Commission Implementing Regulation (EU) 2023/2747 of 8 December 2023 amending Implementing Regulation (EU) 2022/1391 granting a Union authorisation for the biocidal product family Lactic acid based products – CID Lines NV in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Date: 2023-12-08
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal health, biocide, decontamination, food safety, market approval, organic acid, pharmaceutical product








L_202302747EN.000101.fmx.xml












Official Journal of the European Union


EN
Series L













2023/2747


11.12.2023







            COMMISSION IMPLEMENTING REGULATION (EU) 2023/2747
of 8 December 2023
         
amending Implementing Regulation (EU) 2022/1391 granting a Union authorisation for the biocidal product family ‘Lactic acid based products – CID Lines NV’ 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 48(1), point (a), thereof,

Whereas:







(1)


On 26 July 2022, a Union authorisation was granted to CID Lines NV for the making available on the market and use of the biocidal product family ‘Lactic acid-based products – CID Lines NV’ by Commission Implementing Regulation (EU) 2022/1391 (2). In Annex I to Implementing Regulation (EU) 2022/1391 the authorisation holder was required to conduct a long-term storage stability test at ambient temperature of ‘Lactic acid-based products – CID Lines NV’ in commercial packaging in which the products in the family will be made available on the market and to submit the results of the test to the Agency by 1 March 2023.












(2)


The authorisation holder provided the required data on 28 February 2023 to the European Chemicals Agency (ECHA), recorded under the case number BC-RC051007-54. The evaluating competent authority of Belgium submitted the conclusions of its evaluation to ECHA on 9 March 2023.












(3)


On 30 June 2023, ECHA submitted the opinion of the Biocidal Products Committee (3) to the Commission concluding that the submitted data confirms the shelf life of 2 years for the products of the biocidal product family ‘CID Lines – Lactic acid-based products’, except for the packaging Wipe 4, 2L (105 wipes) from meta SPC 7 for which a two-year shelf life could not be confirmed.












(4)


The Commission concurs with the opinion of ECHA and considers it therefore appropriate to amend the Union authorisation of the biocidal product family ‘Lactic acid-based products – CID LINES NV’.












(5)


Since the shelf life of 2 years could not be confirmed for the packaging Wipe 4, 2L (105 wipes) of the biocidal product family, the conditions of Article 19 of Regulation (EU) No 528/2012 are not met for this packaging type for the duration of the shelf life.












(6)


The packaging Wipe 4, 2L (105 wipes) should therefore be removed from the entry ‘Pack sizes and packaging material’ in tables 13, 14, 15, 16, 17 and 18 of meta SPC 7 in Annex II to Implementing Regulation (EU) 2022/1391.












(7)


On 4 August 2023, the Commission informed the authorisation holder of its intention to amend the Union authorisation for the biocidal product family ‘Lactic acid-based products – CID Lines NV’ and gave the opportunity to submit comments or additional information in accordance with Article 48(2) of Regulation (EU) No 528/2012. In its response received on the same day, the authorisation holder agreed with the intended amendment of the authorisation for the packaging Wipe 4, 2L (105 wipes) in meta SPC 7 for which a two-year shelf life could not be confirmed.












(8)


In order to enhance clarity and ease the access of users and interested parties to the final version of the SPC which is to be published in the Register of Biocidal Products, Annex II to Implementing Regulation (EU) 2022/1391 should be replaced in its entirety.












(9)


Implementing Regulation (EU) 2022/1391 should therefore be amended accordingly,





HAS ADOPTED THIS REGULATION:



Article 1
Annex II to Implementing Regulation (EU) 2022/1391 is replaced by the text 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, 8 December 2023.


For the Commission


The President

Ursula VON DER LEYEN
            





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

(2)  Commission Implementing Regulation (EU) 2022/1391 of 26 July 2022 granting a Union authorisation for the biocidal product family ‘Lactic acid based products – CID Lines NV’ (OJ L 211, 12.8.2022, p. 1).

(3)  Opinion of the evaluation of post authorisation conditions for the Union authorisation of Lactic acid based products – CID Lines NV’. ECHA/BPC/384/2023 of 7 June 2023.




ANNEX



‘ANNEX II
Summary of product characteristics for a biocidal product family
Lactic acid based products – CID LINES NV
Product type 1 – Human hygiene (Disinfectants)
Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Product type 3 – Veterinary hygiene (Disinfectants)
Product type 4 – Food and feed area (Disinfectants)
Authorisation number: EU-0027740-0000
R4BP asset number: EU-0027740-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name







Name


Lactic acid based products – CID LINES NV




1.2.   Product type(s)







Product type(s)


PT01 – Human hygiene (Disinfectants)
PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
PT03 – Veterinary hygiene (Disinfectants)
PT04 – Food and feed area (Disinfectants)




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


CID LINES NV




Address


Waterpoortstraat 2, 8900 Ieper Belgium




Authorisation number


EU-0027740-0000





R4BP asset number



EU-0027740-0000




Date of the authorisation


31 December 2023




Expiry date of the authorisation


31 August 2032




1.4.   Manufacturer(s) of the biocidal products







Name of manufacturer


CID LINES NV




Address of manufacturer


Waterpoortstraat 2, 8900 Ieper Belgium




Location of manufacturing sites


Waterpoortstraat 2, 8900 Ieper Belgium




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, 4206 Gorinchem Netherlands




Location of manufacturing sites


Arkelsedijk 46, 4206 Gorinchem Netherlands













Active substance


L-(+)-lactic acid




Name of manufacturer


Jungbunzlauer S.A.




Address of manufacturer


Z.I. et Portuaire, B.P. 32, 67390 Marckolsheim France




Location of manufacturing sites


Z.I. et Portuaire, B.P. 32, 67390 Marckolsheim France




2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the family












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


2,0 


70,0 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


0,0 


12,0 




Sodium lauryl ether sulfate


Alcohols, C12-14, ethoxylated, sulfates, sodium salts


Non-active substance


68891-38-3


500-234-8


0,0 


8,4 




Sulfonic acids, C14-17-sec-alkane, sodium salts


Sulfonic acids, C14-17-sec-alkane, sodium salts


Non-active substance


97489-15-1


307-055-2


0,0 


2,25 




C6 alkyl glucoside


Hexyl D-Glucoside


Non-active substance


54549-24-5


259-217-6


0,0 


2,4 




Isopropanol


Propan-2-ol


Non-active substance


67-63-0


200-661-7


0,0 


5,0 




Methanesulfonic acid


Methanesulfonic acid


Non-active substance


75-75-2


200-898-6


0,0 


19,5 




Sulphuric acid


Sulphuric acid


Non-active substance


7664-93-9


231-639-5


0,0 


10,5 




Butyldiglycol


2-(2-butoxyethoxy)ethanol


Non-active substance


112-34-5


203-961-6


0,0 


10,0 




2.2.   Type(s) of formulation







Formulation(s)


AL – Any other liquid
SL – Soluble concentrate
WI – Wipes




PART II

SECOND INFORMATION LEVEL – META SPC(S)


META SPC 1

1.   META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier







Identifier


Meta SPC 1: Ready to use hygienic handwash (PT1)




1.2.   Suffix to the authorisation number







Number


1-1




1.3.   Product type(s)







Product type(s)


PT01 – Human 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


3,6 


3,6 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


5,0 


5,0 




Isopropanol


Propan-2-ol


Non-active substance


67-63-0


200-661-7


4,0 


4,0 




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


Causes serious eye damage.




Precautionary statements


Wear eyes/face protection.
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.




4.   AUTHORISED USE(S) OF THE META SPC 1

4.1.   Use description


Table 1


Use # 1 – Hygienic handwash for professional use







Product type


PT01 – Human hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: Other: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Other: Yeast
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
Food and feed industry, Public field and Kitchens:
Hygienic handwash




Application method(s)


Method: -
Detailed description:
-




Application rate(s) and frequency


Application Rate: 10 mL of undiluted product (that is four pushes for both hands together)
Dilution (%): -
Number and timing of application:
Apply 10 mL of undiluted product (that is four pushes for both hands together) and wash your hands for at least one minute according to the recommended hand washing procedure, before rinse and dry.




Category(ies) of users


Professional




Pack sizes and packaging material


50 mL, 75 mL, 100 mL, 150 mL, 500 mL, 1L, 5L, 10L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000  L, 1 100  L
HDPE (High Density Polyethylene)




4.1.1.   Use-specific instructions for use

see general directions for use for Meta SPC 1
4.1.2.   Use-specific risk mitigation measures

/
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 Meta SPC 1
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for Meta SPC 1
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

see general directions for Meta SPC 1
5.   GENERAL DIRECTIONS FOR USE (1)
OF THE META SPC 1

5.1.   Instructions for use

Wet your hands with clean, running water at room temperature
Turn off the tap
Apply 10 mL of undiluted product and rub your hands for at least one minute according to the recommended hand washing procedure, before rinse and dry.
For professional use only
5.2.   Risk mitigation measures

/
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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 INHALED: If symptoms occur 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. Immediately call 112/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/ambulance for medical assistance.
5.4.   Instructions for safe disposal of the product and its packaging

The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
6.   OTHER INFORMATION

/
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)


Kenosan Hand Scrub


Market area: EU




Authorisation number


EU-0027740-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


3,6 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


5,0 




Isopropanol


Propan-2-ol


Non-active substance


67-63-0


200-661-7


4,0 





META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier







Identifier


Meta SPC 2: Ready to use Algaecide




1.2.   Suffix to the authorisation number







Number


1-2




1.3.   Product type(s)







Product type(s)


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (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


2,0 


2,0 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


0,6 


0,9 




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 serious eye irritation.




Precautionary statements


If medical advice is needed, have product container or label at hand.
Keep out of reach of children.
Read carefully and follow all instructions.
Wash hands thoroughly after handling.
Wear eyes/face protection.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
If skin irritation occurs:Get medical advice.
If eye irritation persists:Get medical advice.
Take off contaminated clothing.And wash it before reuse.




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

4.1.   Use description


Table 2


Use # 1 – Ready to use algaecide for professional use







Product type


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:
Scientific name: unicellular green algae and blue-green algae
Common name: cyanobacteria
Development stage:




Field(s) of use


Indoor
Outdoor
Public field: Ready-to-use algaecide, on hard/non-porous surfaces without prior cleaning.




Application method(s)


Method: By brushing, by spraying (low pressure) or pouring
Detailed description:
/




Application rate(s) and frequency


Application Rate: 100 mL/m2

Dilution (%): -
Number and timing of application:
Active against bacteria, yeasts and unicellular green algae and blue-green algae (cyanobacteria):
With undiluted product at 20 – 25 °C
In 3h contact time
100 mL/m2

The biocidal product is not intended to be used on surfaces that come into contact with food and feed.




Category(ies) of users


Professional




Pack sizes and packaging material


1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000  L, 1 100  L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000  kg, 1 100  kg
HDPE (High Density Polyethylene)




4.1.1.   Use-specific instructions for use

see general directions for use for Meta SPC 2
4.1.2.   Use-specific risk mitigation measures

/
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 for Meta SPC 2
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 2
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

see general directions for use for Meta SPC 2
4.2.   Use description


Table 3


Use # 2 – Ready to use algaecide for non-professional use







Product type


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:
Scientific name: unicellular green algae and blue-green algae
Common name: Cyanobacteria
Development stage:




Field(s) of use


Indoor
Outdoor
Public field: Ready-to-use algaecide, on hard/non-porous surfaces without prior cleaning.




Application method(s)


Method: By brushing, by spraying (low pressure) or pouring
Detailed description:
/




Application rate(s) and frequency


Application Rate: 100 mL/m2

Dilution (%): -
Number and timing of application:
Active against bacteria, yeasts and unicellular green algae and blue-green algae (cyanobacteria):
With undiluted product at 20 – 25 °C
In 3h contact time
100 mL/m2

The biocidal product is not intended to be used on surfaces that come into contact with food and feed.




Category(ies) of users


General public (non-professional)




Pack sizes and packaging material


1 L, 5 L, 10 L
1 kg, 5 kg, 10 kg
HDPE (High Density Polyethylene)




4.2.1.   Use-specific instructions for use

see general directions for use for Meta SPC 2
4.2.2.   Use-specific risk mitigation measures

/
4.2.3.   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 for Meta SPC 2
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 2
4.2.5.   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 for Meta SPC 2
5.   GENERAL DIRECTIONS FOR USE (2)
OF THE META SPC 2

5.1.   Instructions for use

Comply with the instructions for use
The surfaces to be disinfected must be wet enough in order to be kept wet during the approved contact time for optimal disinfection. The following precautionary sentence shall be added on the product label: “Make sure to wet surfaces completely”.
The required contact time has to be respected until further treatments (for example brushing the surfaces).
Use 100 mL solution/m2

5.2.   Risk mitigation measures

/
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for five minutes. Call a POISON CENTRE or a doctor.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
If medical advice is needed, have product container or label at hand
5.4.   Instructions for safe disposal of the product and its packaging

The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
Keep out of reach of children and non-target animals/pets.
6.   OTHER INFORMATION

/
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)


RTU Algaecide


Market area: EU




Authorisation number


EU-0027740-0002 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


2,0 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


0,6 





META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier







Identifier


Meta SPC 3: concentrated algaecide and hard surface disinfection in food industry




1.2.   Suffix to the authorisation number







Number


1-3




1.3.   Product type(s)







Product type(s)


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
PT04 – Food and feed area (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


70,0 


70,0 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


6,0 


6,0 




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







Formulation(s)


SL – Soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3







Hazard statements


Causes severe skin burns and eye damage.
Causes serious eye damage.




Precautionary statements


Do not breathe vapours.
Wash hands thoroughly after handling.
Wear protective gloves.
Wear protective clothing.
Wear eyes/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 INHALED:Remove person to fresh air and keep comfortable for breathing.
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.
Wash contaminated clothing before reuse.
Store locked up.
Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.




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

4.1.   Use description


Table 4


Use # 1 – concentrated algaecide







Product type


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: unicellular green algae and blue-green algae
Common name: Cyanobacteria
Development stage:




Field(s) of use


Indoor
Outdoor
Food and feed industry; Public field:
Concentrated algaecide, on hard/non-porous surfaces without prior cleaning.




Application method(s)


Method: By spraying (low pressure) or pouring
Detailed description:
/




Application rate(s) and frequency


Application Rate: 100 mL/m2

Dilution (%): 0,5 %
Number and timing of application:
Active against unicellular green algae and blue-green algae (cyanobacteria): 100 mL/m2

Dilute the product to 0,5 % in water, to reach an in use concentration of 0,35 % Lactic acid.
at 20– 25 °C
In 3h contact time




Category(ies) of users


Professional




Pack sizes and packaging material


1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000  L, 1 100  L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000  kg, 1 100  kg
HDPE (High Density Polyethylene)




4.1.1.   Use-specific instructions for use

see general directions for use for Meta SPC 3
4.1.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 3
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 for Meta SPC 3
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 3
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 for Meta SPC 3
4.2.   Use description


Table 5


Use # 2 – Disinfection of hard/non-porous surfaces in the food industry (for example processing machines)







Product type


PT04 – Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
in Food/feed industry:
Disinfection of hard/non-porous surfaces (for example processing machines) without prior cleaning




Application method(s)


Method: Spraying or soaking
Detailed description:
Spraying
Soaking (the bath is intended to be used only once)




Application rate(s) and frequency


Application Rate: 100 mL/m2

Dilution (%): 4 %
Number and timing of application:
Active against bacteria and yeasts at +40 °C:
Dilute the product to 4 % in water, to reach an in use concentration of 2,8 % Lactic acid.
In five seconds contact time
100 mL/m2





Category(ies) of users


Professional




Pack sizes and packaging material


1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000  L, 1 100  L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000  kg, 1 100  kg
HDPE (High Density Polyethylene)




4.2.1.   Use-specific instructions for use

see general directions for use for Meta SPC 3
4.2.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 3
4.2.3.   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 for Meta SPC 3
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 3
4.2.5.   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 for Meta SPC 3
5.   GENERAL DIRECTIONS FOR USE (3)
OF THE META SPC 3

5.1.   Instructions for use

Disinfection cycle:






—


Products must be diluted in potable water before use.










—


Final rinsing (with potable water): if required.




The surfaces to be disinfected must be wet enough in order to be kept wet during the approved contact time for optimal disinfection. The following precautionary sentence shall be added on the product label: “Make sure to wet surfaces completely”.
5.2.   Risk mitigation measures

Gloves and goggles are needed during mixing and loading of the concentrated products.
Wear protective coverall (to be specified by the authorisation holder within the product information).
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/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. Immediately call 112/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/ambulance for medical assistance.
5.4.   Instructions for safe disposal of the product and its packaging

The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
6.   OTHER INFORMATION

/
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)


Concentrated Algaecide


Market area: EU




 


Kenosan Lactic CONC


Market area: EU




Authorisation number


EU-0027740-0003 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


70,0 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


6,0 





META SPC 4

1.   META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier







Identifier


Meta SPC 4: Concentrated surface disinfectants for sanitary hygiene and kitchens (PT2-PT4)




1.2.   Suffix to the authorisation number







Number


1-4




1.3.   Product type(s)







Product type(s)


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
PT04 – Food and feed area (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


16,0 


16,0 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


5,0 


5,0 




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







Formulation(s)


SL – Soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4







Hazard statements


Causes skin irritation.
Causes serious eye damage.
Contains eucalyptus globulus oil (CAS-No 8000-48-4). May produce an allergic reaction.




Precautionary statements


If medical advice is needed, have product container or label at hand.
Keep out of reach of children.
Read carefully and follow all instructions.
Wash hands thoroughly after handling.
Wear protective gloves.
Wear eyes/face protection.
IF ON SKIN:Wash with plenty of 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.
If skin irritation occurs:Get medical advice.
Take off contaminated clothing.And wash it before reuse.




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

4.1.   Use description


Table 6


Use # 1 – Hard surface disinfection for sanitary hygiene, other than in healthcare, for professional use (PT2)







Product type


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
Public field (NOT in HEALTHCARE)
Disinfection of hard/non-porous surfaces (for sanitary hygiene) by spraying without prior cleaning




Application method(s)


Method: By spraying (with wiping if needed, only after the end of the preconised contact time)
Detailed description:
/




Application rate(s) and frequency


Application Rate: 250 mL/m2 diluted product
Dilution (%): 20 %
Number and timing of application:
Active against bacteria and yeasts at room temperature
Dilute the product 20 % in water, to reach an in use concentration of 3,2 % Lactic acid.
In 15 minutes contact time
250 mL/m2 diluted product




Category(ies) of users


Professional




Pack sizes and packaging material


1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000  L, 1 100  L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000  kg, 1 100  kg
HDPE (High Density Polyethylene)




4.1.1.   Use-specific instructions for use

Comply with the instructions for use
4.1.2.   Use-specific risk mitigation measures

Gloves and goggles are needed during handling of the products
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 for Meta SPC 4
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 4
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 for Meta SPC 4
4.2.   Use description


Table 7


Use # 2 – Hard surface disinfection for hygiene in kitchens, for professional use (PT4)







Product type


PT04 – Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
in food/feed areas:
Disinfection of hard/non-porous surfaces (for general hygiene) by spraying without prior cleaning




Application method(s)


Method: By spraying (with wiping if needed, only after the end of the preconised contact time)
Detailed description:
/




Application rate(s) and frequency


Application Rate: 100 mL/m2

Dilution (%): 20 %
Number and timing of application:
Active against bacteria and yeasts at room temperature
Dilute the product 20 % in water, to reach an in use concentration of 3,2 % Lactic acid.
In 15 minutes contact time
100 mL/m2





Category(ies) of users


Professional




Pack sizes and packaging material


1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000  L, 1 100  L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000  kg, 1 100  kg
HDPE (High Density Polyethylene)




4.2.1.   Use-specific instructions for use

Comply with the instructions for use
4.2.2.   Use-specific risk mitigation measures

Gloves and goggles are needed during handling of the products.
4.2.3.   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 for Meta SPC 4
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 4
4.2.5.   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 for Meta SPC 4
4.3.   Use description


Table 8


Use # 3 – Disinfection of toilet bowls, for professional use (PT2)







Product type


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
Public field
Disinfection of hard/non-porous inside surfaces of toilets, without prior cleaning




Application method(s)


Method: By pouring (with brushing – only after the end of the preconised contact time)
Detailed description:
/




Application rate(s) and frequency


Application Rate: 250 mL/m2

Dilution (%): -
Number and timing of application:
Active against bacteria and yeasts at room temperature:
With the undiluted product (with 16 % Lactic acid)
In five minutes contact time




Category(ies) of users


Professional




Pack sizes and packaging material


500 mL, 700 mL, 750 mL, 1L, 1.5 L, 2 L
HDPE (High Density Polyethylene)
Toilet Duck




4.3.1.   Use-specific instructions for use

Comply with the instructions for use
4.3.2.   Use-specific risk mitigation measures

Gloves and goggles are needed during handling of the products.
4.3.3.   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 for Meta SPC 4
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 4
4.3.5.   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 for Meta SPC 4
4.4.   Use description


Table 9


Use # 4 – Disinfection of toilet bowls, for non-professional use (PT2)







Product type


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
Public field
Disinfection of hard/non-porous inside surfaces of toilets, without prior cleaning




Application method(s)


Method: By pouring (with brushing – only after the end of the preconised contact time)
Detailed description:
/




Application rate(s) and frequency


Application Rate: 250 mL/m2

Dilution (%): -
Number and timing of application:
Active against bacteria and yeasts at room temperature:
With the undiluted product (with 16 % Lactic acid)
In five minutes contact time




Category(ies) of users


General public (non-professional)




Pack sizes and packaging material


500 mL, 700 mL, 750 mL, 1L, 1.5 L, 2 L
HDPE (High Density Polyethylene)
Toilet Duck




4.4.1.   Use-specific instructions for use

Comply with the instructions for use
4.4.2.   Use-specific risk mitigation measures

Avoid contact with eyes
A child proof closure is required
The product must be fitted with a pouring spout, the product must be poured gently on the wall of the toilet bowl to avoid the formation of splashes.
Wash hands after application
4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

If medical advice is needed, have product container or label at hand
4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 4
4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Keep out of reach of children and non-target animals/pets.
5.   GENERAL DIRECTIONS FOR USE (4)
OF THE META SPC 4

5.1.   Instructions for use

The surfaces to be disinfected must be wet enough in order to be kept wet during the preconised contact time for optimal disinfection. The following precautionary sentence shall be added on the product label: “Make sure to wet surfaces completely”.
5.2.   Risk mitigation measures

/
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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 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. Immediately call 112/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/ambulance for medical assistance
IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
5.4.   Instructions for safe disposal of the product and its packaging

The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
6.   OTHER INFORMATION

/
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)


Sanifresh


Market area: EU




 


Milcho Des


Market area: EU




Kenolens


Market area: EU




Kenolux S100


Market area: EU




SANI-CAL


Market area: EU




Sani Super


Market area: EU




Scrub


Market area: EU




MiQro Sani Des


Market area: EU




Authorisation number


EU-0027740-0004 1-4




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


16,0 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


5,0 





META SPC 5

1.   META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 5 identifier







Identifier


Meta SPC 5: Concentrated pre-dips (PT3)




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


8,0 


8,0 




Sodium lauryl ether sulfate


Alcohols, C12-14, ethoxylated, sulfates, sodium salts


Non-active substance


68891-38-3


500-234-8


8,4 


8,4 




Sulfonic acids, C14-17-sec-alkane, sodium salts


Sulfonic acids, C14-17-sec-alkane, sodium salts


Non-active substance


97489-15-1


307-055-2


2,25 


2,25 




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







Formulation(s)


SL – Soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5







Hazard statements


Causes serious eye damage.




Precautionary statements


Wear eyes/face protection.
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.




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

4.1.   Use description


Table 10


Use # 1 – Teat disinfection, before milking







Product type


PT03 – Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
Veterinary field
Teat disinfection before milking with concentrated product (to be diluted before disinfection procedure), without prior cleaning




Application method(s)


Method: By dipping, by spraying with spray flacon or spray installation and by wiping with a towel
Detailed description:
By dipping
By spraying with spray flacon or spray installation
By wiping with a towel soaking with the diluted product




Application rate(s) and frequency


Application Rate: 5 – 15 mL
Dilution (%): 40 %
Number and timing of application:
Active against bacteria and yeasts:
Dilution: 40 %
The product must be diluted with RT potable water.
In one minute contact time




Category(ies) of users


Professional




Pack sizes and packaging material


1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000  L, 1 100  L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000  kg, 1 100  kg
HDPE (High Density Polyethylene)




4.1.1.   Use-specific instructions for use


Application rates:
Dilution: 40 % (with 3,2 % LA) – The product must be diluted with RT potable water.






—


5 mL per cow per application for use by dipping










—


7.5 mL per cow per application for use by spray flacon










—


15 mL per cow per application for use by spray installation










—


For use by wiping with a towel: prepare 10 L working solution for 25 towels.




Use one towel per cow.
4.1.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 5
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 for Meta SPC 5
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 5
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 for Meta SPC 5
4.2.   Use description


Table 11


Use # 2 – Intact skin wash/disinfection (of the udder of dairy and beef cattle before calving and of the udder of sows before farrowing)







Product type


PT03 – Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
Veterinary field




Application method(s)


Method: Spraying
Detailed description:
/




Application rate(s) and frequency


Application Rate: 5 – 20 mL
Dilution (%): 40 %
Number and timing of application:
Active against bacteria and yeasts:
Dilution: 40 %
The product must be diluted with Room Temperature potable water.
In one minute contact time






1)


dairy and beef cattle on the udder before calving: 5 mL (1 spray) on each teat










2)


sows on the udder before farrowing: 20 mL




The animals should be kept standing on a clean floor for at least five minutes.




Category(ies) of users


Professional




Pack sizes and packaging material


1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000  L, 1 100  L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000  kg, 1 100  kg
HDPE (High Density Polyethylene)




4.2.1.   Use-specific instructions for use

see general directions for use for Meta SPC 5
4.2.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 5
4.2.3.   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 for Meta SPC 5
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 5
4.2.5.   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 for Meta SPC 5
5.   GENERAL DIRECTIONS FOR USE (5)
OF THE META SPC 5

5.1.   Instructions for use

See use specific instructions for use
5.2.   Risk mitigation measures

Chemical goggles need to be worn.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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. Immediately call 112/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/ambulance for medical assistance.
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 INHALED: If symptoms occur call a POISON CENTRE or a doctor.
5.4.   Instructions for safe disposal of the product and its packaging

The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
6.   OTHER INFORMATION

/
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)


Kenopro Lactic


Market area: EU




 


HCP Foam Concentrate


Market area: EU




Kenopro Lactic


Market area: EU




Reconet+


Market area: EU




Kenopure


Market area: EU




MIROX Pre Lac


Market area: EU




Milchsäure Pre


Market area: EU




Milchsäure Pref


Market area: EU




Lactocid Pre


Market area: EU




Milcho Pre


Market area: EU




Preactive


Market area: EU




Precoop


Market area: EU




Lactipré


Market area: EU




Prelacti


Market area: EU




Prelak


Market area: EU




Power Prep


Market area: EU




Multicleaner


Market area: EU




Kenopure Strong


Market area: EU




Semex Pre


Market area: EU




MEPA Pure


Market area: EU




MEPA Foam


Market area: EU




Eco Lac Foam


Market area: EU




Authorisation number


EU-0027740-0005 1-5




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


8,0 




Sodium lauryl ether sulfate


Alcohols, C12-14, ethoxylated, sulfates, sodium salts


Non-active substance


68891-38-3


500-234-8


8,4 




Sulfonic acids, C14-17-sec-alkane, sodium salts


Sulfonic acids, C14-17-sec-alkane, sodium salts


Non-active substance


97489-15-1


307-055-2


2,25 





META SPC 6

1.   META SPC 6 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 6 identifier







Identifier


Meta SPC 6: Ready to use Pre-dips (PT3)




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


3,6 


3,6 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


5,25 


5,25 




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 serious eye damage.




Precautionary statements


Wear eye/face protection.
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.




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

4.1.   Use description


Table 12


Use # 1 – Teat disinfection, before milking







Product type


PT03 – Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
Veterinary field




Application method(s)


Method: By dipping, by spraying with spray flacon or spray installation, by wiping with a towel
Detailed description:






 


By dipping










 


By spraying with spray flacon or spray installation










 


By wiping with a towel soaking with the diluted product








Application rate(s) and frequency


Application Rate: Active against bacteria and yeasts: (Ready-To-Use) RTU In one minute contact time. The product must “return” to room temperature before use.
Dilution (%): -
Number and timing of application:
Active against bacteria and yeasts:
RTU (with 3,6 % Lactic acid)
In one minute contact time

The product must “return” to RT before use





Category(ies) of users


Professional




Pack sizes and packaging material


1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000  L, 1 100  L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000  kg, 1 100  kg
HDPE (High Density Polyethylene)




4.1.1.   Use-specific instructions for use


Application rates:






—


5 mL per cow per application for use by dipping










—


7,5 mL per cow per application for use by spray flacon










—


15 mL per cow per application for use by spray installation










—


One towel per cow for use by wiping




4.1.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 6
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 for Meta SPC 6
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 6
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 for Meta SPC 6
5.   GENERAL DIRECTIONS FOR USE (6)
OF THE META SPC 6

5.1.   Instructions for use

/
5.2.   Risk mitigation measures

Chemical goggles need to be worn.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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. Immediately call 112/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/ambulance for medical assistance.
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 INHALED: If symptoms occur call a POISON CENTRE or a doctor.
5.4.   Instructions for safe disposal of the product and its packaging

The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
6.   OTHER INFORMATION

/
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)


Kenopure R


Market area: EU




 


Kenopure RTU


Market area: EU




HCP Foam RTU


Market area: EU




Kenoxypure RTU


Market area: EU




Kenopurox RTU


Market area: EU




Kenopure Ox RTU


Market area: EU




Kenopure Plus RTU


Market area: EU




Kenopure Extra RTU


Market area: EU




Kenopure oxylac RTU


Market area: EU




Kenoxylac predip RTU


Market area: EU




Kenoxilac predip RTU


Market area: EU




Kenopure H2O2 RTU


Market area: EU




Oxy Kenopure RTU


Market area: EU




Preactive RTU


Market area: EU




Precoop RTU


Market area: EU




Lactipré RTU


Market area: EU




Prelacti RTU


Market area: EU




Prelak RTU


Market area: EU




Power Prep RTU


Market area: EU




Prelacta Foam


Market area: EU




Authorisation number


EU-0027740-0006 1-6




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


3,6 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


5,25 





META SPC 7

1.   META SPC 7 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 7 identifier







Identifier


Meta SPC 7: Ready to use wipes (PT2, PT4)




1.2.   Suffix to the authorisation number







Number


1-7




1.3.   Product type(s)







Product type(s)


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
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


2,0 


2,0 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


0,6 


0,9 




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







Formulation(s)


WI – Wipes




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7







Hazard statements


Causes serious eye irritation.




Precautionary statements


If medical advice is needed, have product container or label at hand.
Keep out of reach of children.
Read carefully and follow all instructions.
Wash hands thoroughly after handling.
Wear eyes/face protection.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
If skin irritation occurs:Get medical advice.
If eye irritation persists:Get medical advice.
Take off contaminated clothing.And wash it before reuse.




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

4.1.   Use description


Table 13


Use # 1 – Hard surface disinfection in Food and Feed industry, for professional use (PT4)







Product type


PT04 – Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeasts
Common name: Yeasts
Development stage:
Scientific name: other: viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor
Food/feed areas
Disinfection of hard/non-porous surfaces and objects, with prior cleaning




Application method(s)


Method: With pre-impragnated wipes
Detailed description:
/




Application rate(s) and frequency


Application Rate: Active against bacteria, yeasts and viruses: With pre-impregnated wipes at room temperature in two minutes contact time
Dilution (%): -
Number and timing of application:
Active against bacteria, yeasts and viruses:
With pre-impregnated wipes
at room temperature in two minutes contact time




Category(ies) of users


Professional




Pack sizes and packaging material


Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes




4.1.1.   Use-specific instructions for use

see general directions for use for Meta SPC 7
4.1.2.   Use-specific risk mitigation measures

/
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 for Meta SPC 7
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 7
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 for Meta SPC 7
4.2.   Use description


Table 14


Use # 2 – Hard surface disinfection in food and feed area, for non-professional use (PT4)







Product type


PT04 – Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeasts
Common name: Yeasts
Development stage:
Scientific name: other: viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor
Food/feed areas
Disinfection of hard/non-porous surfaces and objects, with prior cleaning




Application method(s)


Method: With pre-impragnated wipes
Detailed description:
Wipes




Application rate(s) and frequency


Application Rate: One wipe/m2

Dilution (%): -
Number and timing of application:
Active against bacteria, yeasts and viruses:
With pre-impregnated wipes
at room temperature in two minutes contact time




Category(ies) of users


General public (non-professional)




Pack sizes and packaging material


Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes




4.2.1.   Use-specific instructions for use

Comply with the instructions for use
4.2.2.   Use-specific risk mitigation measures

/
4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

If medical advice is needed, have product container or label at hand
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 7
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Keep out of reach of children and non-target animals/pets.
4.3.   Use description



Table 15



Use # 3 – Hard surface disinfection, use in healthcare, for professional use (PT2)







Product type


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeasts
Common name: Yeasts
Development stage:
Scientific name: other: viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor
Public field:
Disinfection of hard/non-porous surfaces (walls, floors and other surfaces in indoor spaces, including bathrooms and toilets) with prior cleaning




Application method(s)


Method: With pre-impregnated wipes
Detailed description:
/




Application rate(s) and frequency


Application Rate: Active against bacteria, yeasts and viruses: With pre-impregnated wipes at room temperature in two minutes contact time
Dilution (%): -
Number and timing of application:
Active against bacteria, yeasts and viruses:
With pre-impregnated wipes
at room temperature in two minutes contact time




Category(ies) of users


Professional




Pack sizes and packaging material


Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes




4.3.1.   Use-specific instructions for use

see general directions for use for Meta SPC 7
4.3.2.   Use-specific risk mitigation measures

/
4.3.3.   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 for Meta SPC 7
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 7
4.3.5.   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 for Meta SPC 7
4.4.   Use description


Table 16


Use # 4 – Hard surface disinfection, use in healthcare, for non-professional use (PT2)







Product type


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeasts
Common name: Yeasts
Development stage:
Scientific name: other: viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor
Public field: Disinfection of hard/non-porous surfaces (walls, floors and other surfaces in indoor spaces, including bathrooms and toilets) in healthcare area with prior cleaning




Application method(s)


Method: With pre-impregnated wipes
Detailed description:
/




Application rate(s) and frequency


Application Rate: Active against bacteria, yeasts and viruses: With pre-impregnated wipes at room temperature in two minutes contact time
Dilution (%): -
Number and timing of application:
Active against bacteria, yeasts and viruses:
With pre-impregnated wipes
at room temperature in two minutes contact time




Category(ies) of users


General public (non-professional)




Pack sizes and packaging material


Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes




4.4.1.   Use-specific instructions for use

Comply with the instructions for use
4.4.2.   Use-specific risk mitigation measures

/
4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

If medical advice is needed, have product container or label at hand
4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 7
4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Keep out of reach of children and non-target animals/pets.
4.5.   Use description


Table 17


Use # 5 – Hard surface disinfection, use other than in healthcare, for professional use (PT2)







Product type


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeasts
Common name: Yeasts
Development stage:
Scientific name: other: viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor
Public field:
Disinfection of hard/non-porous surfaces (walls, floors and other surfaces in indoor spaces, including bathrooms and toilets) with prior cleaning




Application method(s)


Method: With pre-impregnated wipes
Detailed description:
/




Application rate(s) and frequency


Application Rate: Active against bacteria, yeasts and viruses: With pre-impregnated wipes at room temperature in two minutes contact time
Dilution (%): -
Number and timing of application:
Active against bacteria, yeasts and viruse:
With pre-impregnated wipes
at room temperature in two minutes contact time




Category(ies) of users


Professional




Pack sizes and packaging material


Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes




4.5.1.   Use-specific instructions for use

see general directions for use for Meta SPC 7
4.5.2.   Use-specific risk mitigation measures

/
4.5.3.   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 for Meta SPC 7
4.5.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 7
4.5.5.   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 for Meta SPC 7
4.6.   Use description


Table 18


Use # 6 – Hard surface disinfection, use other than in healthcare, for non-professional use (PT2)







Product type


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeasts
Common name: Yeasts
Development stage:
Scientific name: other: viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor
Public field:
Disinfection of hard/non-porous surfaces (walls, floors and other surfaces in indoor spaces, including bathrooms and toilets) with prior cleaning




Application method(s)


Method: With pre-impregnated wipes
Detailed description:
/




Application rate(s) and frequency


Application Rate: Active against bacteria, yeasts and viruses: With pre-impregnated wipes at room temperature in two minutes contact time
Dilution (%): -
Number and timing of application:
Active against bacteria, yeasts and viruses:
With pre-impregnated wipes
at room temperature in two minutes contact time




Category(ies) of users


General public (non-professional)




Pack sizes and packaging material


Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes




4.6.1.   Use-specific instructions for use

Comply with the instructions for use
4.6.2.   Use-specific risk mitigation measures

/
4.6.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

If medical advice is needed, have product container or label at hand.
4.6.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 7
4.6.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Keep out of reach of children and non-target animals/pets.
5.   GENERAL DIRECTIONS FOR USE (7)
OF THE META SPC 7

5.1.   Instructions for use

Comply with the instructions for use
First clean thoroughly the surfaces and materials to be disinfected and dry the surface or materials.
Disinfect the dry surface with a wipe. Make sure the surface remains completely wetted during the required contact time.
5.2.   Risk mitigation measures

/
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for five minutes. Call a POISON CENTRE or a doctor.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
If medical advice is needed, have product container or label at hand
5.4.   Instructions for safe disposal of the product and its packaging

The packing and content must be eliminated as dangerous waste product under the fullresponsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use. Store at ambient temperature. Do not store below 0 °C and above 40 °C.
The shelf-life of the products is two years.
Keep out of reach of children and non-target animals/pets
6.   OTHER INFORMATION

/
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)


Kenopure wipes


Market area: EU




 


EP-460 Wipes


Market area: EU




Sani Wipes


Market area: EU




Lactides Wipes


Market area: EU




Keno Lac Wipes


Market area: EU




KL Wipes


Market area: EU




Kenolux Wipes


Market area: EU




Power Des Wipes


Market area: EU




Keno L Wipes


Market area: EU




Keno Des Wipes


Market area: EU




RĘCZNIKI PAPIEROWE MYJĄCO-DEZYNFEKUJĄCE FARMA


Market area: EU




RĘCZNIKI PAPIEROWE MYJĄCO-DEZYNFEKUJĄCE VITTRA


Market area: EU




Ręczniki myjąco-dezynfekujące AGROD


Market area: EU




Authorisation number


EU-0027740-0007 1-7




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


2,0 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


0,6 





META SPC 8

1.   META SPC 8 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 8 identifier







Identifier


Meta SPC 8: Ready to use post-dips by dipping (PT3)




1.2.   Suffix to the authorisation number







Number


1-8




1.3.   Product type(s)







Product type(s)


PT03 – Veterinary hygiene (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


3,6 


7,5 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


1,3 


1,3 




Isopropanol


Propan-2-ol


Non-active substance


67-63-0


200-661-7


1,0 


3,0 




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







Formulation(s)


AL – Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8







Hazard statements


Causes serious eye damage.




Precautionary statements


Wear eyes/face protection.
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.




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

4.1.   Use description



Table 19



Use # 1 – Teat disinfection after milking by dipping







Product type


PT03 – Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
Veterinary field:
(Ready-To-Use) RTU post-dip for teat disinfection, after milking, without prior cleaning




Application method(s)


Method: By dipping
Detailed description:
/




Application rate(s) and frequency


Application Rate: Active against bacteria and yeasts: RTU In five minutes contact time. The product must “return” to RT before use.
Dilution (%): -
Number and timing of application:
Active against bacteria and yeasts:
RTU (with 3.6 – 7,5 % Lactic acid depending on the product considered)
In five minutes contact time
The product must “return” to room temperature before use




Category(ies) of users


Professional




Pack sizes and packaging material


1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000  L, 1 100  L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000  kg, 1 100  kg
HDPE (High Density Polyethylene)




4.1.1.   Use-specific instructions for use

see general directions for use for Meta SPC 8
4.1.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 8
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 for Meta SPC 8
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 8
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 for Meta SPC 8
5.   GENERAL DIRECTIONS FOR USE (8)
OF THE META SPC 8

5.1.   Instructions for use

Apply the product immediately after each milking, two or three times per day. Ensure that the teat is completely covered to three quarter of its length. Fill the dipping cup with the desired amount of product, but do not use more fluid than necessary. Assume 5 mL per cow per treatment. Respect a contact time of five minutes. The product must be brought to a temperature above 20 °C before use. In order to ensure optimal teat disinfection, the animals should be kept standing for at least five minutes.
5.2.   Risk mitigation measures

Chemical goggles need to be worn.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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. Immediately call 112/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/ambulance for medical assistance
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 INHALED: If symptoms occur call a POISON CENTRE or a doctor.
5.4.   Instructions for safe disposal of the product and its packaging

The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
6.   OTHER INFORMATION

/
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)


Kenolac


Market area: EU




 


Kenolac Red


Market area: EU




Kenodip 200


Market area: EU




Stalosan Lac Dip


Market area: EU




HCP Dip


Market area: EU




PEZERK LV PLUS


Market area: EU




MIROX Dip Lac


Market area: EU




Milchsäure Dip


Market area: EU




Milchsäure Tauche


Market area: EU




Lactocid Dip


Market area: EU




GAHERLAC


Market area: EU




Lactidip


Market area: EU




Lacticoop


Market area: EU




Lactactiv


Market area: EU




Laktotop


Market area: EU




Superlac


Market area: EU




MilchsäureFilmdip Super


Market area: EU




MEPA Lac


Market area: EU




Eco Lac


Market area: EU




BluGard Dip


Market area: EU




Blu-Gard Dip


Market area: EU




Authorisation number


EU-0027740-0008 1-8




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


3,6 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


1,3 




Isopropanol


Propan-2-ol


Non-active substance


67-63-0


200-661-7


1,0 




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











Trade name(s)


Kenolac Forte W


Market area: EU




Authorisation number


EU-0027740-0009 1-8




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


7,5 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


1,3 




Isopropanol


Propan-2-ol


Non-active substance


67-63-0


200-661-7


3,0 





META SPC 9

1.   META SPC 9 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 9 identifier







Identifier


Meta SPC 9: Ready to use post-dips by spraying (PT3)




1.2.   Suffix to the authorisation number







Number


1-9




1.3.   Product type(s)







Product type(s)


PT03 – Veterinary hygiene (Disinfectants)




2.   META SPC 9 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 9












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


3,6 


7,5 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


0,5 


1,3 




Isopropanol


Propan-2-ol


Non-active substance


67-63-0


200-661-7


3,0 


3,0 




2.2.   Type(s) of formulation of the meta SPC 9







Formulation(s)


AL – Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9







Hazard statements


Causes serious eye damage.




Precautionary statements


Wear eye/face protection.
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.




4.   AUTHORISED USE(S) OF THE META SPC 9

4.1.   Use description


Table 20


Use # 1 – Teat disinfection after milking by spraying or dipping







Product type


PT03 – Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other yeast
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
Veterinary field:
RTU spray or dip for teat disinfection, after milking, without prior cleaning




Application method(s)


Method: by spraying or dipping
Detailed description:
By spraying or dipping




Application rate(s) and frequency


Application Rate: Active against bacteria and yeasts: RTU In five minutes contact time. The product must “return” to RT before use.
Dilution (%): -
Number and timing of application:
Active against bacteria and yeasts:
RTU (with 3.6 – 7,5 % Lactic acid depending on the product considered)
In five minutes contact time
The product must return to Room temperature before use




Category(ies) of users


Professional




Pack sizes and packaging material


1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000  L, 1 100  L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000  kg, 1 100  kg
HDPE (High Density Polyethylene)




4.1.1.   Use-specific instructions for use

see general directions for use for Meta SPC 9
4.1.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 9
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 for Meta SPC 9
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 9
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 for Meta SPC 9
5.   GENERAL DIRECTIONS FOR USE (9)
OF THE META SPC 9

5.1.   Instructions for use

Apply the product immediately after each milking, two or three times per day. Ensure that the teat is completely covered to three quarter of its length. Fill the dipping cup or spraying flacon with the desired amount of the product, but do not use more fluid that necessary. Assume 5 mL per cow per treatment. Respect a contact time of five minutes.
The product must be brought to a temperature above 20 °C before use.
In order to ensure optimal teat disinfection, the animals should be kept standing for at least five minutes.
5.2.   Risk mitigation measures

Chemical goggles need to be worn.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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. Immediately call 112/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/ambulance for medical assistance
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 INHALED: If symptoms occur call a POISON CENTRE or a doctor.
5.4.   Instructions for safe disposal of the product and its packaging

The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
6.   OTHER INFORMATION

/
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 9

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











Trade name(s)


Kenolac SD


Market area: EU




 


HCP Spray


Market area: EU




Lactospray


Market area: EU




Zitzentop


Market area: EU




Lactosilk


Market area: EU




Milchsäure Spray Bühning


Market area: EU




Lacto SP


Market area: EU




Stalosan Lac Spray


Market area: EU




MIROX Spray Lac


Market area: EU




Milchsäure Sprühe


Market area: EU




Lactocid Spray


Market area: EU




Milcho Spray


Market area: EU




GAHERLAC SPRAY


Market area: EU




Lactispray


Market area: EU




Lacticoop Spray


Market area: EU




Lactactiv Spray


Market area: EU




Laktotop Spray


Market area: EU




Superlac Spray


Market area: EU




Robolac


Market area: EU




MEPA Lac SD


Market area: EU




Eco Lac SD


Market area: EU




Lely Quaress Circum


Market area: EU




BluGard Spray


Market area: EU




Blu-Gard Spray


Market area: EU




Authorisation number


EU-0027740-0010 1-9




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


3,6 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


1,3 




Isopropanol


Propan-2-ol


Non-active substance


67-63-0


200-661-7


3,0 




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











Trade name(s)


Kenolac Forte SD


Market area: EU




Authorisation number


EU-0027740-0011 1-9




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


7,5 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


1,3 




Isopropanol


Propan-2-ol


Non-active substance


67-63-0


200-661-7


3,0 




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











Trade name(s)


Valiant ULTRA EVERYDAY


Market area: EU




Authorisation number


EU-0027740-0018 1-9




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


4,0 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


1,3 




Isopropanol


Propan-2-ol


Non-active substance


67-63-0


200-661-7


3,0 





META SPC 10

1.   META SPC 10 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 10 identifier







Identifier


Meta SPC 10: Ready to use post-dips by spraying and dipping (PT3)




1.2.   Suffix to the authorisation number







Number


1-10




1.3.   Product type(s)







Product type(s)


PT03 – Veterinary hygiene (Disinfectants)




2.   META SPC 10 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 10












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


3,6 


3,6 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


0,05 


0,05 




2.2.   Type(s) of formulation of the meta SPC 10







Formulation(s)


AL – Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 10







Hazard statements


Flammable liquid and vapour.
Causes serious eye damage.
Contains menthan-3-one (CAS-No 14073-97-3). May produce an allergic reaction.




Precautionary statements


Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
Wear eyes/face protection.
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.
In case of fire:Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide to extinguish.
Store in a well-ventilated place.Keep cool.
Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.




4.   AUTHORISED USE(S) OF THE META SPC 10

4.1.   Use description


Table 21


Use # 1 – Teat disinfection after milking by spraying or dipping







Product type


PT03 – Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
Veterinary field:
RTU spray/dip for teat disinfection, after milking, without prior cleaning




Application method(s)


Method: By spraying or dipping
Detailed description:
/




Application rate(s) and frequency


Application Rate: Active against bacteria and yeasts: RTU In five minutes contact time. The product must “return” to RT before use
Dilution (%): -
Number and timing of application:
Active against bacteria and yeasts:
RTU (with 3,6 % Lactic acid)
In five minutes contact time




Category(ies) of users


Professional




Pack sizes and packaging material


1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000  L, 1 100  L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000  kg, 1 100  kg
HDPE (High Density Polyethylene)




4.1.1.   Use-specific instructions for use

Application rates:






—


7.5 mL per cow working solution for use by spraying with flacon










—


15 mL per cow working solution for use by spraying in installation










—


15 mL per cow by for use by spraying with robot










—


2.5-5 mL per cow for use by dipping/foaming




4.1.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 10
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 for Meta SPC 10
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 10
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 for Meta SPC 10
5.   GENERAL DIRECTIONS FOR USE (10)
OF THE META SPC 10

5.1.   Instructions for use

Apply the product immediately after each milking, two or three times per day. Ensure that the teat is completely covered to three quarter of its length. Fill the dipping cup or spraying flacon with the desired amount of product, but do not use more fluid that necessary. The product must be brought to a temperature above 20 °C before use.
In order to ensure optimal teat disinfection, the animals should be kept standing for at least five minutes.
5.2.   Risk mitigation measures

Chemical goggles need to be worn.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
IF 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 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. Immediately call 112/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/ambulance for medical assistance
5.4.   Instructions for safe disposal of the product and its packaging

The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
6.   OTHER INFORMATION

/
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 10

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











Trade name(s)


Kenocool


Market area: EU




 


PEZERK LI PLUS


Market area: EU




Milcho Dip


Market area: EU




Authorisation number


EU-0027740-0012 1-10




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


3,6 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


0,05 





META SPC 11

1.   META SPC 11 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 11 identifier







Identifier


Meta SPC 11: Concentrated Surface and equipment disinfectants (PT3 and PT4)




1.2.   Suffix to the authorisation number







Number


1-11




1.3.   Product type(s)







Product type(s)


PT04 – Food and feed area (Disinfectants)
PT03 – Veterinary hygiene (Disinfectants)




2.   META SPC 11 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 11












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


24,0 


24,0 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


12,0 


12,0 




Isopropanol


Propan-2-ol


Non-active substance


67-63-0


200-661-7


5,0 


5,0 




2.2.   Type(s) of formulation of the meta SPC 11







Formulation(s)


SL – Soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 11







Hazard statements


Causes skin irritation.
Causes serious eye damage.




Precautionary statements


Wash hands thoroughly after handling.
Wear protective gloves.
Wear eyes/face protection.
IF ON SKIN:Wash with plenty of 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.
Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.




4.   AUTHORISED USE(S) OF THE META SPC 11

4.1.   Use description


Table 22


Use # 1 – Hard surface disinfection in food and feed industry







Product type


PT04 – Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
in Food/feed industry + Public field:
Disinfection of hard/non-porous surfaces by spraying or soaking with prior cleaning




Application method(s)


Method: By spraying or by immersion
Detailed description:
Spraying
Immersion (the bath is intended to be used only once)




Application rate(s) and frequency


Application Rate: 100 mL/m2

Dilution (%): 1 % or 3 %
Number and timing of application:
Active against bacteria and yeasts at room temperature:






—


3 % (with 0,72 % Lactic acid) in two minutes contact time










—


1 % (with 0,24 % Lactic acid) in 15 minutes contact time








Category(ies) of users


Professional




Pack sizes and packaging material


1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000  L, 1 100  L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000  kg, 1 100  kg
HDPE (High Density Polyethylene)




4.1.1.   Use-specific instructions for use

see general directions for use for Meta SPC 11
4.1.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 11
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 for Meta SPC 11
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 11
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 for Meta SPC 11
4.2.   Use description


Table 23


Use # 2 – Equipment disinfection by soaking in food and feed industry







Product type


PT04 – Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
Indoor – in Food/feed industry + Public field:
Disinfection of hard/non-porous surfaces (for example processing machines) by spraying or soaking without prior cleaning




Application method(s)


Method: By spraying or immersion
Detailed description:
/




Application rate(s) and frequency


Application Rate: 100 mL/m2

Dilution (%): 8 % or 15 %
Number and timing of application:
Active against bacteria and yeasts at +7 °C:






—


By soaking: 15 % (with 3,6 % Lactic acid) in 30 seconds contact time










—


By spraying: 8 % (with 1,92 % Lactic acid) in two minutes contact time








Category(ies) of users


Professional




Pack sizes and packaging material


1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000  L, 1 100  L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000  kg, 1 100  kg
HDPE (High Density Polyethylene)




4.2.1.   Use-specific instructions for use

see general directions for use for Meta SPC 11
4.2.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 11
4.2.3.   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 for Meta SPC 11
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 11
4.2.5.   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 for Meta SPC 11
4.3.   Use description


Table 24


Use # 3 – Hard surface disinfection for veterinary hygiene







Product type


PT03 – Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
Veterinary field:
Disinfection of hard/non-porous surfaces by spraying or soaking with prior cleaning




Application method(s)


Method: By spraying or immersion
Detailed description:
Spraying
Immersion (the bath is intended to be used only once)




Application rate(s) and frequency


Application Rate: Active against bacteria and yeasts at +10 °C: 4 % in 30 minutes contact time
Dilution (%): 4 %
Number and timing of application:
Active against bacteria and yeasts at +10 °C:
4 % (with 0,96 % Lactic acid) in 30 minutes contact time




Category(ies) of users


Professional




Pack sizes and packaging material


1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000  L, 1 100  L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000  kg, 1 100  kg
HDPE (High Density Polyethylene)




4.3.1.   Use-specific instructions for use

Animal houses must be empty of animals during disinfection. The product is used to disinfect animal housings of pigs, cows, poultry. Clean the surfaces thoroughly with a detergent before disinfection. Rinse with clean water and remove surplus water.
Mixing and loading: container is opened manually and emptied into the reservoir or connected to a pump, which pumps the product into the reservoir of the spraying device which is then filled up with water in order to achieve the correct concentration of use. Apply the product by spraying or immersion. Use as much solution as needed to keep the surfaces wet during the complete contact time. It is not necessary to spray during the complete contact time.
4.3.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 11
4.3.3.   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 for Meta SPC 11
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 11
4.3.5.   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 for Meta SPC 11
5.   GENERAL DIRECTIONS FOR USE (11)
OF THE META SPC 11

5.1.   Instructions for use

Disinfection procedures by spraying: The surfaces to be disinfected must be wet enough in order to be kept wet during the preconised contact time for optimal disinfection. The following precautionary sentence shall be added on the product label: “Make sure to wet surfaces completely”.
Products must be diluted in potable water before use.
5.2.   Risk mitigation measures

Gloves and goggles are needed during mixing and loading.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
IF 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 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. Immediately call 112/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/ambulance for medical assistance
5.4.   Instructions for safe disposal of the product and its packaging

The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
6.   OTHER INFORMATION

/
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 11

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











Trade name(s)


Kenosan Lactic


Market area: EU




 


Lacto Des


Market area: EU




Bio Des 100


Market area: EU




Bio Lac


Market area: EU




Authorisation number


EU-0027740-0013 1-11




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


24,0 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


12,0 




Isopropanol


Propan-2-ol


Non-active substance


67-63-0


200-661-7


5,0 





META SPC 12

1.   META SPC 12 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 12 identifier







Identifier


Meta SPC 12: Inner surface disinfectants by CIP with and without circulation and crate wash (PT4)




1.2.   Suffix to the authorisation number







Number


1-12




1.3.   Product type(s)







Product type(s)


PT04 – Food and feed area (Disinfectants)




2.   META SPC 12 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 12












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


22,0 


22,0 




C6 alkyl glucoside


Hexyl D-Glucoside


Non-active substance


54549-24-5


259-217-6


2,4 


2,4 




Methanesulfonic acid


Methanesulfonic acid


Non-active substance


75-75-2


200-898-6


0,0 


10,5 




Sulphuric acid


Sulphuric acid


Non-active substance


7664-93-9


231-639-5


0,0 


10,5 




2.2.   Type(s) of formulation of the meta SPC 12







Formulation(s)


SL – Soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 12







Hazard statements


Causes severe skin burns and eye damage.
May be corrosive to metals.




Precautionary statements


Keep only in original packaging.
Do not breathe vapours.
Wash hands thoroughly after handling.
Wear protective gloves.
Wear protective clothing.
Wear eyes/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 INHALED:Remove person to fresh air and keep comfortable for breathing.
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.
Absorb spillage to prevent material damage.
Wash contaminated clothing before reuse.
Store locked up.
Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.




4.   AUTHORISED USE(S) OF THE META SPC 12

4.1.   Use description


Table 25


Use # 1 – Inner surface disinfection by CIP with circulation







Product type


PT04 – Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
in Food and feed industry:
Disinfection of hard/non-porous inner surfaces by CIP procedures (with circulation)




Application method(s)


Method: CIP procedures
Detailed description:
/




Application rate(s) and frequency


Application Rate: at +50 °C
Dilution (%): 1 to 4 %
Number and timing of application:
At +50 °C
Active against bacteria and yeasts:






—


with prior cleaning: 2 % (with 0,44 % Lactic acid) in two minutes contact time/1 % in 30 minutes contact time










—


without prior cleaning: 4 % (with 0,88 % Lactic acid) in two minutes contact time Or 1 % (0,22 % Lactic acid) in 30 minutes contact time










—


in milky conditions: 2 % (with 0,44 % Lactic acid) in 15 minutes contact time








Category(ies) of users


Professional




Pack sizes and packaging material


1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000  L, 1 100  L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000  kg, 1 100  kg
HDPE (High Density Polyethylene)




4.1.1.   Use-specific instructions for use

see general directions for use for Meta SPC 12
4.1.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 12
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 for Meta SPC 12
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 12
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 for Meta SPC 12
4.2.   Use description


Table 26


Use # 2 – Inner surface disinfection by CIP without circulation







Product type


PT04 – Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
in Food and feed industry:
Disinfection of hard/non-porous inner surfaces by CIP procedures (without circulation)




Application method(s)


Method: CIP procedures
Detailed description:
/




Application rate(s) and frequency


Application Rate: At +50 °C
Dilution (%): 2 % or 4 %
Number and timing of application:
At +50 °C
Active against bacteria and yeasts:






—


with prior cleaning: 2 % (with 0,44 % Lactic acid) in two minutes contact time










—


without prior cleaning: 4 % (with 0,88 % Lactic acid) in two minutes contact time Or 2 % (with 0,44 % Lactic acid) in 30 minutes contact time








Category(ies) of users


Professional




Pack sizes and packaging material


1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000  L, 1 100  L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000  kg, 1 100  kg
HDPE (High Density Polyethylene)




4.2.1.   Use-specific instructions for use

see general directions for use for Meta SPC 12
4.2.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 12
4.2.3.   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 for Meta SPC 12
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 12
4.2.5.   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 for Meta SPC 12
4.3.   Use description


Table 27


Use # 3 – Crate wash







Product type


PT04 – Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
Indoor – in Food and feed industry
disinfection of hard/non-porous surfaces in crate washers




Application method(s)


Method: Crate wash
Detailed description:
/




Application rate(s) and frequency


Application Rate: At +50 °C
Dilution (%): 2 % or 4 %
Number and timing of application:
At +50 °C
Active against bacteria and yeasts:






—


With prior cleaning: 2 % (with 0,44 % Lactic acid) in two minutes contact










—


without prior cleaning: 4 % (with 0,88 % Lactic acid) in two minutes contact








Category(ies) of users


Professional




Pack sizes and packaging material


1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000  L, 1 100  L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000  kg, 1 100  kg
HDPE (High Density Polyethylene)




4.3.1.   Use-specific instructions for use

see general directions for use for Meta SPC 12
4.3.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 12
4.3.3.   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 for Meta SPC 12
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 12
4.3.5.   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 for Meta SPC 12
5.   GENERAL DIRECTIONS FOR USE (12)
OF THE META SPC 12

5.1.   Instructions for use

Products must be diluted in potable water before use.
5.2.   Risk mitigation measures

Gloves and goggles are needed during mixing and loading.
Wear protective coverall (to be specified by the authorisation holder within the product information).
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/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. Immediately call a Call 112/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/ambulance for medical assistance
5.4.   Instructions for safe disposal of the product and its packaging

The packing and content must be eliminated as dangerous waste product under the whole responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is 2 years.
6.   OTHER INFORMATION

/
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 12

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











Trade name(s)


Pho Cid L


Market area: EU




 


Tornax 100


Market area: EU




Tornax Des


Market area: EU




Lacto CIP


Market area: EU




Pho Cid Eco


Market area: EU




Authorisation number


EU-0027740-0014 1-12




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


22,0 




C6 alkyl glucoside


Hexyl D-Glucoside


Non-active substance


54549-24-5


259-217-6


2,4 




Methanesulfonic acid


Methanesulfonic acid


Non-active substance


75-75-2


200-898-6


10,5 




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











Trade name(s)


Pho Cid LS


Market area: EU




Authorisation number


EU-0027740-0015 1-12




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


22,0 




C6 alkyl glucoside


Hexyl D-Glucoside


Non-active substance


54549-24-5


259-217-6


2,4 




Sulphuric acid


Sulphuric acid


Non-active substance


7664-93-9


231-639-5


10,5 





META SPC 13

1.   META SPC 13 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 13 identifier







Identifier


Meta SPC 13: Hard surface disinfectants (PT4)




1.2.   Suffix to the authorisation number







Number


1-13




1.3.   Product type(s)







Product type(s)


PT04 – Food and feed area (Disinfectants)




2.   META SPC 13 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 13












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


11,0 


11,0 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


4,5 


4,5 




Methanesulfonic acid


Methanesulfonic acid


Non-active substance


75-75-2


200-898-6


10,5 


19,5 




2.2.   Type(s) of formulation of the meta SPC 13







Formulation(s)


SL – Soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 13







Hazard statements


May be corrosive to metals.
Causes severe skin burns and eye damage.




Precautionary statements


Keep only in original packaging.
Do not breathe vapours.
Wash hands thoroughly after handling.
Wear protective gloves.
Wear protective clothing.
Wear eyes/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 INHALED:Remove person to fresh air and keep comfortable for breathing.
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.
Absorb spillage to prevent material damage.
Wash contaminated clothing before reuse.
Store locked up.
Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.




4.   AUTHORISED USE(S) OF THE META SPC 13

4.1.   Use description


Table 28


Use # 1 – Hard surface disinfection (PT4)







Product type


PT04 – Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
Food/feed areas
Disinfection of hard/non-porous surfaces by foaming




Application method(s)


Method: By foaming
Detailed description:
/




Application rate(s) and frequency


Application Rate: At room temperature in 30 minutes contact time Active against bacteria and yeasts: – with prior cleaning: 1 % – without prior cleaning: 5 %
Dilution (%): 1 or 5 %
Number and timing of application:






 


At room temperature in 30 minutes contact time










 


Active against bacteria and yeasts:






—


with prior cleaning: 1 % (with 0,11 % Lactic acid)










—


without prior cleaning: 5 % (with 0,55 % Lactic acid)












Category(ies) of users


Professional




Pack sizes and packaging material


1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000  L, 1 100  L
1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000  kg, 1 100  kg
HDPE (High Density Polyethylene)




4.1.1.   Use-specific instructions for use

see general directions for use for Meta SPC 13
4.1.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 13
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 for Meta SPC 13
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 13
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 for Meta SPC 13
5.   GENERAL DIRECTIONS FOR USE (13)
OF THE META SPC 13

5.1.   Instructions for use

The surfaces to be disinfected must be wet enough in order to be kept wet during the preconised contact time for optimal disinfection.
The following precautionary sentence shall be added on the product label: “Make sure to wet surfaces completely”.
Products must be diluted in potable water before use.
5.2.   Risk mitigation measures

Gloves and goggles are needed during mixing and loading.
Wear protective coverall (to be specified by the authorisation holder within the product information).
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/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. Immediately call 112/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/ambulance for medical assistance
5.4.   Instructions for safe disposal of the product and its packaging

The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
6.   OTHER INFORMATION

/
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 13

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











Trade name(s)


Tornax L


Market area: EU




 


Lacto Cid


Market area: EU




Authorisation number


EU-0027740-0016 1-13




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


11,0 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


4,5 




Methanesulfonic acid


Methanesulfonic acid


Non-active substance


75-75-2


200-898-6


10,5 





META SPC 14

1.   META SPC 14 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 14 identifier







Identifier


Meta SPC 14: Ready to use hygienic handrub (PT1)




1.2.   Suffix to the authorisation number







Number


1-14




1.3.   Product type(s)







Product type(s)


PT01 – Human hygiene (Disinfectants)




2.   META SPC 14 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 14












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


3,6 


3,6 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


2,0 


2,0 




Isopropanol


Propan-2-ol


Non-active substance


67-63-0


200-661-7


4,0 


4,0 




Butyldiglycol


2-(2-butoxyethoxy)ethanol


Non-active substance


112-34-5


203-961-6


10,0 


10,0 




2.2.   Type(s) of formulation of the meta SPC 14







Formulation(s)


AL – Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 14







Hazard statements


Causes serious eye damage.




Precautionary statements


Wear eye/face protection.
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.




4.   AUTHORISED USE(S) OF THE META SPC 14

4.1.   Use description


Table 29


Use # 1 – Hygienic handrub, for professional use (PT1)







Product type


PT01 – Human hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: other: bacteria
Common name: Bacteria
Development stage:
Scientific name: other: yeast
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
in Food/feed industry; Public field; Kitchens
Hygienic handrub, on visibly clean hands




Application method(s)


Method: By rubbing the hands
Detailed description:
/




Application rate(s) and frequency


Application Rate: 6 mL of product
Dilution (%): -
Number and timing of application:
Active against bacteria and yeasts:
RTU (with 3,6 % Lactic acid)
6 mL (that is three pushes for both hands together)
One minute contact time




Category(ies) of users


Professional




Pack sizes and packaging material


50 mL, 75 mL, 100 mL, 150 mL, 500 mL, 1L, 5L, 10L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000  L, 1 100  L
HDPE (High Density Polyethylene)




4.1.1.   Use-specific instructions for use

see general directions for use for Meta SPC 14
4.1.2.   Use-specific risk mitigation measures

/
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 for Meta SPC 14
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general directions for use for Meta SPC 14
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 for Meta SPC 14
5.   GENERAL DIRECTIONS FOR USE (14)
OF THE META SPC 14

5.1.   Instructions for use

Apply 6 ml of the product undiluted. Respect a contact time of 1 minute. Rinse thoroughly after disinfection.
For professional use only
5.2.   Risk mitigation measures

/
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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 INHALED: If symptoms occur 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. Immediately call 112/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/ambulance for medical assistance
5.4.   Instructions for safe disposal of the product and its packaging

The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
6.   OTHER INFORMATION

/
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 14

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











Trade name(s)


Kenosan Hand Rub


Market area: EU




Authorisation number


EU-0027740-0017 1-14




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


3,6 




Sodium Lauryl sulphate


Sulfuric acid, mono-C12-14-alkyl esters, sodium salts


Non-active substance


85586-07-8


287-809-4


2,0 




Isopropanol


Propan-2-ol


Non-active substance


67-63-0


200-661-7


4,0 




Butyldiglycol


2-(2-butoxyethoxy)ethanol


Non-active substance


112-34-5


203-961-6


10,0 






            ’
         


(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.

(9)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 9.

(10)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 10.

(11)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 11.

(12)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 12.

(13)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 13.

(14)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 14.



ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj
ISSN 1977-0677 (electronic edition)