Official Gazette Notification Text
Official TranscriptOfficial Journal EN of the European Union L series 2025/523 21.3.2025 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’ (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard...
Official Journal EN of the European Union L series 2025/523 21.3.2025 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’ (Text with EEA relevance) 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 2012concerning the making available on the market and use of biocidal products(1), and in particular Article 50(2) thereof,
Whereas:
(1) On 27 June 2023, Commission Implementing Regulation (EU) 2023/1311(2)granted a Union authorisation, under number EU-0028957-0000, to CVAS Development GmbH for the making available on the market and use of the biocidal product family ‘CVAS Biocidal Product Family based on L(+) Lactic Acid’. The Annex to that Implementing Regulation provides the summary of product characteristics (‘SPC’) for that biocidal product family.
(2) On 12 September 2023and 4 July 2024, CVAS Development GmbH submitted to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013(3), notifications of administrative changes to the Union authorisation for the biocidal product family ‘CVAS Biocidal Product Family based on L(+) Lactic Acid’, recorded in the register for biocidal products under case numbers BC-XW088611-94 and BC-PQ098457-00. The notified proposed changes concern the addition of trade names.
(3) On 13 October 2023 and 2 August 2024(4), the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, opinions on the notified administrative changes to the Union authorisation for the biocidal product family ‘CVAS Biocidal Product Family based on L(+) Lactic Acid’. In the opinions, the Agency concludes that the proposed changes are administrative changes as referred to in Article 50(3), point (a), of Regulation (EU) No 528/2012 and as specified in Title 1, Section 1, of the Annex to Implementing Regulation (EU) No 354/2013, and that after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.
(4) On 26 July 2024, the Agency transmitted to the Commission the revised summary of the biocidal product characteristics of the Union authorisation for the biocidal product family ‘CVAS Biocidal Product Family based on L(+) Lactic Acid’ in all official languages of the Union, covering all administrative changes applied for, in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.
(5) The Commission concurs with the opinions of the Agency and therefore considers it appropriate to amend the Union authorisation for the biocidal product family ‘CVAS Biocidal Product Family based on L(+) Lactic Acid’ to introduce the administrative changes requested by CVAS Development GmbH.
(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.
(2) Commission Implementing Regulation (EU) 2023/1311 of 27 June 2023 granting a Union authorisation for the biocidal product family ‘CVAS Biocidal Product Family based on L(+) Lactic Acid’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 162, 28.6.2023, p. 11, ELI: http://data.europa.eu/eli/reg_impl/2023/1311/oj).
(3) Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4, ELI: http://data.europa.
eu/eli/reg_impl/2013/354/oj).
(4) ECHA opinions UAD-C-1688636-18-00/F of 13 October 2023 and UAD-C-1756814-27-00/F of 2/08/2024 on administrative changes of the Union authorisation of the biocidal product family ‘CVAS Biocidal Product Family based on L(+) Lactic Acid’, https:// echa.europa.eu/opinions-on-union-authorisation.
ELI: http://data.europa.eu/eli/reg_impl/2025/523/oj 1/40EN OJ L, 21.3.2025
(6) Except for the amendments regarding the administrative changes, all other information included in the summary of the biocidal product characteristics of ‘CVAS Biocidal Product Family based on L(+) Lactic Acid’ as set out in Annex to Implementing Regulation (EU) 2023/1311 remain unchanged.
(7) In order to enhance clarity and to ease the access of users and interested parties to the consolidated version of the summary of the biocidal product characteristics which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2023/1311 should be replaced in its entirety. Due to a change in the format used for the generation of the summary of biocidal product characteristics in the register for biocidal products in February 2024, the summary of biocidal product characteristics in that Annex should also include some minor editorial and layout changes.
(8) Implementing Regulation (EU) No 2023/1311 should therefore be amended accordingly,
HAS ADOPTED THIS REGULATION:
Article 1 The Annex to Implementing Regulation (EU) 2023/1311 is replaced by the text set out in the Annex to this Regulation.
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 20 March 2025.
For the Commission The President Ursula VON DER LEYEN 2/40 ELI: http://data.europa.eu/eli/reg_impl/2025/523/ojEN OJ L, 21.3.2025 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 CVAS Development GmbH Name and address of the authorisation holder 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
ELI: http://data.europa.eu/eli/reg_impl/2025/523/oj 3/40EN OJ L, 21.3.2025 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) Methanesulpho- Methanesulpho- Non-Active 75-75-2 200-898-6 0- 10,5% (w/w) nic acid nic acid substance Phosphoric acid Phosphoric acid Non-Active 7664-38-2 231-633-2 0- 18,75% (w/w) substance Sulphuric acid Sulphuric acid Non-Active 7664-93-9 231-639-5 0- 4,5% (w/w) substance Isononanoic acid Isononanoic Non-Active 3302-10-1 221-975-0 0- 2,5% (w/w) acid substance
2.2. Type(s) of formulation Formulation type(s) AL Any other liquid SL Soluble concentrate 4/40 ELI: http://data.europa.eu/eli/reg_impl/2025/523/ojEN OJ L, 21.3.2025 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 Scientific name: no data stage) Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
ELI: http://data.europa.eu/eli/reg_impl/2025/523/oj 5/40EN OJ L, 21.3.2025 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.
6/40 ELI: http://data.europa.eu/eli/reg_impl/2025/523/ojEN OJ L, 21.3.2025
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 Market area: EU MILCHSÄUREMAN- TEL IWETEC MILCHSÄURE Market area: EU DIPP
Fulldip Lacti Film Market area: EU
ELI: http://data.europa.eu/eli/reg_impl/2025/523/oj 7/40EN OJ L, 21.3.2025
CareDip Film Market area: EU Milchsäure Film Market area: EU
Lactoboost Film Market area: EU
Bonimal CARE Lac Dip Market area: EU
Bonimal CARE Market area: EU LactiVital Dip
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 79-33-4 201-196-2 1,92 % (w/w) substance
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 79-33-4 201-196-2 1,92 % (w/w) substance
7.3. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) calgodip Blue Kamille Market area: EU Film
HappyFarm KamillDip Market area: EU Film
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 Market area: EU Dip 8/40 ELI: http://data.europa.eu/eli/reg_impl/2025/523/ojEN OJ L, 21.3.2025
Bonimal CARE Milki Market area: EU Dip
Bonimal CARE Milk Market area: EU Dip 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 active substance 79-33-4 201-196-2 1,92 % (w/w) acid
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 active substance 79-33-4 201-196-2 1,92 % (w/w) acid
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
ELI: http://data.europa.eu/eli/reg_impl/2025/523/oj 9/40EN OJ L, 21.3.2025
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 10/40 ELI: http://data.europa.eu/eli/reg_impl/2025/523/ojEN OJ L, 21.3.2025 Target organism(s) (including development Scientific name: no data stage) 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.
ELI: http://data.europa.eu/eli/reg_impl/2025/523/oj 11/40EN OJ L, 21.3.2025 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.
12/40 ELI: http://data.europa.eu/eli/reg_impl/2025/523/ojEN OJ L, 21.3.2025
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 Market area: EU Film 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 Market area: EU forte Film 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)
ELI: http://data.europa.eu/eli/reg_impl/2025/523/oj 13/40EN OJ L, 21.3.2025
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 14/40 ELI: http://data.europa.eu/eli/reg_impl/2025/523/ojEN OJ L, 21.3.2025
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 Scientific name: no data stage) 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.
ELI: http://data.europa.eu/eli/reg_impl/2025/523/oj 15/40EN OJ L, 21.3.2025
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.
16/40 ELI: http://data.europa.eu/eli/reg_impl/2025/523/ojEN OJ L, 21.3.2025
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 Market area: EU Spray
AGRIMARKT Market area: EU MILCHSÄURENEBEL IWETEC MILCHSÄURE Market area: EU SPRAY
Fulldip Lacti Spray Market area: EU
CareDip Spray Market area: EU Milchsäure Spray Market area: EU
Lactoboost Spray Market area: EU Care4cows Lactic Acid Market area: EU Spray
Bonimal CARE Lac Market area: EU Spray
Bonimal CARE Market area: EU LactiVital Spray 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)
ELI: http://data.europa.eu/eli/reg_impl/2025/523/oj 17/40EN OJ L, 21.3.2025
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 Market area: EU Spray
HappyFarm KamillDip Market area: EU Spray
Lacto Spray Market area: EU
MS Spray Market area: EU
LA Spray Market area: EU Care4Cows Lactic Acid Market area: EU Kamille Spray
BestFarm Blue Dip Market area: EU Spray
Bonimal CARE Milky Market area: EU Spray
Bonimal CARE Milki Market area: EU Spray
Bonimal CARE Milk Market area: EU Spray 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) 18/40 ELI: http://data.europa.eu/eli/reg_impl/2025/523/ojEN OJ L, 21.3.2025
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
ELI: http://data.europa.eu/eli/reg_impl/2025/523/oj 19/40EN OJ L, 21.3.2025
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 Scientific name: no data stage) 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 20/40 ELI: http://data.europa.eu/eli/reg_impl/2025/523/ojEN OJ L, 21.3.2025 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.
ELI: http://data.europa.eu/eli/reg_impl/2025/523/oj 21/40EN OJ L, 21.3.2025 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.
22/40 ELI: http://data.europa.eu/eli/reg_impl/2025/523/ojEN OJ L, 21.3.2025
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 Market area: EU Spray 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 Market area: EU forte Spray 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 Market area: EU Spray 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)
ELI: http://data.europa.eu/eli/reg_impl/2025/523/oj 23/40EN OJ L, 21.3.2025
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.
24/40 ELI: http://data.europa.eu/eli/reg_impl/2025/523/ojEN OJ L, 21.3.2025 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 Scientific name: no data stage) 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
ELI: http://data.europa.eu/eli/reg_impl/2025/523/oj 25/40EN OJ L, 21.3.2025
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.
26/40 ELI: http://data.europa.eu/eli/reg_impl/2025/523/ojEN OJ L, 21.3.2025 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
ELI: http://data.europa.eu/eli/reg_impl/2025/523/oj 27/40EN OJ L, 21.3.2025
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.
28/40 ELI: http://data.europa.eu/eli/reg_impl/2025/523/ojEN OJ L, 21.3.2025
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 Scientific name: no data stage) 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.
ELI: http://data.europa.eu/eli/reg_impl/2025/523/oj 29/40EN OJ L, 21.3.2025
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.
30/40 ELI: http://data.europa.eu/eli/reg_impl/2025/523/ojEN OJ L, 21.3.2025 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
ELI: http://data.europa.eu/eli/reg_impl/2025/523/oj 31/40EN OJ L, 21.3.2025
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) Methanesulpho- Methanesulpho- Non-Active 75-75-2 200-898-6 6,3- 7% (w/w) nic acid nic acid substance
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.
32/40 ELI: http://data.europa.eu/eli/reg_impl/2025/523/ojEN OJ L, 21.3.2025
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 Scientific name: no data stage) 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.
ELI: http://data.europa.eu/eli/reg_impl/2025/523/oj 33/40EN OJ L, 21.3.2025
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/m2. 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.
34/40 ELI: http://data.europa.eu/eli/reg_impl/2025/523/ojEN OJ L, 21.3.2025 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) Methanesul- Methanesul- Non-Active 75-75-2 200-898-6 7 % (w/w) phonic acid phonic acid substance
1. META SPC 8 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 8 identifier
Identifier Meta SPC: mSPC8
ELI: http://data.europa.eu/eli/reg_impl/2025/523/oj 35/40EN OJ L, 21.3.2025
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) Methanesulpho- Methanesulpho- Non-Active 75-75-2 200-898-6 0 - 10,5 % (w/w) nic acid nic acid substance Phosphoric acid Phosphoric acid Non-Active 7664-38-2 231-633-2 0 - 18,75 % (w/w) substance Sulphuric acid Sulphuric acid Non-Active 7664-93-9 231-639-5 4,5 - 4,5 % (w/w) substance Isononanoic acid Isononanoic Non-Active 3302-10-1 221-975-0 2,25 - 2,5 % (w/w) acid substance
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].
36/40 ELI: http://data.europa.eu/eli/reg_impl/2025/523/ojEN OJ L, 21.3.2025 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 Scientific name: no data stage) 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
ELI: http://data.europa.eu/eli/reg_impl/2025/523/oj 37/40EN OJ L, 21.3.2025
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.
38/40 ELI: http://data.europa.eu/eli/reg_impl/2025/523/ojEN OJ L, 21.3.2025
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) Methanesul- Methanesul- Non-Active 75-75-2 200-898-6 10,5 % (w/w) phonic acid phonic acid substance Sulphuric acid Sulphuric Non-Active 7664-93-9 231-639-5 4,5 % (w/w) acid substance Isononanoic Isononanoic Non-Active 3302-10-1 221-975-0 2,5 % (w/w) acid acid substance
ELI: http://data.europa.eu/eli/reg_impl/2025/523/oj 39/40EN OJ L, 21.3.2025
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 Phosphoric Non-Active 7664-38-2 231-633-2 18,75 % (w/w) acid acid substance Sulphuric acid Sulphuric Non-Active 7664-93-9 231-639-5 4,5 % (w/w) acid substance Isononanoic Isononanoic Non-Active 3302-10-1 221-975-0 2,5 % (w/w) acid acid substance 40/40 ELI: http://data.europa.eu/eli/reg_impl/2025/523/oj