Commission Implementing Regulation (EU) 2023/1758 of 11 September 2023 granting a Union authorisation for the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
Date: 2023-09-11
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, animal welfare, biocide, chemical product, decontamination, food safety, market approval, pharmaceutical product








L_2023224EN.01003401.xml










12.9.2023   


EN


Official Journal of the European Union


L 224/34








            COMMISSION IMPLEMENTING REGULATION (EU) 2023/1758
of 11 September 2023
         
granting a Union authorisation for the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5), first subparagraph, thereof,

Whereas:







(1)


On 26 April 2019, Salveco SAS submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for a Union authorisation of a biocidal product family named ‘SALVECO SALVESAFE PRODUCTS’ of product-types 2, 3 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of France had agreed to evaluate the application. The application was recorded under case number BC-HC051278-51 in the Register for Biocidal Products.












(2)


‘SALVECO SALVESAFE PRODUCTS’ contains L-(+)-lactic acid as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2, 3 and 4.












(3)


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












(4)


On 5 July 2022, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘SALVECO SALVESAFE PRODUCTS’ and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012.












(5)


The opinion concludes that ‘SALVECO SALVESAFE PRODUCTS’ is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.












(6)


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












(7)


The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’.












(8)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,





HAS ADOPTED THIS REGULATION:



Article 1
A Union authorisation with authorisation number EU-0028967-0000 is hereby granted to Salveco SAS for the making available on the market and use of the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 2 October 2023 to 30 September 2033.


Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 11 September 2023.


For the Commission


The President

Ursula VON DER LEYEN
            





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

(2)  ECHA opinion of 15 June 2022 on the Union authorisation of ‘SALVECO SALVESAFE PRODUCTS’ (ECHA/BPC/346/2022), https://echa.europa.eu/opinions-on-union-authorisation.




ANNEX
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
SALVECO SALVESAFE PRODUCTS
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-0028967-0000
R4BP asset number: EU-0028967-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name







Name


SALVECO SALVESAFE PRODUCTS




1.2.   Product type(s)







Product type(s)


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


SALVECO S.A.S.




Address


Avenue Pierre Mendès-France Z.A. Hellieule 4, F 88100 SAINT DIE DES VOSGES France




Authorisation number


EU-0028967-0000





R4BP asset number



EU-0028967-0000




Date of the authorisation


2 October 2023




Expiry date of the authorisation


30 September 2033




1.4.   Manufacturer(s) of the biocidal products







Name of manufacturer


SALVECO S.A.S




Address of manufacturer


Avenue Pierre Mendès-France, F-88100 SAINT DIE DES VOSGES France




Location of manufacturing sites


Avenue Pierre Mendès-France, F-88100 SAINT DIE DES VOSGES France













Name of manufacturer


GESTRA S.A.S




Address of manufacturer


Allée Robert Schumann, F-88110 RAON-L’ETAPE France




Location of manufacturing sites


Allée Robert Schumann, F-88110 RAON-L’ETAPE France




1.5.   Manufacturer(s) of the active substance(s)







Active substance


L-(+)-lactic acid




Name of manufacturer


PURAC BIOCHEM BV




Address of manufacturer


Gran Vial 19-25, 08160 Montmelo Spain




Location of manufacturing sites


Gran Vial 19-25, 08160 Montmelo Spain













Active substance


L-(+)-lactic acid




Name of manufacturer


JUNGBUNGZLAUER S.A




Address of manufacturer


Z.I Portuaire BP 32, 67390 Marckolsheim France




Location of manufacturing sites


Z.I Portuaire BP 32, 67390 Marckolsheim France




2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

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












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


0,627 


31,33 




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


0,0 


28,8 




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


0,0 


8,23 




2.2.   Type(s) of formulation







Formulation(s)


SL – Soluble Concentrate
AL – Any other liquids




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-SPC1




1.2.   Suffix to the authorisation number







Number


1-1




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 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


15,66 


31,33 




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


13,5 


27,0 




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


3,52 


8,23 




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







Formulation(s)


SL – Soluble Concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1







Hazard statements


Causes skin irritation.
Causes serious eye damage.




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, protective clothing and eye 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 POISON CENTER or doctor.
Specific treatment (see supplemental first aid instruction on this label).
If skin irritation occurs:Get medical advice.
Take off contaminated clothing.And wash it before reuse.




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

4.1.   Use description


Table 1


Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in domestic, institutional, medical and industrial areas)







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


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Viruses
Common name: Enveloped viruses
Development stage:




Field(s) of use


Indoor
Outdoor
In domestic, institutional, medical and industrial areas




Application method(s)


Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping
Detailed description:






—


without mechanical action








Application rate(s) and frequency


Application Rate: -
Dilution (%): 0,299% to 1,496%
Number and timing of application:
Mandatory target organisms:






—


Bacteria: 0,299% to 1,496% w/w L-(+)-lactic acid, 5 minutes, 20°C




Other target organisms:






—


Enveloped viruses and yeasts: 0,299% to 1,496% w/w L-(+)-lactic acid, 5 minutes, 20°C




Minimum in use concentration of surfactants shall be 0,29% for any future product included in this meta SPC.




Category(ies) of users


Professional
General public (non-professional)




Pack sizes and packaging material


Package size for non-professional is restricted to maximum 3 liters and packaging above 1 liter should be equipped with a handle






 


Refill caps: 20 - 100ml high density polyethylene (HDPE)










 


Bottles: 0,5 - 5 liters HDPE or polyethylene terephtalate (PET)










 


Jerry can: 1-80 liters HDPE (only for professional users)










 


Drum: 10-210 liters HDPE (only for professional users)










 


Intermediate bulk container (IBC): 1 000  liters HDPE (only for professional users)








4.1.1.   Use-specific instructions for use

See general instructions for use.
4.1.2.   Use-specific risk mitigation measures

See general instructions for use.
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use.
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use.
4.2.   Use description


Table 2


Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in domestic, institutional and food industry areas







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


Indoor
Outdoor






—


in domestic, institutional and food industry areas (general disinfection)








Application method(s)


Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping
Detailed description:






—


without mechanical action








Application rate(s) and frequency


Application Rate: -
Dilution (%): 0,299% to 1,496%
Number and timing of application:
Mandatory target organisms:






—


Bacteria and yeast: 0,299% to 1,496% w/w L-(+)-lactic acid, 5 minutes, 20°C




Minimum in use concentration of surfactants shall be 0,29% for any future product included in this meta SPC.




Category(ies) of users


Professional
General public (non-professional)




Pack sizes and packaging material


Package size for non-professional is restricted to maximum 3 liters and packaging above 1 liter should be equipped with a handle






 


Refill caps: 20 - 100ml high density polyethylene (HDPE)










 


Bottles: 0,5 - 5 liters HDPE or polyethylene terephtalate (PET)










 


Jerry can: 1-80 liters HDPE (only for professional users)










 


Drum: 10-210 liters HDPE (only for professional users)










 


Intermediate bulk container (IBC): 1 000  liters HDPE (only for professional users)








4.2.1.   Use-specific instructions for use

See general instructions for use.
4.2.2.   Use-specific risk mitigation measures

See general instructions for use.
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 instructions for use.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use.
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 instructions for use.
5.   GENERAL DIRECTIONS FOR USE (1)
OF THE META SPC 1

5.1.   Instructions for use







—


Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected).










—


Apply only on non-porous surfaces.










—


Inform the authorisation holder if the treatment is ineffective.










—


Comply with the instructions for use.










—


Each product label shall give information on how the dilution should be made in order to guarantee the efficacy of the product. Since the concentration of L-(+)-lactic acid in products within this meta SPC can range from 15,66% to 31,33%, it is not possible to indicate all product dilution here.












Example for a product containing 15,66% L-(+)-lactic acid

Bacterial and yeasticidal activity


Dilution of the product
0,299% (20 ml product, add water up to 1 liter)


Contact time
5 minutes




The authorisation holder shall indicate on the label the relevant volume of product to be diluted in water for each specific product.
5.2.   Risk mitigation measures







—


Wash hands after use of the concentrate product.










—


Avoid contact with eyes.










—


Avoid splashes and spills during mixing and loading (dilution).










—


For outdoor uses, do not apply the product in case rain is expected within 24 hours.










—


For outdoor uses by spray, avoid transfer to other areas by wind (drift).





For professional use only:







—


Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full texts of the EN standards are available in Section 6. – Personal protective equipment (PPE) material to be specified by the authorisation holder within the product information.





For non-professional use only:







—


A child-proof closure is required.










—


Keep out of reach of children and non-target animals or pets.




5.3.   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










—


IF ON SKIN: take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.










—


IF IN EYES: immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes.




Call 112 or an ambulance for medical assistance.
Information to healthcare personnel or a doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.






—


IF SWALLOWED: immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.










—


IF INHALED: if symptoms occur call a POISON CENTRE or a doctor.




5.4.   Instructions for safe disposal of the product and its packaging







—


Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.










—


Dispose of unused product, its packaging and all other waste, in accordance with local regulations.




5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage







—


Keep out of reach of children and non-target animals or pets.










—


Shelf-life: 2 years.










—


Protect from frost.




6.   OTHER INFORMATION







—


P280 (Wear protective gloves/protective clothing/eye protection/face protection) is not applicable for the non-professional user.




The full titles of the EN standards referenced in section 5.2 "Risk mitigation measures" are:






 


EN 374 - Protective gloves against dangerous chemicals and micro-organisms










 


EN 16321 - Eye and face protection for occupational use










 


EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])




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)


SALVE FAM1_1


Market area: EU




Authorisation number


EU-0028967-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


31,33




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


27,0




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


8,23




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











Trade name(s)


SALVE FAM1_5


Market area: EU




Authorisation number


EU-0028967-0002 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


20,89




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


18,0




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


5,49




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











Trade name(s)


SALVE FAM1_9


Market area: EU




 


OSANIS – Nettoyant désinfectant concentré


Market area: EU




Authorisation number


EU-0028967-0003 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


15,66




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


13,5




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


4,11




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











Trade name(s)


SALVE FAM1_13


Market area: EU




 


MILTON - Dégraissant désinfectant


Market area: EU




Authorisation number


EU-0028967-0004 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


31,33




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


27,0




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


3,52





META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier







Identifier


meta-SPC2




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)
PT04 - Food and feed area (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


15,66 


31,33 




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


13,5 


27,0 




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


3,52 


8,23 




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







Formulation(s)


SL – Soluble Concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2







Hazard statements


Causes skin irritation.
Causes serious eye damage.
Contains Eucalyptol, Carvone and Limonene. May produce an allergic reaction.
Contains Methyl salicylate and Eugenol (Pure fragrance). May produce an allergic reaction.
Contains Eucalyptol (Ecalyptus leaves fragrance). 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, protective clothing and eye 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 POISON CENTER or doctor.
Specific treatment (see supplemental first aid instruction on this label).
If skin irritation occurs: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 3


Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in domestic, institutional, medical and industrial areas)







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


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Viruses
Common name: Enveloped viruses
Development stage:




Field(s) of use


Indoor
Outdoor
in domestic, institutional, medical and industrial area.




Application method(s)


Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping
Detailed description:






—


without mechanical action.








Application rate(s) and frequency


Application Rate: -
Dilution (%): 0,299% to 1,496%
Number and timing of application:
Mandatory target organisms:






—


Bacteria: 0,299% to 1,496% w/w L-(+)-lactic acid, 5 minutes, 20°C




Other target organisms:






—


Enveloped viruses and yeasts: 0,299% to 1,496% w/w L-(+)-lactic acid, 5 minutes, 20°C




Minimum in use concentration of surfactants shall be 0,29% for any future product included in this meta SPC.




Category(ies) of users


Professional
General public (non-professional)




Pack sizes and packaging material


Package size for non-professional is restricted to maximum 3 liters and packaging above 1 liter should be equipped with a handle
Refill caps: 20 - 100 ml HDPE
Bottles: 0,5 - 5 liters HDPE or PET
Jerry can: 1-80 liters HDPE (only for professional users)
Drum: 10-210 liters HDPE (only for professional users)
IBC: 1 000  liters HDPE (only for professional users)




4.1.1.   Use-specific instructions for use

See general instructions for use
4.1.2.   Use-specific risk mitigation measures

See general instructions for use
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use
4.2.   Use description


Table 4


Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in domestic, institutional and food industry areas)







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


Indoor
Outdoor






—


in domestic, institutional and food industry areas (general disinfection)








Application method(s)


Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping
Detailed description:






—


without mechanical action








Application rate(s) and frequency


Application Rate: -
Dilution (%): 0,299% to 1,496%
Number and timing of application:
Mandatory target organisms:






—


Bacteria and yeast: 0,299% to 1,496% w/w L-(+)-lactic acid, 5 minutes, 20°C




Minimum in use concentration of surfactants shall be 0,29% for any future product included in this meta SPC.




Category(ies) of users


Professional
General public (non-professional)




Pack sizes and packaging material


Package size for non-professional is restricted to maximum 3 liters and packaging above 1 liter should be equipped with a handle
Refill caps: 20 - 100ml HDPE
Bottles: 0,5 - 5 liters HDPE or PET
Jerry can: 1-80 liters HDPE (only for professional users)
Drum: 10-210 liters HDPE (only for professional users)
IBC: 1 000  liters HDPE (only for professional users)




4.2.1.   Use-specific instructions for use

See general instructions for use
4.2.2.   Use-specific risk mitigation measures

See general instructions for use
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 instructions for use
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use
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 instructions for use
5.   GENERAL DIRECTIONS FOR USE (2)
OF THE META SPC 2

5.1.   Instructions for use







—


Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected).










—


Apply only on non porous surfaces.










—


Inform the authorisation holder if the treatment is ineffective.










—


Comply with the instructions for use.










—


Each product label shall give information on how the dilution should be made in order to guarantee the efficacy of the product. Since the concentration of L-(+)-lactic acid in products within this meta SPC can range from 15,66% to 31,33%, it is not possible to indicate all product dilution here.












Example for a product containing 15,66% L-(+)-lactic acid

Bacterial and yeasticidal activity


Dilution of the product
0,299% (20 ml product, add water up to 1 liter)


Contact time
5 minutes




The authorisation holder shall indicate on the label the relevant volume of product to be diluted in water on the label of each specific product.
5.2.   Risk mitigation measures







—


Wash hands after use of the concentrate product.










—


Avoid contact with eyes










—


Avoid splashes and spills during mixing and load ing (dilution).










—


For outdoor uses, do not apply the product in case rain is expected within 24 hours.










—


For outdoor uses by spray, avoid transfer to other areas by wind (drift).





For professional use only:







—


Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titles of the EN standards are available in Section 6. – PPE material to be specified by the authorisation holder within the product information.





For non-professional use only:







—


A child-proof closure is required.










—


Keep out of reach of children and non-target animals or pets.




5.3.   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










—


IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation or rash occur: Get medical advice.










—


IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes.




Call 112 or an ambulance for medical assistance.
Information to healthcare personnel or doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid






—


IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.










—


IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.




5.4.   Instructions for safe disposal of the product and its packaging







—


Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.










—


Dispose of unused product, its packaging and all other waste, in accordance with local regulations.




5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage







—


Keep out of reach of children and non-target animals or pets.










—


Shelf-life: 2 years.










—


Protect from frost.




6.   OTHER INFORMATION







—


P280 is not applicable for the non-professional user.




The full titles of the EN standards referenced in section 5.2 "Risk mitigation measures" are:






 


EN 374 - Protective gloves against dangerous chemicals and micro-organisms










 


EN 16321 - Eye and face protection for occupational use










 


EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])




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)


SALVE FAM1_2


Market area: EU




Authorisation number


EU-0028967-0005 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


31,33




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


27,0




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


8,23




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











Trade name(s)


SALVE FAM1_3


Market area: EU




Authorisation number


EU-0028967-0006 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


31,33




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


27,0




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


8,23




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











Trade name(s)


SALVE FAM1_4


Market area: EU




 


MAISON VERTE - Recharge pour spray désinfectant multi-usages


Market area: EU




MAISON VERTE PRO - Recharge pour spray désinfectant multi-usages


Market area: EU




MAISON VERTE PRO - Recharge pour spray désinfectant salle de bain


Market area: EU




SANIVERT - Recharge pour spray désinfectant multi-usages


Market area: EU




YOU - Recharge désinfectant toutes surfaces


Market area: EU




YOU - Recharge désinfectant WC


Market area: EU




SANILAK - Recharge Nettoyant désinfectant multi-usages Eucalyptus


Market area: EU




SANILAK - Recharge Nettoyant désinfectant sanitaires Eucalyptus


Market area: EU




SANILAK - Recharge Nettoyant désinfectant cuisine Eucalyptus


Market area: EU




YOU - Refill All purpose disinfecting cleaner


Market area: EU




Authorisation number


EU-0028967-0007 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


31,33




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


27,0




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


8,23




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











Trade name(s)


SALVE FAM1_6


Market area: EU




Authorisation number


EU-0028967-0008 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


20,89




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


18,0




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


5,49




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











Trade name(s)


SALVE FAM1_7


Market area: EU




Authorisation number


EU-0028967-0009 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


20,89




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


18,0




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


5,49




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











Trade name(s)


SALVE FAM1_8


Market area: EU




Authorisation number


EU-0028967-0010 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


20,89




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


18,0




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


5,49




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











Trade name(s)


SALVE FAM1_10


Market area: EU




 


SANILAK - Nettoyant désinfectant concentré Menthe


Market area: EU




SANILAK - Recharge Nettoyant désinfectant sols et surfaces Menthe


Market area: EU




Authorisation number


EU-0028967-0011 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


15,66




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


13,5




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


4,11




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











Trade name(s)


SALVE FAM1_11


Market area: EU




Authorisation number


EU-0028967-0012 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


15,66




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


13,5




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


4,11




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











Trade name(s)


SALVE FAM1_12


Market area: EU




 


MAISON VERTE - Recharge pour sol désinfectant multi-surfaces


Market area: EU




MAISON VERTE PRO - Recharge pour désinfectant sol


Market area: EU




MAISON VERTE PRO - Recharge pour désinfectant Multi-surfaces


Market area: EU




SANIVERT - Recharge désinfectant multi-surfaces


Market area: EU




YOU - Recharge désinfectant sols & surfaces


Market area: EU




SANILAK - Nettoyant désinfectant concentré Eucalyptus


Market area: EU




SANILAK - Recharge Nettoyant désinfectant sols et surfaces Eucalyptus


Market area: EU




Authorisation number


EU-0028967-0013 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


15,66




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


13,5




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


4,11




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











Trade name(s)


SALVE FAM1_14


Market area: EU




Authorisation number


EU-0028967-0014 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


31,33




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


27,0




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


8,23




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











Trade name(s)


SALVE FAM1_15


Market area: EU




 


TECH'LAB - Concentré détergent désinfectant sols & surfaces


Market area: EU




Authorisation number


EU-0028967-0015 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


15,66




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


13,5




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


4,11




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











Trade name(s)


SALVE FAM1_16


Market area: EU




Authorisation number


EU-0028967-0016 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


15,66




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


13,5




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


4,11





META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier







Identifier


meta-SPC3




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


7,83 


31,33 




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


6,75 


27,0 




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


1,32 


3,52 




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 skin irritation.
Causes serious eye damage.




Precautionary statements


Wash hands thoroughly after handling.
Wear protective gloves, protective clothing and eye 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 POISON CENTER or doctor.
Specific treatment (see supplemental first aid instruction on this label).
If skin irritation occurs:Get medical advice.
Take off contaminated clothing.And wash it before reuse.




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

4.1.   Use description


Table 5


Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in institutional, and industrial areas)







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


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Viruses
Common name: Enveloped viruses
Development stage:




Field(s) of use


Indoor
Outdoor






—


in institutional and industrial area








Application method(s)


Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping
Detailed description:






—


without mechanical action








Application rate(s) and frequency


Application Rate: -
Dilution (%): 0,299%
Number and timing of application:
Mandatory target organisms:






—


Bacteria and yeasts: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C




Other target organisms:






—


Enveloped viruses: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C




Minimum in use concentration of surfactants shall be 0,29% for any future product included in this meta SPC.




Category(ies) of users


Professional




Pack sizes and packaging material


Refill caps: 20 – 100ml HDPE
Bottles: 0,5 - 5 liters HDPE or PET
Jerry can: 1-80 liters HDPE
Drum: 10-210 liters HDPE
IBC: 1 000  liters HDPE




4.1.1.   Use-specific instructions for use

See general instructions for use
4.1.2.   Use-specific risk mitigation measures

See general instructions for use
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use
4.2.   Use description


Table 6


Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in institutional and industrial areas)







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


Indoor
Outdoor






—


in institutional and industrial area (general)








Application method(s)


Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping
Detailed description:






—


without mechanical action








Application rate(s) and frequency


Application Rate: -
Dilution (%): 0,299%
Number and timing of application:
Mandatory target organisms:






—


Bacteria and yeast: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C




Minimum in use concentration of surfactants shall be 0,29% for any future product included in this meta SPC.




Category(ies) of users


Professional




Pack sizes and packaging material


Refill caps: 20 – 100ml HDPE
Bottles: 0,5 - 5 liters HDPE or PET
Jerry can: 1-80 liters HDPE
Drum: 10-210 liters HDPE
IBC: 1 000  liters HDPE




4.2.1.   Use-specific instructions for use

See general instructions for use
4.2.2.   Use-specific risk mitigation measures

See general instructions for use
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 instructions for use
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use
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 instructions for use
5.   GENERAL DIRECTIONS FOR USE (3)
OF THE META SPC 3

5.1.   Instructions for use







—


Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected).










—


Apply only on non-porous surfaces.










—


Inform the auhtorisation holder if the treatment is ineffective.










—


Each product label shall give information on how the dilution should be made in order to guarantee the efficacy of the product. Since the concentration of L-(+)-lactic acid in products within this meta SPC can range from 7,83% to 31,33%, it is not possible to indicate all product dilution here.








Example for a product containing 7,83% L-(+)-lactic acid

Bacterial and yeasticidal activity


Dilution of the product
0,299% (40 ml product, add water up to 1 liter)


Contact time
5 minutes








The authorisation holder shall indicate on the label the relevant volume of product to be diluted in water on the label of each specific product.
5.2.   Risk mitigation measures







—


Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titless of the EN standard are available under section 6.










—


PPE material to be specified by the authorisation holder within the product information.










—


Wash hands after use of the concentrate product.










—


Avoid contact with eyes.










—


Avoid splashes and spills during mixing and loading (dilution).










—


For outdoor uses, do not apply the product in case rain is expected within 24 hours.










—


For outdoor uses by spray, avoid transfer to other areas by wind (drift).




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







—


IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.










—


IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes.




Call 112 or an ambulance for medical assistance.
Information to healthcare personnel or a doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid






—


IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.










—


IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.




5.4.   Instructions for safe disposal of the product and its packaging







—


Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.










—


Dispose of unused product, its packaging and all other waste, in accordance with local regulations.




5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage







—


Shelf-life: 2 years.










—


Protect from frost.




6.   OTHER INFORMATION

The full titles of the EN standards referenced in section 5.2 "Risk mitigation measures" are:






 


EN 374 - Protective gloves against dangerous chemicals and micro-organisms










 


EN 16321 - Eye and face protection for occupational use










 


EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])




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)


SALVE FAM2_1


Market area: EU




Authorisation number


EU-0028967-0017 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


15,66




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


13,5




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


1,76




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











Trade name(s)


SALVE FAM2_2


Market area: EU




Authorisation number


EU-0028967-0018 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


31,33




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


27,0




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


3,52




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











Trade name(s)


SALVE FAM2_6


Market area: EU




Authorisation number


EU-0028967-0019 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


7,83




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


6,75




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


1,32





META SPC 4

1.   META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier







Identifier


meta-SPC4




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


7,83 


31,33 




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


6,75 


27,0 




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


1,32 


5,28 




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 Eucalyptol, Carvone and Limonene (Cool Mint fragrance). May produce an allergic reaction.
Contains Methyl salicylate and Eugenol (Pure fragrance). May produce an allergic reaction.




Precautionary statements


Wash hands thoroughly after handling.
Wear protective gloves, protective clothing and eye 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 POISON CENTER or doctor.
Specific treatment (see supplemental first aid instruction on this label).
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 7


Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in institutional and industrial areas)







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


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Viruses
Common name: Enveloped viruses
Development stage:




Field(s) of use


Indoor
Outdoor






—


In institutional and industrial area








Application method(s)


Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping
Detailed description:






—


without mechanical action








Application rate(s) and frequency


Application Rate: -
Dilution (%): 0,299%
Number and timing of application:
Mandatory target organisms:






—


Bacteria and yeasts: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C




Other target organisms:






—


Enveloped viruses: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C




Minimum in use concentration of surfactants shall be 0,29% for any future product included in this meta SPC.




Category(ies) of users


Professional




Pack sizes and packaging material


Refill caps: 20 – 100ml HDPE
Bottles: 0,5 - 5 liters HDPE or PET
Jerry can: 1-80 liters HDPE
Drum: 10-210 liters HDPE
IBC: 1 000  liters HDPE




4.1.1.   Use-specific instructions for use

See general instructions for use
4.1.2.   Use-specific risk mitigation measures

See general instructions for use
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use
4.2.   Use description


Table 8


Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in institutional and industrial areas)







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


Indoor
Outdoor






—


In institutional and industrial area








Application method(s)


Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping
Detailed description:






—


without mechanical action








Application rate(s) and frequency


Application Rate: -
Dilution (%): 0,299%
Number and timing of application:
Mandatory target organisms:






—


Bacteria and yeast: 0,299% w/w L-(+)-lactic cid, 5 minutes, 20°C




Minimum in use concentration of surfactants shall be 0,29% for any future product included in this meta SPC.




Category(ies) of users


Professional




Pack sizes and packaging material


Refill caps: 20 – 100ml HDPE
Bottles: 0,5 - 5 liters HDPE or PET
Jerry can: 1-80 liters HDPE
Drum: 10-210 liters HDPE
IBC: 1 000  liters HDPE




4.2.1.   Use-specific instructions for use

See general instructions for use
4.2.2.   Use-specific risk mitigation measures

See general instructions for use
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 instructions for use
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use
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 instructions for use
5.   GENERAL DIRECTIONS FOR USE (4)
OF THE META SPC 4

5.1.   Instructions for use







—


Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected).










—


Apply only on non porous surfaces.










—


Inform the authorisation holder if the treatment is ineffective.










—


Each product label shall give information on how the dilution should be made in order to guarantee the efficacy of the product. Since the concentration of L-(+)-lactic acid in products within this meta SPC can range from 7,83% to 31,33%, it is not possible to indicate all product dilution here.








Example for a product containing 7,83% L-(+)-lactic acid

Bacterial and yeasticidal activity


Dilution of the product
0,299% (40 ml product, add water up to 1 liter)


Contact time
5 minutes








The authorisation holder shall indicate on the label the relevant volume of product to be diluted in water on the label of each specific product.
5.2.   Risk mitigation measures







—


Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titless of the EN standard are available under section 6.










—


PPE material to be specified by the authorisation holder within the product information.










—


Wash hands after use of the concentrate product.










—


Avoid contact with eyes.










—


Avoid splashes and spills during mixing and loading (dilution).










—


For outdoor uses, do not apply the product in case rain is expected within 24 hours.










—


For outdoor uses by spray, avoid transfer to other areas by wind (drift).




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







—


IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation or rash occur: Get medical advice.










—


IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes.




Call 112 or an ambulance for medical assistance.
Information to healthcare personnel or a doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid






—


IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.










—


IF INHALED: If symptoms occur call a POISON CENTER or a doctor.




5.4.   Instructions for safe disposal of the product and its packaging







—


Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.










—


Dispose of unused product, its packaging and all other waste, in accordance with local regulations.




5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage







—


Shelf-life: 2 years.










—


Protect from frost.




6.   OTHER INFORMATION

The full titles of the EN standards referenced in section 5.2 "Risk mitigation measures" are:






 


EN 374 - Protective gloves against dangerous chemicals and micro-organisms










 


EN 16321 - Eye and face protection for occupational use










 


EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])




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)


SALVE FAM2_3


Market area: EU




 


ATOUT-VERT - DD303


Market area: EU




SANILAK - Recharge Nettoyant Désinfectant Multi-usages Menthe


Market area: EU




SANILAK - Recharge Nettoyant Désinfectant Sanitaires Menthe


Market area: EU




SANILAK - Recharge Nettoyant Désinfectant Cuisine Menthe


Market area: EU




Authorisation number


EU-0028967-0020 1-4




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


31,33




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


27,0




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


5,28




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











Trade name(s)


SALVE FAM2_4


Market area: EU




Authorisation number


EU-0028967-0021 1-4




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


31,33




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


27,0




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


5,28




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











Trade name(s)


SALVE FAM2_5


Market area: EU




 


ATOUT-VERT - DDP38


Market area: EU




Authorisation number


EU-0028967-0022 1-4




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


7,83




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


6,75




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


1,32





META SPC 5

1.   META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 5 identifier







Identifier


meta-SPC5




1.2.   Suffix to the authorisation number







Number


1-5




1.3.   Product type(s)







Product type(s)


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


31,33 


31,33 




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


28,8 


28,8 




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


3,52 


3,52 




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 skin irritation.
Causes serious eye damage.




Precautionary statements


Wash hands thoroughly after handling.
Wear protective gloves, protective clothing and eye 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 POISON CENTER or doctor.
Specific treatment (see supplemental first aid instruction on this label).
If skin irritation occurs:Get medical advice.
Take off contaminated clothing.And wash it before reuse.




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

4.1.   Use description


Table 9


Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in institutional, medical, and industrial areas)







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


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Viruses
Common name: Enveloped viruses
Development stage:




Field(s) of use


Indoor
Outdoor






—


In institutional, medical and industrial area








Application method(s)


Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion except in medical areas, mopping
Detailed description:






—


without mechanical action








Application rate(s) and frequency


Application Rate: -
Dilution (%): 0,4485%
Number and timing of application:
Mandatory target organisms:






—


Bacteria and yeasts: 0,4485% w/w L-(+)-lactic acid, 5 minutes, 20°C




Other target organisms:






—


Enveloped viruses: 0,4485% w/w L-(+)-lactic acid, 5 minutes, 20°C




The concentrated product is to be diluted at 1,5% v/v before use.




Category(ies) of users


Professional




Pack sizes and packaging material


Bottles: 0,5 - 5 liters HDPE or PET
Jerry can: 1-80 liters HDPE
Drum: 10-210 liters HDPE
IBC: 1 000  liters HDPE




4.1.1.   Use-specific instructions for use

See general instructions for use
4.1.2.   Use-specific risk mitigation measures

See general instructions for use
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use
4.2.   Use description


Table 10


Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in institutional and industrial (food industry) areas)







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


Indoor
Outdoor






—


In institutional and industrial (food industry (general, meat (except slaughterhouses) and milk industries)) area








Application method(s)


Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping
Detailed description:






—


without mechanical action








Application rate(s) and frequency


Application Rate: -
Dilution (%): 0,4485% to 0,598%
Number and timing of application:
General disinfection and meat industries
Mandatory target organisms:






—


Bacteria and yeast: 0,4485% to 0,598% w/w L-(+)-lactic acid, 5 minutes, 20°C




The concentrated product is to be diluted between 1,5% and 2% v/v before use.
Milk industries
Mandatory target organisms:






—


Bacteria and yeast: 0,598% w/w L-(+)-lactic acid, 5 minutes, 20°C




The concentrated product is to be diluted at 2% v/v before use.




Category(ies) of users


Professional




Pack sizes and packaging material


Bottles: 0,5 - 5 liters HDPE or PET
Jerry can: 1-80 liters HDPE
Drum: 10-210 liters HDPE
IBC: 1 000  liters HDPE




4.2.1.   Use-specific instructions for use

See general instructions for use
4.2.2.   Use-specific risk mitigation measures

See general instructions for use
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 instructions for use
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use
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 instructions for use
4.3.   Use description


Table 11


Use # 3 – Disinfectants used to disinfect the materials and surfaces associated with the housing of animals (disinfectants for all washable hard surfaces in veterinary area)







Product type


PT03 - Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


Indoor
Outdoor




Application method(s)


Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping
Detailed description:






—


without mechanical action








Application rate(s) and frequency


Application Rate: -
Dilution (%): 0,299%
Number and timing of application:
Mandatory target organisms:






—


Bacteria and yeast: 0,299% w/w L-(+)-lactic acid 30 minutes, 10°C




The concentrated product is to be diluted at 1% v/v before use.




Category(ies) of users


Professional




Pack sizes and packaging material


Bottles: 0,5 - 5 liters HDPE or PET
Jerry can: 1-80 liters HDPE
Drum: 10-210 liters HDPE
IBC: 1 000  liters HDPE




4.3.1.   Use-specific instructions for use







—


Clean carefully the surfaces before application of the product.




4.3.2.   Use-specific risk mitigation measures

See general instructions for use
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 instructions for use
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use
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 instructions for use
5.   GENERAL DIRECTIONS FOR USE (5)
OF THE META SPC 5

5.1.   Instructions for use







—


Apply the product by fully wetting all surface for 5 to 30 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected).










—


Apply only on non-porous surfaces.










—


Inform the auhtorisation holder if the treatment is ineffective.




5.2.   Risk mitigation measures







—


Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titless of the EN standard are available under section 6.










—


PPE material to be specified by the authorisation holder within the product information.










—


Wash hands after use of the concentrate product.










—


Avoid contact with eyes.










—


Avoid splashes and spills during mixing and loading (dilution).










—


For outdoor uses, do not apply the product in case rain is expected within 24 hours.










—


For outdoor uses by spray, avoid transfer to other areas by wind (drift).




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







—


IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.










—


IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes.




Call 112 or an ambulance for medical assistance.
Information to healthcare personnel or a doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid






—


IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.










—


IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.




5.4.   Instructions for safe disposal of the product and its packaging







—


Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.










—


Dispose of unused product, its packaging and all other waste, in accordance with local regulations.




5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage







—


Shelf-life: 2 years.










—


Protect from frost.




6.   OTHER INFORMATION







—


The product is a foaming formulation.




The full titles of the EN standards referenced in section 5.2 "Risk mitigation measures" are:






 


EN 374 - Protective gloves against dangerous chemicals and micro-organisms










 


EN 16321 - Eye and face protection for occupational use










 


EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])




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)


SALVE FAM3_1


Market area: EU




 


CLEAN DESINFECTANT


Market area: EU




GERM D


Market area: EU




Authorisation number


EU-0028967-0023 1-5




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


31,33




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


28,8




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


3,52





META SPC 6

1.   META SPC 6 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 6 identifier







Identifier


meta-SPC6




1.2.   Suffix to the authorisation number







Number


1-6




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 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


31,33 


31,33 




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


28,8 


28,8 




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


5,28 


5,28 




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







Formulation(s)


SL – Soluble Concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6







Hazard statements


Causes skin irritation.
Causes serious eye damage.
Contains Eucalyptol and Carvone. May produce an allergic reaction.




Precautionary statements


Wash hands thoroughly after handling.
Wear protective gloves, protective clothing and eye 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 POISON CENTER or doctor.
Specific treatment (see supplemental first aid instruction on this label).
If skin irritation occurs:Get medical advice.
Take off contaminated clothing.And wash it before reuse.




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

4.1.   Use description


Table 12


Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in medical area)







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


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Viruses
Common name: Enveloped viruses
Development stage:




Field(s) of use


Indoor
Outdoor






—


in medical area








Application method(s)


Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, mopping
Detailed description:






—


without mechanical action








Application rate(s) and frequency


Application Rate: -
Dilution (%): 0,4485%
Number and timing of application:
Mandatory target organisms:






—


Bacteria and yeast: 0,4485% w/w L-(+)-lactic acid, 5 minutes, 20°C




Other target organisms:






—


Enveloped viruses: 0,4485% w/w L-(+)-lactic acid, 5 minutes, 20°C




The concentrated product is to be diluted at 1,5 % before use.




Category(ies) of users


Professional




Pack sizes and packaging material


Bottles: 0,5 - 5 liters HDPE or PET
Jerry can: 1-80 liters HDPE
Drum: 10-210 liters HDPE
IBC: 1 000  liters HDPE




4.1.1.   Use-specific instructions for use

See general instructions for use
4.1.2.   Use-specific risk mitigation measures

See general instructions for use
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use
5.   GENERAL DIRECTIONS FOR USE (6)
OF THE META SPC 6

5.1.   Instructions for use







—


Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected).










—


Apply only on non porous surfaces.










—


Inform the authorisation holder if the treatment is ineffective.




5.2.   Risk mitigation measures







—


Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titless of the EN standard are available under section 6.










—


PPE material to be specified by the authorisation holder within the product information.










—


Wash hands after use of the concentrate product.










—


Avoid contact with eyes.










—


Avoid splashes and spills during mixing and loading (dilution).










—


For outdoor uses, do not apply the product in case rain is expected within 24 hours.










—


For outdoor uses by spray, avoid transfer to other areas by wind (drift).




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







—


IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation or rash occur: Get medical advice.










—


IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes.




Call 112 or an ambulance for medical assistance.
Information to healthcare personnel or a doctor:






—


The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid










—


IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.










—


IF INHALED: If symptoms occur call a POISON CENTRE or a doctor




5.4.   Instructions for safe disposal of the product and its packaging







—


Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.










—


Dispose of unused product, its packaging and all other waste, in accordance with local regulations.




5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage







—


Shelf-life: 2 years.










—


Protect from frost.




6.   OTHER INFORMATION

The full titles of the EN standards referenced in section 5.2 "Risk mitigation measures" are:






 


EN 374 - Protective gloves against dangerous chemicals and micro-organisms










 


EN 16321 - Eye and face protection for occupational use










 


EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])




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)


SALVE FAM3_2


Market area: EU




Authorisation number


EU-0028967-0024 1-6




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


31,33




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


28,8




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


5,28





META SPC 7

1.   META SPC 7 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 7 identifier







Identifier


meta-SPC7




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)
PT03 - Veterinary hygiene (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


31,33 


31,33 




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


24,93 


24,93 




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


3,52 


3,52 




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







Formulation(s)


SL – Soluble Concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7







Hazard statements


Causes skin irritation.
Causes serious eye damage.




Precautionary statements


Wash hands thoroughly after handling.
Wear protective gloves, protective clothing and eye 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 POISON CENTER or doctor.
Specific treatment (see supplemental first aid instruction on this label).
If skin irritation occurs: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 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in domestic, institutional and industrial areas)







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


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Viruses
Common name: Enveloped viruses
Development stage:




Field(s) of use


Indoor
Outdoor






—


In domestic, institutional and industrial area








Application method(s)


Method: Wiping, moping or brush, spraying, soaking or dipping (immersion)
Detailed description:






—


without mechanical action








Application rate(s) and frequency


Application Rate: -
Dilution (%): 0,299%
Number and timing of application:
Mandatory target organisms:






—


Bacteria and yeasts: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C




Other target organisms:






—


Enveloped viruses: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C




The concentrated product is to be diluted at 1% v/v before use.




Category(ies) of users


Professional




Pack sizes and packaging material


Bottles: 0,5 - 5 liters HDPE or PET
Jerry can: 1-80 liters HDPE
Drum: 10-210 liters HDPE
IBC: 1 000  liters HDPE
Soft container: 1,5, 2,5 liters Low density polyethylene (LDPE)




4.1.1.   Use-specific instructions for use

Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays/m2 or 20 ml/m2 or fully cover the object to be disinfected).
4.1.2.   Use-specific risk mitigation measures

See general instructions for use.
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use.
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use.
4.2.   Use description


Table 14


Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in domestic, institutional and industrial (food industry) areas)







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Virus
Common name: Enveloped viruses only
Development stage:




Field(s) of use


Indoor
Outdoor






—


In domestic, institutional and food industry areas








Application method(s)


Method: Wiping, moping or brush, spraying, soaking or dipping (immersion)
Detailed description:






—


without mechanical action








Application rate(s) and frequency


Application Rate: -
Dilution (%): 0,299%
Number and timing of application:
Mandatory target organisms:






—


Bacteria and yeast: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C




Other target organisms:






—


Enveloped viruses: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C




The concentrated product is to be diluted at 1% v/v before use as indicated on label.




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Bottles: 0,5 - 5 liters HDPE or PET
Jerry can: 1-80 liters HDPE
Drum: 10-210 liters HDPE
IBC: 1 000  liters HDPE
Soft container: 1,5, 2,5 liters LDPE




4.2.1.   Use-specific instructions for use







—


Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays/m2 or 20 ml/m2 or fully cover the object to be disinfected).




4.2.2.   Use-specific risk mitigation measures

See general instructions for use
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 instructions for use
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use
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 instructions for use
4.3.   Use description


Table 15


Use # 3 – Disinfectants used to disinfect the materials and surfaces associated with the housing of animals (disinfectants for all washable hard surfaces in veterinary area)







Product type


PT03 - Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


Indoor
Outdoor
-




Application method(s)


Method: Wiping, moping or brush, spraying, soaking or dipping (immersion)
Detailed description:






—


without mechanical action








Application rate(s) and frequency


Application Rate: -
Dilution (%): 0,748%
Number and timing of application:
Mandatory target organisms:






—


Bacteria and yeast: 0,748% w/w L-(+)-lactic acid, 30 minutes, 10°C




The concentrated product is to be diluted at 2,5% v/v before use as indicated on label.




Category(ies) of users


Professional




Pack sizes and packaging material


Bottles: 0,5 - 5 liters HDPE or PET
Jerry can: 1-80 liters HDPE
Drum: 10-210 liters HDPE
IBC: 1 000  liters HDPE
Soft container: 1,5, 2,5 liters LDPE




4.3.1.   Use-specific instructions for use







—


Clean carefully the surfaces before application of the product.










—


Apply the product by fully wetting all surface for 30 minutes (apply approx. 18 sprays/m2 or 20 ml/m2 or fully cover the object to be disinfected).




4.3.2.   Use-specific risk mitigation measures

See general instructions for use
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 instructions for use
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use
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 instructions for use
5.   GENERAL DIRECTIONS FOR USE (7)
OF THE META SPC 7

5.1.   Instructions for use







—


Apply only on non porous surfaces.










—


Inform the authorisation holder if the treatment is ineffective.




5.2.   Risk mitigation measures







—


Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titless of the EN standard are available under section 6.










—


PPE material to be specified by the authorisation holder within the product information.










—


Wash hands after use of the concentrate product.










—


Avoid contact with eyes.










—


Avoid splashes and spills during mixing and loading (dilution).










—


For outdoor uses, do not apply the product in case rain is expected within 24 hours.










—


For outdoor uses by spray, avoid transfer to other areas by wind (drift).




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







—


IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.










—


IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes.




Call 112 or an ambulance for medical assistance.
Information to healthcare personnel or a doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid






—


IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.










—


IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.




5.4.   Instructions for safe disposal of the product and its packaging







—


Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.










—


Dispose of unused product, its packaging and all other waste, in accordance with local regulations.




5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage







—


Shelf-life: 2 years.










—


Protect from frost.




6.   OTHER INFORMATION

The full titles of the EN standards referenced in section 5.2 "Risk mitigation measures" are:






 


EN 374 - Protective gloves against dangerous chemicals and micro-organisms










 


EN 16321 - Eye and face protection for occupational use










 


EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])




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)


SALVE 15


Market area: EU




Authorisation number


EU-0028967-0025 1-7




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


31,33




Sodium octyl ether carboxylate


 


Non-active substance


53563-70-5


 


24,93




D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides


 


Non-active substance


110615-47-9


 


3,52





META SPC 8

1.   META SPC 8 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 8 identifier







Identifier


meta-SPC8




1.2.   Suffix to the authorisation number







Number


1-8




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 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


0,627 


1,566 




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







Formulation(s)


AL – Any other liquids




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8







Hazard statements


 




Precautionary statements


 




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

4.1.   Use description


Table 16


Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in domestic, institutional and industrial areas)







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


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Viruses
Common name: Enveloped viruses
Development stage:




Field(s) of use


Indoor
Outdoor






—


In domestic, institutional and industrial areas.








Application method(s)


Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion
Detailed description:






—


without mechanical action








Application rate(s) and frequency


Application Rate: -
Dilution (%): 0
Number and timing of application:
Ready to use products.
Contact time: 5 minutes, 20°C




Category(ies) of users


Professional
General public (non-professional)




Pack sizes and packaging material


Package size for non-professional is restricted to maximum 3 liters and packaging above 1 liter should be equipped with a handle.
Sprays (SP05): 0,5 liter - 0,75 liter HDPE or PET
Bottles: 0,5 - 5 liters HDPE or PET
Jerry can: 1-80 liters HDPE (only for professional users)
Drum: 10-210 liters HDPE (only for professional users)
IBC: 1 000  liters HDPE (only for professional users)




4.1.1.   Use-specific instructions for use

See general instructions for use
4.1.2.   Use-specific risk mitigation measures

See general instructions for use
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use
4.2.   Use description


Table 17


Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in domestic, institutional and industrial areas)







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


Indoor
Outdoor






—


In domestic, institutional and industrial (food industry (general)) areas.








Application method(s)


Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion>Detailed description:
-




Application rate(s) and frequency


Application Rate: ->Dilution (%): 0>Number and timing of application:>Ready to use products.>Contact time: 5 minutes, 20°C




Category(ies) of users


Professional
General public (non-professional)




Pack sizes and packaging material


Package size for non-professional is restricted to maximum 3 liters and packaging above 1 liter should be equipped with a handle.>Sprays (SP05): 0,5 liter - 0,75 liter HDPE or PET>Bottles: 0,5 - 5 liters HDPE or PET>Jerry can: 1-80 liters HDPE (only for professional users)
Drum: 10-210 liters HDPE (only for professional users)
IBC: 1 000  liters HDPE (only for professional users)




4.2.1.   Use-specific instructions for use

See general instructions for use
4.2.2.   Use-specific risk mitigation measures

See general instructions for use
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 instructions for use
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use
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 instructions for use
5.   GENERAL DIRECTIONS FOR USE (8)
OF THE META SPC 8

5.1.   Instructions for use







—


Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected).










—


Apply only on non porous surfaces.










—


Inform the authorisation holder if the treatment is ineffective.










—


Comply with the instructions for use.




5.2.   Risk mitigation measures







—


For outdoor uses, do not apply the product in case rain is expected within 24 hours.










—


For outdoor uses by spray, avoid transfer to other areas by wind (drift).




5.3.   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










—


IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.










—


IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.










—


IF SWALLOWED: If symptoms occur 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







—


Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.










—


Dispose of unused product, its packaging and all other waste, in accordance with local regulations.




5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage







—


Keep out of reach of children and non-target animals or pets.










—


Shelf-life: 2 years.










—


Protect from frost.




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)


SALVE FAM5_1


Market area: EU




Authorisation number


EU-0028967-0026 1-8




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


0,627




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











Trade name(s)


SALVE FAM5_2


Market area: EU




Authorisation number


EU-0028967-0027 1-8




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


0,627




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











Trade name(s)


SANILAK - Nettoyant désinfectant multi-usages Eucalyptus


Market area: EU




 


SANILAK - Nettoyant désinfectant sanitaires Eucalyptus


Market area: EU




SANILAK - Nettoyant désinfectant cuisine Eucalyptus


Market area: EU




SALVE FAM5_3


Market area: EU




Authorisation number


EU-0028967-0028 1-8




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


0,627




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











Trade name(s)


SALVE FAM5_4


Market area: EU




 


YOU - All purpose disinfecting cleaner


Market area: EU




MAISON VERTE - Désinfectant


Market area: EU




MAISON VERTE PRO - Désinfectant Multi-usages


Market area: EU




MAISON VERTE PRO - Désinfectant Salle de Bain


Market area: EU




SANIVERT - Désinfectant


Market area: EU




YOU - Nettoyant désinfectant toutes surfaces


Market area: EU




YOU - Désinfectant WC détartrant


Market area: EU




Authorisation number


EU-0028967-0029 1-8




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


0,627




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











Trade name(s)


SALVE FAM5_5


Market area: EU




Authorisation number


EU-0028967-0030 1-8




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


1,566




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











Trade name(s)


SALVE FAM5_6


Market area: EU




 


SANILAK - Nettoyant désinfectant sols et surfaces


Market area: EU




Authorisation number


EU-0028967-0031 1-8




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


1,566




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











Trade name(s)


SALVE FAM5_7


Market area: EU




 


SANILAK - Nettoyant désinfectant sols et surfaces Eucalyptus


Market area: EU




Authorisation number


EU-0028967-0032 1-8




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


1,566




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











Trade name(s)


SALVE FAM5_8


Market area: EU




 


MAISON VERTE - Désinfectant Multi-surfaces


Market area: EU




MAISON VERTE PRO - Désinfectant Sol


Market area: EU




MAISON VERTE PRO - Désinfectant Multi-surfaces


Market area: EU




SANIVERT - Désinfectant Multi-surfaces


Market area: EU




YOU - Désinfectant sols & surfaces


Market area: EU




Authorisation number


EU-0028967-0033 1-8




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


1,566





META SPC 9

1.   META SPC 9 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 9 identifier







Identifier


meta-SPC9




1.2.   Suffix to the authorisation number







Number


1-9




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 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


0,627 


0,627 




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







Formulation(s)


AL – Any other liquids




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9







Hazard statements


 




Precautionary statements


 




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

4.1.   Use description


Table 18


Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in domestic, institutional and industrial areas)







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


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Viruses
Common name: Enveloped viruses
Development stage:




Field(s) of use


Indoor
Outdoor






—


In domestic, institutional and industrial area.








Application method(s)


Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping
Detailed description:






—


without mechanical action








Application rate(s) and frequency


Application Rate: -
Dilution (%): -
Number and timing of application:
Ready to use products.
Contact time: 5 minutes, 20°C




Category(ies) of users


Professional
General public (non-professional)




Pack sizes and packaging material


Package size for non-professional is restricted to maximum 3 liters and packaging above 1 liter should be equipped with a handle
Sprays (SP05): 0,5 liter - 0,75 liter HDPE or PET
Bottles: 0,5 - 5 liters HDPE or PET
Jerry can: 1-80 liters HDPE (only for professional users)
Drum: 10-210 liters HDPE (only for professional users)




4.1.1.   Use-specific instructions for use

See general instructions for use
4.1.2.   Use-specific risk mitigation measures

See general instructions for use
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general instructions for use
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general instructions for use
4.2.   Use description


Table 19


Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in domestic, institutional and industrial areas)







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


Indoor
Outdoor






—


In domestic, institutional and industrial (general) area








Application method(s)


Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping
Detailed description:






—


without mechanical action








Application rate(s) and frequency


Application Rate: -
Dilution (%): -
Number and timing of application:
Ready to use products.
Contact time: 5 minutes, 20°C




Category(ies) of users


Professional
General public (non-professional)




Pack sizes and packaging material


Package size for non-professional is restricted to maximum 3 liters and packaging above 1 liter should be eqquiped with a handle.
Sprays (SP05): 0,5 liter - 0,75 liter HDPE or PET
Bottles: 0,5 - 5 liters HDPE or PET
Jerry can: 1-80 liters HDPE (only for professional users)
Drum: 10-210 liters HDPE (only for professional users)




4.2.1.   Use-specific instructions for use

See general instructions for use
4.2.2.   Use-specific risk mitigation measures

See general instructions for use
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 instructions for use
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions for use
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 instructions for use
5.   GENERAL DIRECTIONS FOR USE (9)
OF THE META SPC 9

5.1.   Instructions for use







—


Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected).










—


Comply with the instructions for use.










—


Apply only on non-porous surfaces




5.2.   Risk mitigation measures







—


For outdoor uses, do not apply the product in case rain is expected within 24 hours.










—


For outdoor uses by spray, avoid transfer to other areas by wind (drift).




5.3.   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










—


IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.










—


IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.










—


IF SWALLOWED: If symptoms occur 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







—


Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.










—


Dispose of unused product, its packaging and all other waste, in accordance with local regulations.




5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage







—


Keep out of reach of children and non-target animals or pets.










—


Shelf-life: 2 years.










—


Protect from frost.




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)


SALVE FAM6_1


Market area: EU




Authorisation number


EU-0028967-0034 1-9




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


0,627




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











Trade name(s)


SALVE FAM6_2


Market area: EU




 


SANILAK - Nettoyant désinfectant multi-usages Menthe


Market area: EU




SANILAK - Nettoyant désinfectant sanitaires Menthe


Market area: EU




SANILAK - Nettoyant désinfectant cuisine Menthe


Market area: EU




Authorisation number


EU-0028967-0035 1-9




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


0,627




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











Trade name(s)


SALVE FAM6_3


Market area: EU




Authorisation number


EU-0028967-0036 1-9




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


Active Substance


79-33-4


201-196-2


0,627






(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.