Commission Implementing Regulation (EU) 2023/2747 of 8 December 2023 amending Implementing Regulation (EU) 2022/1391 granting a Union authorisation for the biocidal product family Lactic acid based products – CID Lines NV in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

ANNEX
ANNEX
‘ANNEX II
Summary of product characteristics for a biocidal product family
Lactic acid based products – CID LINES NV
Product type 1 – Human hygiene (Disinfectants)
Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Product type 3 – Veterinary hygiene (Disinfectants)
Product type 4 – Food and feed area (Disinfectants)
Authorisation number: EU-0027740-0000
R4BP asset number: EU-0027740-0000
PART I
FIRST INFORMATION LEVEL
1.    ADMINISTRATIVE INFORMATION
1.1.    Family name
Name
Lactic acid based products – CID LINES NV
1.2.    Product type(s)
Product type(s)
PT01 – Human hygiene (Disinfectants)
PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
PT03 – Veterinary hygiene (Disinfectants)
PT04 – Food and feed area (Disinfectants)
1.3.    Authorisation holder
Name and address of the authorisation holder
Name
CID LINES NV
Address
Waterpoortstraat 2, 8900 Ieper Belgium
Authorisation number
EU-0027740-0000
R4BP asset number
EU-0027740-0000
Date of the authorisation
31 December 2023
Expiry date of the authorisation
31 August 2032
1.4.    Manufacturer(s) of the biocidal products
Name of manufacturer
CID LINES NV
Address of manufacturer
Waterpoortstraat 2, 8900 Ieper Belgium
Location of manufacturing sites
Waterpoortstraat 2, 8900 Ieper Belgium
1.5.    Manufacturer(s) of the active substance(s)
Active substance
L-(+)-lactic acid
Name of manufacturer
Purac Biochem bv
Address of manufacturer
Arkelsedijk 46, 4206 Gorinchem Netherlands
Location of manufacturing sites
Arkelsedijk 46, 4206 Gorinchem Netherlands
Active substance
L-(+)-lactic acid
Name of manufacturer
Jungbunzlauer S.A.
Address of manufacturer
Z.I. et Portuaire, B.P. 32, 67390 Marckolsheim France
Location of manufacturing sites
Z.I. et Portuaire, B.P. 32, 67390 Marckolsheim France
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
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
2,0
70,0
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
0,0
12,0
Sodium lauryl ether sulfate
Alcohols, C12-14, ethoxylated, sulfates, sodium salts
Non-active substance
68891-38-3
500-234-8
0,0
8,4
Sulfonic acids, C14-17-sec-alkane, sodium salts
Sulfonic acids, C14-17-sec-alkane, sodium salts
Non-active substance
97489-15-1
307-055-2
0,0
2,25
C6 alkyl glucoside
Hexyl D-Glucoside
Non-active substance
54549-24-5
259-217-6
0,0
2,4
Isopropanol
Propan-2-ol
Non-active substance
67-63-0
200-661-7
0,0
5,0
Methanesulfonic acid
Methanesulfonic acid
Non-active substance
75-75-2
200-898-6
0,0
19,5
Sulphuric acid
Sulphuric acid
Non-active substance
7664-93-9
231-639-5
0,0
10,5
Butyldiglycol
2-(2-butoxyethoxy)ethanol
Non-active substance
112-34-5
203-961-6
0,0
10,0
2.2.    Type(s) of formulation
Formulation(s)
AL – Any other liquid
SL – Soluble concentrate
WI – Wipes
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: Ready to use hygienic handwash (PT1)
1.2.    Suffix to the authorisation number
Number
1-1
1.3.    Product type(s)
Product type(s)
PT01 – Human 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
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
3,6
3,6
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
5,0
5,0
Isopropanol
Propan-2-ol
Non-active substance
67-63-0
200-661-7
4,0
4,0
2.2.    Type(s) of formulation of the meta SPC 1
Formulation(s)
AL – Any other liquid
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
Hazard statements
Causes serious eye damage.
Precautionary statements
Wear eyes/face 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 doctor.
4.    AUTHORISED USE(S) OF THE META SPC 1
4.1.    Use description
Table 1
Use # 1 – Hygienic handwash for professional use
Product type
PT01 – Human hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Other: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Other: Yeast
Common name: Yeasts
Development stage:
Field(s) of use
Indoor
Food and feed industry, Public field and Kitchens:
Hygienic handwash
Application method(s)
Method: -
Detailed description:
-
Application rate(s) and frequency
Application Rate: 10 mL of undiluted product (that is four pushes for both hands together)
Dilution (%): -
Number and timing of application:
Apply 10 mL of undiluted product (that is four pushes for both hands together) and wash your hands for at least one minute according to the recommended hand washing procedure, before rinse and dry.
Category(ies) of users
Professional
Pack sizes and packaging material
50 mL, 75 mL, 100 mL, 150 mL, 500 mL, 1L, 5L, 10L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L
HDPE (High Density Polyethylene)
4.1.1.    Use-specific instructions for use
see general directions for use for Meta SPC 1
4.1.2.    Use-specific risk mitigation measures
/
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 Meta SPC 1
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for 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 Meta SPC 1
5.    GENERAL DIRECTIONS FOR USE   ( 1 )
OF THE META SPC 1
5.1.    Instructions for use
Wet your hands with clean, running water at room temperature
Turn off the tap
Apply 10 mL of undiluted product and rub your hands for at least one minute according to the recommended hand washing procedure, before rinse and dry.
For professional use only
5.2.    Risk mitigation measures
/
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Immediately call 112/ambulance for medical assistance.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
5.4.    Instructions for safe disposal of the product and its packaging
The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
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)
Kenosan Hand Scrub
Market area: EU
Authorisation number
EU-0027740-0001 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
3,6
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
5,0
Isopropanol
Propan-2-ol
Non-active substance
67-63-0
200-661-7
4,0
META SPC 2
1.    META SPC 2 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 2 identifier
Identifier
Meta SPC 2: Ready to use Algaecide
1.2.    Suffix to the authorisation number
Number
1-2
1.3.    Product type(s)
Product type(s)
PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
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
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
2,0
2,0
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
0,6
0,9
2.2.    Type(s) of formulation of the meta SPC 2
Formulation(s)
AL – Any other liquid
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
Hazard statements
Causes serious eye irritation.
Precautionary statements
If medical advice is needed, have product container or label at hand.
Keep out of reach of children.
Read carefully and follow all instructions.
Wash hands thoroughly after handling.
Wear eyes/face protection.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
If skin irritation occurs:Get medical advice.
If eye irritation persists:Get medical advice.
Take off contaminated clothing.And wash it before reuse.
4.    AUTHORISED USE(S) OF THE META SPC 2
4.1.    Use description
Table 2
Use # 1 – Ready to use algaecide for professional use
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
Not relevant
Target organism(s) (including development stage)
Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:
Scientific name: unicellular green algae and blue-green algae
Common name: cyanobacteria
Development stage:
Field(s) of use
Indoor
Outdoor
Public field: Ready-to-use algaecide, on hard/non-porous surfaces without prior cleaning.
Application method(s)
Method: By brushing, by spraying (low pressure) or pouring
Detailed description:
/
Application rate(s) and frequency
Application Rate: 100 mL/m 2
Dilution (%): -
Number and timing of application:
Active against bacteria, yeasts and unicellular green algae and blue-green algae (cyanobacteria):
With undiluted product at 20 – 25 °C
In 3h contact time
100 mL/m 2
The biocidal product is not intended to be used on surfaces that come into contact with food and feed.
Category(ies) of users
Professional
Pack sizes and packaging material
1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg
HDPE (High Density Polyethylene)
4.1.1.    Use-specific instructions for use
see general directions for use for Meta SPC 2
4.1.2.    Use-specific risk mitigation measures
/
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 for 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 for 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 for Meta SPC 2
4.2.    Use description
Table 3
Use # 2 – Ready to use algaecide for non-professional use
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
Not relevant
Target organism(s) (including development stage)
Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:
Scientific name: unicellular green algae and blue-green algae
Common name: Cyanobacteria
Development stage:
Field(s) of use
Indoor
Outdoor
Public field: Ready-to-use algaecide, on hard/non-porous surfaces without prior cleaning.
Application method(s)
Method: By brushing, by spraying (low pressure) or pouring
Detailed description:
/
Application rate(s) and frequency
Application Rate: 100 mL/m 2
Dilution (%): -
Number and timing of application:
Active against bacteria, yeasts and unicellular green algae and blue-green algae (cyanobacteria):
With undiluted product at 20 – 25 °C
In 3h contact time
100 mL/m 2
The biocidal product is not intended to be used on surfaces that come into contact with food and feed.
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
1 L, 5 L, 10 L
1 kg, 5 kg, 10 kg
HDPE (High Density Polyethylene)
4.2.1.    Use-specific instructions for use
see general directions for use for Meta SPC 2
4.2.2.    Use-specific risk mitigation measures
/
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 for 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 for 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 for Meta SPC 2
5.    GENERAL DIRECTIONS FOR USE   ( 2 )
OF THE META SPC 2
5.1.    Instructions for use
Comply with the instructions for use
The surfaces to be disinfected must be wet enough in order to be kept wet during the approved contact time for optimal disinfection. The following precautionary sentence shall be added on the product label: “Make sure to wet surfaces completely”.
The required contact time has to be respected until further treatments (for example brushing the surfaces).
Use 100 mL solution/m 2
5.2.    Risk mitigation measures
/
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for five minutes. Call a POISON CENTRE or a doctor.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
If medical advice is needed, have product container or label at hand
5.4.    Instructions for safe disposal of the product and its packaging
The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
Keep out of reach of children and non-target animals/pets.
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)
RTU Algaecide
Market area: EU
Authorisation number
EU-0027740-0002 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
2,0
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
0,6
META SPC 3
1.    META SPC 3 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 3 identifier
Identifier
Meta SPC 3: concentrated algaecide and hard surface disinfection in food industry
1.2.    Suffix to the authorisation number
Number
1-3
1.3.    Product type(s)
Product type(s)
PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
PT04 – Food and feed area (Disinfectants)
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
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
70,0
70,0
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
6,0
6,0
2.2.    Type(s) of formulation of the meta SPC 3
Formulation(s)
SL – Soluble concentrate
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
Hazard statements
Causes severe skin burns and eye damage.
Causes serious eye damage.
Precautionary statements
Do not breathe vapours.
Wash hands thoroughly after handling.
Wear protective gloves.
Wear protective clothing.
Wear eyes/face protection.
IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.
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.
Immediately call a doctor.
Wash contaminated clothing before reuse.
Store locked up.
Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
4.    AUTHORISED USE(S) OF THE META SPC 3
4.1.    Use description
Table 4
Use # 1 – concentrated algaecide
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
Not relevant
Target organism(s) (including development stage)
Scientific name: unicellular green algae and blue-green algae
Common name: Cyanobacteria
Development stage:
Field(s) of use
Indoor
Outdoor
Food and feed industry; Public field:
Concentrated algaecide, on hard/non-porous surfaces without prior cleaning.
Application method(s)
Method: By spraying (low pressure) or pouring
Detailed description:
/
Application rate(s) and frequency
Application Rate: 100 mL/m 2
Dilution (%): 0,5 %
Number and timing of application:
Active against unicellular green algae and blue-green algae (cyanobacteria): 100 mL/m 2
Dilute the product to 0,5 % in water, to reach an in use concentration of 0,35 % Lactic acid.
at 20– 25 °C
In 3h contact time
Category(ies) of users
Professional
Pack sizes and packaging material
1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg
HDPE (High Density Polyethylene)
4.1.1.    Use-specific instructions for use
see general directions for use for Meta SPC 3
4.1.2.    Use-specific risk mitigation measures
see general directions for use for Meta SPC 3
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 for 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 for 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 for Meta SPC 3
4.2.    Use description
Table 5
Use # 2 – Disinfection of hard/non-porous surfaces in the food industry (for example processing machines)
Product type
PT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Field(s) of use
Indoor
in Food/feed industry:
Disinfection of hard/non-porous surfaces (for example processing machines) without prior cleaning
Application method(s)
Method: Spraying or soaking
Detailed description:
Spraying
Soaking (the bath is intended to be used only once)
Application rate(s) and frequency
Application Rate: 100 mL/m 2
Dilution (%): 4 %
Number and timing of application:
Active against bacteria and yeasts at +40 °C:
Dilute the product to 4 % in water, to reach an in use concentration of 2,8 % Lactic acid.
In five seconds contact time
100 mL/m 2
Category(ies) of users
Professional
Pack sizes and packaging material
1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg
HDPE (High Density Polyethylene)
4.2.1.    Use-specific instructions for use
see general directions for use for Meta SPC 3
4.2.2.    Use-specific risk mitigation measures
see general directions for use for Meta SPC 3
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 for 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 for 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 for Meta SPC 3
5.    GENERAL DIRECTIONS FOR USE   ( 3 )
OF THE META SPC 3
5.1.    Instructions for use
Disinfection cycle:
—
Products must be diluted in potable water before use.
—
Final rinsing (with potable water): if required.
The surfaces to be disinfected must be wet enough in order to be kept wet during the approved contact time for optimal disinfection. The following precautionary sentence shall be added on the product label: “Make sure to wet surfaces completely”.
5.2.    Risk mitigation measures
Gloves and goggles are needed during mixing and loading of the concentrated products.
Wear protective coverall (to be specified by the authorisation holder within the product information).
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Immediately call 112/ambulance for medical assistance.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
5.4.    Instructions for safe disposal of the product and its packaging
The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
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)
Concentrated Algaecide
Market area: EU
Kenosan Lactic CONC
Market area: EU
Authorisation number
EU-0027740-0003 1-3
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
70,0
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
6,0
META SPC 4
1.    META SPC 4 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 4 identifier
Identifier
Meta SPC 4: Concentrated surface disinfectants for sanitary hygiene and kitchens (PT2-PT4)
1.2.    Suffix to the authorisation number
Number
1-4
1.3.    Product type(s)
Product type(s)
PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
PT04 – Food and feed area (Disinfectants)
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
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
16,0
16,0
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
5,0
5,0
2.2.    Type(s) of formulation of the meta SPC 4
Formulation(s)
SL – Soluble concentrate
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
Hazard statements
Causes skin irritation.
Causes serious eye damage.
Contains eucalyptus globulus oil (CAS-No 8000-48-4). May produce an allergic reaction.
Precautionary statements
If medical advice is needed, have product container or label at hand.
Keep out of reach of children.
Read carefully and follow all instructions.
Wash hands thoroughly after handling.
Wear protective gloves.
Wear eyes/face protection.
IF ON SKIN:Wash with plenty of water.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Immediately call a doctor.
If skin irritation occurs:Get medical advice.
Take off contaminated clothing.And wash it before reuse.
4.    AUTHORISED USE(S) OF THE META SPC 4
4.1.    Use description
Table 6
Use # 1 – Hard surface disinfection for sanitary hygiene, other than in healthcare, for professional use (PT2)
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
Not relevant
Target organism(s) (including development stage)
Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:
Field(s) of use
Indoor
Public field (NOT in HEALTHCARE)
Disinfection of hard/non-porous surfaces (for sanitary hygiene) by spraying without prior cleaning
Application method(s)
Method: By spraying (with wiping if needed, only after the end of the preconised contact time)
Detailed description:
/
Application rate(s) and frequency
Application Rate: 250 mL/m 2 diluted product
Dilution (%): 20 %
Number and timing of application:
Active against bacteria and yeasts at room temperature
Dilute the product 20 % in water, to reach an in use concentration of 3,2 % Lactic acid.
In 15 minutes contact time
250 mL/m 2 diluted product
Category(ies) of users
Professional
Pack sizes and packaging material
1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg
HDPE (High Density Polyethylene)
4.1.1.    Use-specific instructions for use
Comply with the instructions for use
4.1.2.    Use-specific risk mitigation measures
Gloves and goggles are needed during handling of the products
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 for 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 for 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 for Meta SPC 4
4.2.    Use description
Table 7
Use # 2 – Hard surface disinfection for hygiene in kitchens, for professional use (PT4)
Product type
PT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:
Field(s) of use
Indoor
in food/feed areas:
Disinfection of hard/non-porous surfaces (for general hygiene) by spraying without prior cleaning
Application method(s)
Method: By spraying (with wiping if needed, only after the end of the preconised contact time)
Detailed description:
/
Application rate(s) and frequency
Application Rate: 100 mL/m 2
Dilution (%): 20 %
Number and timing of application:
Active against bacteria and yeasts at room temperature
Dilute the product 20 % in water, to reach an in use concentration of 3,2 % Lactic acid.
In 15 minutes contact time
100 mL/m 2
Category(ies) of users
Professional
Pack sizes and packaging material
1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg
HDPE (High Density Polyethylene)
4.2.1.    Use-specific instructions for use
Comply with the instructions for use
4.2.2.    Use-specific risk mitigation measures
Gloves and goggles are needed during handling of the products.
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 for Meta SPC 4
4.2.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 4
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 for Meta SPC 4
4.3.    Use description
Table 8
Use # 3 – Disinfection of toilet bowls, for professional use (PT2)
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
Not relevant
Target organism(s) (including development stage)
Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:
Field(s) of use
Indoor
Public field
Disinfection of hard/non-porous inside surfaces of toilets, without prior cleaning
Application method(s)
Method: By pouring (with brushing – only after the end of the preconised contact time)
Detailed description:
/
Application rate(s) and frequency
Application Rate: 250 mL/m 2
Dilution (%): -
Number and timing of application:
Active against bacteria and yeasts at room temperature:
With the undiluted product (with 16 % Lactic acid)
In five minutes contact time
Category(ies) of users
Professional
Pack sizes and packaging material
500 mL, 700 mL, 750 mL, 1L, 1.5 L, 2 L
HDPE (High Density Polyethylene)
Toilet Duck
4.3.1.    Use-specific instructions for use
Comply with the instructions for use
4.3.2.    Use-specific risk mitigation measures
Gloves and goggles are needed during handling of the products.
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 for Meta SPC 4
4.3.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 4
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 for Meta SPC 4
4.4.    Use description
Table 9
Use # 4 – Disinfection of toilet bowls, for non-professional use (PT2)
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
Not relevant
Target organism(s) (including development stage)
Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:
Field(s) of use
Indoor
Public field
Disinfection of hard/non-porous inside surfaces of toilets, without prior cleaning
Application method(s)
Method: By pouring (with brushing – only after the end of the preconised contact time)
Detailed description:
/
Application rate(s) and frequency
Application Rate: 250 mL/m 2
Dilution (%): -
Number and timing of application:
Active against bacteria and yeasts at room temperature:
With the undiluted product (with 16 % Lactic acid)
In five minutes contact time
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
500 mL, 700 mL, 750 mL, 1L, 1.5 L, 2 L
HDPE (High Density Polyethylene)
Toilet Duck
4.4.1.    Use-specific instructions for use
Comply with the instructions for use
4.4.2.    Use-specific risk mitigation measures
Avoid contact with eyes
A child proof closure is required
The product must be fitted with a pouring spout, the product must be poured gently on the wall of the toilet bowl to avoid the formation of splashes.
Wash hands after application
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
If medical advice is needed, have product container or label at hand
4.4.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 4
4.4.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep out of reach of children and non-target animals/pets.
5.    GENERAL DIRECTIONS FOR USE   ( 4 )
OF THE META SPC 4
5.1.    Instructions for use
The surfaces to be disinfected must be wet enough in order to be kept wet during the preconised contact time for optimal disinfection. The following precautionary sentence shall be added on the product label: “Make sure to wet surfaces completely”.
5.2.    Risk mitigation measures
/
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. If skin irritation occurs: Get medical advice.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Immediately call 112/ambulance for medical assistance.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance
IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
5.4.    Instructions for safe disposal of the product and its packaging
The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
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)
Sanifresh
Market area: EU
Milcho Des
Market area: EU
Kenolens
Market area: EU
Kenolux S100
Market area: EU
SANI-CAL
Market area: EU
Sani Super
Market area: EU
Scrub
Market area: EU
MiQro Sani Des
Market area: EU
Authorisation number
EU-0027740-0004 1-4
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
16,0
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
5,0
META SPC 5
1.    META SPC 5 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 5 identifier
Identifier
Meta SPC 5: Concentrated pre-dips (PT3)
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
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
8,0
8,0
Sodium lauryl ether sulfate
Alcohols, C12-14, ethoxylated, sulfates, sodium salts
Non-active substance
68891-38-3
500-234-8
8,4
8,4
Sulfonic acids, C14-17-sec-alkane, sodium salts
Sulfonic acids, C14-17-sec-alkane, sodium salts
Non-active substance
97489-15-1
307-055-2
2,25
2,25
2.2.    Type(s) of formulation of the meta SPC 5
Formulation(s)
SL – Soluble concentrate
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
Hazard statements
Causes serious eye damage.
Precautionary statements
Wear eyes/face 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 doctor.
4.    AUTHORISED USE(S) OF THE META SPC 5
4.1.    Use description
Table 10
Use # 1 – Teat disinfection, before milking
Product type
PT03 – Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:
Field(s) of use
Indoor
Veterinary field
Teat disinfection before milking with concentrated product (to be diluted before disinfection procedure), without prior cleaning
Application method(s)
Method: By dipping, by spraying with spray flacon or spray installation and by wiping with a towel
Detailed description:
By dipping
By spraying with spray flacon or spray installation
By wiping with a towel soaking with the diluted product
Application rate(s) and frequency
Application Rate: 5 – 15 mL
Dilution (%): 40 %
Number and timing of application:
Active against bacteria and yeasts:
Dilution: 40 %
The product must be diluted with RT potable water.
In one minute contact time
Category(ies) of users
Professional
Pack sizes and packaging material
1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg
HDPE (High Density Polyethylene)
4.1.1.    Use-specific instructions for use
Application rates :
Dilution: 40 % (with 3,2 % LA) – The product must be diluted with RT potable water.
—
5 mL per cow per application for use by dipping
—
7.5 mL per cow per application for use by spray flacon
—
15 mL per cow per application for use by spray installation
—
For use by wiping with a towel: prepare 10 L working solution for 25 towels.
Use one towel per cow.
4.1.2.    Use-specific risk mitigation measures
see general directions for use for Meta SPC 5
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 for 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 for 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 for Meta SPC 5
4.2.    Use description
Table 11
Use # 2 – Intact skin wash/disinfection (of the udder of dairy and beef cattle before calving and of the udder of sows before farrowing)
Product type
PT03 – Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:
Field(s) of use
Indoor
Veterinary field
Application method(s)
Method: Spraying
Detailed description:
/
Application rate(s) and frequency
Application Rate: 5 – 20 mL
Dilution (%): 40 %
Number and timing of application:
Active against bacteria and yeasts:
Dilution: 40 %
The product must be diluted with Room Temperature potable water.
In one minute contact time
1)
dairy and beef cattle on the udder before calving: 5 mL (1 spray) on each teat
2)
sows on the udder before farrowing: 20 mL
The animals should be kept standing on a clean floor for at least five minutes.
Category(ies) of users
Professional
Pack sizes and packaging material
1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg
HDPE (High Density Polyethylene)
4.2.1.    Use-specific instructions for use
see general directions for use for Meta SPC 5
4.2.2.    Use-specific risk mitigation measures
see general directions for use for Meta SPC 5
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 for 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 for 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 for Meta SPC 5
5.    GENERAL DIRECTIONS FOR USE   ( 5 )
OF THE META SPC 5
5.1.    Instructions for use
See use specific instructions for use
5.2.    Risk mitigation measures
Chemical goggles need to be worn.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Immediately call 112/ambulance for medical assistance.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
5.4.    Instructions for safe disposal of the product and its packaging
The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
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)
Kenopro Lactic
Market area: EU
HCP Foam Concentrate
Market area: EU
Kenopro Lactic
Market area: EU
Reconet+
Market area: EU
Kenopure
Market area: EU
MIROX Pre Lac
Market area: EU
Milchsäure Pre
Market area: EU
Milchsäure Pref
Market area: EU
Lactocid Pre
Market area: EU
Milcho Pre
Market area: EU
Preactive
Market area: EU
Precoop
Market area: EU
Lactipré
Market area: EU
Prelacti
Market area: EU
Prelak
Market area: EU
Power Prep
Market area: EU
Multicleaner
Market area: EU
Kenopure Strong
Market area: EU
Semex Pre
Market area: EU
MEPA Pure
Market area: EU
MEPA Foam
Market area: EU
Eco Lac Foam
Market area: EU
Authorisation number
EU-0027740-0005 1-5
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
8,0
Sodium lauryl ether sulfate
Alcohols, C12-14, ethoxylated, sulfates, sodium salts
Non-active substance
68891-38-3
500-234-8
8,4
Sulfonic acids, C14-17-sec-alkane, sodium salts
Sulfonic acids, C14-17-sec-alkane, sodium salts
Non-active substance
97489-15-1
307-055-2
2,25
META SPC 6
1.    META SPC 6 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 6 identifier
Identifier
Meta SPC 6: Ready to use Pre-dips (PT3)
1.2.    Suffix to the authorisation number
Number
1-6
1.3.    Product type(s)
Product type(s)
PT03 – Veterinary hygiene (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
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
3,6
3,6
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
5,25
5,25
2.2.    Type(s) of formulation of the meta SPC 6
Formulation(s)
AL – Any other liquid
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6
Hazard statements
Causes serious eye damage.
Precautionary statements
Wear eye/face 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 doctor.
4.    AUTHORISED USE(S) OF THE META SPC 6
4.1.    Use description
Table 12
Use # 1 – Teat disinfection, before milking
Product type
PT03 – Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:
Field(s) of use
Indoor
Veterinary field
Application method(s)
Method: By dipping, by spraying with spray flacon or spray installation, by wiping with a towel
Detailed description:
By dipping
By spraying with spray flacon or spray installation
By wiping with a towel soaking with the diluted product
Application rate(s) and frequency
Application Rate: Active against bacteria and yeasts: (Ready-To-Use) RTU In one minute contact time. The product must “return” to room temperature before use.
Dilution (%): -
Number and timing of application:
Active against bacteria and yeasts:
RTU (with 3,6 % Lactic acid)
In one minute contact time
The product must “return” to RT before use
Category(ies) of users
Professional
Pack sizes and packaging material
1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg
HDPE (High Density Polyethylene)
4.1.1.    Use-specific instructions for use
Application rates :
—
5 mL per cow per application for use by dipping
—
7,5 mL per cow per application for use by spray flacon
—
15 mL per cow per application for use by spray installation
—
One towel per cow for use by wiping
4.1.2.    Use-specific risk mitigation measures
see general directions for use for Meta SPC 6
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 for Meta SPC 6
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 6
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 for Meta SPC 6
5.    GENERAL DIRECTIONS FOR USE   ( 6 )
OF THE META SPC 6
5.1.    Instructions for use
/
5.2.    Risk mitigation measures
Chemical goggles need to be worn.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Immediately call 112/ambulance for medical assistance.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
5.4.    Instructions for safe disposal of the product and its packaging
The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
6.    OTHER INFORMATION
/
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)
Kenopure R
Market area: EU
Kenopure RTU
Market area: EU
HCP Foam RTU
Market area: EU
Kenoxypure RTU
Market area: EU
Kenopurox RTU
Market area: EU
Kenopure Ox RTU
Market area: EU
Kenopure Plus RTU
Market area: EU
Kenopure Extra RTU
Market area: EU
Kenopure oxylac RTU
Market area: EU
Kenoxylac predip RTU
Market area: EU
Kenoxilac predip RTU
Market area: EU
Kenopure H 2 O 2 RTU
Market area: EU
Oxy Kenopure RTU
Market area: EU
Preactive RTU
Market area: EU
Precoop RTU
Market area: EU
Lactipré RTU
Market area: EU
Prelacti RTU
Market area: EU
Prelak RTU
Market area: EU
Power Prep RTU
Market area: EU
Prelacta Foam
Market area: EU
Authorisation number
EU-0027740-0006 1-6
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
3,6
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
5,25
META SPC 7
1.    META SPC 7 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 7 identifier
Identifier
Meta SPC 7: Ready to use wipes (PT2, PT4)
1.2.    Suffix to the authorisation number
Number
1-7
1.3.    Product type(s)
Product type(s)
PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
PT04 – Food and feed area (Disinfectants)
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
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
2,0
2,0
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
0,6
0,9
2.2.    Type(s) of formulation of the meta SPC 7
Formulation(s)
WI – Wipes
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7
Hazard statements
Causes serious eye irritation.
Precautionary statements
If medical advice is needed, have product container or label at hand.
Keep out of reach of children.
Read carefully and follow all instructions.
Wash hands thoroughly after handling.
Wear eyes/face protection.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
If skin irritation occurs:Get medical advice.
If eye irritation persists:Get medical advice.
Take off contaminated clothing.And wash it before reuse.
4.    AUTHORISED USE(S) OF THE META SPC 7
4.1.    Use description
Table 13
Use # 1 – Hard surface disinfection in Food and Feed industry, for professional use (PT4)
Product type
PT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeasts
Common name: Yeasts
Development stage:
Scientific name: other: viruses
Common name: Viruses
Development stage:
Field(s) of use
Indoor
Food/feed areas
Disinfection of hard/non-porous surfaces and objects, with prior cleaning
Application method(s)
Method: With pre-impragnated wipes
Detailed description:
/
Application rate(s) and frequency
Application Rate: Active against bacteria, yeasts and viruses: With pre-impregnated wipes at room temperature in two minutes contact time
Dilution (%): -
Number and timing of application:
Active against bacteria, yeasts and viruses:
With pre-impregnated wipes
at room temperature in two minutes contact time
Category(ies) of users
Professional
Pack sizes and packaging material
Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes
4.1.1.    Use-specific instructions for use
see general directions for use for Meta SPC 7
4.1.2.    Use-specific risk mitigation measures
/
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 for Meta SPC 7
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 7
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 for Meta SPC 7
4.2.    Use description
Table 14
Use # 2 – Hard surface disinfection in food and feed area, for non-professional use (PT4)
Product type
PT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeasts
Common name: Yeasts
Development stage:
Scientific name: other: viruses
Common name: Viruses
Development stage:
Field(s) of use
Indoor
Food/feed areas
Disinfection of hard/non-porous surfaces and objects, with prior cleaning
Application method(s)
Method: With pre-impragnated wipes
Detailed description:
Wipes
Application rate(s) and frequency
Application Rate: One wipe/m 2
Dilution (%): -
Number and timing of application:
Active against bacteria, yeasts and viruses:
With pre-impregnated wipes
at room temperature in two minutes contact time
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes
4.2.1.    Use-specific instructions for use
Comply with the instructions for use
4.2.2.    Use-specific risk mitigation measures
/
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
If medical advice is needed, have product container or label at hand
4.2.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 7
4.2.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep out of reach of children and non-target animals/pets.
4.3.    Use description
Table 15
Use # 3 – Hard surface disinfection, use in healthcare, for professional use (PT2)
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
Not relevant
Target organism(s) (including development stage)
Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeasts
Common name: Yeasts
Development stage:
Scientific name: other: viruses
Common name: Viruses
Development stage:
Field(s) of use
Indoor
Public field:
Disinfection of hard/non-porous surfaces (walls, floors and other surfaces in indoor spaces, including bathrooms and toilets) with prior cleaning
Application method(s)
Method: With pre-impregnated wipes
Detailed description:
/
Application rate(s) and frequency
Application Rate: Active against bacteria, yeasts and viruses: With pre-impregnated wipes at room temperature in two minutes contact time
Dilution (%): -
Number and timing of application:
Active against bacteria, yeasts and viruses:
With pre-impregnated wipes
at room temperature in two minutes contact time
Category(ies) of users
Professional
Pack sizes and packaging material
Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes
4.3.1.    Use-specific instructions for use
see general directions for use for Meta SPC 7
4.3.2.    Use-specific risk mitigation measures
/
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 for Meta SPC 7
4.3.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 7
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 for Meta SPC 7
4.4.    Use description
Table 16
Use # 4 – Hard surface disinfection, use in healthcare, for non-professional use (PT2)
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
Not relevant
Target organism(s) (including development stage)
Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeasts
Common name: Yeasts
Development stage:
Scientific name: other: viruses
Common name: Viruses
Development stage:
Field(s) of use
Indoor
Public field: Disinfection of hard/non-porous surfaces (walls, floors and other surfaces in indoor spaces, including bathrooms and toilets) in healthcare area with prior cleaning
Application method(s)
Method: With pre-impregnated wipes
Detailed description:
/
Application rate(s) and frequency
Application Rate: Active against bacteria, yeasts and viruses: With pre-impregnated wipes at room temperature in two minutes contact time
Dilution (%): -
Number and timing of application:
Active against bacteria, yeasts and viruses:
With pre-impregnated wipes
at room temperature in two minutes contact time
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes
4.4.1.    Use-specific instructions for use
Comply with the instructions for use
4.4.2.    Use-specific risk mitigation measures
/
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
If medical advice is needed, have product container or label at hand
4.4.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 7
4.4.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep out of reach of children and non-target animals/pets.
4.5.    Use description
Table 17
Use # 5 – Hard surface disinfection, use other than in healthcare, for professional use (PT2)
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
Not relevant
Target organism(s) (including development stage)
Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeasts
Common name: Yeasts
Development stage:
Scientific name: other: viruses
Common name: Viruses
Development stage:
Field(s) of use
Indoor
Public field:
Disinfection of hard/non-porous surfaces (walls, floors and other surfaces in indoor spaces, including bathrooms and toilets) with prior cleaning
Application method(s)
Method: With pre-impregnated wipes
Detailed description:
/
Application rate(s) and frequency
Application Rate: Active against bacteria, yeasts and viruses: With pre-impregnated wipes at room temperature in two minutes contact time
Dilution (%): -
Number and timing of application:
Active against bacteria, yeasts and viruse:
With pre-impregnated wipes
at room temperature in two minutes contact time
Category(ies) of users
Professional
Pack sizes and packaging material
Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes
4.5.1.    Use-specific instructions for use
see general directions for use for Meta SPC 7
4.5.2.    Use-specific risk mitigation measures
/
4.5.3.    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 for Meta SPC 7
4.5.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 7
4.5.5.    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 for Meta SPC 7
4.6.    Use description
Table 18
Use # 6 – Hard surface disinfection, use other than in healthcare, for non-professional use (PT2)
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
Not relevant
Target organism(s) (including development stage)
Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeasts
Common name: Yeasts
Development stage:
Scientific name: other: viruses
Common name: Viruses
Development stage:
Field(s) of use
Indoor
Public field:
Disinfection of hard/non-porous surfaces (walls, floors and other surfaces in indoor spaces, including bathrooms and toilets) with prior cleaning
Application method(s)
Method: With pre-impregnated wipes
Detailed description:
/
Application rate(s) and frequency
Application Rate: Active against bacteria, yeasts and viruses: With pre-impregnated wipes at room temperature in two minutes contact time
Dilution (%): -
Number and timing of application:
Active against bacteria, yeasts and viruses:
With pre-impregnated wipes
at room temperature in two minutes contact time
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes
4.6.1.    Use-specific instructions for use
Comply with the instructions for use
4.6.2.    Use-specific risk mitigation measures
/
4.6.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
If medical advice is needed, have product container or label at hand.
4.6.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 7
4.6.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep out of reach of children and non-target animals/pets.
5.    GENERAL DIRECTIONS FOR USE   ( 7 )
OF THE META SPC 7
5.1.    Instructions for use
Comply with the instructions for use
First clean thoroughly the surfaces and materials to be disinfected and dry the surface or materials.
Disinfect the dry surface with a wipe. Make sure the surface remains completely wetted during the required contact time.
5.2.    Risk mitigation measures
/
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for five minutes. Call a POISON CENTRE or a doctor.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
If medical advice is needed, have product container or label at hand
5.4.    Instructions for safe disposal of the product and its packaging
The packing and content must be eliminated as dangerous waste product under the fullresponsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use. Store at ambient temperature. Do not store below 0 °C and above 40 °C.
The shelf-life of the products is two years.
Keep out of reach of children and non-target animals/pets
6.    OTHER INFORMATION
/
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)
Kenopure wipes
Market area: EU
EP-460 Wipes
Market area: EU
Sani Wipes
Market area: EU
Lactides Wipes
Market area: EU
Keno Lac Wipes
Market area: EU
KL Wipes
Market area: EU
Kenolux Wipes
Market area: EU
Power Des Wipes
Market area: EU
Keno L Wipes
Market area: EU
Keno Des Wipes
Market area: EU
RĘCZNIKI PAPIEROWE MYJĄCO-DEZYNFEKUJĄCE FARMA
Market area: EU
RĘCZNIKI PAPIEROWE MYJĄCO-DEZYNFEKUJĄCE VITTRA
Market area: EU
Ręczniki myjąco-dezynfekujące AGROD
Market area: EU
Authorisation number
EU-0027740-0007 1-7
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
2,0
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
0,6
META SPC 8
1.    META SPC 8 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 8 identifier
Identifier
Meta SPC 8: Ready to use post-dips by dipping (PT3)
1.2.    Suffix to the authorisation number
Number
1-8
1.3.    Product type(s)
Product type(s)
PT03 – Veterinary hygiene (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
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
3,6
7,5
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
1,3
1,3
Isopropanol
Propan-2-ol
Non-active substance
67-63-0
200-661-7
1,0
3,0
2.2.    Type(s) of formulation of the meta SPC 8
Formulation(s)
AL – Any other liquid
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8
Hazard statements
Causes serious eye damage.
Precautionary statements
Wear eyes/face 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 doctor.
4.    AUTHORISED USE(S) OF THE META SPC 8
4.1.    Use description
Table 19
Use # 1 – Teat disinfection after milking by dipping
Product type
PT03 – Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:
Field(s) of use
Indoor
Veterinary field:
(Ready-To-Use) RTU post-dip for teat disinfection, after milking, without prior cleaning
Application method(s)
Method: By dipping
Detailed description:
/
Application rate(s) and frequency
Application Rate: Active against bacteria and yeasts: RTU In five minutes contact time. The product must “return” to RT before use.
Dilution (%): -
Number and timing of application:
Active against bacteria and yeasts:
RTU (with 3.6 – 7,5 % Lactic acid depending on the product considered)
In five minutes contact time
The product must “return” to room temperature before use
Category(ies) of users
Professional
Pack sizes and packaging material
1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg
HDPE (High Density Polyethylene)
4.1.1.    Use-specific instructions for use
see general directions for use for Meta SPC 8
4.1.2.    Use-specific risk mitigation measures
see general directions for use for Meta SPC 8
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 for Meta SPC 8
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 8
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 for Meta SPC 8
5.    GENERAL DIRECTIONS FOR USE   ( 8 )
OF THE META SPC 8
5.1.    Instructions for use
Apply the product immediately after each milking, two or three times per day. Ensure that the teat is completely covered to three quarter of its length. Fill the dipping cup with the desired amount of product, but do not use more fluid than necessary. Assume 5 mL per cow per treatment. Respect a contact time of five minutes. The product must be brought to a temperature above 20 °C before use. In order to ensure optimal teat disinfection, the animals should be kept standing for at least five minutes.
5.2.    Risk mitigation measures
Chemical goggles need to be worn.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Immediately call 112/ambulance for medical assistance.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
5.4.    Instructions for safe disposal of the product and its packaging
The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
6.    OTHER INFORMATION
/
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)
Kenolac
Market area: EU
Kenolac Red
Market area: EU
Kenodip 200
Market area: EU
Stalosan Lac Dip
Market area: EU
HCP Dip
Market area: EU
PEZERK LV PLUS
Market area: EU
MIROX Dip Lac
Market area: EU
Milchsäure Dip
Market area: EU
Milchsäure Tauche
Market area: EU
Lactocid Dip
Market area: EU
GAHERLAC
Market area: EU
Lactidip
Market area: EU
Lacticoop
Market area: EU
Lactactiv
Market area: EU
Laktotop
Market area: EU
Superlac
Market area: EU
MilchsäureFilmdip Super
Market area: EU
MEPA Lac
Market area: EU
Eco Lac
Market area: EU
BluGard Dip
Market area: EU
Blu-Gard Dip
Market area: EU
Authorisation number
EU-0027740-0008 1-8
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
3,6
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
1,3
Isopropanol
Propan-2-ol
Non-active substance
67-63-0
200-661-7
1,0
7.2.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Kenolac Forte W
Market area: EU
Authorisation number
EU-0027740-0009 1-8
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
7,5
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
1,3
Isopropanol
Propan-2-ol
Non-active substance
67-63-0
200-661-7
3,0
META SPC 9
1.    META SPC 9 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 9 identifier
Identifier
Meta SPC 9: Ready to use post-dips by spraying (PT3)
1.2.    Suffix to the authorisation number
Number
1-9
1.3.    Product type(s)
Product type(s)
PT03 – Veterinary hygiene (Disinfectants)
2.    META SPC 9 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 9
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Min
Max
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
3,6
7,5
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
0,5
1,3
Isopropanol
Propan-2-ol
Non-active substance
67-63-0
200-661-7
3,0
3,0
2.2.    Type(s) of formulation of the meta SPC 9
Formulation(s)
AL – Any other liquid
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9
Hazard statements
Causes serious eye damage.
Precautionary statements
Wear eye/face 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 doctor.
4.    AUTHORISED USE(S) OF THE META SPC 9
4.1.    Use description
Table 20
Use # 1 – Teat disinfection after milking by spraying or dipping
Product type
PT03 – Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other yeast
Common name: Yeasts
Development stage:
Field(s) of use
Indoor
Veterinary field:
RTU spray or dip for teat disinfection, after milking, without prior cleaning
Application method(s)
Method: by spraying or dipping
Detailed description:
By spraying or dipping
Application rate(s) and frequency
Application Rate: Active against bacteria and yeasts: RTU In five minutes contact time. The product must “return” to RT before use.
Dilution (%): -
Number and timing of application:
Active against bacteria and yeasts:
RTU (with 3.6 – 7,5 % Lactic acid depending on the product considered)
In five minutes contact time
The product must return to Room temperature before use
Category(ies) of users
Professional
Pack sizes and packaging material
1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg
HDPE (High Density Polyethylene)
4.1.1.    Use-specific instructions for use
see general directions for use for Meta SPC 9
4.1.2.    Use-specific risk mitigation measures
see general directions for use for Meta SPC 9
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 for Meta SPC 9
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 9
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 for Meta SPC 9
5.    GENERAL DIRECTIONS FOR USE   ( 9 )
OF THE META SPC 9
5.1.    Instructions for use
Apply the product immediately after each milking, two or three times per day. Ensure that the teat is completely covered to three quarter of its length. Fill the dipping cup or spraying flacon with the desired amount of the product, but do not use more fluid that necessary. Assume 5 mL per cow per treatment. Respect a contact time of five minutes.
The product must be brought to a temperature above 20 °C before use.
In order to ensure optimal teat disinfection, the animals should be kept standing for at least five minutes.
5.2.    Risk mitigation measures
Chemical goggles need to be worn.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Immediately call 112/ambulance for medical assistance.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
5.4.    Instructions for safe disposal of the product and its packaging
The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
6.    OTHER INFORMATION
/
7.    THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 9
7.1.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Kenolac SD
Market area: EU
HCP Spray
Market area: EU
Lactospray
Market area: EU
Zitzentop
Market area: EU
Lactosilk
Market area: EU
Milchsäure Spray Bühning
Market area: EU
Lacto SP
Market area: EU
Stalosan Lac Spray
Market area: EU
MIROX Spray Lac
Market area: EU
Milchsäure Sprühe
Market area: EU
Lactocid Spray
Market area: EU
Milcho Spray
Market area: EU
GAHERLAC SPRAY
Market area: EU
Lactispray
Market area: EU
Lacticoop Spray
Market area: EU
Lactactiv Spray
Market area: EU
Laktotop Spray
Market area: EU
Superlac Spray
Market area: EU
Robolac
Market area: EU
MEPA Lac SD
Market area: EU
Eco Lac SD
Market area: EU
Lely Quaress Circum
Market area: EU
BluGard Spray
Market area: EU
Blu-Gard Spray
Market area: EU
Authorisation number
EU-0027740-0010 1-9
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
3,6
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
1,3
Isopropanol
Propan-2-ol
Non-active substance
67-63-0
200-661-7
3,0
7.2.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Kenolac Forte SD
Market area: EU
Authorisation number
EU-0027740-0011 1-9
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
7,5
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
1,3
Isopropanol
Propan-2-ol
Non-active substance
67-63-0
200-661-7
3,0
7.3.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Valiant ULTRA EVERYDAY
Market area: EU
Authorisation number
EU-0027740-0018 1-9
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
4,0
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
1,3
Isopropanol
Propan-2-ol
Non-active substance
67-63-0
200-661-7
3,0
META SPC 10
1.    META SPC 10 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 10 identifier
Identifier
Meta SPC 10: Ready to use post-dips by spraying and dipping (PT3)
1.2.    Suffix to the authorisation number
Number
1-10
1.3.    Product type(s)
Product type(s)
PT03 – Veterinary hygiene (Disinfectants)
2.    META SPC 10 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 10
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Min
Max
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
3,6
3,6
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
0,05
0,05
2.2.    Type(s) of formulation of the meta SPC 10
Formulation(s)
AL – Any other liquid
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 10
Hazard statements
Flammable liquid and vapour.
Causes serious eye damage.
Contains menthan-3-one (CAS-No 14073-97-3). May produce an allergic reaction.
Precautionary statements
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
Wear eyes/face 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 doctor.
In case of fire:Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide to extinguish.
Store in a well-ventilated place.Keep cool.
Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
4.    AUTHORISED USE(S) OF THE META SPC 10
4.1.    Use description
Table 21
Use # 1 – Teat disinfection after milking by spraying or dipping
Product type
PT03 – Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:
Field(s) of use
Indoor
Veterinary field:
RTU spray/dip for teat disinfection, after milking, without prior cleaning
Application method(s)
Method: By spraying or dipping
Detailed description:
/
Application rate(s) and frequency
Application Rate: Active against bacteria and yeasts: RTU In five minutes contact time. The product must “return” to RT before use
Dilution (%): -
Number and timing of application:
Active against bacteria and yeasts:
RTU (with 3,6 % Lactic acid)
In five minutes contact time
Category(ies) of users
Professional
Pack sizes and packaging material
1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg
HDPE (High Density Polyethylene)
4.1.1.    Use-specific instructions for use
Application rates:
—
7.5 mL per cow working solution for use by spraying with flacon
—
15 mL per cow working solution for use by spraying in installation
—
15 mL per cow by for use by spraying with robot
—
2.5-5 mL per cow for use by dipping/foaming
4.1.2.    Use-specific risk mitigation measures
see general directions for use for Meta SPC 10
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 for Meta SPC 10
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 10
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 for Meta SPC 10
5.    GENERAL DIRECTIONS FOR USE   ( 10 )
OF THE META SPC 10
5.1.    Instructions for use
Apply the product immediately after each milking, two or three times per day. Ensure that the teat is completely covered to three quarter of its length. Fill the dipping cup or spraying flacon with the desired amount of product, but do not use more fluid that necessary. The product must be brought to a temperature above 20 °C before use.
In order to ensure optimal teat disinfection, the animals should be kept standing for at least five minutes.
5.2.    Risk mitigation measures
Chemical goggles need to be worn.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. If skin irritation occurs: Get medical advice.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Immediately call 112/ambulance for medical assistance.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance
5.4.    Instructions for safe disposal of the product and its packaging
The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
6.    OTHER INFORMATION
/
7.    THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 10
7.1.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Kenocool
Market area: EU
PEZERK LI PLUS
Market area: EU
Milcho Dip
Market area: EU
Authorisation number
EU-0027740-0012 1-10
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
3,6
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
0,05
META SPC 11
1.    META SPC 11 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 11 identifier
Identifier
Meta SPC 11: Concentrated Surface and equipment disinfectants (PT3 and PT4)
1.2.    Suffix to the authorisation number
Number
1-11
1.3.    Product type(s)
Product type(s)
PT04 – Food and feed area (Disinfectants)
PT03 – Veterinary hygiene (Disinfectants)
2.    META SPC 11 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 11
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Min
Max
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
24,0
24,0
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
12,0
12,0
Isopropanol
Propan-2-ol
Non-active substance
67-63-0
200-661-7
5,0
5,0
2.2.    Type(s) of formulation of the meta SPC 11
Formulation(s)
SL – Soluble concentrate
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 11
Hazard statements
Causes skin irritation.
Causes serious eye damage.
Precautionary statements
Wash hands thoroughly after handling.
Wear protective gloves.
Wear eyes/face protection.
IF ON SKIN:Wash with plenty of water.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Immediately call a doctor.
Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
4.    AUTHORISED USE(S) OF THE META SPC 11
4.1.    Use description
Table 22
Use # 1 – Hard surface disinfection in food and feed industry
Product type
PT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:
Field(s) of use
Indoor
in Food/feed industry + Public field:
Disinfection of hard/non-porous surfaces by spraying or soaking with prior cleaning
Application method(s)
Method: By spraying or by immersion
Detailed description:
Spraying
Immersion (the bath is intended to be used only once)
Application rate(s) and frequency
Application Rate: 100 mL/m 2
Dilution (%): 1 % or 3 %
Number and timing of application:
Active against bacteria and yeasts at room temperature:
—
3 % (with 0,72 % Lactic acid) in two minutes contact time
—
1 % (with 0,24 % Lactic acid) in 15 minutes contact time
Category(ies) of users
Professional
Pack sizes and packaging material
1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg
HDPE (High Density Polyethylene)
4.1.1.    Use-specific instructions for use
see general directions for use for Meta SPC 11
4.1.2.    Use-specific risk mitigation measures
see general directions for use for Meta SPC 11
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 for Meta SPC 11
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 11
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 for Meta SPC 11
4.2.    Use description
Table 23
Use # 2 – Equipment disinfection by soaking in food and feed industry
Product type
PT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:
Field(s) of use
Indoor
Indoor – in Food/feed industry + Public field:
Disinfection of hard/non-porous surfaces (for example processing machines) by spraying or soaking without prior cleaning
Application method(s)
Method: By spraying or immersion
Detailed description:
/
Application rate(s) and frequency
Application Rate: 100 mL/m 2
Dilution (%): 8 % or 15 %
Number and timing of application:
Active against bacteria and yeasts at +7 °C:
—
By soaking: 15 % (with 3,6 % Lactic acid) in 30 seconds contact time
—
By spraying: 8 % (with 1,92 % Lactic acid) in two minutes contact time
Category(ies) of users
Professional
Pack sizes and packaging material
1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg
HDPE (High Density Polyethylene)
4.2.1.    Use-specific instructions for use
see general directions for use for Meta SPC 11
4.2.2.    Use-specific risk mitigation measures
see general directions for use for Meta SPC 11
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 for Meta SPC 11
4.2.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 11
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 for Meta SPC 11
4.3.    Use description
Table 24
Use # 3 – Hard surface disinfection for veterinary hygiene
Product type
PT03 – Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Field(s) of use
Indoor
Veterinary field:
Disinfection of hard/non-porous surfaces by spraying or soaking with prior cleaning
Application method(s)
Method: By spraying or immersion
Detailed description:
Spraying
Immersion (the bath is intended to be used only once)
Application rate(s) and frequency
Application Rate: Active against bacteria and yeasts at +10 °C: 4 % in 30 minutes contact time
Dilution (%): 4 %
Number and timing of application:
Active against bacteria and yeasts at +10 °C:
4 % (with 0,96 % Lactic acid) in 30 minutes contact time
Category(ies) of users
Professional
Pack sizes and packaging material
1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg
HDPE (High Density Polyethylene)
4.3.1.    Use-specific instructions for use
Animal houses must be empty of animals during disinfection. The product is used to disinfect animal housings of pigs, cows, poultry. Clean the surfaces thoroughly with a detergent before disinfection. Rinse with clean water and remove surplus water.
Mixing and loading: container is opened manually and emptied into the reservoir or connected to a pump, which pumps the product into the reservoir of the spraying device which is then filled up with water in order to achieve the correct concentration of use. Apply the product by spraying or immersion. Use as much solution as needed to keep the surfaces wet during the complete contact time. It is not necessary to spray during the complete contact time.
4.3.2.    Use-specific risk mitigation measures
see general directions for use for Meta SPC 11
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 for Meta SPC 11
4.3.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 11
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 for Meta SPC 11
5.    GENERAL DIRECTIONS FOR USE   ( 11 )
OF THE META SPC 11
5.1.    Instructions for use
Disinfection procedures by spraying: The surfaces to be disinfected must be wet enough in order to be kept wet during the preconised contact time for optimal disinfection. The following precautionary sentence shall be added on the product label: “Make sure to wet surfaces completely”.
Products must be diluted in potable water before use.
5.2.    Risk mitigation measures
Gloves and goggles are needed during mixing and loading.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. If skin irritation occurs: Get medical advice.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Immediately call 112/ambulance for medical assistance.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance
5.4.    Instructions for safe disposal of the product and its packaging
The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
6.    OTHER INFORMATION
/
7.    THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 11
7.1.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Kenosan Lactic
Market area: EU
Lacto Des
Market area: EU
Bio Des 100
Market area: EU
Bio Lac
Market area: EU
Authorisation number
EU-0027740-0013 1-11
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
24,0
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
12,0
Isopropanol
Propan-2-ol
Non-active substance
67-63-0
200-661-7
5,0
META SPC 12
1.    META SPC 12 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 12 identifier
Identifier
Meta SPC 12: Inner surface disinfectants by CIP with and without circulation and crate wash (PT4)
1.2.    Suffix to the authorisation number
Number
1-12
1.3.    Product type(s)
Product type(s)
PT04 – Food and feed area (Disinfectants)
2.    META SPC 12 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 12
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Min
Max
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
22,0
22,0
C6 alkyl glucoside
Hexyl D-Glucoside
Non-active substance
54549-24-5
259-217-6
2,4
2,4
Methanesulfonic acid
Methanesulfonic acid
Non-active substance
75-75-2
200-898-6
0,0
10,5
Sulphuric acid
Sulphuric acid
Non-active substance
7664-93-9
231-639-5
0,0
10,5
2.2.    Type(s) of formulation of the meta SPC 12
Formulation(s)
SL – Soluble concentrate
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 12
Hazard statements
Causes severe skin burns and eye damage.
May be corrosive to metals.
Precautionary statements
Keep only in original packaging.
Do not breathe vapours.
Wash hands thoroughly after handling.
Wear protective gloves.
Wear protective clothing.
Wear eyes/face protection.
IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.
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.
Immediately call a doctor.
Absorb spillage to prevent material damage.
Wash contaminated clothing before reuse.
Store locked up.
Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
4.    AUTHORISED USE(S) OF THE META SPC 12
4.1.    Use description
Table 25
Use # 1 – Inner surface disinfection by CIP with circulation
Product type
PT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Field(s) of use
Indoor
in Food and feed industry:
Disinfection of hard/non-porous inner surfaces by CIP procedures (with circulation)
Application method(s)
Method: CIP procedures
Detailed description:
/
Application rate(s) and frequency
Application Rate: at +50 °C
Dilution (%): 1 to 4 %
Number and timing of application:
At +50 °C
Active against bacteria and yeasts:
—
with prior cleaning: 2 % (with 0,44 % Lactic acid) in two minutes contact time/1 % in 30 minutes contact time
—
without prior cleaning: 4 % (with 0,88 % Lactic acid) in two minutes contact time Or 1 % (0,22 % Lactic acid) in 30 minutes contact time
—
in milky conditions: 2 % (with 0,44 % Lactic acid) in 15 minutes contact time
Category(ies) of users
Professional
Pack sizes and packaging material
1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg
HDPE (High Density Polyethylene)
4.1.1.    Use-specific instructions for use
see general directions for use for Meta SPC 12
4.1.2.    Use-specific risk mitigation measures
see general directions for use for Meta SPC 12
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 for Meta SPC 12
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 12
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 for Meta SPC 12
4.2.    Use description
Table 26
Use # 2 – Inner surface disinfection by CIP without circulation
Product type
PT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:
Field(s) of use
Indoor
in Food and feed industry:
Disinfection of hard/non-porous inner surfaces by CIP procedures (without circulation)
Application method(s)
Method: CIP procedures
Detailed description:
/
Application rate(s) and frequency
Application Rate: At +50 °C
Dilution (%): 2 % or 4 %
Number and timing of application:
At +50 °C
Active against bacteria and yeasts:
—
with prior cleaning: 2 % (with 0,44 % Lactic acid) in two minutes contact time
—
without prior cleaning: 4 % (with 0,88 % Lactic acid) in two minutes contact time Or 2 % (with 0,44 % Lactic acid) in 30 minutes contact time
Category(ies) of users
Professional
Pack sizes and packaging material
1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg
HDPE (High Density Polyethylene)
4.2.1.    Use-specific instructions for use
see general directions for use for Meta SPC 12
4.2.2.    Use-specific risk mitigation measures
see general directions for use for Meta SPC 12
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 for Meta SPC 12
4.2.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 12
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 for Meta SPC 12
4.3.    Use description
Table 27
Use # 3 – Crate wash
Product type
PT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Field(s) of use
Indoor
Indoor – in Food and feed industry
disinfection of hard/non-porous surfaces in crate washers
Application method(s)
Method: Crate wash
Detailed description:
/
Application rate(s) and frequency
Application Rate: At +50 °C
Dilution (%): 2 % or 4 %
Number and timing of application:
At +50 °C
Active against bacteria and yeasts:
—
With prior cleaning: 2 % (with 0,44 % Lactic acid) in two minutes contact
—
without prior cleaning: 4 % (with 0,88 % Lactic acid) in two minutes contact
Category(ies) of users
Professional
Pack sizes and packaging material
1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg
HDPE (High Density Polyethylene)
4.3.1.    Use-specific instructions for use
see general directions for use for Meta SPC 12
4.3.2.    Use-specific risk mitigation measures
see general directions for use for Meta SPC 12
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 for Meta SPC 12
4.3.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 12
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 for Meta SPC 12
5.    GENERAL DIRECTIONS FOR USE   ( 12 )
OF THE META SPC 12
5.1.    Instructions for use
Products must be diluted in potable water before use.
5.2.    Risk mitigation measures
Gloves and goggles are needed during mixing and loading.
Wear protective coverall (to be specified by the authorisation holder within the product information).
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Immediately call a Call 112/ambulance for medical assistance.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance
5.4.    Instructions for safe disposal of the product and its packaging
The packing and content must be eliminated as dangerous waste product under the whole responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is 2 years.
6.    OTHER INFORMATION
/
7.    THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 12
7.1.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Pho Cid L
Market area: EU
Tornax 100
Market area: EU
Tornax Des
Market area: EU
Lacto CIP
Market area: EU
Pho Cid Eco
Market area: EU
Authorisation number
EU-0027740-0014 1-12
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
22,0
C6 alkyl glucoside
Hexyl D-Glucoside
Non-active substance
54549-24-5
259-217-6
2,4
Methanesulfonic acid
Methanesulfonic acid
Non-active substance
75-75-2
200-898-6
10,5
7.2.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Pho Cid LS
Market area: EU
Authorisation number
EU-0027740-0015 1-12
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
22,0
C6 alkyl glucoside
Hexyl D-Glucoside
Non-active substance
54549-24-5
259-217-6
2,4
Sulphuric acid
Sulphuric acid
Non-active substance
7664-93-9
231-639-5
10,5
META SPC 13
1.    META SPC 13 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 13 identifier
Identifier
Meta SPC 13: Hard surface disinfectants (PT4)
1.2.    Suffix to the authorisation number
Number
1-13
1.3.    Product type(s)
Product type(s)
PT04 – Food and feed area (Disinfectants)
2.    META SPC 13 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 13
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Min
Max
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
11,0
11,0
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
4,5
4,5
Methanesulfonic acid
Methanesulfonic acid
Non-active substance
75-75-2
200-898-6
10,5
19,5
2.2.    Type(s) of formulation of the meta SPC 13
Formulation(s)
SL – Soluble concentrate
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 13
Hazard statements
May be corrosive to metals.
Causes severe skin burns and eye damage.
Precautionary statements
Keep only in original packaging.
Do not breathe vapours.
Wash hands thoroughly after handling.
Wear protective gloves.
Wear protective clothing.
Wear eyes/face protection.
IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.
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.
Immediately call a doctor.
Absorb spillage to prevent material damage.
Wash contaminated clothing before reuse.
Store locked up.
Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
4.    AUTHORISED USE(S) OF THE META SPC 13
4.1.    Use description
Table 28
Use # 1 – Hard surface disinfection (PT4)
Product type
PT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:
Field(s) of use
Indoor
Food/feed areas
Disinfection of hard/non-porous surfaces by foaming
Application method(s)
Method: By foaming
Detailed description:
/
Application rate(s) and frequency
Application Rate: At room temperature in 30 minutes contact time Active against bacteria and yeasts: – with prior cleaning: 1 % – without prior cleaning: 5 %
Dilution (%): 1 or 5 %
Number and timing of application:
At room temperature in 30 minutes contact time
Active against bacteria and yeasts:
—
with prior cleaning: 1 % (with 0,11 % Lactic acid)
—
without prior cleaning: 5 % (with 0,55 % Lactic acid)
Category(ies) of users
Professional
Pack sizes and packaging material
1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg
HDPE (High Density Polyethylene)
4.1.1.    Use-specific instructions for use
see general directions for use for Meta SPC 13
4.1.2.    Use-specific risk mitigation measures
see general directions for use for Meta SPC 13
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 for Meta SPC 13
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 13
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 for Meta SPC 13
5.    GENERAL DIRECTIONS FOR USE   ( 13 )
OF THE META SPC 13
5.1.    Instructions for use
The surfaces to be disinfected must be wet enough in order to be kept wet during the preconised contact time for optimal disinfection.
The following precautionary sentence shall be added on the product label: “Make sure to wet surfaces completely”.
Products must be diluted in potable water before use.
5.2.    Risk mitigation measures
Gloves and goggles are needed during mixing and loading.
Wear protective coverall (to be specified by the authorisation holder within the product information).
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Immediately call 112/ambulance for medical assistance.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance
5.4.    Instructions for safe disposal of the product and its packaging
The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
6.    OTHER INFORMATION
/
7.    THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 13
7.1.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Tornax L
Market area: EU
Lacto Cid
Market area: EU
Authorisation number
EU-0027740-0016 1-13
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
11,0
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
4,5
Methanesulfonic acid
Methanesulfonic acid
Non-active substance
75-75-2
200-898-6
10,5
META SPC 14
1.    META SPC 14 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 14 identifier
Identifier
Meta SPC 14: Ready to use hygienic handrub (PT1)
1.2.    Suffix to the authorisation number
Number
1-14
1.3.    Product type(s)
Product type(s)
PT01 – Human hygiene (Disinfectants)
2.    META SPC 14 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 14
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Min
Max
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
3,6
3,6
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
2,0
2,0
Isopropanol
Propan-2-ol
Non-active substance
67-63-0
200-661-7
4,0
4,0
Butyldiglycol
2-(2-butoxyethoxy)ethanol
Non-active substance
112-34-5
203-961-6
10,0
10,0
2.2.    Type(s) of formulation of the meta SPC 14
Formulation(s)
AL – Any other liquid
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 14
Hazard statements
Causes serious eye damage.
Precautionary statements
Wear eye/face 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 doctor.
4.    AUTHORISED USE(S) OF THE META SPC 14
4.1.    Use description
Table 29
Use # 1 – Hygienic handrub, for professional use (PT1)
Product type
PT01 – Human hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:
Field(s) of use
Indoor
in Food/feed industry; Public field; Kitchens
Hygienic handrub, on visibly clean hands
Application method(s)
Method: By rubbing the hands
Detailed description:
/
Application rate(s) and frequency
Application Rate: 6 mL of product
Dilution (%): -
Number and timing of application:
Active against bacteria and yeasts:
RTU (with 3,6 % Lactic acid)
6 mL (that is three pushes for both hands together)
One minute contact time
Category(ies) of users
Professional
Pack sizes and packaging material
50 mL, 75 mL, 100 mL, 150 mL, 500 mL, 1L, 5L, 10L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L
HDPE (High Density Polyethylene)
4.1.1.    Use-specific instructions for use
see general directions for use for Meta SPC 14
4.1.2.    Use-specific risk mitigation measures
/
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 for Meta SPC 14
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 14
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 for Meta SPC 14
5.    GENERAL DIRECTIONS FOR USE   ( 14 )
OF THE META SPC 14
5.1.    Instructions for use
Apply 6 ml of the product undiluted. Respect a contact time of 1 minute. Rinse thoroughly after disinfection.
For professional use only
5.2.    Risk mitigation measures
/
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Immediately call 112/ambulance for medical assistance.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance
5.4.    Instructions for safe disposal of the product and its packaging
The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
6.    OTHER INFORMATION
/
7.    THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 14
7.1.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Kenosan Hand Rub
Market area: EU
Authorisation number
EU-0027740-0017 1-14
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
Active Substance
79-33-4
201-196-2
3,6
Sodium Lauryl sulphate
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Non-active substance
85586-07-8
287-809-4
2,0
Isopropanol
Propan-2-ol
Non-active substance
67-63-0
200-661-7
4,0
Butyldiglycol
2-(2-butoxyethoxy)ethanol
Non-active substance
112-34-5
203-961-6
10,0
’
( 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.
( 9 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 9.
( 10 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 10.
( 11 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 11.
( 12 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 12.
( 13 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 13.
( 14 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 14.
Schedules & Appendices

Cite this act
