2.   META SPC 4 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 4

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,1 | 63,1 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,1

63,1

2.2.   Type(s) of formulation of the meta SPC 4

| Formulation(s) | Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation |
| --- | --- |

Formulation(s)

Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

| Hazard statements | Highly flammable liquid and vapour.
  Causes serious eye irritation.
  May cause drowsiness or dizziness.
  Repeated exposure may cause skin dryness or cracking. |
| --- | --- |
| Precautionary statements | Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
  Keep container tightly closed.
  Ground and bond container and receiving equipment.
  Use explosion-proof electrical/ventilating/lighting equipment.
  Use non-sparking tools.
  Take action to prevent static discharges.
  Avoid breathing vapours.
  Avoid breathing spray.
  Use only outdoors or in a well-ventilated area.
  Wear eye protection.
  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
  Call a POISON CENTER or doctor if you feel unwell.
  If eye irritation persists: Get medical advice.
  If eye irritation persists: Get medical attention.
  In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
  Store in a well-ventilated place. Keep cool.
  Store locked up.
  Dispose of contents/container to an approved waste disposal plant. |

Hazard statements

Highly flammable liquid and vapour.

Causes serious eye irritation.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

Keep container tightly closed.

Ground and bond container and receiving equipment.

Use explosion-proof electrical/ventilating/lighting equipment.

Use non-sparking tools.

Take action to prevent static discharges.

Avoid breathing vapours.

Avoid breathing spray.

Use only outdoors or in a well-ventilated area.

Wear eye protection.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

Call a POISON CENTER or doctor if you feel unwell.

If eye irritation persists: Get medical advice.

If eye irritation persists: Get medical attention.

In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.

Store in a well-ventilated place. Keep cool.

Store locked up.

Dispose of contents/container to an approved waste disposal plant.

4.   AUTHORISED USE(S) OF THE META SPC 4

4.1.   Use description

Table 11. Use # 1 – disinfection of surfaces – wiping

| Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria including Mycobacterium tuberculosis
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  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) |
| Application method(s) | Wiping
  Product will be wiped directly on the surface. |
| Application rate(s) and frequency | Ready-to-use wipes – -
  Disinfection when required according to SOP. |
| Category(ies) of users | Industrial
  Professional |
| Pack sizes and packaging material | Soft pack: 1-200 wipes
  Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
  Pouch: 10-200 wipes
  Packaging material: LDPE/PET
  Tub: 50-200 wipes
  Packaging material: HDPE
  closure material is either PP, PE3385 |

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria including Mycobacterium tuberculosis

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Field(s) of use

Indoor

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)

Application method(s)

Wiping

Product will be wiped directly on the surface.

Application rate(s) and frequency

Ready-to-use wipes – -

Disinfection when required according to SOP.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Soft pack: 1-200 wipes

Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP

Pouch: 10-200 wipes

Packaging material: LDPE/PET

Tub: 50-200 wipes

Packaging material: HDPE

closure material is either PP, PE3385

4.1.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect 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

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria incl. Mycobacterium tuberculosis
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: -
  Scientific name: Viruses
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B) |
| Application method(s) | Wiping
  Product will be wiped directly on the surface. |
| Application rate(s) and frequency | Ready-to-use wipes
  Disinfection when required according to SOP. |
| Category(ies) of users | Industrial
  Professional |
| Pack sizes and packaging material | Soft pack: 1-200 wipes
  Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
  Pouch: 10-200 wipes
  Packaging material: LDPE/PET
  Tub: 50-200 wipes
  Packaging material: HDPE
  closure material is either PP, PE3385 |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria incl. Mycobacterium tuberculosis

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: Viruses

Common name: -

Development stage: -

Field(s) of use

Indoor

Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)

Application method(s)

Wiping

Product will be wiped directly on the surface.

Application rate(s) and frequency

Ready-to-use wipes

Disinfection when required according to SOP.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Soft pack: 1-200 wipes

Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP

Pouch: 10-200 wipes

Packaging material: LDPE/PET

Tub: 50-200 wipes

Packaging material: HDPE

closure material is either PP, PE3385

4.2.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C).

4.2.2.   Use-specific risk mitigation measures

See general directions for use.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

-

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (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:

| | In case of accident: Call a poison centre or a doctor. |
| --- | --- |

In case of accident: Call a poison centre or a doctor.

| | IF INHALED: Remove person to fresh air and keep comfortable for breathing. |
| --- | --- |

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

| | If on skin: Wash with water. If skin irritation occurs: Get medical advice. |
| --- | --- |

If on skin: Wash with water. If skin irritation occurs: Get medical advice.

| | IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. |
| --- | --- |

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

| | IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell. |
| --- | --- |

IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.

5.4.   Instructions for safe disposal of the product and its packaging

-

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   OTHER INFORMATION

The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | Schülke® 9 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0023860-0004 1-4 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,1 |

Trade name(s)

Schülke® 9

Market area: EU

Authorisation number

EU-0023860-0004 1-4

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,1

META SPC 5

1.   META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 5 identifier

| Identifier | meta-SPC 5 |
| --- | --- |

Identifier

meta-SPC 5

1.2.   Suffix to the authorisation number

| Number | 1-5 |
| --- | --- |

Number

1-5

1.3.   Product type(s)

| Product type(s) | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 – Food and feed area (Disinfectants)

2.   META SPC 5 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 5

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,1 | 63,1 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,1

63,1

2.2.   Type(s) of formulation of the meta SPC 5

| Formulation(s) | Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation |
| --- | --- |

Formulation(s)

Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

| Hazard statements | Highly flammable liquid and vapour.
  Causes serious eye irritation.
  May cause drowsiness or dizziness.
  Repeated exposure may cause skin dryness or cracking. |
| --- | --- |
| Precautionary statements | Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
  Keep container tightly closed.
  Ground and bond container and receiving equipment.
  Use explosion-proof electrical/ventilating/lighting equipment.
  Use non-sparking tools.
  Take action to prevent static discharges.
  Avoid breathing vapours.
  Avoid breathing spray.
  Use only outdoors or in a well-ventilated area.
  Wear eye protection.
  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
  Call a POISON CENTER or doctor if you feel unwell.
  If eye irritation persists: Get medical advice.
  If eye irritation persists: Get medical attention.
  In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
  Store in a well-ventilated place. Keep cool.
  Store locked up.
  Dispose of contents/container to an approved waste disposal plant. |

Hazard statements

Highly flammable liquid and vapour.

Causes serious eye irritation.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

Keep container tightly closed.

Ground and bond container and receiving equipment.

Use explosion-proof electrical/ventilating/lighting equipment.

Use non-sparking tools.

Take action to prevent static discharges.

Avoid breathing vapours.

Avoid breathing spray.

Use only outdoors or in a well-ventilated area.

Wear eye protection.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

Call a POISON CENTER or doctor if you feel unwell.

If eye irritation persists: Get medical advice.

If eye irritation persists: Get medical attention.

In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.

Store in a well-ventilated place. Keep cool.

Store locked up.

Dispose of contents/container to an approved waste disposal plant.

4.   AUTHORISED USE(S) OF THE META SPC 5

4.1.   Use description

Table 13. Use # 1 – Disinfection of surfaces – wiping

| Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria including Mycobacterium tuberculosis
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  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) |
| Application method(s) | Wiping
  Product will be wiped directly on the surface. |
| Application rate(s) and frequency | Ready-to-use wipes |
| Category(ies) of users | Industrial
  Professional |
| Pack sizes and packaging material | Soft pack: 1-200 wipes
  Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
  Pouch: 10-200 wipes
  Packaging material: LDPE/PET
  Tub: 50-200 wipes
  Packaging material: HDPE
  closure material is either PP, PE3385 |

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria including Mycobacterium tuberculosis

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Field(s) of use

Indoor

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)

Application method(s)

Wiping

Product will be wiped directly on the surface.

Application rate(s) and frequency

Ready-to-use wipes

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Soft pack: 1-200 wipes

Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP

Pouch: 10-200 wipes

Packaging material: LDPE/PET

Tub: 50-200 wipes

Packaging material: HDPE

closure material is either PP, PE3385

4.1.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect 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

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria including Mycobacterium tuberculosis
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: -
  Scientific name: Viruses
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B) |
| Application method(s) | Wiping
  Product will be wiped directly on the surface. |
| Application rate(s) and frequency | Ready-to-use wipes |
| Category(ies) of users | Industrial
  Professional |
| Pack sizes and packaging material | Soft pack: 1-200 wipes
  Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
  Pouch: 10-200 wipes
  Packaging material: LDPE/PET
  Tub: 50-200 wipes
  Packaging material: HDPE
  closure material is either PP, PE3385 |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria including Mycobacterium tuberculosis

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: Viruses

Common name: -

Development stage: -

Field(s) of use

Indoor

Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)

Application method(s)

Wiping

Product will be wiped directly on the surface.

Application rate(s) and frequency

Ready-to-use wipes

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Soft pack: 1-200 wipes

Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP

Pouch: 10-200 wipes

Packaging material: LDPE/PET

Tub: 50-200 wipes

Packaging material: HDPE

closure material is either PP, PE3385

4.2.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C).

4.2.2.   Use-specific risk mitigation measures

See general directions for use.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

-

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (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:

| | In case of accident: Call a poison centre or a doctor. |
| --- | --- |

In case of accident: Call a poison centre or a doctor.

| | IF INHALED: Remove person to fresh air and keep comfortable for breathing. |
| --- | --- |

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

| | If on skin: Wash with water. If skin irritation occurs: Get medical advice. |
| --- | --- |

If on skin: Wash with water. If skin irritation occurs: Get medical advice.

| | IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. |
| --- | --- |

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

| | IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell. |
| --- | --- |

IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.

5.4.   Instructions for safe disposal of the product and its packaging

-

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   OTHER INFORMATION

The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | Schülke® 10 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0023860-0005 1-5 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,1 |

Trade name(s)

Schülke® 10

Market area: EU

Authorisation number

EU-0023860-0005 1-5

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,1

META SPC 6

1.   META SPC 6 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 6 identifier

| Identifier | meta-SPC6 kodan wipes IPA |
| --- | --- |

Identifier

meta-SPC6 kodan wipes IPA

1.2.   Suffix to the authorisation number

| Number | 1-6 |
| --- | --- |

Number

1-6

1.3.   Product type(s)

| Product type(s) | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 – Food and feed area (Disinfectants)

2.   META SPC 6 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 6

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,1 | 63,1 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,1

63,1

2.2.   Type(s) of formulation of the meta SPC 6

| Formulation(s) | Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation |
| --- | --- |

Formulation(s)

Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6

| Hazard statements | Highly flammable liquid and vapour.
  Causes serious eye irritation.
  May cause drowsiness or dizziness.
  Repeated exposure may cause skin dryness or cracking. |
| --- | --- |
| Precautionary statements | If medical advice is needed, have product container or label at hand.
  Keep out of reach of children.
  Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
  Keep container tightly closed.
  Ground and bond container and receiving equipment.
  Use explosion-proof electrical/ventilating/lighting equipment.
  Use non-sparking tools.
  Take action to prevent static discharges.
  Avoid breathing vapours.
  Avoid breathing spray.
  Use only outdoors or in a well-ventilated area.
  IF INHALED: Remove person to fresh air and keep comfortable for breathing.
  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
  Call a POISON CENTER or doctor if you feel unwell.
  If eye irritation persists: Get medical advice.
  If eye irritation persists: Get medical attention.
  In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
  Store in a well-ventilated place. Keep cool.
  Store locked up.
  Dispose of contents/container to an approved waste disposal plant. |

Hazard statements

Highly flammable liquid and vapour.

Causes serious eye irritation.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

If medical advice is needed, have product container or label at hand.

Keep out of reach of children.

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

Keep container tightly closed.

Ground and bond container and receiving equipment.

Use explosion-proof electrical/ventilating/lighting equipment.

Use non-sparking tools.

Take action to prevent static discharges.

Avoid breathing vapours.

Avoid breathing spray.

Use only outdoors or in a well-ventilated area.

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

Call a POISON CENTER or doctor if you feel unwell.

If eye irritation persists: Get medical advice.

If eye irritation persists: Get medical attention.

In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.

Store in a well-ventilated place. Keep cool.

Store locked up.

Dispose of contents/container to an approved waste disposal plant.

4.   AUTHORISED USE(S) OF THE META SPC 6

4.1.   Use description

Table 15. Use # 1 – Disinfection of surfaces – wiping

| Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria including Mycobacterium tuberculosis
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  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) |
| Application method(s) | Wiping
  Product will be wiped directly on the surface. |
| Application rate(s) and frequency | Ready-to-use wipes |
| Category(ies) of users | Industrial
  Professional
  General public (non-professional) |
| Pack sizes and packaging material | Soft pack: 1-200 wipes
  Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
  Pouch: 10-200 wipes
  Packaging material: LDPE/PET
  Tub: 50-200 wipes
  Packaging material: HDPE
  closure material is either PP, PE3385 |

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria including Mycobacterium tuberculosis

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Field(s) of use

Indoor

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)

Application method(s)

Wiping

Product will be wiped directly on the surface.

Application rate(s) and frequency

Ready-to-use wipes

Category(ies) of users

Industrial

Professional

General public (non-professional)

Pack sizes and packaging material

Soft pack: 1-200 wipes

Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP

Pouch: 10-200 wipes

Packaging material: LDPE/PET

Tub: 50-200 wipes

Packaging material: HDPE

closure material is either PP, PE3385

4.1.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect 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

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria including Mycobacterium tuberculosis
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: -
  Scientific name: Viruses
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B) |
| Application method(s) | Wiping
  Product will be wiped directly on the surface. |
| Application rate(s) and frequency | Ready-to-use wipes |
| Category(ies) of users | Industrial
  Professional
  General public (non-professional) |
| Pack sizes and packaging material | Soft pack: 1-200 wipes
  Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
  Pouch: 10-200 wipes
  Packaging material: LDPE/PET
  Tub: 50-200 wipes
  Packaging material: HDPE
  closure material is either PP, PE3385 |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria including Mycobacterium tuberculosis

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: Viruses

Common name: -

Development stage: -

Field(s) of use

Indoor

Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)

Application method(s)

Wiping

Product will be wiped directly on the surface.

Application rate(s) and frequency

Ready-to-use wipes

Category(ies) of users

Industrial

Professional

General public (non-professional)

Pack sizes and packaging material

Soft pack: 1-200 wipes

Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP

Pouch: 10-200 wipes

Packaging material: LDPE/PET

Tub: 50-200 wipes

Packaging material: HDPE

closure material is either PP, PE3385

4.2.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C).

4.2.2.   Use-specific risk mitigation measures

See general directions for use.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

-

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (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:

| | In case of accident: Call a poison centre or a doctor. |
| --- | --- |

In case of accident: Call a poison centre or a doctor.

| | IF INHALED: Remove person to fresh air and keep comfortable for breathing. |
| --- | --- |

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

| | If on skin: Wash with water. If skin irritation occurs: Get medical advice. |
| --- | --- |

If on skin: Wash with water. If skin irritation occurs: Get medical advice.

| | IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. |
| --- | --- |

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

| | IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell. |
| --- | --- |

IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.

5.4.   Instructions for safe disposal of the product and its packaging

-

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   OTHER INFORMATION

The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | Schülke® 11 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0023860-0006 1-6 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,1 |

Trade name(s)

Schülke® 11

Market area: EU

Authorisation number

EU-0023860-0006 1-6

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,1

META SPC 7

1.   META SPC 7 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 7 identifier

| Identifier | meta-SPC7 |
| --- | --- |

Identifier

meta-SPC7

1.2.   Suffix to the authorisation number

| Number | 1-7 |
| --- | --- |

Number

1-7

1.3.   Product type(s)

| Product type(s) | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 – Food and feed area (Disinfectants)

2.   META SPC 7 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 7

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,1 | 63,1 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,1

63,1

2.2.   Type(s) of formulation of the meta SPC 7

| Formulation(s) | Any other liquid (AL), ready-to-use |
| --- | --- |

Formulation(s)

Any other liquid (AL), ready-to-use

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7

| Hazard statements | Highly flammable liquid and vapour.
  Causes serious eye irritation.
  May cause drowsiness or dizziness.
  Repeated exposure may cause skin dryness or cracking. |
| --- | --- |
| Precautionary statements | Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
  Keep container tightly closed.
  Ground and bond container and receiving equipment.
  Use explosion-proof electrical/ventilating/lighting equipment.
  Use non-sparking tools.
  Take action to prevent static discharges.
  Avoid breathing vapours.
  Avoid breathing spray.
  Use only outdoors or in a well-ventilated area.
  Wear eye protection.
  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
  Call a POISON CENTER or doctor if you feel unwell.
  If eye irritation persists: Get medical advice.
  If eye irritation persists: Get medical attention.
  In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
  Store in a well-ventilated place. Keep cool.
  Store locked up.
  Dispose of contents/container to an approved waste disposal plant. |

Hazard statements

Highly flammable liquid and vapour.

Causes serious eye irritation.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

Keep container tightly closed.

Ground and bond container and receiving equipment.

Use explosion-proof electrical/ventilating/lighting equipment.

Use non-sparking tools.

Take action to prevent static discharges.

Avoid breathing vapours.

Avoid breathing spray.

Use only outdoors or in a well-ventilated area.

Wear eye protection.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

Call a POISON CENTER or doctor if you feel unwell.

If eye irritation persists: Get medical advice.

If eye irritation persists: Get medical attention.

In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.

Store in a well-ventilated place. Keep cool.

Store locked up.

Dispose of contents/container to an approved waste disposal plant.

4.   AUTHORISED USE(S) OF THE META SPC 7

4.1.   Use description

Table 17. Use # 1 – Disinfection of surfaces – spraying

| Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  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) |
| Application method(s) | Spraying
  Product will be sprayed directly on the surface. |
| Application rate(s) and frequency | Ready-to-use. Do not apply more than 25 ml/m2. |
| Category(ies) of users | Industrial
  Professional |
| Pack sizes and packaging material | Bottle: 125-1000 ml
  packaging material: HDPE
  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) |

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Field(s) of use

Indoor

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)

Application method(s)

Spraying

Product will be sprayed directly on the surface.

Application rate(s) and frequency

Ready-to-use. Do not apply more than 25 ml/m2.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Bottle: 125-1000 ml

packaging material: HDPE

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)

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

| Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  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) |
| Application method(s) | Wiping
  Product is applied on wipes by pouring, spraying or soaking and the surface is thoroughly wiped with the soaked wipe afterwards (wet-wiping). |
| Application rate(s) and frequency | Ready-to-use. Do not apply more than 25 ml/m2. |
| Category(ies) of users | Industrial
  Professional |
| Pack sizes and packaging material | Bottle: 125-1000 ml
  packaging material: HDPE
  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)
  Canister: 5-30 L
  packaging material: HDPE
  closure material: HDPE |

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Field(s) of use

Indoor

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)

Application method(s)

Wiping

Product is applied on wipes by pouring, spraying or soaking and the surface is thoroughly wiped with the soaked wipe afterwards (wet-wiping).

Application rate(s) and frequency

Ready-to-use. Do not apply more than 25 ml/m2.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Bottle: 125-1000 ml

packaging material: HDPE

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)

Canister: 5-30 L

packaging material: HDPE

closure material: HDPE

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

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: -
  Scientific name: Viruses
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B) |
| Application method(s) | Spraying
  Product will be sprayed directly on the surface. |
| Application rate(s) and frequency | Ready-to-use. Do not apply more than 25 ml/m2.
  - |
| Category(ies) of users | Industrial
  Professional |
| Pack sizes and packaging material | Bottle: 125-1000 ml
  packaging material: HDPE
  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) |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: Viruses

Common name: -

Development stage: -

Field(s) of use

Indoor

Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)

Application method(s)

Spraying

Product will be sprayed directly on the surface.

Application rate(s) and frequency

Ready-to-use. Do not apply more than 25 ml/m2.

-

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Bottle: 125-1000 ml

packaging material: HDPE

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)

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 minute (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

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: -
  Scientific name: Viruses
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B) |
| Application method(s) | Wiping
  Product is applied on wipes by pouring, spraying or soaking and the surface is thoroughly wiped with the soaked wipe afterwards (wet-wiping). |
| Application rate(s) and frequency | Ready-to-use. Do not apply more than 25 ml/m2. |
| Category(ies) of users | Industrial
  Professional |
| Pack sizes and packaging material | Bottle: 125-1000 ml
  packaging material: HDPE
  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)
  Canister: 5-30 L
  packaging material: HDPE
  closure material: HDPE |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: Viruses

Common name: -

Development stage: -

Field(s) of use

Indoor

Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)

Application method(s)

Wiping

Product is applied on wipes by pouring, spraying or soaking and the surface is thoroughly wiped with the soaked wipe afterwards (wet-wiping).

Application rate(s) and frequency

Ready-to-use. Do not apply more than 25 ml/m2.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Bottle: 125-1000 ml

packaging material: HDPE

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)

Canister: 5-30 L

packaging material: HDPE

closure material: HDPE

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/m2.

Make sure to wet surfaces completely.

Used wipes must be disposed in a closed container.

5.2.   Risk mitigation measures

The product must only be applied for disinfection of small surfaces.

Ensure adequate ventilation to prevent the formation of explosive atmospheres.

Avoid contact with eyes.

Apply a funnel for refilling.

Keep out of reach of children and pets.

Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid:

| | In case of accident: Call a poison centre or a doctor. |
| --- | --- |

In case of accident: Call a poison centre or a doctor.

| | IF INHALED: Remove person to fresh air and keep comfortable for breathing. |
| --- | --- |

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

| | If on skin: Wash with water. If skin irritation occurs: Get medical advice. |
| --- | --- |

If on skin: Wash with water. If skin irritation occurs: Get medical advice.

| | IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. |
| --- | --- |

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

| | IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell. |
| --- | --- |

IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.

5.4.   Instructions for safe disposal of the product and its packaging

-

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 36 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   OTHER INFORMATION

The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | Superficid®
  Desocid rapid
  Neoseptin rapid
  Novosept rapid
  Novoseptin rapid
  Lyorthol rapid
  Cosmo rapid
  Fordesin rapid
  Saltero rapid
  Prop70 rapid
  Aldovet rapid
  Vetfarm rapid
  MDI rapid
  Antiseptica rapid
  Sterisol Surface
  MENNO® I-QUICK plus | Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0023860-0007 1-7 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,1 |

Trade name(s)

Superficid®

Desocid rapid

Neoseptin rapid

Novosept rapid

Novoseptin rapid

Lyorthol rapid

Cosmo rapid

Fordesin rapid

Saltero rapid

Prop70 rapid

Aldovet rapid

Vetfarm rapid

MDI rapid

Antiseptica rapid

Sterisol Surface

MENNO® I-QUICK plus

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Authorisation number

EU-0023860-0007 1-7

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,1

7.2.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | Superficid® pure
  Desocid rapid pure
  Neoseptin rapid pure
  Novosept rapid pure
  Novoseptin rapid pure
  Lyorthol rapid pure
  Cosmo rapid pure
  Fordesin rapid pure
  Saltero rapid pure
  Prop70 rapid pure
  Aldovet rapid pure
  Vetfarm rapid pure
  MDI rapid pure
  Antiseptica rapid pure
  Sterisol Surface pure
  BTS 6000
  MENNO® I-QUICK
  EWA® DES ready
  Kiehl-Rapinol
  Des A | Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0023860-0008 1-7 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,1 |

Trade name(s)

Superficid® pure

Desocid rapid pure

Neoseptin rapid pure

Novosept rapid pure

Novoseptin rapid pure

Lyorthol rapid pure

Cosmo rapid pure

Fordesin rapid pure

Saltero rapid pure

Prop70 rapid pure

Aldovet rapid pure

Vetfarm rapid pure

MDI rapid pure

Antiseptica rapid pure

Sterisol Surface pure

BTS 6000

MENNO® I-QUICK

EWA® DES ready

Kiehl-Rapinol

Des A

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Authorisation number

EU-0023860-0008 1-7

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,1

META SPC 8

1.   META SPC 8 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 8 identifier

| Identifier | meta-SPC8 |
| --- | --- |

Identifier

meta-SPC8

1.2.   Suffix to the authorisation number

| Number | 1-8 |
| --- | --- |

Number

1-8

1.3.   Product type(s)

| Product type(s) | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 – Food and feed area (Disinfectants)

2.   META SPC 8 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 8

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,1 | 63,1 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,1

63,1

2.2.   Type(s) of formulation of the meta SPC 8

| Formulation(s) | Any other liquid (AL), ready-to-use wipes impregnated with disinfectant formulation |
| --- | --- |

Formulation(s)

Any other liquid (AL), ready-to-use wipes impregnated with disinfectant formulation

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8

| Hazard statements | Highly flammable liquid and vapour.
  Causes serious eye irritation.
  May cause drowsiness or dizziness.
  Repeated exposure may cause skin dryness or cracking. |
| --- | --- |
| Precautionary statements | Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
  Keep container tightly closed.
  Ground and bond container and receiving equipment.
  Use explosion-proof electrical/ventilating/lighting equipment.
  Use non-sparking tools.
  Take action to prevent static discharges.
  Avoid breathing vapours.
  Avoid breathing spray.
  Use only outdoors or in a well-ventilated area.
  Wear eye protection.
  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
  Call a POISON CENTER or doctor if you feel unwell.
  If eye irritation persists: Get medical advice.
  If eye irritation persists: Get medical attention.
  In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
  Store in a well-ventilated place. Keep cool.
  Store locked up.
  Dispose of contents/container to an approved waste disposal plant. |

Hazard statements

Highly flammable liquid and vapour.

Causes serious eye irritation.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

Keep container tightly closed.

Ground and bond container and receiving equipment.

Use explosion-proof electrical/ventilating/lighting equipment.

Use non-sparking tools.

Take action to prevent static discharges.

Avoid breathing vapours.

Avoid breathing spray.

Use only outdoors or in a well-ventilated area.

Wear eye protection.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

Call a POISON CENTER or doctor if you feel unwell.

If eye irritation persists: Get medical advice.

If eye irritation persists: Get medical attention.

In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.

Store in a well-ventilated place. Keep cool.

Store locked up.

Dispose of contents/container to an approved waste disposal plant.

4.   AUTHORISED USE(S) OF THE META SPC 8

4.1.   Use description

Table 21. Use # 1 – Disinfection of surfaces – wiping

| Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  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) |
| Application method(s) | Wiping
  Product will be wiped directly on the surface. |
| Application rate(s) and frequency | Ready-to-use wipes |
| Category(ies) of users | Industrial
  Professional |
| Pack sizes and packaging material | Can: 100-150 wipes
  Packaging: HDPE
  Closure material: HDPE
  Pack: 100-150 wipes
  Packaging: PET/PE |

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Field(s) of use

Indoor

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)

Application method(s)

Wiping

Product will be wiped directly on the surface.

Application rate(s) and frequency

Ready-to-use wipes

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Can: 100-150 wipes

Packaging: HDPE

Closure material: HDPE

Pack: 100-150 wipes

Packaging: PET/PE

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

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: -
  Scientific name: Viruses
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B) |
| Application method(s) | Wiping
  Product will be wiped directly on the surface. |
| Application rate(s) and frequency | Ready-to-use wipes |
| Category(ies) of users | Industrial
  Professional |
| Pack sizes and packaging material | Can: 100-150 wipes
  Packaging: HDPE
  Closure material: HDPE
  Pack: 100-150 wipes
  Packaging: PET/PE |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: Viruses

Common name: -

Development stage: -

Field(s) of use

Indoor

Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)

Application method(s)

Wiping

Product will be wiped directly on the surface.

Application rate(s) and frequency

Ready-to-use wipes

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Can: 100-150 wipes

Packaging: HDPE

Closure material: HDPE

Pack: 100-150 wipes

Packaging: PET/PE

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:

| | In case of accident: Call a poison centre or a doctor. |
| --- | --- |

In case of accident: Call a poison centre or a doctor.

| | IF INHALED: Remove person to fresh air and keep comfortable for breathing. |
| --- | --- |

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

| | If on skin: Wash with water. If skin irritation occurs: Get medical advice. |
| --- | --- |

If on skin: Wash with water. If skin irritation occurs: Get medical advice.

| | IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. |
| --- | --- |

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

| | IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell. |
| --- | --- |

IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.

5.4.   Instructions for safe disposal of the product and its packaging

-

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   OTHER INFORMATION

The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | Descorapid® Tücher
  Desocid Tücher
  Neoseptin Tücher
  Novosept Tücher
  Novoseptin Tücher
  Lyorthol Tücher
  Cosmo Tücher
  Fordesin Tücher
  Saltero Tücher
  Prop70 Tücher
  Manosafe Tücher
  Dermoguard Tücher
  Dermosafe Tücher
  Aldovet Tücher
  Vetfarm Tücher
  MDI Tücher
  Antiseptica Tücher
  Antiseptica wipes
  MENNO®WIP
  Descorapid® wipes
  Desocid wipes
  Neoseptin wipes
  Novosept wipes
  Novoseptin wipes
  Lyorthol wipes
  Cosmo wipes
  Fordesin wipes
  Saltero wipes
  Prop70 wipes
  Manosafe wipes
  Dermoguard wipes
  Dermosafe wipes
  Aldovet wipes
  Vetfarm wipes
  MDI wipes | Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0023860-0009 1-8 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,1 |

Trade name(s)

Descorapid® Tücher

Desocid Tücher

Neoseptin Tücher

Novosept Tücher

Novoseptin Tücher

Lyorthol Tücher

Cosmo Tücher

Fordesin Tücher

Saltero Tücher

Prop70 Tücher

Manosafe Tücher

Dermoguard Tücher

Dermosafe Tücher

Aldovet Tücher

Vetfarm Tücher

MDI Tücher

Antiseptica Tücher

Antiseptica wipes

MENNO®WIP

Descorapid® wipes

Desocid wipes

Neoseptin wipes

Novosept wipes

Novoseptin wipes

Lyorthol wipes

Cosmo wipes

Fordesin wipes

Saltero wipes

Prop70 wipes

Manosafe wipes

Dermoguard wipes

Dermosafe wipes

Aldovet wipes

Vetfarm wipes

MDI wipes

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Authorisation number

EU-0023860-0009 1-8

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,1

7.2.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | Superficid® pure wipes
  Desocid rapid pure wipes
  Neoseptin rapid pure wipes
  Novosept rapid pure wipes
  Novoseptin rapid pure wipes
  Lyorthol rapid pure wipes
  Cosmo rapid pure wipes
  Fordesin rapid pure wipes
  Saltero rapid pure wipes
  Prop70 rapid pure wipes
  Aldovet rapid pure wipes
  Vetfarm rapid pure wipes
  MDI rapid pure wipes
  Antiseptica rapid pure wipes | Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU
  Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0023860-0010 1-8 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,1 |

Trade name(s)

Superficid® pure wipes

Desocid rapid pure wipes

Neoseptin rapid pure wipes

Novosept rapid pure wipes

Novoseptin rapid pure wipes

Lyorthol rapid pure wipes

Cosmo rapid pure wipes

Fordesin rapid pure wipes

Saltero rapid pure wipes

Prop70 rapid pure wipes

Aldovet rapid pure wipes

Vetfarm rapid pure wipes

MDI rapid pure wipes

Antiseptica rapid pure wipes

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Market area: EU

Authorisation number

EU-0023860-0010 1-8

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,1

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(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.

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