Contents
THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal productsnote, and in particular Article 44(5), first subparagraph, thereof,Whereas:
(1)On 26 April 2019, PRODHYNET SA submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013note for Union authorisation of the same biocidal product family, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named ‘PRODHYNET's Lactic acid based products’, of product-type 3, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-XX051283-02 in the Register for Biocidal Products. The application also indicated the case number of the related reference biocidal product family ‘Kersia’s Lactic acid based products’ later authorised by Commission Implementing Regulation (EU) 2024/2188note, with authorisation number EU-0031195-0000.
(2)The biocidal product family ‘PRODHYNET's Lactic acid based products’ contains L-(+)-lactic acid as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-type 3.
(3)On 24 April 2024, the Agency submitted to the Commission its opinionnote and the draft summary of the biocidal product characteristics (‘SPC’) of ‘PRODHYNET's Lactic acid based products’ in accordance with Article 6 of Implementing Regulation (EU) No 414/2013.
(4)In its opinion, the Agency concludes that the proposed differences between the biocidal product family ‘PRODHYNET’s Lactic acid based products’ and the related reference biocidal product family ‘Kersia’s Lactic acid based products’, are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013note, and that based on the assessment of the related reference biocidal product family ‘Kersia’s Lactic acid based products’ and subject to compliance with the draft SPC, the same biocidal product family ‘PRODHYNET’s Lactic acid based products’ meets the conditions laid down in Article 19(6) of Regulation (EU) No 528/2012.
(5)On 22 May 2024, the Agency also transmitted to the Commission the draft SPC of ‘PRODHYNET’s Lactic acid based products’ in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.
(6)The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same biocidal product family ‘PRODHYNET’s Lactic acid based products’.
(7)The expiry date of the authorisation should be aligned with the expiry date of the authorisation of the related reference biocidal product family ‘Kersia’s Lactic acid based products’.
(8)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,
HAS ADOPTED THIS REGULATION:
Article 1#
A Union authorisation with authorisation number EU-0033504-0000 is hereby granted to PRODHYNET SA for the making available on the market and use of the same biocidal product family ‘PRODHYNET’s Lactic acid based products’ in accordance with the summary of the biocidal product characteristics set out in the Annex.The Union authorisation is valid from 7 July 2025 until 31 August 2034.
Article 2#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
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 / Dinard55, Boulevard Jules Verger; BP 10180 35803 DINARD Cedex FranceHYPRED SAS - KERSIA Group / VaasZone Industrielle Le Roineau 72500 VAAS FranceMedentech Ltd – KERSIA GroupClonard Road Y35Y7WY WEXFORD IrelandSOPURA – KERSIA GroupParc Paysager de Tyberchamps 14 7180 SENEFFE BelgiumKERSIA DEUTSCHLAND GmbHMarie-Curie-Straße 23 53332 BORNHEIM – SECHTEM GermanyHolchem Laboratories Ltd – KERSIA GroupGateway House, Pilsworth Road, Pilsworth Industrial Estate BL9 8RD Bury United Kingdom of Great Britain and Northern Ireland (the)KERSIA AUSTRIA GmbHPFONGAUERSTRAßE 17 5202 NEUMARKT AM WALLERSEE AustriaKERSIA POLSKA Sp.z.o.oNiepruszewo, ul. Kasztanowa 4 64-320 BUK PolandKERSIA ITALIA S.r.lStrada Montodine – Gombito; Loc. Cà Nova 26010 RIPALTA ARPINA (CR) ItalyKERSIA IBERICA SL / EstellaPol. Miguel Eguía C/Zarapuz s/n 31200 ESTELLA (NAVARRA) SpainKilco Holdings Ltd – KERSIA GroupBroomhouses 2 Industrial Estate; Old Glasgow Road DG11 2SD LOCKERBIE United Kingdom of Great Britain and Northern Ireland (the)Kilco (International) Ltd – KERSIA Group1A Trench Road Mallusk; Newtownabbey BT36 4TY CO ANTRIM IrelandSOPURA Quimica – KERSIA GroupPol. Ind. “La Canaleta“; Avinguda Júpiter n° 7 25300 TARREGA (LLEIDA) SpainKERSIA DEUTSCHLAND GmbHOberbrühlstraße 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 SpainPURAC BIOCHEM BV Arkelsedijk 46 4206 AC Gorinchem Netherlands (the)Purac Sínteses Ltda Av. Rui Barbosa, 521 CEP 28015-520 Campos dos Goytacazes - RJ BrazilPurac 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
| Product type | PT03: Veterinary hygiene |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: no dataCommon name: BacteriaDevelopment stage: no dataScientific name: no dataCommon name: YeastsDevelopment stage: no data |
| Field(s) of use | indoor useManual or automated disinfection of teats of milk producing animals by dipping, foaming or spraying after milking |
| Application method(s) | Method: Dipping, foaming or sprayingDetailed 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 productNumber and timing of application:Contact time : 5 minutesFrequency: 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 litreHDPE barrel 60 litreHDPE drums 120 and 220 litreHDPE 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
| Product type | PT03: Veterinary hygiene |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: no dataCommon name: BacteriaDevelopment stage: no dataScientific name: no dataCommon name: YeastsDevelopment stage: no data |
| Field(s) of use | indoor useManual or automated disinfection of teats of milk producing animals by dipping after milking |
| Application method(s) | Method: DippingDetailed 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 productNumber and timing of application:Contact time : 5 minutesFrequency: 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 litreHDPE barrel 60 litreHDPE drums 120 and 220 litreHDPE 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) |
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