Commission Implementing Regulation (EU) 2025/523 of 20 March 2025 amending Implementing Regulation (EU) 2023/1311 as regards administrative changes to the Union authorisation for the biocidal product family CVAS Biocidal Product Family based on L(+) Lactic Acid

ANNEXSummary of product characteristics for a biocidal product family
ANNEX
Summary of product characteristics for a biocidal product family
CVAS Biocidal Product Family based on L(+) Lactic Acid
Product type(s)
PT03: Veterinary hygiene
PT04: Food and feed area
Authorisation number EU-0028957-0000
R4BP asset number EU-0028957-0000
PART I
FIRST INFORMATION LEVEL
1.    ADMINISTRATIVE INFORMATION
1.1.    Family name
Name
CVAS Biocidal Product Family based on L(+) Lactic Acid
1.2.    Product type(s)
Product type(s)
PT03: Veterinary hygiene
PT04: Food and feed area
1.3.    Authorisation holder
Name and address of the authorisation holder
Name
CVAS Development GmbH
Address
Am Hafen 16 68526 Ladenburg DE
Authorisation number
EU-0028957-0000
R4BP asset number
EU-0028957-0000
Date of the authorisation
18.7.2023
Expiry date of the authorisation
30.6.2033
1.4.    Manufacturer(s) of the product
Name of manufacturer
Calvatis GmbH
Address of manufacturer
Am Hafen 16 68526 Ladenburg Germany
Location of manufacturing sites
Calvatis GmbH site 1
Am Hafen 16 68526 Ladenburg Germany
Name of manufacturer
Arthur Schopf Hygiene GmbH & Co. KG
Address of manufacturer
Pfaffensteinstraße 1 83115 Neubeuern Germany
Location of manufacturing sites
Arthur Schopf Hygiene GmbH & Co. KG site 1
Pfaffensteinstraße 1 83115 Neubeuern Germany
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 4206AC Gorinchem Netherlands (the)
Location of manufacturing sites
Purac Biochem bv site 1
Arkelsedijk 46 4206AC Gorinchem Netherlands (the)
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 (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
1,92 - 17,6 % (w/w)
Methanesulphonic acid
Methanesulphonic acid
Non-Active substance
75-75-2
200-898-6
0 - 10,5 % (w/w)
Phosphoric acid
Phosphoric acid
Non-Active substance
7664-38-2
231-633-2
0 - 18,75 % (w/w)
Sulphuric acid
Sulphuric acid
Non-Active substance
7664-93-9
231-639-5
0 - 4,5 % (w/w)
Isononanoic acid
Isononanoic acid
Non-Active substance
3302-10-1
221-975-0
0 - 2,5 % (w/w)
2.2.    Type(s) of formulation
Formulation type(s)
AL Any other liquid
SL Soluble concentrate
PART II
SECOND INFORMATION LEVEL - META SPC(S)
1.    META SPC 1 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 1 identifier
Identifier
Meta SPC: mSPC1
1.2.    Suffix to the authorisation number
Number
1-1
1.3.    Product type(s)
Product type(s)
PT03: Veterinary hygiene
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 (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
1,92 - 1,96 % (w/w)
2.2.    Type(s) of formulation of the meta SPC 1
Formulation type(s)
AL Any other liquid
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
Hazard statements
Precautionary statements
4.    AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1
Use # 1.1 – Teat-disinfection post-milking by manual or automated dipping
Product type
PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Field(s) of use
indoor use
Teat-disinfection post-milking
Application method(s)
Method: Dipping
Detailed description:
Teat-disinfection post-milkingManual dipping using a dip cupAutomated dipping by robot
Application rate(s) and frequency
Application rate: Ready-To-Use (RTU) product, 1,92-1,96% L-(+)-lactic acid -
Number and timing of application:
2-3 times a day (after each milking)
Category(ies) of users
professional
Pack sizes and packaging material
High density polyethylene (HDPE) jerrycan: 5-60 kg
HDPE drum: 60-200 kg
HDPE Intermediate Bulk Container (IBC): 600-1000 kg
4.1.1.    Use-specific instructions
See general directions for use.
4.1.2.    Use-specific risk mitigation measures
See general directions for use.
4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
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.
5.    GENERAL DIRECTIONS FOR USE OF THE META SPC 1
5.1.    Instructions for use
The product must be brought to a temperature between 20°C and 30°C before use.
The use of a dosing pump for filling the product into the application equipment is recommended.
Fill in the dosing pump reservoir with the RTU product. Avoid discharge of surplus fluids.
Apply the product by manual or automated dipping. Make sure that the teats are fully covered with disinfectant. Application volumes for cows and buffaloes - 5 ml/treatment and for sheep and goats - 3 ml/treatment.
Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.
After disinfection clean the application equipment by rinsing with water.
5.2.    Risk mitigation measures
None
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid instructions
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: if symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.
IF SWALLOWED: if symptoms occur call a POISON CENTRE or a doctor.
Emergency measure to protect the environment
Environmental precautions: do not allow product to reach sewage systems or water bodies.
Methods and material for containment and cleaning up: absorb with liquid-binding material (sand, diatomite, universal binder). Do not use combustible material like
sawdust. Dispose of the material collected in accordance with local regulations.
5.4.    Instructions for safe disposal of the product and its packaging
At the end of the treatment, dispose unused product and the packaging in accordance with local requirements.
Used product can be flushed to municipal sewer or disposed to the manure deposit depending on local requirements.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf life: 24 months
Do not store at temperatures above 40°C.
Keep away from heat and direct sunlight.
Protect from frost.
Keep container tightly closed.
6.    OTHER INFORMATION
Not relevant
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)
calgodip Amadine Film
Market area: EU
AGRIMARKT MILCHSÄUREMANTEL
Market area: EU
IWETEC MILCHSÄURE DIPP
Market area: EU
Fulldip Lacti Film
Market area: EU
CareDip Film
Market area: EU
Milchsäure Film
Market area: EU
Lactoboost Film
Market area: EU
Bonimal CARE Lac Dip
Market area: EU
Bonimal CARE LactiVital Dip
Market area: EU
Impos Filmdipp M
Market area: EU
Melkpower Filmdipp M
Market area: EU
Authorisation number
EU-0028957-0001 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
1,92 % (w/w)
7.2.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Dip es lac DL
Market area: EU
Traylac O-F
Market area: EU
Baktostop Lactic
Market area: EU
Lacti-Bac Dip
Market area: EU
DS 1.0 F
Market area: EU
Authorisation number
EU-0028957-0002 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
1,92 % (w/w)
7.3.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
calgodip Blue Kamille Film
Market area: EU
HappyFarm KamillDip Film
Market area: EU
Lacto Film
Market area: EU
MS Film
Market area: EU
LA Film
Market area: EU
BestFarm Blue Dip Film
Market area: EU
Bonimal CARE Milky Dip
Market area: EU
Bonimal CARE Milki Dip
Market area: EU
Bonimal CARE Milk Dip
Market area: EU
PQ-Blue Film
Market area: EU
Dipp Top
Market area: EU
Authorisation number
EU-0028957-0003 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
1,92 % (w/w)
7.4.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Dip es protect DL
Market area: EU
BaktoStop lactic H
Market area: EU
Dip Agro Protect
Market area: EU
Kuhmilin Dip Top M
Market area: EU
Lacti-Protect Dip
Market area: EU
DSR 1.5 F
Market area: EU
ProfiMix inSilk
Market area: EU
Authorisation number
EU-0028957-0004 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
1,92 % (w/w)
1.    META SPC 2 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 2 identifier
Identifier
Meta SPC: mSPC2
1.2.    Suffix to the authorisation number
Number
1-2
1.3.    Product type(s)
Product type(s)
PT03: Veterinary hygiene
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 (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
6,8 - 6,8 % (w/w)
2.2.    Type(s) of formulation of the meta SPC 2
Formulation type(s)
AL Any other liquid
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
Hazard statements
H315: Causes skin irritation.
H318: Causes serious eye damage.
Precautionary statements
P264: Wash hands thoroughly after handling.
P280: Wear protective gloves.
P280: Wear eye protection.
P302+P352: IF ON SKIN: Wash with plenty of water.
P332+P313: If skin irritation occurs: Get medical advice.
P332+P313: If skin irritation occurs: Get medical attention.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310: Immediately call a POISON CENTER.
P310: Immediately call a doctor.
P501: Dispose of contents to in accordance with local regulations.
P501: Dispose of container to in accordance with local regulations.
4.    AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1
Use # 2.1 – Teat-disinfection post-milking by manual or automated dipping
Product type
PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Field(s) of use
indoor use
Teat-disinfection post-milking
Application method(s)
Method: Dipping
Detailed description:
Teat-disinfection post-milkingManual dipping using a dip cupAutomated dipping by robot
Application rate(s) and frequency
Application rate: RTU product, 6,80% L-(+)-lactic acid -
Number and timing of application:
2-3 times a day (after each milking)
Category(ies) of users
professional
Pack sizes and packaging material
HDPE jerrycan: 5-60 kg
HDPE drum: 60-200 kg
HDPE IBC: 600-1000 kg
4.1.1.    Use-specific instructions
See general directions for use.
4.1.2.    Use-specific risk mitigation measures
See general directions for use.
4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
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.
5.    GENERAL DIRECTIONS FOR USE OF THE META SPC 2
5.1.    Instructions for use
The product must be brought to a temperature between 20°C and 30°C before use.
The use of a dosing pump for filling the product into the application equipment is recommended.
Fill in the dosing pump reservoir with the RTU product. Avoid discharge of surplus fluids.
Apply the product by manual or automated dipping. Make sure that the teats are fully covered with disinfectant. Application volumes for cows and buffaloes - 5 ml/treatment and for sheep and goats - 3 ml/treatment.
Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.
After disinfection clean the application equipment by rinsing with water.
Keep out of reach of children.
5.2.    Risk mitigation measures
Wear chemical goggles consistent with the European Standard EN ISO 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN ISO 374 or equivalent. See section 6 for the full titles of the EN standards.
Google, gloves and coverall material to be specified by the authorisation holder within the product information.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to this act.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid instructions
IF INHALED: if symptoms occur call a POISON CENTRE or a doctor.
IF ON SKIN: take off all contaminated clothing and wash it before reuse. Wash skin with water. 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. Call 112 or an 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 or an ambulance for medical assistance.
Emergency measure to protect the environment
Environmental precautions: do not allow product to reach sewage systems or water bodies.
Methods and material for containment and cleaning up: absorb with liquid-binding material (sand, diatomite, universal binder). Do not use combustible material like sawdust. Dispose of the material collected in accordance with local regulations.
5.4.    Instructions for safe disposal of the product and its packaging
At the end of the treatment, dispose unused product and the packaging in accordance with local requirements.
Used product can be flushed to municipal sewer or disposed to the manure deposit depending on local requirements.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf life: 24 months
Do not store at temperatures above 40°C.
Keep away from heat and direct sunlight.
Protect from frost.
Keep container tightly closed.
6.    OTHER INFORMATION
The full titles of EN standards mentioned in the section 5.2 ‘Risk mitigation measures’ are:
EN ISO 16321– Eye and face protection for occupational users.
EN ISO 374 – Protective gloves against dangerous chemicals and micro-organisms.
The full reference of the legal act mentioned in the section 5.2 ‘Risk mitigation measures’ is:
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) ( OJ L 131, 5.5.1998, p. 11 ).
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)
calgodip Amadine forte Film
Market area: EU
Authorisation number
EU-0028957-0005 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
6,8 % (w/w)
7.2.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Dip es lac DLX
Market area: EU
Authorisation number
EU-0028957-0006 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
6,8 % (w/w)
7.3.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
calgodip Blue Kamille forte Film
Market area: EU
Authorisation number
EU-0028957-0007 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
6,8 % (w/w)
7.4.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Dip es protect DLX
Market area: EU
Authorisation number
EU-0028957-0008 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
6,8 % (w/w)
1.    META SPC 3 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 3 identifier
Identifier
Meta SPC: mSPC3
1.2.    Suffix to the authorisation number
Number
1-3
1.3.    Product type(s)
Product type(s)
PT03: Veterinary hygiene
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 (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
1,92 - 1,96 % (w/w)
2.2.    Type(s) of formulation of the meta SPC 3
Formulation type(s)
AL Any other liquid
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
Hazard statements
Precautionary statements
4.    AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1
Use # 3.1 – Teat-disinfection post-milking by manual or automated dipping or spraying
Product type
PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Field(s) of use
indoor use
Teat-disinfection post-milking
Application method(s)
Method: Dipping
Detailed description:
Teat-disinfection post-milkingManual dipping using a dip cupAutomated dipping by robot
Method: Spraying
Detailed description:
Teat-disinfection post-milkingManual spraying using a trigger sprayerManual spraying using an electronic sprayerAutomated spraying by robot
Application rate(s) and frequency
Application rate: RTU product, 1,92-1,96% L-(+)-lactic acid -
Number and timing of application:
2-3 times a day (after each milking)
Application rate: RTU product, 1,92-1,96% L-(+)-lactic acid -
Number and timing of application:
2-3 times a day (after each milking)
Category(ies) of users
professional
Pack sizes and packaging material
HDPE jerrycan: 5-60 kg
HDPE drum: 60-200 kg
HDPE IBC: 600-1000 kg
4.1.1.    Use-specific instructions
See general directions for use.
4.1.2.    Use-specific risk mitigation measures
See general directions for use.
4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
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.
5.    GENERAL DIRECTIONS FOR USE OF THE META SPC 3
5.1.    Instructions for use
The product must be brought to a temperature between 20°C and 30°C before use.
The use of a dosing pump for filling the product into the application equipment is recommended.
Fill in the dosing pump reservoir with the RTU product. Avoid discharge of surplus fluids.
Apply the product by manual or automated dipping or spraying. Make sure that the teats are fully covered with disinfectant. Application volumes for cows and buffaloes - 5 ml/treatment and for sheep and goats - 3 ml/treatment.
Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.
After disinfection clean the application equipment by rinsing with water.
5.2.    Risk mitigation measures
None
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid instructions
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: if symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.
IF SWALLOWED: if symptoms occur call a POISON CENTRE or a doctor.
Emergency measure to protect the environment
Environmental precautions: do not allow product to reach sewage systems or water bodies.
Methods and material for containment and cleaning up: absorb with liquid-binding material (sand, diatomite, universal binder). Do not use combustible material like sawdust. Dispose of the material collected in accordance with local regulations.
5.4.    Instructions for safe disposal of the product and its packaging
At the end of the treatment, dispose unused product and the packaging in accordance with local requirements.
Used product can be flushed to municipal sewer or disposed to the manure deposit depending on local requirements.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf life: 24 months
Do not store at temperatures above 40°C.
Keep away from heat and direct sunlight.
Protect from frost.
Keep container tightly closed.
6.    OTHER INFORMATION
Not relevant
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)
calgodip Amadine Spray
Market area: EU
AGRIMARKT MILCHSÄURENEBEL
Market area: EU
IWETEC MILCHSÄURE SPRAY
Market area: EU
Fulldip Lacti Spray
Market area: EU
CareDip Spray
Market area: EU
Milchsäure Spray
Market area: EU
Lactoboost Spray
Market area: EU
Care4cows Lactic Acid Spray
Market area: EU
Bonimal CARE Lac Spray
Market area: EU
Bonimal CARE LactiVital Spray
Market area: EU
Authorisation number
EU-0028957-0009 1-3
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
1,92 % (w/w)
7.2.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Dip es lac DL Spray
Market area: EU
Traylac O-S
Market area: EU
Lacti-Bac Spray
Market area: EU
DS 1.0 S
Market area: EU
Authorisation number
EU-0028957-0010 1-3
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
1,92 % (w/w)
7.3.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
calgodip Blue Kamille Spray
Market area: EU
HappyFarm KamillDip Spray
Market area: EU
Lacto Spray
Market area: EU
MS Spray
Market area: EU
LA Spray
Market area: EU
Care4Cows Lactic Acid Kamille Spray
Market area: EU
BestFarm Blue Dip Spray
Market area: EU
Bonimal CARE Milky Spray
Market area: EU
Bonimal CARE Milki Spray
Market area: EU
Bonimal CARE Milk Spray
Market area: EU
PQ-Blue Spray
Market area: EU
Authorisation number
EU-0028957-0011 1-3
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
1,92 % (w/w)
7.4.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Dip es protect DL Spray
Market area: EU
Dip Agro Protect SP
Market area: EU
Kuhmilin Sprüh Top M
Market area: EU
Lacti-Protect Spray
Market area: EU
DSR 1.5 S
Market area: EU
Authorisation number
EU-0028957-0012 1-3
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
1,92 % (w/w)
1.    META SPC 4 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 4 identifier
Identifier
Meta SPC: mSPC4
1.2.    Suffix to the authorisation number
Number
1-4
1.3.    Product type(s)
Product type(s)
PT03: Veterinary hygiene
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 (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
6,8 - 6,8 % (w/w)
2.2.    Type(s) of formulation of the meta SPC 4
Formulation type(s)
AL Any other liquid
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
Hazard statements
H315: Causes skin irritation.
H318: Causes serious eye damage.
Precautionary statements
P264: Wash hands thoroughly after handling.
P280: Wear protective gloves.
P280: Wear eye protection.
P302+P352: IF ON SKIN: Wash with plenty of water.
P332+P313: If skin irritation occurs: Get medical advice.
P332+P313: If skin irritation occurs: Get medical attention.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310: Immediately call a POISON CENTER.
P310: Immediately call a doctor.
P501: Dispose of contents to in accordance with local regulations.
P501: Dispose of container to in accordance with local regulations.
4.    AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1
Use # 4.1 – Teat-disinfection post-milking by manual or automated dipping or spraying
Product type
PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Field(s) of use
indoor use
Teat-disinfection post-milking
Application method(s)
Method: Dipping
Detailed description:
Teat-disinfection post-milkingManual dipping using a dip cupAutomated dipping by robot
Method: Spraying
Detailed description:
Teat-disinfection post-milkingManual spraying using a trigger sprayerManual spraying using an electronic sprayerAutomated spraying by robot
Application rate(s) and frequency
Application rate: RTU product, 6,80% L-(+)-lactic acid -
Number and timing of application:
2-3 times a day (after each milking)
Application rate: RTU product, 6,80% L-(+)-lactic acid -
Number and timing of application:
2-3 times a day (after each milking)
Category(ies) of users
professional
Pack sizes and packaging material
HDPE jerrycan: 5-60 kg
HDPE drum: 60-200 kg
HDPE IBC: 600-1000 kg
4.1.1.    Use-specific instructions
See general directions for use.
4.1.2.    Use-specific risk mitigation measures
See general directions for use.
4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
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.
5.    GENERAL DIRECTIONS FOR USE OF THE META SPC 4
5.1.    Instructions for use
The product must be brought to a temperature between 20°C and 30°C before use.
The use of a dosing pump for filling the product into the application equipment is recommended.
Fill in the dosing pump reservoir with the RTU product. Avoid discharge of surplus fluids.
Apply the product by manual or automated dipping or spraying. Make sure that the teats are fully covered with disinfectant. Application volumes for cows and buffaloes - 5 ml/treatment and for sheep and goats - 3 ml/treatment.
Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.
After disinfection clean the application equipment by rinsing with water.
Keep out of reach of children.
5.2.    Risk mitigation measures
Wear chemical goggles consistent with the European Standard EN ISO 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN ISO 374 or equivalent.
Google, gloves and coverall material to be specified by the authorisation holder within the product information.
This is without prejudice to the application of Directive 98/24/EC and other Union legislation in the area of health and safety at work.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid instructions
IF INHALED: if symptoms occur call a POISON CENTRE or a doctor.
IF ON SKIN: take off all contaminated clothing and wash it before reuse. Wash skin with water. 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. Call 112 or an 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 or an ambulance for medical assistance.
Emergency measure to protect the environment
Environmental precautions: do not allow product to reach sewage systems or water bodies.
Methods and material for containment and cleaning up: absorb with liquid-binding material (sand, diatomite, universal binder). Do not use combustible material like
sawdust. Dispose of the material collected in accordance with local regulations.
5.4.    Instructions for safe disposal of the product and its packaging
At the end of the treatment, dispose unused product and the packaging in accordance with local requirements.
Used product can be flushed to municipal sewer or disposed to the manure deposit depending on local requirements.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf life: 24 months
Do not store at temperatures above 40°C.
Keep away from heat and direct sunlight.
Protect from frost.
Keep container tightly closed.
6.    OTHER INFORMATION
Not relevant
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)
calgodip Amadine forte Spray
Market area: EU
Authorisation number
EU-0028957-0013 1-4
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
6,8 % (w/w)
7.2.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Dip es lac DLX Spray
Market area: EU
Authorisation number
EU-0028957-0014 1-4
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
6,8 % (w/w)
7.3.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
calgodip Blue Kamille forte Spray
Market area: EU
Authorisation number
EU-0028957-0015 1-4
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
6,8 % (w/w)
7.4.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Dip es protect DLX Spray
Market area: EU
Authorisation number
EU-0028957-0016 1-4
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
6,8 % (w/w)
1.    META SPC 5 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 5 identifier
Identifier
Meta SPC: mSPC5
1.2.    Suffix to the authorisation number
Number
1-5
1.3.    Product type(s)
Product type(s)
PT03: Veterinary hygiene
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 (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
1,92 - 1,96 %(w/w)
2.2.    Type(s) of formulation of the meta SPC 5
Formulation type(s)
AL Any other liquid
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
Hazard statements
H315: Causes skin irritation.
H319: Causes serious eye irritation.
Precautionary statements
P264: Wash hands thoroughly after handling.
P280: Wear protective gloves.
P280: Wear eye protection.
P302+P352: IF ON SKIN: Wash with plenty of water.
P332+P313: If skin irritation occurs: Get medical advice.
P332+P313: If skin irritation occurs: Get medical attention.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice.
P337+P313: If eye irritation persists: Get medical attention.
P501: Dispose of container to in accordance with local regulations.
P501: Dispose of contents to in accordance with local regulations.
4.    AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1
Use # 5.1 – Teat-disinfection post-milking by manual or automated dipping or spraying
Product type
PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Field(s) of use
indoor use
Teat-disinfection post-milking
Application method(s)
Method: Dipping
Detailed description:
Teat-disinfection post-milkingManual dipping using a dip cupAutomated dipping by robot
Method: Spraying
Detailed description:
Teat-disinfection post-milkingManual spraying using a trigger sprayerManual spraying using an electronic sprayerAutomated spraying by robot
Application rate(s) and frequency
Application rate: RTU product, 1,92-1,96% L-(+)-lactic acid -
Number and timing of application:
2-3 times a day (after each milking)
Application rate: RTU product, 1,92-1,96% L-(+)-lactic acid -
Number and timing of application:
2-3 times a day (after each milking)
Category(ies) of users
professional
Pack sizes and packaging material
HDPE jerrycan: 5-60 kg
HDPE drum: 60-200 kg
HDPE IBC: 600-1000 kg
4.1.1.    Use-specific instructions
See general directions for use.
4.1.2.    Use-specific risk mitigation measures
See general directions for use.
4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
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.
5.    GENERAL DIRECTIONS FOR USE OF THE META SPC 5
5.1.    Instructions for use
The product must be brought to a temperature between 20°C and 30°C before use.
The use of a dosing pump for filling the product into the application equipment is recommended.
Fill in the dosing pump reservoir with the RTU product. Avoid discharge of surplus fluids.
Apply the product by manual or automated dipping or spraying. Make sure that the teats are fully covered with disinfectant. Application volumes for cows and buffaloes - 5 ml/treatment and for sheep and goats - 3 ml/treatment.
Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.
After disinfection clean the application equipment by rinsing with water.
Keep out of reach of children.
5.2.    Risk mitigation measures
Wear chemical goggles consistent with the European Standard EN ISO 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN ISO 374 or equivalent.
Google, gloves and coverall material to be specified by the authorisation holder within the product information.
This is without prejudice to the application of Directive 98/24/EC and other Union legislation in the area of health and safety at work.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid instructions
IF INHALED: if symptoms occur call a POISON CENTRE or a doctor.
IF ON SKIN: take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.
IF IN EYES: rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF SWALLOWED: rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.
Emergency measure to protect the environment
Environmental precautions: no special environmental measures are necessary. Clean contaminated articles and floor in accordance with the environmental legislation.
Methods and material for containment: absorb with liquid-binding material (e.g. sand, diatomaceous earth, acid- or universal binding agents).
5.4.    Instructions for safe disposal of the product and its packaging
At the end of the application, dispose unused product and the packaging in accordance with local requirements.
Used product can be flushed to municipal sewer or disposed to the manure deposit depending on local requirements.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf life: 24 months
Do not store at temperatures above 40°C.
Keep away from heat and direct sunlight.
Protect from frost.
Keep container tightly closed.
6.    OTHER INFORMATION
Not relevant
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)
Dip es poly-film Spray
Market area: EU
Lacti-Shield Spray
Market area: EU
DS 2.0 SP
Market area: EU
Authorisation number
EU-0028957-0017 1-5
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
1,92 % (w/w)
1.    META SPC 6 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 6 identifier
Identifier
Meta SPC: mSPC6
1.2.    Suffix to the authorisation number
Number
1-6
1.3.    Product type(s)
Product type(s)
PT03: Veterinary hygiene
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 (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
6,8 - 6,8 % (w/w)
2.2.    Type(s) of formulation of the meta SPC 6
Formulation type(s)
AL Any other liquid
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6
Hazard statements
H315: Causes skin irritation.
H318: Causes serious eye damage.
Precautionary statements
P264: Wash hands thoroughly after handling.
P280: Wear protective gloves.
P280: Wear eye protection.
P302+P352: IF ON SKIN: Wash with plenty of water.
P332+P313: If skin irritation occurs: Get medical advice.
P332+P313: If skin irritation occurs: Get medical attention.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310: Immediately call a POISON CENTER.
P310: Immediately call a doctor.
P501: Dispose of contents to in accordance with local regulations.
P501: Dispose of container to in accordance with local regulations.
4.    AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1
Use # 6.1 – Teat-disinfection post-milking by manual or automated dipping or spraying
Product type
PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Field(s) of use
indoor use
Teat-disinfection post-milking
Application method(s)
Method: Dipping
Detailed description:
Teat-disinfection post-milkingManual dipping using a dip cupAutomated dipping by robot
Method: Spraying
Detailed description:
Teat-disinfection post-milkingManual spraying using a trigger sprayerManual spraying using an electronic sprayerAutomated spraying by robot
Application rate(s) and frequency
Application rate: RTU product, 6,80% L-(+)-lactic acid -
Number and timing of application:
2-3 times a day (after each milking)
Application rate: RTU product, 6,80% L-(+)-lactic acid -
Number and timing of application:
2-3 times a day (after each milking)
Category(ies) of users
professional
Pack sizes and packaging material
HDPE jerrycan: 5-60 kg
HDPE drum: 60-200 kg
HDPE IBC: 600-1000 kg
4.1.1.    Use-specific instructions
See general directions for use.
4.1.2.    Use-specific risk mitigation measures
See general directions for use.
4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
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.
5.    GENERAL DIRECTIONS FOR USE OF THE META SPC 6
5.1.    Instructions for use
The product must be brought to a temperature between 20°C and 30°C before use.
The use of a dosing pump for filling the product into the application equipment is recommended.
Fill in the dosing pump reservoir with the RTU product. Avoid discharge of surplus fluids.
Apply the product by manual or automated dipping or spraying. Make sure that the teats are fully covered with disinfectant. Application volumes for cows and buffaloes - 5 ml/treatment and for sheep and goats - 3 ml/treatment.
Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.
After disinfection clean the application equipment by rinsing with water.
Keep out of reach of children.
5.2.    Risk mitigation measures
Wear chemical goggles consistent with the European Standard EN ISO 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN ISO 374 or equivalent.
Google, gloves and coverall material to be specified by the authorisation holder within the product information.
This is without prejudice to the application of Directive 98/24/EC and other Union legislation in the area of health and safety at work.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid instructions
IF INHALED: if symptoms occur call a POISON CENTRE or a doctor.
IF ON SKIN: take off all contaminated clothing and wash it before reuse. Wash skin with water. 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. Call 112 or an 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 or an ambulance for medical assistance.
Emergency measure to protect the environment
Environmental precautions: no special environmental measures are necessary. Clean contaminated articles and floor in accordance with the environmental legislation.
Methods and material for containment: absorb with liquid-binding material (e.g. sand, diatomaceous earth, acid- or universal binding agents).
5.4.    Instructions for safe disposal of the product and its packaging
At the end of the application, dispose unused product and the packaging in accordance with local requirements.
Used product can be flushed to municipal sewer or disposed to the manure deposit depending on local requirements.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf life: 24 months
Do not store at temperatures above 40°C.
Keep away from heat and direct sunlight.
Protect from frost.
Keep container tightly closed.
6.    OTHER INFORMATION
Not relevant
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)
Dip es poly-spray DLX
Market area: EU
Authorisation number
EU-0028957-0018 1-6
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
6,8 % (w/w)
1.    META SPC 7 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 7 identifier
Identifier
Meta SPC: mSPC7
1.2.    Suffix to the authorisation number
Number
1-7
1.3.    Product type(s)
Product type(s)
PT04: Food and feed area
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 (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
16 - 17,6 % (w/w)
Methanesulphonic acid
Methanesulphonic acid
Non-Active substance
75-75-2
200-898-6
6,3 - 7 % (w/w)
2.2.    Type(s) of formulation of the meta SPC 7
Formulation type(s)
SL Soluble concentrate
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7
Hazard statements
H290: May be corrosive to metals.
H314: Causes severe skin burns and eye damage.
EUH071: Corrosive to the respiratory tract.
Precautionary statements
P260: Do not breathe spray.
P280: Wear protective gloves.
P280: Wear protective clothing.
P280: Wear eye protection.
P280: Wear face protection.
P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting.
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310: Immediately call a doctor.
P310: Immediately call a POISON CENTER.
P406: Store in a corrosion resistant container with a resistant inner liner.
P501: Dispose of contents to in accordance with local regulations.
P501: Dispose of container to in accordance with local regulations.
4.    AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1
Use # 7.1 – Hard surface disinfection by manual or automated foaming
Product type
PT04: Food and feed area
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Field(s) of use
indoor use
Hard surface disinfection
Application method(s)
Method: Foaming
Detailed description:
Hard surface disinfection Manual foaming using a foam lanceAutomated foaming with fixed installed foaming nozzlesFoaming equipmentSatellite stations: fixed installations connected to jerrycans, drums or IBCs and mobile trolleys equipped with 20 litres container of concentrated product
Application rate(s) and frequency
Application rate: Concentrated product, 16,0-17,6% L-(+)-lactic acid Bactericidal claim: 5,0% (w/w) dilution of the product, 0,80-0,88% L-(+)-lactic acid Yeasticidal claim: 5,0% (w/w) dilution of the product, 0,80-0,88% L-(+)-lactic acid
Number and timing of application:
once a day
Category(ies) of users
professional
Pack sizes and packaging material
HDPE jerrycan: 5-60 kg
HDPE drum: 60-200 kg
HDPE IBC: 600-1000 kg
4.1.1.    Use-specific instructions
See general directions for use.
4.1.2.    Use-specific risk mitigation measures
See general directions for use.
4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
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.
5.    GENERAL DIRECTIONS FOR USE OF THE META SPC 7
5.1.    Instructions for use
For fixed installations, connect the jerrycan, drum or IBC containing the product with the dosing unit of the satellite station. For mobile versions, place a 20 litres container of the neat product on the trolley and put the suction hose in. Connect water supply to the dosing unit. Dilution is performed automatically via the dosing unit of the fixed or mobile station and monitored by conductivity measurements.
Before disinfection remove loose dirt, any further precleaning is not necessary.
Apply the foam to the hard surfaces. Application volume is 350 ml of diluted product/m 2 . Make sure that surfaces are well covered with the disinfectant.
Minimum contact time is 5 minutes for bacteria and 15 minutes for yeasts.
After application, rinse treated surfaces and flush foaming equipment thoroughly with clean water. For flushing of mobile systems, put the suction hose into a container with clean water.
5.2.    Risk mitigation measures
Wear chemical goggles consistent with the European Standard EN ISO 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN ISO 374 or equivalent.
Google, gloves and coverall material to be specified by the authorisation holder within the product information.
Wear respiratory protection when handling the concentrated product. Respiratory protection to be specified by the authorisation holder within the product information. Avoid standing in areas with aerosol formation.
This is without prejudice to the application of Directive 98/24/EC and other Union legislation in the area of health and safety at work.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid instructions
IF INHALED: move to fresh air and keep at rest in a position comfortable for breathing.
If symptoms: call 112 or an 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. Call 112 or an 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 or an ambulance for medical assistance.
Emergency measure to protect the environment
Environmental precautions: do not allow product to reach sewage systems or water bodies.
Methods and material for containment and cleaning up: absorb with liquid-binding material (sand, diatomite, universal binder). Do not use combustible material like sawdust. Dispose of the material collected in accordance with local regulations. Ensure adequate ventilation.
5.4.    Instructions for safe disposal of the product and its packaging
At the end of the application, dispose unused product and the packaging in accordance with local requirements.
Used product can be flushed to municipal sewer depending on local requirements.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf life: 24 months
Ensure good ventilation or exhaustion.
Do not store together with alkalis (caustic solutions).
Do not store at temperatures above 40°C.
Keep away from heat and direct sunlight.
Protect from frost.
Keep container tightly closed.
6.    OTHER INFORMATION
Not relevant
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)
calgonit DS 633
Market area: EU
Authorisation number
EU-0028957-0019 1-7
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
16 % (w/w)
Methanesulphonic acid
Methanesulphonic acid
Non-Active substance
75-75-2
200-898-6
7 % (w/w)
1.    META SPC 8 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 8 identifier
Identifier
Meta SPC: mSPC8
1.2.    Suffix to the authorisation number
Number
1-8
1.3.    Product type(s)
Product type(s)
PT04: Food and feed area
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 (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
16 - 17,6 % (w/w)
Methanesulphonic acid
Methanesulphonic acid
Non-Active substance
75-75-2
200-898-6
0 - 10,5 % (w/w)
Phosphoric acid
Phosphoric acid
Non-Active substance
7664-38-2
231-633-2
0 - 18,75 % (w/w)
Sulphuric acid
Sulphuric acid
Non-Active substance
7664-93-9
231-639-5
4,5 - 4,5 % (w/w)
Isononanoic acid
Isononanoic acid
Non-Active substance
3302-10-1
221-975-0
2,25 - 2,5 % (w/w)
2.2.    Type(s) of formulation of the meta SPC 8
Formulation type(s)
SL Soluble concentrate
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8
Hazard statements
H290: May be corrosive to metals.
H314: Causes severe skin burns and eye damage.
EUH071: Corrosive to the respiratory tract.
Precautionary statements
P260: Do not breathe spray.
P280: Wear protective gloves.
P280: Wear protective clothing.
P280: Wear eye protection.
P280: Wear face protection.
P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting.
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310: Immediately call a POISON CENTER.
P310: Immediately call a doctor.
P406: Store in a corrosion resistant container with a resistant inner liner.
P501: Dispose of contents to in accordance with local regulations.
P501: Dispose of container to in accordance with local regulations.
4.    AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1
Use # 8.1 – Hard surface disinfection by automated spraying in closed cleaning in place (CIP) system
Product type
PT04: Food and feed area
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Field(s) of use
indoor use
Hard surface disinfection
Application method(s)
Method: Spraying
Detailed description:
Hard surface disinfection Automated dosing and spraying in closed CIP systemCIP system: pipe work, fermentation and storage tanks
Application rate(s) and frequency
Application rate: Concentrated product, 16,0-17,6% L-(+)-lactic acid Bactericidal claim: 2,5% (w/w) dilution of the product, 0,40-0,44% L-(+)-lactic acid Yeasticidal claim: 2% (w/w) dilution of the product, 0,32-0,35% L-(+)-lactic acid
Number and timing of application:
once a day
Category(ies) of users
professional
Pack sizes and packaging material
HDPE jerrycan: 5-60 kg
HDPE drum: 60-200 kg
HDPE IBC: 600-1000 kg
4.1.1.    Use-specific instructions
See general directions for use.
4.1.2.    Use-specific risk mitigation measures
See general directions for use.
4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
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.
5.    GENERAL DIRECTIONS FOR USE OF THE META SPC 8
5.1.    Instructions for use
Connect the jerrycan, drum or IBC containing the product with the dosing unit of the CIP system. Dosing and dilution are performed automatically via the dosing unit of the CIP system and monitored by conductivity measurements.
Avoid contact with aluminium, non-ferrous metals and galvanised materials.
Precleaning is not necessary.
Minimum contact time is 5 minutes for bacteria and 15 minutes for yeasts.
After application, rinse the treated system thoroughly with clean water.
5.2.    Risk mitigation measures
Wear chemical goggles consistent with the European Standard EN ISO 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN ISO 374 or equivalent.
Google, gloves and coverall material to be specified by the authorisation holder within the product information.
Wear respiratory protection when handling the concentrated product. Respiratory protection to be specified by the authorisation holder within the product information. Avoid standing in areas with aerosol formation.
This is without prejudice to the application of Directive 98/24/EC and other Union legislation in the area of health and safety at work.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid instructions
IF INHALED: move to fresh air and keep at rest in a position comfortable for breathing.
If symptoms: call 112 or an 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. Call 112 or an 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 or an ambulance for medical assistance.
Emergency measure to protect the environment
Environmental precautions: do not allow product to reach sewage systems or water bodies.
Methods and material for containment and cleaning up: absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). Dispose of the material collected in accordance with local regulations.
5.4.    Instructions for safe disposal of the product and its packaging
At the end of the application, dispose unused product and the packaging in accordance with local requirements.
Used product can be flushed to municipal sewer depending on local requirements.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf life: 24 months
Ensure good ventilation or exhaustion.
Do not store together with alkalis (caustic solutions).
Do not store at temperatures above 40°C.
Keep away from heat and direct sunlight.
Protect from frost.
Keep container tightly closed.
6.    OTHER INFORMATION
Not relevant
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)
calgonit Duocip
Market area: EU
Authorisation number
EU-0028957-0020 1-8
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
16 % (w/w)
Methanesulphonic acid
Methanesulphonic acid
Non-Active substance
75-75-2
200-898-6
10,5 % (w/w)
Sulphuric acid
Sulphuric acid
Non-Active substance
7664-93-9
231-639-5
4,5 % (w/w)
Isononanoic acid
Isononanoic acid
Non-Active substance
3302-10-1
221-975-0
2,5 % (w/w)
7.2.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
calgonit Duocip P
Market area: EU
Authorisation number
EU-0028957-0021 1-8
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
16 % (w/w)
Phosphoric acid
Phosphoric acid
Non-Active substance
7664-38-2
231-633-2
18,75 % (w/w)
Sulphuric acid
Sulphuric acid
Non-Active substance
7664-93-9
231-639-5
4,5 % (w/w)
Isononanoic acid
Isononanoic acid
Non-Active substance
3302-10-1
221-975-0
2,5 % (w/w)
Commission Implementing Regulation (EU) 2025/523 of 20 March 2025 amending Implementing Regulation (EU) 2023/1311 as regards administrative changes to the Union authorisation for the biocidal product family CVAS Biocidal Product Family based on L(+) Lactic Acid

Schedules & Appendices

Cite this act
