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 (Text with EEA relevance)
Date: 2023-06-27
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal health, biocide, dairy cow, decontamination, market approval, organic acid








L_2023162EN.01001101.xml










28.6.2023   


EN


Official Journal of the European Union


L 162/11








            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
(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 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5), first subparagraph, thereof,

Whereas:







(1)


On 24 April 2019, CVAS Development GmbH submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for a Union authorisation of a biocidal product family named ‘CVAS Biocidal Product Family based on L (+) Lactic Acid’ of product-types 3 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Slovenia had agreed to evaluate the application. The application was recorded under case number BC-XR051157-11 in the Register for Biocidal Products.












(2)


‘CVAS Biocidal Product Family based on L (+) Lactic Acid’ 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-types 3 and 4.












(3)


On 7 January 2022, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.












(4)


On 5 July 2022, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘CVAS Biocidal Product Family based on L (+) Lactic Acid’ and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012.












(5)


The opinion concludes that ‘CVAS Biocidal Product Family based on L (+) Lactic Acid’ is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.












(6)


On 20 July 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.












(7)


The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘CVAS Biocidal Product Family based on L (+) Lactic Acid’.












(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-0028957-0000 is hereby granted 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’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 18 July 2023 to 30 June 2033.


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, 27 June 2023.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1.

(2)  ECHA opinion of 15 June 2022 on the Union authorisation of ‘CVAS Biocidal Product Family based on L (+) Lactic Acid’ (ECHA/BPC/345/2022), https://echa.europa.eu/opinions-on-union-authorisation




ANNEX
Summary of product characteristics for a biocidal product family

CVAS Biocidal Product Family based on L(+) Lactic Acid


Product type 3 - Veterinary hygiene (Disinfectants)


Product type 4 - Food and feed area (Disinfectants)


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 (Disinfectants)
PT04 - Food and feed area (Disinfectants)




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


CVAS Development GmbH




Address


Am Hafen 16, 68526 Ladenburg Germany




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 biocidal products







Name of manufacturer


Calvatis GmbH




Address of manufacturer


Am Hafen 16, 68526 Ladenburg Germany




Location of manufacturing sites


Am Hafen 16, 68526 Ladenburg Germany













Name of manufacturer


Arthur Schopf Hygiene GmbH & Co. KG




Address of manufacturer


Pfaffensteinstraße 1, 83115 Neubeuern Germany




Location of manufacturing sites


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




Location of manufacturing sites


Arkelsedijk 46, 4206AC Gorinchem Netherlands




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 (%)




Min


Max




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


1,92 


17,6 




Methanesulphonic acid


Methanesulphonic acid


Non-active substance


75-75-2


200-898-6


0,0 


10,5 




Phosphoric acid


Phosphoric acid


Non-active substance


7664-38-2


231-633-2


0,0 


18,75 




Sulphuric acid


Sulphuric acid


Non-active substance


7664-93-9


231-639-5


0,0 


4,5 




Isononanoic acid


Isononanoic acid


Non-active substance


3302-10-1


221-975-0


0,0 


2,5 




2.2.   Type(s) of formulation







Formulation(s)


AL - Any other liquid
SL - Soluble concentrate




PART II

SECOND INFORMATION LEVEL - META SPC(S)


META SPC 1

1.   META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier







Identifier


mSPC1




1.2.   Suffix to the authorisation number







Number


1-1




1.3.   Product type(s)







Product type(s)


PT03 - Veterinary hygiene (Disinfectants)




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 (%)




Min


Max




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


1,92 


1,96 




2.2.   Type(s) of formulation of the meta SPC 1







Formulation(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 1

4.1.   Use description


Table 1


Use # 1 – Use # 1.1 - Teat-disinfection post-milking by manual or automated dipping







Product type


PT03 - Veterinary hygiene (Disinfectants)




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
Teat-disinfection post-milking




Application method(s)


Method: Dipping
Detailed description:






 


Teat-disinfection post-milking










 


Manual dipping using a dip cup










 


Automated dipping by robot








Application rate(s) and frequency


Application Rate: Ready-To-Use (RTU) product, 1,92-1,96% L-(+)-lactic acid
Dilution (%): -
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): 600-1 000  kg




4.1.1.   Use-specific instructions for use

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 (1)
OF THE META SPC 1

5.1.   Instructions for use

The product must be brought to a temperature between 20°C and 30°C before use.
The use of a dosing pump for filling the product into the application equipment is recommended.
Fill in the dosing pump reservoir with the RTU product. Avoid discharge of surplus fluids.
Apply the product by manual or automated dipping. Make sure that the teats are fully covered with disinfectant. Application volumes for cows and buffaloes - 5 ml/treatment and for sheep and goats - 3 ml/treatment.
Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.
After disinfection clean the application equipment by rinsing with water.
5.2.   Risk mitigation measures

None
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment


First aid instructions

IF INHALED: if symptoms occur call a POISON CENTRE or a doctor.
IF ON SKIN: wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.
IF IN EYES: if symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.
IF SWALLOWED: if symptoms occur call a POISON CENTRE or a doctor.

Emergency measure to protect the environment

Environmental precautions: do not allow product to reach sewage systems or water bodies.
Methods and material for containment and cleaning up: absorb with liquid-binding material (sand, diatomite, universal binder). Do not use combustible material like
sawdust. Dispose of the material collected in accordance with local regulations.
5.4.   Instructions for safe disposal of the product and its packaging

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements.
Used product can be flushed to municipal sewer or disposed to the manure deposit depending on local requirements.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf life: 24 months
Do not store at temperatures above 40°C.
Keep away from heat and direct sunlight.
Protect from frost.
Keep container tightly closed.
6.   OTHER INFORMATION

Not relevant
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1

7.1.   Trade name(s), authorisation number and specific composition of each individual product











Trade name(s)


calgodip Amadine Film


Market area: EU




AGRIMARKT MILCHSÄUREMANTEL


Market area: EU




IWETEC MILCHSÄURE DIPP


Market area: EU




Authorisation number


EU-0028957-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


1,92 




7.2.   Trade name(s), authorisation number and specific composition of each individual product











Trade name(s)


Dip es lac DL


Market area: EU




Traylac O-F


Market area: EU




Baktostop Lactic


Market area: EU




Lacti-Bac Dip


Market area: EU




DS 1.0 F


Market area: EU




Authorisation number


EU-0028957-0002 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


1,92 




7.3.   Trade name(s), authorisation number and specific composition of each individual product











Trade name(s)


calgodip Blue Kamille Film


Market area: EU




Authorisation number


EU-0028957-0003 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


1,92 




7.4.   Trade name(s), authorisation number and specific composition of each individual product











Trade name(s)


Dip es protect DL


Market area: EU




 


BaktoStop lactic H


Market area: EU




Dip Agro Protect


Market area: EU




Kuhmilin Dip Top M


Market area: EU




Lacti-Protect Dip


Market area: EU




DSR 1.5 F


Market area: EU




ProfiMix inSilk


Market area: EU




Authorisation number


EU-0028957-0004 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


1,92 





META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier







Identifier


mSPC2




1.2.   Suffix to the authorisation number







Number


1-2




1.3.   Product type(s)







Product type(s)


PT03 - Veterinary hygiene (Disinfectants)




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 (%)




Min


Max




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


6,8 


6,8 




2.2.   Type(s) of formulation of the meta SPC 2







Formulation(s)


AL - Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2







Hazard statements


Causes skin irritation.
Causes serious eye damage.




Precautionary statements


Wash hands thoroughly after handling.
Wear protective gloves.
Wear eye protection.
IF ON SKIN:Wash with plenty of water.
If skin irritation occurs:Get medical advice.
If skin irritation occurs:Get medical attention.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Immediately call a POISON CENTER.
Immediately call a doctor.
Dispose of contents in accordance with local regulations.
Dispose of container in accordance with local regulations.




4.   AUTHORISED USE(S) OF THE META SPC 2

4.1.   Use description


Table 2


Use # 1 – Use # 2.1 - Teat-disinfection post-milking by manual or automated dipping







Product type


PT03 - Veterinary hygiene (Disinfectants)




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
Teat-disinfection post-milking




Application method(s)


Method: Dipping
Detailed description:






 


Teat-disinfection post-milking










 


Manual dipping using a dip cup










 


Automated dipping by robot








Application rate(s) and frequency


Application Rate: RTU product, 6,80% L-(+)-lactic acid
Dilution (%): -
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: 600-1 000  kg




4.1.1.   Use-specific instructions for use

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 (2)
OF THE META SPC 2

5.1.   Instructions for use

The product must be brought to a temperature between 20°C and 30°C before use.
The use of a dosing pump for filling the product into the application equipment is recommended.
Fill in the dosing pump reservoir with the RTU product. Avoid discharge of surplus fluids.
Apply the product by manual or automated dipping. Make sure that the teats are fully covered with disinfectant. Application volumes for cows and buffaloes - 5 ml/treatment and for sheep and goats - 3 ml/treatment.
Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.
After disinfection clean the application equipment by rinsing with water.
Keep out of reach of children.
5.2.   Risk mitigation measures

Wear chemical goggles consistent with the European Standard EN ISO 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN ISO 374 or equivalent. See section 6 for the full titles of the EN standards.
Goggles, gloves and coverall material to be specified by the authorisation holder within the product information.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to this act.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment


First aid instructions

IF INHALED: if symptoms occur call a POISON CENTRE or a doctor.
IF ON SKIN: take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.
IF IN EYES: immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112 or an ambulance for medical assistance.
IF SWALLOWED: immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.

Emergency measure to protect the environment

Environmental precautions: do not allow product to reach sewage systems or water bodies.
Methods and material for containment and cleaning up: absorb with liquid-binding material (sand, diatomite, universal binder). Do not use combustible material like sawdust. Dispose of the material collected in accordance with local regulations.
5.4.   Instructions for safe disposal of the product and its packaging

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements.
Used product can be flushed to municipal sewer or disposed to the manure deposit depending on local requirements.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf life: 24 months
Do not store at temperatures above 40°C.
Keep away from heat and direct sunlight.
Protect from frost.
Keep container tightly closed.
6.   OTHER INFORMATION

The full titles of EN standards mentioned in the section 5.2 ‘Risk mitigation measures’ are:






 


EN ISO 16321– Eye and face protection for occupational users.










 


EN ISO 374 – Protective gloves against dangerous chemicals and micro-organisms.




The full reference of the legal act mentioned in the section 5.2 ‘Risk mitigation measures’ is:






 


Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).




7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2

7.1.   Trade name(s), authorisation number and specific composition of each individual product











Trade name(s)


calgodip Amadine forte Film


Market area: EU




Authorisation number


EU-0028957-0005 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


6,8 




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 




7.3.   Trade name(s), authorisation number and specific composition of each individual product











Trade name(s)


calgodip Blue Kamille forte Film


Market area: EU




Authorisation number


EU-0028957-0007 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


6,8 




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 





META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier







Identifier


mSPC3




1.2.   Suffix to the authorisation number







Number


1-3




1.3.   Product type(s)







Product type(s)


PT03 - Veterinary hygiene (Disinfectants)




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 (%)




Min


Max




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


1,92 


1,96 




2.2.   Type(s) of formulation of the meta SPC 3







Formulation(s)


AL - Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3







Hazard statements


 




Precautionary statements


 




4.   AUTHORISED USE(S) OF THE META SPC 3

4.1.   Use description


Table 3


Use # 1 – Use # 3.1 – Teat-disinfection post-milking by manual or automated dipping or spraying







Product type


PT03 - Veterinary hygiene (Disinfectants)




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
Teat-disinfection post-milking




Application method(s)


Method: Dipping
Detailed description:






 


Teat-disinfection post-milking










 


Manual dipping using a dip cup










 


Automated dipping by robot




Method: Spraying
Detailed description:






 


Teat-disinfection post-milking










 


Manual spraying using a trigger sprayer










 


Manual spraying using an electronic sprayer










 


Automated spraying by robot








Application rate(s) and frequency


Application Rate: RTU product, 1,92-1,96% L-(+)-lactic acid
Dilution (%): -
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: 600-1 000  kg




4.1.1.   Use-specific instructions for use

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 (3)
OF THE META SPC 3

5.1.   Instructions for use

The product must be brought to a temperature between 20°C and 30°C before use.
The use of a dosing pump for filling the product into the application equipment is recommended.
Fill in the dosing pump reservoir with the RTU product. Avoid discharge of surplus fluids.
Apply the product by manual or automated dipping or spraying. Make sure that the teats are fully covered with disinfectant. Application volumes for cows and buffaloes - 5 ml/treatment and for sheep and goats - 3 ml/treatment.
Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.
After disinfection clean the application equipment by rinsing with water.
5.2.   Risk mitigation measures

None
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment


First aid instructions

IF INHALED: if symptoms occur call a POISON CENTRE or a doctor.
IF ON SKIN: wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.
IF IN EYES: if symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.
IF SWALLOWED: if symptoms occur call a POISON CENTRE or a doctor.

Emergency measure to protect the environment

Environmental precautions: do not allow product to reach sewage systems or water bodies.
Methods and material for containment and cleaning up: absorb with liquid-binding material (sand, diatomite, universal binder). Do not use combustible material like sawdust. Dispose of the material collected in accordance with local regulations.
5.4.   Instructions for safe disposal of the product and its packaging

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements.
Used product can be flushed to municipal sewer or disposed to the manure deposit depending on local requirements.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf life: 24 months
Do not store at temperatures above 40°C.
Keep away from heat and direct sunlight.
Protect from frost.
Keep container tightly closed.
6.   OTHER INFORMATION

Not relevant
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3

7.1.   Trade name(s), authorisation number and specific composition of each individual product











Trade name(s)


calgodip Amadine Spray


Market area: EU




AGRIMARKT MILCHSÄURENEBEL


Market area: EU




IWETEC MILCHSÄURE SPRAY


Market area: EU




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 




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 




7.3.   Trade name(s), authorisation number and specific composition of each individual product











Trade name(s)


calgodip Blue Kamille 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 




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 





META SPC 4

1.   META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier







Identifier


mSPC4




1.2.   Suffix to the authorisation number







Number


1-4




1.3.   Product type(s)







Product type(s)


PT03 - Veterinary hygiene (Disinfectants)




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 (%)




Min


Max




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


6,8 


6,8 




2.2.   Type(s) of formulation of the meta SPC 4







Formulation(s)


AL - Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4







Hazard statements


Causes skin irritation.
Causes serious eye damage.




Precautionary statements


Wash hands thoroughly after handling.
Wear protective gloves.
Wear eye protection.
IF ON SKIN:Wash with plenty of water.
If skin irritation occurs:Get medical advice.
If skin irritation occurs:Get medical attention.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Immediately call a POISON CENTER.
Immediately call a doctor.
Dispose of contents in accordance with local regulations.
Dispose of container in accordance with local regulations.




4.   AUTHORISED USE(S) OF THE META SPC 4

4.1.   Use description


Table 4


Use # 1 – Use # 4.1 - Teat-disinfection post-milking by manual or automated dipping or spraying







Product type


PT03 - Veterinary hygiene (Disinfectants)




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
Teat-disinfection post-milking




Application method(s)


Method: Dipping
Detailed description:






 


Teat-disinfection post-milking










 


Manual dipping using a dip cup










 


Automated dipping by robot




Method: Spraying
Detailed description:






 


Teat-disinfection post-milking










 


Manual spraying using a trigger sprayer










 


Manual spraying using an electronic sprayer










 


Automated spraying by robot








Application rate(s) and frequency


Application Rate: RTU product, 6,80% L-(+)-lactic acid
Dilution (%): -
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: 600-1 000  kg




4.1.1.   Use-specific instructions for use

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 (4)
OF THE META SPC 4

5.1.   Instructions for use

The product must be brought to a temperature between 20°C and 30°C before use.
The use of a dosing pump for filling the product into the application equipment is recommended.
Fill in the dosing pump reservoir with the RTU product. Avoid discharge of surplus fluids.
Apply the product by manual or automated dipping or spraying. Make sure that the teats are fully covered with disinfectant. Application volumes for cows and buffaloes - 5 ml/treatment and for sheep and goats - 3 ml/treatment.
Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.
After disinfection clean the application equipment by rinsing with water.
Keep out of reach of children.
5.2.   Risk mitigation measures

Wear chemical goggles consistent with the European Standard EN ISO 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN ISO 374 or equivalent.
Goggles, gloves and coverall material to be specified by the authorisation holder within the product information.
This is without prejudice to the application of Directive 98/24/EC and other Union legislation in the area of health and safety at work.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment


First aid instructions

IF INHALED: if symptoms occur call a POISON CENTRE or a doctor.
IF ON SKIN: take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.
IF IN EYES: immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112 or an ambulance for medical assistance.
IF SWALLOWED: immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.

Emergency measure to protect the environment

Environmental precautions: do not allow product to reach sewage systems or water bodies.
Methods and material for containment and cleaning up: absorb with liquid-binding material (sand, diatomite, universal binder). Do not use combustible material like
sawdust. Dispose of the material collected in accordance with local regulations.
5.4.   Instructions for safe disposal of the product and its packaging

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements.
Used product can be flushed to municipal sewer or disposed to the manure deposit depending on local requirements.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf life: 24 months
Do not store at temperatures above 40°C.
Keep away from heat and direct sunlight.
Protect from frost.
Keep container tightly closed.
6.   OTHER INFORMATION

Not relevant
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4

7.1.   Trade name(s), authorisation number and specific composition of each individual product











Trade name(s)


calgodip Amadine forte Spray


Market area: EU




Authorisation number


EU-0028957-0013 1-4




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


6,8 




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 




7.3.   Trade name(s), authorisation number and specific composition of each individual product











Trade name(s)


calgodip Blue Kamille forte Spray


Market area: EU




Authorisation number


EU-0028957-0015 1-4




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


6,8 




7.4.   Trade name(s), authorisation number and specific composition of each individual product











Trade name(s)


Dip es protect DLX Spray


Market area: EU




Authorisation number


EU-0028957-0016 1-4




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


6,8 





META SPC 5

1.   META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 5 identifier







Identifier


mSPC5




1.2.   Suffix to the authorisation number







Number


1-5




1.3.   Product type(s)







Product type(s)


PT03 - Veterinary hygiene (Disinfectants)




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 (%)




Min


Max




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


1,92 


1,96 




2.2.   Type(s) of formulation of the meta SPC 5







Formulation(s)


AL - Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5







Hazard statements


Causes skin irritation.
Causes serious eye irritation.




Precautionary statements


Wash hands thoroughly after handling.
Wear protective gloves.
Wear eye protection.
IF ON SKIN:Wash with plenty of water.
If skin irritation occurs:Get medical advice.
If skin irritation occurs:Get medical attention.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
If eye irritation persists:Get medical advice.
If eye irritation persists:Get medical attention.
Dispose of container in accordance with local regulations.
Dispose of contents in accordance with local regulations.




4.   AUTHORISED USE(S) OF THE META SPC 5

4.1.   Use description


Table 5


Use # 1 – Use # 5.1 – Teat-disinfection post-milking by manual or automated dipping or spraying







Product type


PT03 - Veterinary hygiene (Disinfectants)




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
Teat-disinfection post-milking




Application method(s)


Method: Dipping
Detailed description:






 


Teat-disinfection post-milking










 


Manual dipping using a dip cup










 


Automated dipping by robot




Method: Spraying
Detailed description:






 


Teat-disinfection post-milking










 


Manual spraying using a trigger sprayer










 


Manual spraying using an electronic sprayer










 


Automated spraying by robot








Application rate(s) and frequency


Application Rate: RTU product, 1,92-1,96% L-(+)-lactic acid
Dilution (%): -
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: 600-1 000  kg




4.1.1.   Use-specific instructions for use

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 (5)
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.
Goggles, gloves and coverall material to be specified by the authorisation holder within the product information.
This is without prejudice to the application of Directive 98/24/EC and other Union legislation in the area of health and safety at work.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment


First aid instructions

IF INHALED: if symptoms occur call a POISON CENTRE or a doctor.
IF ON SKIN: take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.
IF IN EYES: rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF SWALLOWED: rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.

Emergency measure to protect the environment

Environmental precautions: no special environmental measures are necessary. Clean contaminated articles and floor in accordance with the environmental legislation.
Methods and material for containment: absorb with liquid-binding material (e.g. sand, diatomaceous earth, acid- or universal binding agents).
5.4.   Instructions for safe disposal of the product and its packaging

At the end of the application, dispose unused product and the packaging in accordance with local requirements.
Used product can be flushed to municipal sewer or disposed to the manure deposit depending on local requirements.
Avoid release to an individual waste water treatment plant.
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 





META SPC 6

1.   META SPC 6 ADMINISTRATIVE INFORMATION
1.1.   Meta SPC 6 identifier







Identifier


mSPC6




1.2.   Suffix to the authorisation number







Number


1-6




1.3.   Product type(s)







Product type(s)


PT03 - Veterinary hygiene (Disinfectants)




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 (%)




Min


Max




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


6,8 


6,8 




2.2.   Type(s) of formulation of the meta SPC 6







Formulation(s)


AL - Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6







Hazard statements


Causes skin irritation.
Causes serious eye damage.




Precautionary statements


Wash hands thoroughly after handling.
Wear protective gloves.
Wear eye protection.
IF ON SKIN:Wash with plenty of water.
If skin irritation occurs:Get medical advice.
If skin irritation occurs:Get medical attention.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Immediately call a POISON CENTER.
Immediately call a doctor.
Dispose of contents in accordance with local regulations.
Dispose of container in accordance with local regulations.




4.   AUTHORISED USE(S) OF THE META SPC 6

4.1.   Use description


Table 6


Use # 1 – Use # 6.1 - Teat-disinfection post-milking by manual or automated dipping or spraying







Product type


PT03 - Veterinary hygiene (Disinfectants)




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
Teat-disinfection post-milking




Application method(s)


Method: Dipping
Detailed description:






 


Teat-disinfection post-milking










 


Manual dipping using a dip cup










 


Automated dipping by robot




Method: Spraying
Detailed description:






 


Teat-disinfection post-milking










 


Manual spraying using a trigger sprayer










 


Manual spraying using an electronic sprayer










 


Automated spraying by robot








Application rate(s) and frequency


Application Rate: RTU product, 6,80% L-(+)-lactic acid
Dilution (%): -
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: 600-1 000  kg




4.1.1.   Use-specific instructions for use

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 (6)
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.
Goggles, gloves and coverall material to be specified by the authorisation holder within the product information.
This is without prejudice to the application of Directive 98/24/EC and other Union legislation in the area of health and safety at work.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment


First aid instructions

IF INHALED: if symptoms occur call a POISON CENTRE or a doctor.
IF ON SKIN: take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.
IF IN EYES: immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112 or an ambulance for medical assistance.
IF SWALLOWED: immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.

Emergency measure to protect the environment

Environmental precautions: no special environmental measures are necessary. Clean contaminated articles and floor in accordance with the environmental legislation.
Methods and material for containment: absorb with liquid-binding material (e.g. sand, diatomaceous earth, acid- or universal binding agents).
5.4.   Instructions for safe disposal of the product and its packaging

At the end of the application, dispose unused product and the packaging in accordance with local requirements.
Used product can be flushed to municipal sewer or disposed to the manure deposit depending on local requirements.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf life: 24 months
Do not store at temperatures above 40°C.
Keep away from heat and direct sunlight.
Protect from frost.
Keep container tightly closed.
6.   OTHER INFORMATION

Not relevant
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6

7.1.   Trade name(s), authorisation number and specific composition of each individual product











Trade name(s)


Dip es poly-spray DLX


Market area: EU




Authorisation number


EU-0028957-0018 1-6




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


6,8 





META SPC 7

1.   META SPC 7 ADMINISTRATIVE INFORMATION
1.1.   Meta SPC 7 identifier







Identifier


mSPC7




1.2.   Suffix to the authorisation number







Number


1-7




1.3.   Product type(s)







Product type(s)


PT04 - Food and feed area (Disinfectants)




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 (%)




Min


Max




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


16,0 


17,6 




Methanesulphonic acid


Methanesulphonic acid


Non-active substance


75-75-2


200-898-6


6,3 


7,0 




2.2.   Type(s) of formulation of the meta SPC 7







Formulation(s)


SL - Soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7







Hazard statements


May be corrosive to metals.
Causes severe skin burns and eye damage.
Corrosive to the respiratory tract.




Precautionary statements


Do not breathe spray.
Wear protective gloves.
Wear protective clothing.
Wear eye protection.
Wear face protection.
IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Immediately call a doctor.
Immediately call a POISON CENTER.
Store in corrosion resistant container with a resistant inner liner.
Dispose of contents in accordance with local regulations.
Dispose of container in accordance with local regulations.




4.   AUTHORISED USE(S) OF THE META SPC 7

4.1.   Use description


Table 7


Use # 1 – Use # 7.1 – Hard surface disinfection by manual or automated foaming







Product type


PT04 - Food and feed area (Disinfectants)




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
Hard surface disinfection




Application method(s)


Method: Foaming
Detailed description:






 


Hard surface disinfection










 


Manual foaming using a foam lance










 


Automated foaming with fixed installed foaming nozzles




Foaming equipment
Satellite 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
Dilution (%): 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: 600-1 000  kg




4.1.1.   Use-specific instructions for use

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 (7)
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.
Goggles, gloves and coverall material to be specified by the authorisation holder within the product information.
Wear respiratory protection when handling the concentrated product. Respiratory protection to be specified by the authorisation holder within the product information. Avoid standing in areas with aerosol formation.
This is without prejudice to the application of Directive 98/24/EC and other Union legislation in the area of health and safety at work.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment


First aid instructions

IF INHALED: move to fresh air and keep at rest in a position comfortable for breathing.
If symptoms: call 112 or an ambulance for medical assistance.
If no symptoms: call a POISON CENTRE or a doctor.
IF ON SKIN: immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112 or an ambulance for medical assistance.
IF SWALLOWED: immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.

Emergency measure to protect the environment

Environmental precautions: do not allow product to reach sewage systems or water bodies.
Methods and material for containment and cleaning up: absorb with liquid-binding material (sand, diatomite, universal binder). Do not use combustible material like sawdust. Dispose of the material collected in accordance with local regulations. Ensure adequate ventilation.
5.4.   Instructions for safe disposal of the product and its packaging

At the end of the application, dispose unused product and the packaging in accordance with local requirements.
Used product can be flushed to municipal sewer depending on local requirements.
Avoid release to an individual waste water treatment plant.
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


16,0 




Methanesulphonic acid


Methanesulphonic acid


Non-active substance


75-75-2


200-898-6


7,0 





META SPC 8

1.   META SPC 8 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 8 identifier







Identifier


mSPC8




1.2.   Suffix to the authorisation number







Number


1-8




1.3.   Product type(s)







Product type(s)


PT04 - Food and feed area (Disinfectants)




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 (%)




Min


Max




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


16,0 


17,6 




Methanesulphonic acid


Methanesulphonic acid


Non-active substance


75-75-2


200-898-6


0,0 


10,5 




Phosphoric acid


Phosphoric acid


Non-active substance


7664-38-2


231-633-2


0,0 


18,75 




Sulphuric acid


Sulphuric acid


Non-active substance


7664-93-9


231-639-5


4,5 


4,5 




Isononanoic acid


Isononanoic acid


Non-active substance


3302-10-1


221-975-0


2,25 


2,5 




2.2.   Type(s) of formulation of the meta SPC 8







Formulation(s)


SL - Soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8







Hazard statements


May be corrosive to metals.
Causes severe skin burns and eye damage.
Corrosive to the respiratory tract.




Precautionary statements


Do not breathe spray.
Wear protective gloves.
Wear protective clothing.
Wear eye protection.
Wear face protection.
IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Immediately call a POISON CENTER.
Immediately call a doctor.
Store in corrosion resistant container with a resistant inner liner.
Dispose of contents in accordance with local regulations.
Dispose of container in accordance with local regulations.




4.   AUTHORISED USE(S) OF THE META SPC 8

4.1.   Use description


Table 8


Use # 1 – Use # 8.1 – Hard surface disinfection by automated spraying in closed cleaning in place (CIP) system







Product type


PT04 - Food and feed area (Disinfectants)




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
Hard surface disinfection




Application method(s)


Method: Spraying
Detailed description:






 


Hard surface disinfection










 


Automated dosing and spraying in closed CIP system




CIP system: pipe work, fermentation and storage tanks




Application rate(s) and frequency


Application Rate: Concentrated product, 16,0-17,6% L-(+)-lactic acid
Dilution (%): 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: 600-1 000  kg




4.1.1.   Use-specific instructions for use

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 (8)
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.
Goggles, gloves and coverall material to be specified by the authorisation holder within the product information.
Wear respiratory protection when handling the concentrated product. Respiratory protection to be specified by the authorisation holder within the product information. Avoid standing in areas with aerosol formation.
This is without prejudice to the application of Directive 98/24/EC and other Union legislation in the area of health and safety at work.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment


First aid instructions

IF INHALED: move to fresh air and keep at rest in a position comfortable for breathing.
If symptoms: call 112 or an ambulance for medical assistance.
If no symptoms: call a POISON CENTRE or a doctor.
IF ON SKIN: immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112 or an ambulance for medical assistance.
IF SWALLOWED: immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.

Emergency measure to protect the environment

Environmental precautions: do not allow product to reach sewage systems or water bodies.
Methods and material for containment and cleaning up: absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). Dispose of the material collected in accordance with local regulations.
5.4.   Instructions for safe disposal of the product and its packaging

At the end of the application, dispose unused product and the packaging in accordance with local requirements.
Used product can be flushed to municipal sewer depending on local requirements.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf life: 24 months
Ensure good ventilation or exhaustion.
Do not store together with alkalis (caustic solutions).
Do not store at temperatures above 40°C.
Keep away from heat and direct sunlight.
Protect from frost.
Keep container tightly closed.
6.   OTHER INFORMATION

Not relevant
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8

7.1.   Trade name(s), authorisation number and specific composition of each individual product











Trade name(s)


calgonit Duocip


Market area: EU




Authorisation number


EU-0028957-0020 1-8




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


16,0 




Methanesulphonic acid


Methanesulphonic acid


Non-active substance


75-75-2


200-898-6


10,5 




Sulphuric acid


Sulphuric acid


Non-active substance


7664-93-9


231-639-5


4,5 




Isononanoic acid


Isononanoic acid


Non-active substance


3302-10-1


221-975-0


2,5 




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


16,0 




Phosphoric acid


Phosphoric acid


Non-active substance


7664-38-2


231-633-2


18,75 




Sulphuric acid


Sulphuric acid


Non-active substance


7664-93-9


231-639-5


4,5 




Isononanoic acid


Isononanoic acid


Non-active substance


3302-10-1


221-975-0


2,5 






(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.

(2)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.

(3)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.

(4)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4.

(5)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 5.

(6)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 6.

(7)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 7.

(8)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 8.