ANNEX

Summary of product characteristics for a biocidal product family

PRODHYNET’s Lactic acid based products

Product type(s)

PT03: Veterinary hygiene

Authorisation number EU-0032621-0000

R4BP asset number EU-0032621-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

Name	PRODHYNET’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	PRODHYNET SA
	Address	11 avenue des châtelets 22440 PLOUFRAGAN FR
Authorisation number		EU-0032621-0000
R4BP asset number		EU-0032621-0000
Date of the authorisation		7 July 2025
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 / Dinard 55, Boulevard Jules Verger; BP 10180 35803 DINARD Cedex France HYPRED SAS - KERSIA Group / Vaas 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 / Estella 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	Jungbunzlauer S.A. 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) 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)			DOUPIS FLUIDE		Market area: EU
			PRO AL SPRAY		Market area: EU
			GALACTIK FL		Market area: EU
			Spray Guard		Market area: EU
			ExtraGuard Spray		Market area: EU
			ROBOLAK FL		Market area: EU
			GALACTIK PULVE		Market area: EU
			LACTI FLUIDE		Market area: EU
			AGRILAC FLUIDE		Market area: EU
			LACTI SPRAY FLUIDE		Market area: EU
			HYGIALAC FLUIDE		Market area: EU
			BRETALAC FLUIDE		Market area: EU
Authorisation number					EU-0032621-0001 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 % (w/w)
Sodium p-cumenesulphonate		Non-Active substance		15763-76-5		239-854-6	1,32 % (w/w)
Diethanolamine		Non-Active substance		111-42-2		203-868-0	4,234 % (w/w)

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) 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)			EDDAR FILM		Market area: EU
			DOUPIS FILM		Market area: EU
			GALACTIK EP		Market area: EU
			Xtrem Guard		Market area: EU
			ExtraGuard Xtrem		Market area: EU
			LACTI EPAIS		Market area: EU
			HYGIALAC EPAIS		Market area: EU
			TREMPAGE EPAIS LACTI		Market area: EU
			AGRILAC EPAIS		Market area: EU
			FILMOGENE		Market area: EU
			AGRIFILM		Market area: EU
			BRETADINE		Market area: EU
			BRETALAC FILM		Market area: EU
			GEL TRAYON		Market area: EU
			APROMADINE		Market area: EU
			CELTADINE		Market area: EU
			DALFILM		Market area: EU
			FILM-AGRI		Market area: EU
			HYGIA’TREMP		Market area: EU
			HYGIAFILM		Market area: EU
			PRODINE		Market area: EU
			PRO AL		Market area: EU
			ADIEL FILM		Market area: EU
			CORIAFILM		Market area: EU
			GANAFILM		Market area: EU
			MAGDINE		Market area: EU
			NUTRIDINE		Market area: EU
			PLUSAFILM		Market area: EU
			PROXAFILM		Market area: EU
Authorisation number					EU-0032621-0002 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 % (w/w)
Sodium p-cumenesulphonate		Non-Active substance		15763-76-5		239-854-6	1,32 % (w/w)
Sodium 2-ethylhexyl sulfate		Non-Active substance		126-92-1		204-812-8	2,1 % (w/w)
Diethanolamine		Non-Active substance		111-42-2		203-868-0	3,92 % (w/w)