# L_2020410EN.01000101.xml

| 7.12.2020 | EN | Official Journal of the European Union | L 410/1 |
| --- | --- | --- | --- |

7.12.2020

EN

Official Journal of the European Union

L 410/1

---

COMMISSION IMPLEMENTING REGULATION (EU) 2020/1991

of 27 November 2020

granting a Union authorisation for the biocidal product family ‘perform-IPA’

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5) thereof,

Whereas:

| (1) | On 19 April 2016, Schuelke & Mayr GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘perform-IPA’ of product-types 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Germany had agreed to evaluate the application. The application was recorded under case number BC-AB023095-72 in the Register for Biocidal Products. |
| --- | --- |

(1)

On 19 April 2016, Schuelke & Mayr GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘perform-IPA’ of product-types 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Germany had agreed to evaluate the application. The application was recorded under case number BC-AB023095-72 in the Register for Biocidal Products.

| (2) | ‘perform-IPA’ 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. |
| --- | --- |

(2)

‘perform-IPA’ 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 27 August 2019, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, the assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’). |
| --- | --- |

(3)

On 27 August 2019, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, the assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

| (4) | On 7 April 2020, the Agency submitted to the Commission an opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘perform-IPA’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. |
| --- | --- |

(4)

On 7 April 2020, the Agency submitted to the Commission an opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘perform-IPA’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.

| (5) | The opinion concludes that ‘perform-IPA’ is a biocidal product family within the meaning of Article 3(1)(s) of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation. |
| --- | --- |

(5)

The opinion concludes that ‘perform-IPA’ is a biocidal product family within the meaning of Article 3(1)(s) of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.

| (6) | On 27 April 2020, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. |
| --- | --- |

(6)

On 27 April 2020, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

| (7) | The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘perform-IPA’. |
| --- | --- |

(7)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘perform-IPA’.

| (8) | According to the opinion of the Agency, as regards the non-active substance diethyl phthalate contained in ‘perform-IPA’, 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 (3) within the period for the evaluation of the application. Further examination of diethyl phthalate should therefore take place. If it is concluded that diethyl phthalate is considered as having endocrine-disrupting properties, the Commission will consider whether to cancel or amend the Union authorisation for ‘perform-IPA’ in accordance with Article 48 of Regulation (EU) No 528/2012. |
| --- | --- |

(8)

According to the opinion of the Agency, as regards the non-active substance diethyl phthalate contained in ‘perform-IPA’, 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 (3) within the period for the evaluation of the application. Further examination of diethyl phthalate should therefore take place. If it is concluded that diethyl phthalate is considered as having endocrine-disrupting properties, the Commission will consider whether to cancel or amend the Union authorisation for ‘perform-IPA’ in accordance with Article 48 of Regulation (EU) No 528/2012.

| (9) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(9)

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-0023656-0000 is granted to Schuelke & Mayr GmbH for the making available on the market and use of the biocidal product family ‘perform-IPA’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 27 December 2020 until 30 November 2030.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 27 November 2020.

For the Commission

The President

Ursula VON DER LEYEN

---

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

1

(2)  ECHA opinion of 5 March 2020 on the Union authorisation of ‘perform-IPA’ (ECHA/BPC/245/2020), https://echa.europa.eu/bpc-opinions-on-union-authorisation

2

(3)  Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p. 1).

3

---

ANNEX

Summary of product characteristics for a biocidal product family

perform-IPA

Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Product type 4 – Food and feed area (Disinfectants)

Authorisation number: EU-0023656-0000

R4BP asset number: EU-0023656-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

| Name | perform-IPA |
| --- | --- |

Name

perform-IPA

1.2.   Product type(s)

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

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-0023656-0000 |
| R4BP asset number | EU-0023656-0000 |
| Date of the authorisation | 27 December 2020 |
| 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-0023656-0000

R4BP asset number

EU-0023656-0000

Date of the authorisation

27 December 2020

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 Naumburg (Saale) Germany |
| Location of manufacturing sites | Am Hohen Stein 11, 06618 Naumburg (Saale) Germany |

Name of manufacturer

Innovate GmbH

Address of manufacturer

Am Hohen Stein 11, 06618 Naumburg (Saale) Germany

Location of manufacturing sites

Am Hohen Stein 11, 06618 Naumburg (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 SPC 1 perform IPA liquid |
| --- | --- |

Identifier

meta SPC 1 perform IPA liquid

1.2.   Suffix to the authorisation number

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

Number

1-1

1.3.   Product type(s)

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

Product type(s)

PT04 - Food and feed area (Disinfectants)

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

2.   META SPC 1 COMPOSITION

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

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| 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 to /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 to /container to an approved waste disposal plant.

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

4.1.   Use description

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

| Product type | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: - |
| 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 (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) | perform® sterile alcohol IPA
  perform® classic alcohol IPA
  buraton® IPA
  perform® advanced alcohol IPA
  arcana® IPA
  clear IPA
  pure IPA
  disinfectant IPA
  Surface disinfection liquid classic
  sterile IPA
  mikrozid® sterile liquid
  Surface disinfection liquid sterile
  BTS 6000 |
| --- | --- |
| Authorisation number | EU-0023656-0001 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)

perform® sterile alcohol IPA

perform® classic alcohol IPA

buraton® IPA

perform® advanced alcohol IPA

arcana® IPA

clear IPA

pure IPA

disinfectant IPA

Surface disinfection liquid classic

sterile IPA

mikrozid® sterile liquid

Surface disinfection liquid sterile

BTS 6000

Authorisation number

EU-0023656-0001 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 perform wipes IPA |
| --- | --- |

Identifier

meta SPC 2 perform wipes IPA

1.2.   Suffix to the authorisation number

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

Number

1-2

1.3.   Product type(s)

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

Product type(s)

PT04 - Food and feed area (Disinfectants)

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

2.   META SPC 2 COMPOSITION

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

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| 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
  Tube: 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

Tube: 50-200 wipes

Packaging material: HDPE

closure material is either PP, PE3385

4.1.1.   Use-specific instructions for use

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

Tube: 50-200 wipes

Packaging material: HDPE

closure material is either PP, PE3385

4.2.1.   Use-specific instructions for use

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

4.2.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

-

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

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (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) | perform classic wipes IPA
  buraton® wipes IPA
  perform® advanced wipes IPA
  arcana® wipes IPA
  clear IPA wipes
  pure IPA wipes
  disinfectant IPA wipes
  Surface disinfection wipes classic
  perform® sterile wipes IPA
  sterile IPA wipes
  mikrozid® sterile wipes
  Surface disinfection wipes sterile |
| --- | --- |
| Authorisation number | EU-0023656-0002 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)

perform classic wipes IPA

buraton® wipes IPA

perform® advanced wipes IPA

arcana® wipes IPA

clear IPA wipes

pure IPA wipes

disinfectant IPA wipes

Surface disinfection wipes classic

perform® sterile wipes IPA

sterile IPA wipes

mikrozid® sterile wipes

Surface disinfection wipes sterile

Authorisation number

EU-0023656-0002 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 mikrozid liquid |
| --- | --- |

Identifier

meta SPC 3 mikrozid liquid

1.2.   Suffix to the authorisation number

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

Number

1-3

1.3.   Product type(s)

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

Product type(s)

PT04 - Food and feed area (Disinfectants)

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

2.   META SPC 3 COMPOSITION

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

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| 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 rready-to-use product on the surface and wipe afterwards or wet a wipe with the ready-to-use product by spraying or pouring and thereafter wipe the surface. Allow to take effect for at least 5 minutes at room temperature (20± 2°C).

4.2.2.   Use-specific risk mitigation measures

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

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

See general directions for use.

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

-

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

See general directions for use.

4.3.   Use description

Table 9. Use # 3 – disinfection of surfaces with food and feed contact - spraying

| 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 (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 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 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 material: 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) | mikrozid® classic liquid
  mikrozid® IPA liquid
  Surface Disinfection liquid pure |
| --- | --- |
| Authorisation number | EU-0023656-0003 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)

mikrozid® classic liquid

mikrozid® IPA liquid

Surface Disinfection liquid pure

Authorisation number

EU-0023656-0003 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 mikrozid wipes |
| --- | --- |

Identifier

meta SPC 4 mikrozid wipes

1.2.   Suffix to the authorisation number

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

Number

1-4

1.3.   Product type(s)

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

Product type(s)

PT04 - Food and feed area (Disinfectants)

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

2.   META SPC 4 COMPOSITION

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

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| 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
  Tube: 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

Tube: 50-200 wipes

Packaging material: HDPE

closure material is either PP, PE3385

4.1.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect 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 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
  Disinfection when required according to SOP. |
| Category(ies) of users | Industrial
  Professional |
| Pack sizes and packaging material | Soft pack: 1-200 wipes
  Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
  Pouch: 10-200 wipes
  Packaging material: LDPE/PET
  Tube: 50-200 wipes
  Packaging material: HDPE
  closure material is either PP, PE3385 |

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

Disinfection when required according to SOP.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Soft pack: 1-200 wipes

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

Pouch: 10-200 wipes

Packaging material: LDPE/PET

Tube: 50-200 wipes

Packaging material: HDPE

closure material is either PP, PE3385

4.2.1.   Use-specific instructions for use

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

4.2.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

-

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

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (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) | mikrozid® classic wipes
  mikrozid® IPA wipes
  surface disinfection wipes classic |
| --- | --- |
| Authorisation number | EU-0023656-0004 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)

mikrozid® classic wipes

mikrozid® IPA wipes

surface disinfection wipes classic

Authorisation number

EU-0023656-0004 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 kodan wipes IPA pro |
| --- | --- |

Identifier

meta SPC 5 kodan wipes IPA pro

1.2.   Suffix to the authorisation number

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

Number

1-5

1.3.   Product type(s)

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

Product type(s)

PT04 - Food and feed area (Disinfectants)

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

2.   META SPC 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
  Tube: 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

Tube: 50-200 wipes

Packaging material: HDPE

closure material is either PP, PE3385

4.1.1.   Use-specific instructions for use

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

Tube: 50-200 wipes

Packaging material: HDPE

closure material is either PP, PE3385

4.2.1.   Use-specific instructions for use

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

4.2.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

-

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

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (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) | kodan® wipes pure
  schülke® classic wipes |
| --- | --- |
| Authorisation number | EU-0023656-0005 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)

kodan® wipes pure

schülke® classic wipes

Authorisation number

EU-0023656-0005 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 SPC 6 kodan wipes IPA |
| --- | --- |

Identifier

meta SPC 6 kodan wipes IPA

1.2.   Suffix to the authorisation number

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

Number

1-6

1.3.   Product type(s)

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

Product type(s)

PT04 - Food and feed area (Disinfectants)

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

2.   META SPC 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
  Tube: 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

Tube: 50-200 wipes

Packaging material: HDPE

closure material is either PP, PE3385

4.1.1.   Use-specific instructions for use

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

Tube: 50-200 wipes

Packaging material: HDPE

closure material is either PP, PE3385

4.2.1.   Use-specific instructions for use

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

4.2.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

-

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

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (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 Hygiene-Tücher
  SOS Desinfizierende Feuchttücher
  SOS Hygiene-Tücher
  kodan® clean comfort wipes
  schülke clean comfort wipes
  Hygiene-Tücher
  Desinfizierende Feuchttücher
  Desinfektionstücher
  clean comfort wipes
  disinfecting wipes |
| --- | --- |
| Authorisation number | EU-0023656-0006 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 Hygiene-Tücher

SOS Desinfizierende Feuchttücher

SOS Hygiene-Tücher

kodan® clean comfort wipes

schülke clean comfort wipes

Hygiene-Tücher

Desinfizierende Feuchttücher

Desinfektionstücher

clean comfort wipes

disinfecting wipes

Authorisation number

EU-0023656-0006 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 SPC 7 AntiLy SD |
| --- | --- |

Identifier

meta SPC 7 AntiLy SD

1.2.   Suffix to the authorisation number

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

Number

1-7

1.3.   Product type(s)

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

Product type(s)

PT04 - Food and feed area (Disinfectants)

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

2.   META SPC 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 (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) | AntiLy 5 |
| --- | --- |
| Authorisation number | EU-0023656-0007 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)

AntiLy 5

Authorisation number

EU-0023656-0007 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) | AntiLy 6 |
| --- | --- |
| Authorisation number | EU-0023656-0008 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)

AntiLy 6

Authorisation number

EU-0023656-0008 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 SPC 8 AntiLy SD wipes |
| --- | --- |

Identifier

meta SPC 8 AntiLy SD wipes

1.2.   Suffix to the authorisation number

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

Number

1-8

1.3.   Product type(s)

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

Product type(s)

PT04 - Food and feed area (Disinfectants)

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

2.   META SPC 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) | AntiLy 5 wipes |
| --- | --- |
| Authorisation number | EU-0023656-0009 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)

AntiLy 5 wipes

Authorisation number

EU-0023656-0009 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) | AntiLy 6 wipes |
| --- | --- |
| Authorisation number | EU-0023656-0010 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)

AntiLy 6 wipes

Authorisation number

EU-0023656-0010 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

---

(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.

---