Commission Implementing Regulation (EU) 2024/2188 of 3 September 2024 granting a Union authorisation for the biocidal product family Kersia’s Lactic acid based products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

ANNEX
ANNEX
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
Kersia’s Lactic acid based products
Product type(s)
: PT03: Veterinary hygiene
Authorisation number
: EU-0031195-0000
R4BP asset number
: EU-0031195-0000
PART I
FIRST INFORMATION LEVEL
1.    ADMINISTRATIVE INFORMATION
1.1.    Family name
Name
Kersia’s Lactic acid based products
1.2.    Product type(s)
Product type(s)
PT03: Veterinary hygiene
1.3.    Authorisation holder
Name and address of the authorisation holder
Name
HYPRED SAS
Address
55, boulevard Jules Verger 35803 DINARD FR
Authorisation number
EU-0031195-0000
R4BP asset number
EU-0031195-0000
Date of the authorisation
24 September 2024
Expiry date of the authorisation
31 August 2034
1.4.    Manufacturer(s) of the product
Name of manufacturer
HYPRED SAS - KERSIA Group
Address of manufacturer
55, Boulevard Jules Verger BP10180 35803 DINARD France
Location of manufacturing sites
HYPRED SAS - KERSIA Group 55, Boulevard Jules Verger; BP 10180 35803 DINARD Cedex France
HYPRED SAS - KERSIA Group Zone Industrielle Le Roineau 72500 VAAS France
Medentech Ltd – KERSIA Group Clonard Road Y35Y7WY WEXFORD Ireland
SOPURA – KERSIA Group Parc Paysager de Tyberchamps 14 7180 SENEFFE Belgium
KERSIA DEUTSCHLAND GmbH Marie-Curie-Straße 23 53332 BORNHEIM – SECHTEM Germany
Holchem Laboratories Ltd – KERSIA Group Gateway House, Pilsworth Road, Pilsworth Industrial Estate BL9 8RD Bury United Kingdom of Great Britain and Northern Ireland (the)
KERSIA AUSTRIA GmbH PFONGAUERSTRAßE 17 5202 NEUMARKT AM WALLERSEE Austria
KERSIA POLSKA Sp.z.o.o Niepruszewo, ul. Kasztanowa 4 64-320 BUK Poland
KERSIA ITALIA S.r.l Strada Montodine – Gombito; Loc. Cà Nova 26010 RIPALTA ARPINA (CR) Italy
KERSIA IBERICA SL Pol. Miguel Eguía C/Zarapuz s/n 31200 ESTELLA (NAVARRA) Spain
Kilco Holdings Ltd – KERSIA Group Broomhouses 2 Industrial Estate; Old Glasgow Road DG11 2SD LOCKERBIE United Kingdom of Great Britain and Northern Ireland (the)
Kilco (International) Ltd – KERSIA Group 1A Trench Road Mallusk; Newtownabbey BT36 4TY CO ANTRIM Ireland
SOPURA Quimica – KERSIA Group Pol. Ind. “La Canaleta“; Avinguda Júpiter n° 7 25300 TARREGA (LLEIDA) Spain
KERSIA DEUTSCHLAND GmbH Oberbrühlstraße 16-18 87700 Memmingen Germany
1.5.    Manufacturer(s) of the active substance(s)
Active substance
L-(+)-lactic acid
Name of manufacturer
PURAC Bioquimica SA
Address of manufacturer
Gran Vial 19-25 8160 Montmelo - Barcelona Spain
Location of manufacturing sites
PURAC Bioquimica SA Gran Vial 19-25 8160 Montmelo - Barcelona Spain
PURAC BIOCHEM BV Arkelsedijk 46 4206 AC Gorinchem Netherlands (the)
Purac Sínteses Ltda Av. Rui Barbosa, 521 CEP 28015-520 Campos dos Goytacazes - RJ Brazil
Purac America Inc. 650 Industrial Park Drive, P.O. Box 38 NE 68008 Blair United States (the)
Purac (Corbion) Thailand Ltd Tambol Huay Pong, Amphoe Muang 21150 Rayong Thailand
Active substance
L-(+)-lactic acid
Name of manufacturer
Jungbunzlauer S.A.
Address of manufacturer
Z.I. Portuaire BP 32 67390 Marckolsheim France
Location of manufacturing sites
Z.I. Portuaire BP 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 (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
8,4 - 8,4 % (w/w)
Sodium p-cumenesulphonate
Non-active substance
15763-76-5
239-854-6
1,32 - 1,32 % (w/w)
Sodium 2-ethylhexyl sulfate
Non-active substance
126-92-1
204-812-8
0 - 2,1 % (w/w)
Diethanolamine
Non-active substance
111-42-2
203-868-0
3,92 - 4,234 % (w/w)
2.2.    Type(s) of formulation
Formulation type(s)
AL Any other liquid
PART II
SECOND INFORMATION LEVEL - META SPC(S)
1.    META SPC 1 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 1 identifier
Identifier
Meta SPC: meta SPC 1 - Dipping, foaming, spraying ready to use products
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
8,4 - 8,4 % (w/w)
Sodium p-cumenesulphonate
Non-active substance
15763-76-5
239-854-6
1,32 - 1,32 % (w/w)
Diethanolamine
Non-active substance
111-42-2
203-868-0
4,234 - 4,234 % (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
H319: Causes serious eye irritation.
Precautionary statements
P264: Wash hands thoroughly after handling.
P280: Wear eye protection.
P280: Wear face protection.
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 attention.
P337+P313: If eye irritation persists: Get medical advice.
4.    AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1
Disinfection of teats of milk producing animals by manual or automated dipping, foaming or spraying after milking
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
Manual or automated disinfection of teats of milk producing animals by dipping, foaming or spraying after milking
Application method(s)
Method: Dipping, foaming or spraying
Detailed description: Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine.
Application rate(s) and frequency
Application rate: application rate per animal: - cows and buffaloes 3 to 10 ml (5 to 8 ml recommended) - sheep 1,5 to 5 ml (1,5 to 3 ml recommended) - goats 2,5 to 6 ml (2,5 to 4 ml recommended)
Dilution (%): Ready to use product
Number and timing of application:
Contact time : 5 minutes
Frequency: 2 to 3 times per day
Category(ies) of users
professional
Pack sizes and packaging material
HDPE (High Density Polyethylene) jerrycans 5, 10, 22, 25 and 30 litre
HDPE barrel 60 litre
HDPE drums 120 and 220 litre
HDPE container 640 and 1000 litre
4.1.1.    Use-specific instructions
See general directions for use of meta SPC 1
4.1.2.    Use-specific risk mitigation measures
See general directions for use of meta SPC 1
4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use of meta SPC 1
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of meta SPC 1
4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use of meta SPC 1
5.    GENERAL DIRECTIONS FOR USE OF THE META SPC 1
5.1.    Instructions for use
Fill the dipping/foaming cup/sprayer manually or automatically with the ready to use product.
Manual or automatic dipping/foaming/spraying on animal’s teats on the full length of the teat after milking.
Make sure that the teats are fully covered with disinfectant.
Leave the product until next milking.
Keep the animals standing for at least 5 minutes until the product has dried.
At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.
Avoid contact with eyes.
Wash hands after work.
Product must be brought to a temperature between 20°C and 30°C before use.
5.2.    Risk mitigation measures
Wear chemical goggles or face protection consistent with European Standard EN ISO 16321 or equivalent.
For manual application by spraying: Wear protective chemical resistant gloves consistent with European Standard EN ISO 374 during product handling phase.
Keep out of reach of children.
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 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.
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 5 minutes. Call a POISON CENTRE or a doctor.
Refer to the safety data sheet available for professional user: it contains an emergency phone number.
Large spillage: Mark out, soak up with an inert absorbant and pump in an emergency tank. Never return spills in original containers for re-use. Keep in suitable, properly labelled and closed containers for disposal.
5.4.    Instructions for safe disposal of the product and its packaging
At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
The paper towels used for removing the product and drying the teats are disposed in the normal domestic waste.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf life: 2 years in HDPE
6.    OTHER INFORMATION
Full titles of EN standards and legislation referred to in section 5.2:
EN ISO 374 – Protective gloves against dangerous chemicals and micro-organisms.
EN ISO 16321 – Eye and face protection for occupational use.
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)
NATIDINE
Market area: EU
Bonimal H Lactiliquid
Market area: EU
LACTILIQ
Market area: EU
MilchsäureDip-Spray
Market area: EU
NATILAC
Market area: EU
PRIMAMO
Market area: EU
RBT LACTIC
Market area: EU
ROBOSPRAY LACTIC
Market area: EU
SPRAYLAC
Market area: EU
Bonimal CARE LactiLiquid
Market area: EU
Authorisation number
EU-0031195-0001 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
8,4
Sodium p-cumenesulphonate
Non-active substance
15763-76-5
239-854-6
1,32
Diethanolamine
Non-active substance
111-42-2
203-868-0
4,234
1.    META SPC 2 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 2 identifier
Identifier
Meta SPC: meta SPC 2 - Dipping ready to use products
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
8,4 - 8,4 % (w/w)
Sodium p-cumenesulphonate
Non-active substance
15763-76-5
239-854-6
1,32 - 1,32 % (w/w)
Sodium 2-ethylhexyl sulfate
Non-active substance
126-92-1
204-812-8
0 - 2,1 % (w/w)
Diethanolamine
Non-active substance
111-42-2
203-868-0
3,92 - 3,92 % (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
H319: Causes serious eye irritation.
Precautionary statements
P264: Wash hands thoroughly after handling.
P280: Wear eye protection.
P280: Wear face protection.
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 attention.
P337+P313: If eye irritation persists: Get medical advice.
4.    AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1
Disinfection of teats of milk producing animals by manual or automated dipping after milking
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
Manual or automated disinfection of teats of milk producing animals by dipping after milking
Application method(s)
Method: Dipping
Detailed description: Dipping cup or automated dipping machine.
Application rate(s) and frequency
Application rate: application rate per animal: - cows and buffaloes 3 to 10 ml (5 ml recommended) - sheep 1,5 to 5 ml (1,5 ml recommended) - goats 2,5 to 6 ml (2,5 ml recommended)
Dilution (%): Ready to use product
Number and timing of application:
Contact time : 5 minutes
Frequency: 2 to 3 times per day
Category(ies) of users
professional
Pack sizes and packaging material
HDPE (High Density Polyethylene) jerrycans 5, 10, 22, 25 and 30 litre
HDPE barrel 60 litre
HDPE drums 120 and 220 litre
HDPE container 640 and 1000 litre
4.1.1.    Use-specific instructions
See general directions for use of meta SPC 2
4.1.2.    Use-specific risk mitigation measures
See general directions for use of meta SPC 2
4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use of meta SPC 2
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of meta SPC 2
4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use of meta SPC 2
5.    GENERAL DIRECTIONS FOR USE OF THE META SPC 2
5.1.    Instructions for use
Fill the dipping cup manually or automatically with the ready to use product.
Apply by dipping manually or automatically on animal’s teats on the full length of the teat after milking.
Make sure that the teats are fully covered with disinfectant.
Leave the product until next milking. Keep the animals standing for at least 5 minutes until the product has dried.
At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.
Avoid contact with eyes.
Wash hands after work.
Product must be brought to a temperature between 20°C and 30°C before use.
5.2.    Risk mitigation measures
Wear chemical goggles or face protection consistent with European Standard EN ISO 16321 or equivalent.
Keep out of reach of children.
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 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.
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 5 minutes. Call a POISON CENTRE or a doctor.
Refer to the safety data sheet available for professional user: it contains an emergency phone number.
Large spillage: Mark out, soak up with an inert absorbant and pump in an emergency tank. Never return spills in original containers for re-use. Keep in suitable, properly labelled and closed containers for disposal.
5.4.    Instructions for safe disposal of the product and its packaging
At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
The paper towels used for removing the product and drying the teats are disposed in the normal domestic waste.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf life: 2 years in HDPE
Store below 30°C
6.    OTHER INFORMATION
Full titles of EN standards and legislation referred to in section 5.2:
EN ISO 16321 – Eye and face protection for occupational use.
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)
FILMADINE LL
Market area: EU
Authorisation number
EU-0031195-0002 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
8,4
Sodium p-cumenesulphonate
Non-active substance
15763-76-5
239-854-6
1,32
Diethanolamine
Non-active substance
111-42-2
203-868-0
3,92
7.2.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
FILMADINE LC
Market area: EU
FILMADINE C
Market area: EU
Bonimal H Lactidip C
Market area: EU
CERTI CREME C
Market area: EU
CERTI FILM C
Market area: EU
COSMADINE C
Market area: EU
DIPLAC C
Market area: EU
EQUO LACTO C
Market area: EU
FILMADIP C
Market area: EU
FILMALAC C
Market area: EU
FILMALINE C
Market area: EU
FILMATREMP C
Market area: EU
FILMORANGE C
Market area: EU
FP FILM C
Market area: EU
HY-COSMETIC C
Market area: EU
HYPREDIP PLUS C
Market area: EU
INO EXTRA C
Market area: EU
INO FILM C
Market area: EU
LACTIDIP C
Market area: EU
MilchsäureFilmdip-Super C
Market area: EU
PRIMASKIN C
Market area: EU
SUPREMADINE C
Market area: EU
ZOO FILM RED C
Market area: EU
Authorisation number
EU-0031195-0003 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
8,4
Sodium p-cumenesulphonate
Non-active substance
15763-76-5
239-854-6
1,32
Sodium 2-ethylhexyl sulfate
Non-active substance
126-92-1
204-812-8
2,1
Diethanolamine
Non-active substance
111-42-2
203-868-0
3,92
7.3.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
FILMADINE
Market area: EU
Bonimal H Lactidip
Market area: EU
CERTI CREME +
Market area: EU
CERTI FILM
Market area: EU
COSMADINE
Market area: EU
DIPLAC
Market area: EU
EQUO LACTO
Market area: EU
FILMADIP
Market area: EU
FILMALAC
Market area: EU
FILMALINE
Market area: EU
FILMATREMP
Market area: EU
FILMORANGE
Market area: EU
FP FILM
Market area: EU
HY-COSMETIC
Market area: EU
HYPREDIP PLUS
Market area: EU
INO EXTRA
Market area: EU
INO FILM
Market area: EU
LACTIDIP
Market area: EU
MilchsäureFilmdip-Super
Market area: EU
PRIMASKIN
Market area: EU
SUPREMADINE
Market area: EU
ZOO FILM RED
Market area: EU
LAURACTIV
Market area: EU
Salus TOP
Market area: EU
LAURAFILM
Market area: EU
Juvelit-extreme
Market area: EU
Bonimal CARE LactiDip
Market area: EU
Authorisation number
EU-0031195-0004 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
8,4
Sodium p-cumenesulphonate
Non-active substance
15763-76-5
239-854-6
1,32
Sodium 2-ethylhexyl sulfate
Non-active substance
126-92-1
204-812-8
2,1
Diethanolamine
Non-active substance
111-42-2
203-868-0
3,92
Commission Implementing Regulation (EU) 2024/2188 of 3 September 2024 granting a Union authorisation for the biocidal product family Kersia’s Lactic acid based products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Schedules & Appendices

Cite this act
