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.

ANNEX

Summary of product characteristics for a biocidal product family

perform-IPA

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

Product type 4 – Food and feed area (Disinfectants)

Authorisation number: EU-0023656-0000

R4BP asset number: EU-0023656-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

Name	perform-IPA

1.2.   Product type(s)

Product type(s)

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

1.3.   Authorisation holder

Name and address of the authorisation holder	Name	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	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	Tristel Solutions Limited
Address of manufacturer	Lynx Business Park, Fordham Road, Snailwell, CB8 7NY Cambridgeshire United Kingdom
Location of manufacturing sites	Lynx Business Park, Fordham Road, Snailwell, CB8 7NY Cambridgeshire United Kingdom

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

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

Name of manufacturer	Innovate GmbH
Address of manufacturer	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	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

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

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

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

2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

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

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

2.2.   Type(s) of formulation

Formulation(s)

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

PART II

SECOND INFORMATION LEVEL – META SPC(S)

META SPC 1

1.   META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier

Identifier

meta SPC 1 perform IPA liquid

1.2.   Suffix to the authorisation number

Number

1-1

1.3.   Product type(s)

Product type(s)

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

2.   META SPC 1 COMPOSITION

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

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

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

Formulation(s)

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

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements

Highly flammable liquid and vapour. Causes serious eye irritation. May cause drowsiness or dizziness. Repeated exposure may cause skin dryness or cracking.

Precautionary statements

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

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

4.1.   Use description

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

Product type	PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: -
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.

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.

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.

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.

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

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

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

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

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

-

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

Shelf-life: 36 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   OTHER INFORMATION

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

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

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

Trade name(s)	perform® sterile alcohol IPA perform® 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

1.2.   Suffix to the authorisation number

Number

1-2

1.3.   Product type(s)

Product type(s)

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

2.   META SPC 2 COMPOSITION

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

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

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

Formulation(s)

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

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

Hazard statements

Highly flammable liquid and vapour. Causes serious eye irritation. May cause drowsiness or dizziness. Repeated exposure may cause skin dryness or cracking.

Precautionary statements

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

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

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.

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

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

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

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

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

-

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

Shelf-life: 24 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   OTHER INFORMATION

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

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

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

Trade name(s)	perform classic wipes IPA 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

1.2.   Suffix to the authorisation number

Number

1-3

1.3.   Product type(s)

Product type(s)

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

2.   META SPC 3 COMPOSITION

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

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

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

Formulation(s)

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

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

Hazard statements

Highly flammable liquid and vapour. Causes serious eye irritation. May cause drowsiness or dizziness. Repeated exposure may cause skin dryness or cracking.

Precautionary statements

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

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

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

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

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.

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

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

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

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

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

-

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

Shelf-life: 36 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   OTHER INFORMATION

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

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

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

Trade name(s)	mikrozid® classic liquid mikrozid® 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

1.2.   Suffix to the authorisation number

Number

1-4

1.3.   Product type(s)

Product type(s)

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

2.   META SPC 4 COMPOSITION

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

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

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

Formulation(s)

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

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

Hazard statements

Highly flammable liquid and vapour. Causes serious eye irritation. May cause drowsiness or dizziness. Repeated exposure may cause skin dryness or cracking.

Precautionary statements

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

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

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.

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

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

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

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

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

-

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

Shelf-life: 24 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   OTHER INFORMATION

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

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

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

Trade name(s)	mikrozid® classic wipes mikrozid® 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

1.2.   Suffix to the authorisation number

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)

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

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

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.

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

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

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.

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

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

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

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

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

-

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

Shelf-life: 24 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   OTHER INFORMATION

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

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

META SPC 6

1.   META SPC 6 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 6 identifier

Identifier

meta SPC 6 kodan wipes IPA

1.2.   Suffix to the authorisation number

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)

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

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

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.

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

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

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.

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

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

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

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

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

-

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

Shelf-life: 24 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   OTHER INFORMATION

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

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

META SPC 7

1.   META SPC 7 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 7 identifier

Identifier

meta SPC 7 AntiLy SD

1.2.   Suffix to the authorisation number

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)

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

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

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.

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)

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

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)

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

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.

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

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

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

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

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

-

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

Shelf-life: 36 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   OTHER INFORMATION

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

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

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

META SPC 8

1.   META SPC 8 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 8 identifier

Identifier

meta SPC 8 AntiLy SD wipes

1.2.   Suffix to the authorisation number

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)

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

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

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.

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

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

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.

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

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

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

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

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

-

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

Shelf-life: 24 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   OTHER INFORMATION

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

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

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

---

(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.

Article 1

Regulation (EC) No 474/2006 is amended as follows:

(1)	Annex A is replaced by the text in Annex I to this Regulation;

(2)	Annex B is replaced by the text in Annex II to this Regulation.

Article 2

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

ANNEX I

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(1)  Air carriers listed in Annex A could be permitted to exercise traffic rights by using wet-leased aircraft of an air carrier which is not subject to an operating ban, provided that the relevant safety standards are complied with.

ANNEX II

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(1)  Air carriers listed in Annex B could be permitted to exercise traffic rights by using wet-leased aircraft of an air carrier which is not subject to an operating ban, provided that the relevant safety standards are complied with.

Article 1

Article 2

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 3

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

ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

(1)

in Table 1 (Authorised novel foods), the following entry is inserted: Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements ‘Selenium-containing yeast (Yarrowia lipolytica) biomass Specified food category Maximum levels The designation of the novel food on the labelling of the foodstuffs containing it shall be “selenium-containing yeast (Yarrowia lipolytica) biomass”. The labelling of food supplements containing selenium-containing yeast (Yarrowia lipolytica) biomass shall bear a statement that the food supplements should not be consumed by infants and children under 4 years of age/children under 7 years of age/children under 11 years of age/children and adolescents under 18 years of age (*1).   Food supplements as defined in Directive 2002/46/EC (1), excluding food supplements for infants and children under 4 years of age 50 mg/day for children from 4 to 6 years of age, resulting in 10 μg of selenium per day 100 mg/day for children from 7 to 10 years of age, resulting in 20 μg of selenium per day 500 mg/day for adolescents from 11 to 17 years of age, resulting in 100 μg of selenium per day 800 mg/day for adults, resulting in 160 μg of selenium per day

(2)

in Table 2 (Specifications), the following entry is inserted: Authorised Novel Food Specification ‘Selenium-containing yeast (Yarrowia lipolytica) biomass Description/Definition: The novel food is the dried and heat-killed selenium-containing biomass of the yeast Yarrowia lipolytica. The novel food is produced by fermentation in the presence of sodium selenite followed by a number of purification steps including a heat-killing step of the yeast to ensure the absence of viable Yarrowia lipolytica cells in the novel food. Characteristics/Composition: Total selenium: 165–200 μg/g Se-methionine (2): 100–140 μg/g Protein: 40–50 g/100 g Dietary fibre: 24–32 g/100 g Sugars: < 1 g/100 g Fat: 6–12 g/100 g Total ash: ≤ 15 % Water: ≤ 5 % Dry matter: ≥ 95 % Heavy metals: Lead: ≤ 3,0 mg/kg Cadmium: ≤ 1,0 mg/kg Mercury: ≤ 0,1 mg/kg Microbiological criteria: Total aerobic microbial count: ≤ 5 × 103 CFU/g Total yeast and mould count: ≤ 102 CFU/g Viable Yarrowia lipolytica cells (3): < 10 CFU/g (i.e. limit of detection) Coliforms: ≤ 10 CFU/g Salmonella spp.: Absence in 25 g CFU: colony forming units

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(1)  Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).

(*1)  Depending on the age group the food supplement is intended for.’

(2)  Expressed as selenium.

(3)  Applicable at all stages after the heat-treatment step to guarantee the absence of viable Yarrowia lipolytica cells and to be first tested immediately after the heat-treatment step. Measures have to be in place to prevent cross-contamination with viable Yarrowia lipolytica cells during packaging and/or storage of the novel food.’

Article 1

Article 2

This Regulation shall enter into force with retroactive effect as from 6 August 2020.

Article 1

Implementing Regulation (EU) 2018/1261 is amended as follows:

(1)	in Article 1, ‘HYPRED SAS’ is replaced by ‘HYPRED SAS – KERSIA Group’;

(2)	the Annex is replaced by the Annex to this Regulation.

Article 2

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

ANNEX

Summary of product characteristics for a biocidal product family

HYPRED's iodine based products

Product type 3 - Veterinary hygiene (Disinfectants)

Authorisation number: EU-0018397-0000

R4BP asset number: EU-0018397-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

Name	HYPRED's iodine based products

1.2.   Product type(s)

Product type(s)	PT03 - Veterinary hygiene (Disinfectants)

1.3.   Authorisation holder

Name and address of the authorisation holder	Name	HYPRED SAS – KERSIA Group
	Address	55, Boulevard Jules Verger - BP10180 35803 DINARD Cedex France
Authorisation number	EU-0018397-0000
R4BP asset number	EU-0018397-0000
Date of the authorisation	11 October 2018
Expiry date of the authorisation	30 September 2028

1.4.   Manufacturer(s) of the biocidal products

Name of manufacturer	HYPRED SAS – KERSIA Group
Address of manufacturer	55, Boulevard Jules Verger - BP10180 35803 DINARD France
Location of manufacturing sites	HYPRED SAS – KERSIA Group - 55, Boulevard Jules Verger - BP10180 35803 DINARD France KERSIA POLSKA Sp.z.o.o. - NIEPRUSZEWO, KASZTANOWA 4 64320 Buk Poland KERSIA IBERICA SL - Pol. Miguel Eguía C/Zarapuz s/n 31200 ESTELLA (NAVARRA) Spain KERSIA DEUTSCHLAND GmbH Marie-Curie-Straße 23 53332 Bornheim – Sechtem Germany HYPRED Italia s.r.l. – KERSIA Group Strada Montodine-Gombito Loc. Cà Nova 26010 Ripalta Arpina CR Italy AG France S.A.S – KERSIA Group - Zone Industrielle Le Roineau, 72500 VAAS, FRANCE KERSIA DEUTSCHLAND GmbH - OBERBRÜHLSTRAßE 16-18, 87700 MEMMINGEN, GERMANY KERSIA AUSTRIA GmbH - PFONGAUERSTRAßE 17, 5202 NEUMARKT AM WALLERSEE, AUSTRIA Kilco Holdings Ltd – KERSIA Group - Broomhouses 2 Industrial Estate, Old Glasgow Road, LOCKERBIE - DG11 2SD, UNITED KINGDOM Kilco (International) Ltd – KERSIA Group - 1A Trench Road Mallusk, Newtownabbey, CO ANTRIM BT36 4TY, IRELAND Medentech Ltd – KERSIA Group - Clonard Road, WEXFORD, Y35Y7WY, IRELAND

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

Active substance	Iodine
Name of manufacturer	COSAYACH : SCM Cía. Cosayach Minera Negreiros, Rut. N°96.625.710-5
Address of manufacturer	Terrenos de Elena S/N Terrenos de Elena S/N Huara, Región de Tarapacá Chile
Location of manufacturing sites	Mined at: S.C.M. Cía. Minera Negreiros, S.C.M. Cosayach Soledad. Refined at: S.C.M. Cía. Minera Negreiros. Pozo Almonte Chile

Active substance	Iodine
Name of manufacturer	ACF MINERA SA
Address of manufacturer	San Martín 499 Iquique Chile
Location of manufacturing sites	Faena Lagunas KM. 1.722 Ruta A-5, Pozo Almonte Chile

Active substance	Iodine
Name of manufacturer	SOCIEDAD QUIMICA y MINERA SA
Address of manufacturer	Los Militares 4290 SANTIAGO DE CHILE Chile
Location of manufacturing sites	Pedro de Valdivia (PV) Route B 180 Antofagasta Chile Nueva Victoria (NV) Route 5 North, Km 1925 Pozo Almonte Chile

Active substance	Iodine
Name of manufacturer	ISE Chemicals Corporation
Address of manufacturer	3-1, Kyobashi 1-Chome, Chuo-ku, Tokyo Japan
Location of manufacturing sites	Shirasato Plant (3695 Kitaimaizumi, Oamishirasato City, Chiba, Japan)

Active substance	Iodine
Name of manufacturer	Nihon Tennen Gas Development Co., Ltd
Address of manufacturer	661 Mobara 297-8550 Mobara City, Chiba Japan
Location of manufacturing sites	Chiba Plant, 2508 Minami Hinata, 299-4205 Shirako-Machi, Chosei-Gun, Chiba Japan

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
Iodine		Active substance	7553-56-2	231-442-4	0,25	2,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non active substance	68439-50-9		2,697	24,199

2.2.   Type(s) of formulation

Formulation(s)	AL - Any other liquid SL - Soluble concentrate

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 : Dipping products - ready to use

1.2.   Suffix to the authorisation number

Number

1-1

1.3.   Product type(s)

Product type(s)	PT03 - Veterinary hygiene (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
Iodine		Active substance	7553-56-2	231-442-4	0,25	0,49
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non active substance	68439-50-9		2,697	4,993

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

Formulation	AL - Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements	Causes serious eye irritation. Harmful to aquatic life with long lasting effects.
Precautionary statements	Keep out of reach of children. Wash hands thoroughly after handling. Wear protective gloves. Wear protective clothing. Wear eye protection. 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.

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

4.1.   Use description

Table 1. Use # 1 – Manual or automated dipping after milking

Product Type	PT03 - Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Bacteria Yeasts Algae
Field(s) of use	Indoor Disinfection of teats of milk producing animals by dipping after milking
Application method(s)	Dipping - Manual or automated disinfection of teats by dipping after milking. Dipping cup or automated dipping machine.
Application rate(s) and frequency	— cows and buffaloes (3 to 10ml : 5 ml recommended) — sheep (1.5 to 5 ml : 1.5 ml recommended) — goats (2.5 to 6 ml : 2.5 ml recommended) Frequency : 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1000L

4.1.1.   Use-specific instructions for use

See general directions for use of meta SPC 1

4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 1

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 of meta SPC 1

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

None: See general directions for use of meta SPC 1

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 of meta SPC 1

5.   GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1

5.1.   Instructions for use

Always read the label or leaflet before use and follow all the instructions provided.

The product must be brought to a temperature above 20°C before use.

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the dipping cup manually or automatically with the ready to use product.

Apply by dipping manually or automatically on animal's teats on the full length of the teat after milking.

—	cows and buffaloes (3 to 10ml : 5 ml recommended)

—	sheep (1.5 to 5 ml : 1.5 ml recommended)

—	goats (2.5 to 6 ml : 2.5 ml recommended)

Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).

At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

Where necessary, repeat the application after each milking.

Clean the application equipment regularly with warm water.

5.2.   Risk mitigation measures

Wear eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

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

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

FIRST AID INSTRUCTIONS

—	In the event of inhalation: Bring to fresh air.

—	In the event of contact with the skin: Wash with water.

—	In the event of contact with the eyes :

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.

—	In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

Refer to the safety data sheet available for professional user: it contains an emergency phone number.

Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

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

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

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

Shelf life : 2 years in HDPE

Do not store at a temperature higher than 30°C.

6.   OTHER INFORMATION

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)	Dip-io 2500 JOD DIP IODERM PSP DERMINO FR Iododip IODEX EXTRA Iodystrong DERMIODE INO IODE EPAIS INO STAR + IODACTIV 2500 IODIUM BX2500 Usual Iod Post ASiRAL Dip Coat IODOCAN EXTRA UDDER PLUS PRIMADIODE CERTIODE EPAIS IODIPACK GEL HELIO IODE EPAIS VAGEL GELAPIS ACTIV IOSAPIS GEL ZENCARE FLASH REPROGEL DERMADINE + KRONI Jod Dipp 2500 WÜBBELMANN JOD DIP Iodine Cleaner&Sanitizer MUNGIFILM ZEP FS FILMIODINE NIPPLE NP IODOFILM EMPRASAN UDDER SHIELD ANGLIA FARMERS IO-FILM BARRICADE STANTON IODOFILM WYNNSAN IOFILM TEAT DIP
Authorisation number	EU-0018397-0001 1-1
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active substance	7553-56-2	231-442-4	0,25
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non active substance	68439-50-9		2,697

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

Trade name(s)	Dip-io YB MAX INO Io Dip MAX JOD DIP YB MAX IodoDip YB MAX Iodium Dip YB MAX JodyDip YB MAX Delta IoDip YB MAX
Authorisation number	EU-0018397-0002 1-1
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active substance	7553-56-2	231-442-4	0,49
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non active substance	68439-50-9		4,993

META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

Identifier

meta SPC 2 : Dipping, foaming, spraying products - Ready to use

1.2.   Suffix to the authorisation number

Number

1-2

1.3.   Product type(s)

Product type(s)	PT03 - Veterinary hygiene (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
Iodine		Active substance	7553-56-2	231-442-4	0,25	0,49
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non active substance	68439-50-9		2,697	4,69

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

Formulation	AL - Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

Hazard statements	Causes serious eye irritation. Harmful to aquatic life with long lasting effects.
Precautionary statements	Keep out of reach of children. Wash hands thoroughly after handling. Wear protective gloves. Wear protective clothing. Wear eye protection. 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.

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

4.1.   Use description

Table 2. Use # 1 – Manual or automated dipping, foaming or spraying before milking

Product Type	PT03 - Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Bacteria Yeasts
Field(s) of use	Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking
Application method(s)	Dipping, foaming or spraying before milking - Manual or automated disinfection of teats by dipping, foaming or spraying before milking Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine
Application rate(s) and frequency	— cows and buffaloes (3 to 10ml : 5 to 8 ml recommended) — sheep (1.5 to 5 ml : 1.5 to 3ml recommended) — goats (2.5 to 6 ml : 2.5 to 4 ml recommended) Frequency : 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1000L

4.1.1.   Use-specific instructions for use

Eliminate all visible dirt before applying the product.

Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat before milking.

Let the product act at least one minute.

Use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general instructions for use of meta SPC 2.

4.1.2.   Use-specific risk mitigation measures

For manual dipping/foaming application: Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/ eye protection.

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing /eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection.

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 of meta SPC 2

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

See general directions for use of meta SPC 2

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 of meta SPC 2

4.2.   Use description

Table 3. Use # 2 – Manual or automated dipping, foaming or spraying after milking

Product Type	PT03 - Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Bacteria Yeasts Algae
Field(s) of use	Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking
Application method(s)	Dipping, foaming, spraying after milking - Manual or automated disinfection of teats by dipping, foaming or spraying after milking Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine
Application rate(s) and frequency	— cows and buffaloes (3 to 10ml : 5 to 8 ml recommended) — sheep (1,5 to 5 ml : 1,5 to 3ml recommended) — goats (2,5 to 6 ml : 2,5 to 4 ml recommended) Frequency : 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1000L

4.2.1.   Use-specific instructions for use

Manual or automatic dipping / foaming / spraying on animal's teats on the full length of the teat after milking.

Leave the product until next milking. Keep the cows standing until the product has dried. (at least 5 minutes)

At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general instructions for use of meta SPC 2.

4.2.2.   Use-specific risk mitigation measures

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing /eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

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 of meta SPC 2

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

See general directions for use of meta SPC 2

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 of meta SPC 2

5.   GENERAL DIRECTIONS FOR USE (2) OF THE META SPC 2

5.1.   Instructions for use

See use-specific instructions for each use.

Always read the label or leaflet before use and follow all the instructions provided.

The product must be brought to a temperature above 20°C before use.

The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping/foaming cup/sprayer manually or automatically with the ready to use product.

Where necessary repeat the application at each milking

Clean the application equipment regularly with warm water.

5.2.   Risk mitigation measures

See use-specific risk mitigation measures for each use.

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

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

FIRST AID INSTRUCTIONS

—	In the event of inhalation: Bring to fresh air.

—	In the event of contact with the skin: Wash with water.

—	In the event of contact with the eyes :

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.

—	In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

Refer to the safety data sheet available for professional user: it contains an emergency phone number.

Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

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

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

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

Shelf life : 2 years in HDPE

Do not store at a temperature higher than 30°C.

6.   OTHER INFORMATION

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)	Liq-io 2500 JOD SPRAY IODINE 3000 RTU IODEX 2500 Usual Iod Liquid Iodoliquid Iodospray DESINTEAT IODYSPRAY RBT 2500 IODY’FLASH INO IODE SPRAY IODYPRO 2500 IODYPRO BL2500 Robot Liq-io 25 ADF iDip+ ASiRAL Dip Spray J IODIPACK HELIO IODE LIQUIDE POLY-IODE CERTIODE LIQUIDE IOSAPIS FLUID GELAPIS ROBOT ZENCARE SPRAY HELIO IODE SPRAY + IODIP + KRONI Jod Spray 2500 WÜBBELMANN JOD LIQUID PRECEPT ANGLIA FARMERS PRECLENZ H&M PREDIP FULLWOOD PRECLEANSE M WILLIAMS PRECEPT STANTON PREDIP RTU WYNNSAN IODINE PREDIP RTU PREMIER GOLD PRE-DIP HODGES & MOSS PREDIP LANODIP PREPOST DAIRYSAN MULTICARE EMPRASAN ADVANCE UDDERWASH IODINE ANGLIA FARMERS PREPOST-IO PREMIER GOLD PRE/POST FULLWOOD PRE/POST IODINE HODGES & MOSS ADVANCE WYNNSAN IODINE PREPOST
Authorisation number	EU-0018397-0003 1-2
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active substance	7553-56-2	231-442-4	0,25
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non active substance	68439-50-9		2,697

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

Trade name(s)	Liq-io YB MAX INO Io Liquid Max Iodoliquid YB MAX Iodospray YB MAX Desinteat YB MAX Iodium Spray YB MAX JodySpray YB MAX Delta IoSpray YB MAX
Authorisation number	EU-0018397-0004 1-2
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active substance	7553-56-2	231-442-4	0,49
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non active substance	68439-50-9		4,69

META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier

Identifier

meta SPC 3 : Dipping, foaming, spraying concentrated products

1.2.   Suffix to the authorisation number

Number

1-3

1.3.   Product type(s)

Product type(s)	PT03 - Veterinary hygiene (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
Iodine		Active substance	7553-56-2	231-442-4	2,5	2,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non active substance	68439-50-9		24,199	24,199

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

Formulation	SL - Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

Hazard statements

Causes serious eye damage. May cause damage to organs (thyroid) through prolonged or repeated exposure oral. Toxic to aquatic life with long lasting effects. May be corrosive to metals.

Precautionary statements

Keep out of reach of children. Do not breathe mist. Do not breathe vapours. Do not breathe spray. Wash hands thoroughly after handling. Wear protective gloves. Wear protective clothing. Wear eye protection. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a poison center / doctor. Get medical advice/attention if you feel unwell. Dispose of contents to in accordance with local/ regional/ national/ international regulations. Dispose of container to in accordance with local/ regional/ national/ international regulations. Keep only in original container. Absorb spillage to prevent material damage.

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

4.1.   Use description

Table 4. Use # 1 – Manual or automated dipping, foaming or spraying before milking

Product Type	PT03 - Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
Target organism(s) (including development stage)	Bacteria Yeasts
Field(s) of use	Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking
Application method(s)	Dipping, foaming, spraying - Manual or automated disinfection of teats by dipping, foaming or spraying before milking. Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine
Application rate(s) and frequency	A dilution at 10% (v/v) should be prepared Application rate for the diluted product: — cows and buffaloes (3 to 10ml : 5 to 8 ml recommended) — sheep (1.5 to 5 ml: 1.5 to 3 ml recommended) — goats (2.5 to 6 ml: 2.5 to 4 ml recommended) Frequency: 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1000L

4.1.1.   Use-specific instructions for use

Prepare a dilution at 10% (v/v: 10 ml product, add water up to 100ml) for bactericidal and yeasticidal activity.

Fill the dipping / foaming cup / sprayer manually or automatically with the prepared dilution.

Eliminate all visible dirt before applying the product.

Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat before milking.

Let the product act at least one minute.

Use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general directions for use of meta SPC 3.

4.1.2.   Use-specific risk mitigation measures

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing /eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection.

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 of meta SPC 3

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

See general directions for use of meta SPC 3

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 of meta SPC 3

4.2.   Use description

Table 5. Use # 2 – Manual or automated dipping, foaming or spraying after milking

Product Type	PT03 - Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Bacteria Yeasts Algae Viruses
Field(s) of use	Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking
Application method(s)	Dipping, foaming, spraying - Manual or automated disinfection of teats by dipping, foaming or spraying after milking. Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine
Application rate(s) and frequency	For disinfection of bacteria, yeasts and algae a dilution at 10% (v/v: 10 ml product, add water up to 100ml) should be prepared. For disinfection of viruses a dilution at 20% (v/v: 20 ml product, add water up to 100ml) should be prepared Application rate for the diluted product: — cows and buffaloes (3 to 10ml : 5 to 8 ml recommended) — sheep (1,5 to 5 ml : 1,5 to 3ml recommended) — goats (2,5 to 6 ml : 2,5 to 4 ml recommended) Frequency : 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1000L

4.2.1.   Use-specific instructions for use

Prepare a dilution at 10% (v/v: 10 ml product, add water up to 100ml) for bactericidal, yeasticidal and algaecidal activity or 20% (v/v: 20 ml product, add water up to 100ml) in case virucidal activity is also needed.

Fill the dipping / foaming cup / sprayer manually or automatically with the prepared dilution.

Manual or automatic dipping / foaming / spraying on animal's teats on the full length of the teat after milking.

Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).

At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general directions for use of meta SPC 3

4.2.2.   Use-specific risk mitigation measures

For manual spraying applications wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) /protective clothing/eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

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 of meta SPC 3

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

See general directions for use of meta SPC 3

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 of meta SPC 3

5.   GENERAL DIRECTIONS FOR USE (3) OF THE META SPC 3

5.1.   Instructions for use

See use-specific instructions for each use.

Always read the label or leaflet before use and follow all the instructions provided.

The product must be brought to a temperature above 20°C before use.

The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping / foaming cup / sprayer manually or automatically with the prepared dilution.

Where necessary, repeat the application at each milking

Clean the application equipment regularly with warm water.

5.2.   Risk mitigation measures

See use-specific risk mitigation measures for each use.

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

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

In case of faintness, get medical advice/attention. Show this safety data sheet to the doctor.

FIRST AID INSTRUCTIONS

—	In the event of inhalation: Bring to fresh air.

—	In the event of contact with the skin: Wash with water.

—	In the event of contact with the eyes: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open.

Remove contact lenses if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER or doctor/physician.

—	In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

Refer to the safety data sheet available for professional user: it contains an emergency phone number.

Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

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

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

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

Shelf life : 2 years in HDPE

Do not store at a temperature higher than 30°C.

6.   OTHER INFORMATION

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)	Liq-io concentrate INO Jod Konzentrat Usual Iod Concent Iodoconcentrat D 10 IODINE D 5 IODINE Liq-io C INO IODE C D 4 IODINE ADF iDip+ concentrate Mammizan Concentré WYNNSAN IODINE CONCENTRATE EMPRASAN OPTIMA ANGLIA FARMERS CONC PROLAC SENTINEL CONC PREMIER GOLD CONCENTRATE FULLWOOD IODINE CONC H&M OPTIMA SENTINAL CONC HARRY TRAVIS SUPER CONC TEAT DIP LANODIP CONC E/SAN SOVEREIGN PROLAC SENTINEL CONC
Authorisation number	EU-0018397-0005 1-3
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active substance	7553-56-2	231-442-4	2,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non active substance	68439-50-9		24,199

META SPC 4

1.   META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier

Identifier

meta SPC 4 : Dipping products reaching virucidal activity – Ready to use

1.2.   Suffix to the authorisation number

Number

1-4

1.3.   Product type(s)

Product type(s)	PT03 - Veterinary hygiene (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
Iodine		Active substance	7553-56-2	231-442-4	0,5	0,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non active substance	68439-50-9		4,993	4,993

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

Formulation	AL - Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

Hazard statements	Causes serious eye irritation. Harmful to aquatic life with long lasting effects.
Precautionary statements	Keep out of reach of children. Wash hands thoroughly after handling. Wear protective gloves. Wear protective clothing. Wear eye protection. 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.

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

4.1.   Use description

Table 6. Use # 1 – Manual or automated dipping after milking

Product Type	PT03 - Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Bacteria Yeasts Algae Viruses
Field(s) of use	Indoor Disinfection of teats of milk producing animals by dipping after milking
Application method(s)	Dipping - Manual or automated disinfection of teats by dipping after milking. Dipping cup or automated dipping machine.
Application rate(s) and frequency	— cows and buffaloes (3 to 10ml : 5 ml recommended) — sheep (1,5 to 5 ml : 1,5 ml recommended) — goats (2,5 to 6 ml : 2,5 ml recommended) Frequency : 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1000L

4.1.1.   Use-specific instructions for use

See general directions for use of meta SPC 4

4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 4

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 of meta SPC 4

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

See general directions for use of meta SPC 4

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 of meta SPC 4

5.   GENERAL DIRECTIONS FOR USE (4) OF THE META SPC 4

5.1.   Instructions for use

Always read the label or leaflet before use and follow all the instructions provided.

The product must be brought to a temperature above 20°C before use.

The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping cup manually or automatically with the ready to use product.

Apply by dipping manually or automatically on animal's teats on the full length of the teat after milking.

—	cows and buffaloes (3 to 10ml : 5 ml recommended)

—	sheep (1,5 to 5 ml : 1,5 ml recommended)

—	goats (2,5 to 6 ml : 2,5 ml recommended)

Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).

At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

Where necessary, repeat the application after each milking.

Clean the application equipment regularly with warm water.

5.2.   Risk mitigation measures

Wear eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

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

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

FIRST AID INSTRUCTIONS

—	In the event of inhalation: Bring to fresh air.

—	In the event of contact with the skin: Wash with water.

—	In the event of contact with the eyes :

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.

—	In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

Refer to the safety data sheet available for professional user: it contains an emergency phone number.

Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

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

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

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

Shelf life : 2 years in HDPE

Do not store at a temperature higher than 30°C.

6.   OTHER INFORMATION

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)	Dip-io 5000 IODIUM TX INO JOD 50 DIP Usual Iod Post + IODIUM PRO DIP IODERM PSP + IODEX EXTRA + Iododip + IODYSTRONG PLUS INO TREMP INO STAR IODACTIV 5000 DERMINO IODERM 5000 IODIUM BX5000 HOEVE-PLUS DIP TREMPASEPT IODE DERMADINE MAMMO-DERM KRONI Jod Dipp 5000
Authorisation number	EU-0018397-0006 1-4
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active substance	7553-56-2	231-442-4	0,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non active substance	68439-50-9		4,993

META SPC 5

1.   META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 5 identifier

Identifier

meta SPC 5 : Dipping, foaming, spraying products 5500 ppm – Ready to use

1.2.   Suffix to the authorisation number

Number

1-5

1.3.   Product type(s)

Product type(s)	PT03 - Veterinary hygiene (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
Iodine		Active substance	7553-56-2	231-442-4	0,55	0,55
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non active substance	68439-50-9		4,69	4,69

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

Formulation	AL - Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

Hazard statements	Causes serious eye irritation. Harmful to aquatic life with long lasting effects.
Precautionary statements	Keep out of reach of children. Wash hands thoroughly after handling. Wear protective gloves. Wear protective clothing. Wear eye protection. 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.

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

4.1.   Use description

Table 7. Use # 1 – Manual or automated dipping, foaming or spraying before milking

Product Type	PT03 - Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
Target organism(s) (including development stage)	Bacteria Yeasts
Field(s) of use	Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking
Application method(s)	Dipping, foaming, spraying - Manual or automated disinfection of teats by dipping, foaming or spraying before milking Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine
Application rate(s) and frequency	— cows and buffaloes (3 to 10ml : 5 to 8 ml recommended) — sheep (1,5 to 5 ml : 1,5 to 3ml recommended) — goats (2,5 to 6 ml : 2,5 to 4 ml recommended) Frequency : 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1000L

4.1.1.   Use-specific instructions for use

Fill the dipping / foaming cup / sprayer manually or automatically with the ready to use product.

Eliminate all visible dirt before applying the product.

Manual or automatic dipping / foaming / spraying on animal's teats on the full length of the teat before milking.

Let the product act at least one minute.

Use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general instructions for use of meta SPC5.

4.1.2.   Use-specific risk mitigation measures

For manual dipping/foaming application : Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/ eye protection.

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing /eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection.

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 of meta SPC 5

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

See general directions for use of meta SPC 5

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 of meta SPC 5

4.2.   Use description

Table 8. Use # 2 – Manual or automated dipping, foaming or spraying after milking

Product Type	PT03 - Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Bacteria Yeasts Algae Viruses
Field(s) of use	Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking
Application method(s)	Dipping, foaming, spraying - Manual or automated disinfection of teats by dipping, foaming or spraying after milking. Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine.
Application rate(s) and frequency	— cows and buffaloes (3 to 10ml : 5 to 8 ml recommended) — sheep (1,5 to 5 ml : 1,5 to 3ml recommended) — goats (2,5 to 6 ml : 2,5 to 4 ml recommended) Frequency : 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1000L

4.2.1.   Use-specific instructions for use

Fill the dipping / foaming cup / sprayer manually or automatically with the ready to use product.

Manual or automatic dipping / foaming / spraying on animal's teats on the full length of the teat after milking.

Leave the product until next milking. Keep the cows standing until the product has dried. (at least 5 minutes)

At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general instructions for use of meta SPC 5.

4.2.2.   Use-specific risk mitigation measures

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

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 of meta SPC 5

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

See general directions for use of meta SPC 5

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 of meta SPC 5

5.   GENERAL DIRECTIONS FOR USE (5) OF THE META SPC 5

5.1.   Instructions for use

See use-specific instructions for each use.

Always read the label or leaflet before use and follow all the instructions provided.

The product must be brought to a temperature above 20°C before use.

The use of a dosing pump for filling the product into the application equipment is recommended.

Where necessary repeat the application at each milking

Clean the application equipment regularly with warm water.

5.2.   Risk mitigation measures

See use-specific risk mitigation measures for each use.

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

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

FIRST AID INSTRUCTIONS

—	In the event of inhalation: Bring to fresh air.

—	In the event of contact with the skin: Wash with water.

—	In the event of contact with the eyes :

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.

—	In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

Refer to the safety data sheet available for professional user: it contains an emergency phone number.

Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

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

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

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

Shelf life : 2 years in HDPE

Do not store at a temperature higher than 30°C.

6.   OTHER INFORMATION

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)	Liq-io 5500 IODYPRO INO JOD 50 Liquid Usual Iod Liquid + IODIUM PRO SPRAY IODEX Iodoliquid + Iodospray Plus DESINTEAT PLUS ROBOSPRAY IODE INOTRAYON IODYPRO 5500 Robot Liq-io 55 IODYPRO BL5500 ADF iDip+ 5500 HOEVE-JODIUM SPRAY GRUPAIODE IODOCAN JOFO JODI PLUS K-AGRO PRODIP ID IODIP HELIO IODE SPRAY MAMMO-JOD KRONI Jod Spray 5500 MUNGI-IOD LELY QUARESS-Iodine GOLD GLYCODIP EMPRASAN EXTRA CARE H&M RTU IODINE ANGLIA FARMERS SUPPLEDIP-IO PROLAC RTU IODINE TEAT DIP PREMIER GOLD POST DIP FULLWOOD IODINE EXTRA H&M EXTRACARE M WILLIAMS TEAT DIP PLATINUM WDH GOLD DIP RTU WYNNSAN IODINE HE RTU
Authorisation number	EU-0018397-0007 1-5
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active substance	7553-56-2	231-442-4	0,55
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non active substance	68439-50-9		4,69

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(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC1.

(2)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC2.

(3)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC3.

(4)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC4.

(5)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC5.