ANNEX
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
SICO Biocidal Product Family
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
Authorisation number: EU-0029486-0000
R4BP asset number: EU-0029486-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
1.1. Family name
Name
SICO Biocidal Product Family
1.2. Product type(s)
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
1.3. Authorisation holder
Name and address of the authorisation holder
Name
SICO
Address
577 RUE DU POMMARIN BP16 VOREPPE 38340 MOIRANS CEDEX FR
Authorisation number
EU-0029486-0000
R4BP asset number
EU-0029486-0000
Date of the authorisation
25 September 2024
Expiry date of the authorisation
30 September 2033
1.4. Manufacturer(s) of the product
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
SALVECO S.A.S site 1 Avenue Pierre Mendès-France F-88100 SAINT DIE DES VOSGES France
Name of manufacturer
S.I.C.O
Address of manufacturer
577 Rue du Pommarin F-38340 VOREPPE France
Location of manufacturing sites
S.I.C.O site 1 577 Rue du Pommarin F-38340 VOREPPE France
S.I.C.O site 2 53 Avenue de l’Europe F-38522 SAINT-EGREVE France
S.I.C.O site 3 436 Rue Emile Romanet F-38340 VOREPPE 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
PURAC BIOCHEM BV site 1 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
JUNGBUNGZLAUER S.A site 1 Z.I Portuaire BP 32 67390 Marckolsheim France
2. PRODUCT FAMILY COMPOSITION AND FORMULATION
2.1. Qualitative and quantitative information on the composition of the family
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
0,627–31,33 % (w/w)
Sodium octyl ether carboxylate
Non-Active substance
53563-70-5
0–28,8 % (w/w)
D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides
Non-Active substance
110615-47-9
0–8,23 % (w/w)
2.2. Type(s) of formulation
Formulation type(s)
SL – Soluble Concentrate
PART II
SECOND INFORMATION LEVEL –META SPC(S)
1. META SPC 1 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 1 identifier
Identifier
Meta SPC: meta-SPC2
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
PT04: Food and feed area
2. META SPC 1 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
15,66–31,33 % (w/w)
Sodium octyl ether carboxylate
Non-Active substance
53563-70-5
13,5–27 % (w/w)
D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides
Non-Active substance
110615-47-9
3,52–8,23 % (w/w)
2.2. Type(s) of formulation of the meta SPC 1
Formulation type(s)
SL – Soluble Concentrate
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
Hazard statements
H315: Causes skin irritation.
H318: Causes serious eye damage.
EUH208: Contains Eucalyptol, Carvone and Limonene. May produce an allergic reaction.
EUH208: Contains Methyl salicylate and Eugenol (Pure fragrance). May produce an allergic reaction.
EUH208: Contains Eucalyptol (Eucalyptus leaves fragrance). May produce an allergic reaction.
Precautionary statements
P101: If medical advice is needed, have product container or label at hand.
P102: Keep out of reach of children.
P103: Read carefully and follow all instructions.
P264: Wash hands thoroughly after handling.
P280: Wear protective gloves, protective clothing and eye protection.
P302 + P352: IF ON SKIN: Wash with plenty of water.
P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310: Immediately call a POISON CENTER or doctor.
P321: Specific treatment (see supplemental first aid instruction on this label).
P332 + P313: If skin irritation occurs: Get medical advice.
P362 + P364: Take off contaminated clothing and wash it before reuse.
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 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
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Viruses
Common name: Enveloped viruses
Development stage: no data
Field(s) of use
indoor use
outdoor use
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 (%): 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 litres and packaging above 1 litre should be equipped with a handle
Refill caps: 20–100 ml HDPE
Bottles: 0,5–5 litres HDPE or PET
Jerry can: 1–80 litres HDPE (only for professional users)
Drum: 10–210 litres HDPE (only for professional users)
IBC: 1 000 litres HDPE (only for professional users)
4.1.1. Use-specific instructions
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
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
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Field(s) of use
indoor use
outdoor use
—
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 litres and packaging above 1 litre should be equipped with a handle
Refill caps: 20–100 ml HDPE
Bottles: 0,5–5 litres HDPE or PET
Jerry can: 1–80 litres HDPE (only for professional users)
Drum: 10–210 litres HDPE (only for professional users)
IBC: 1 000 litres HDPE (only for professional users)
4.2.1. Use-specific instructions
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 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/m 2 or 20 ml/m 2 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 litre)
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 1
7.1. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
5 EN 1 DETERGENT DEGRAISSANT DETARTRANT DESINFECTANT DESODORISANT
Market area: EU
NETTOYANT DESINFECTANT ANTI-CALCAIRE CONCENTRE DILUTION 2 %
Market area: EU
DETERGENT DEGRAISSANT DETARTRANT DESINFECTANT DESODORISANT DILUTION 2 %
Market area: EU
5D CONCENTRE DILUTION 2 %
Market area: EU
5 EN 1 CONCENTRE PARFUME
Market area: EU
FLASH GERM 5 EN 1
Market area: EU
FLASH GERM CONCENTRE PARFUME DILUTION 2 %
Market area: EU
FLASH GERM PARFUME
Market area: EU
Authorisation number
EU-0029486-0001 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 % (w/w)
Sodium octyl ether carboxylate
Non-Active substance
53563-70-5
13,5 % (w/w)
D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides
Non-Active substance
110615-47-9
4,11 % (w/w)
1. META SPC 2 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 2 identifier
Identifier
Meta SPC: meta-SPC3
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
PT04: Food and feed area
2. META SPC 2 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
L-(+)-lactic acid
active substance
79-33-4
201-196-2
7,83 –31,33 % (w/w)
Sodium octyl ether carboxylate
Non-Active substance
53563-70-5
6,75 –27 % (w/w)
D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides
Non-Active substance
110615-47-9
1,32 –3,52 % (w/w)
2.2. Type(s) of formulation of the meta SPC 2
Formulation type(s)
SL – Soluble Concentrate
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
Hazard statements
H315: Causes skin irritation.
H318: Causes serious eye damage.
Precautionary statements
P264: Wash hands thoroughly after handling.
P280: Wear protective gloves, protective clothing and eye protection.
P302 + P352: IF ON SKIN: Wash with plenty of water.
P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310: Immediately call a POISON CENTER or doctor.
P321: Specific treatment (see supplemental first aid instruction on this label).
P332 + P313: If skin irritation occurs: Get medical advice.
P362 + P364: Take off contaminated clothing and wash it before reuse.
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 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
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Viruses
Common name: Enveloped viruses
Development stage: no data
Field(s) of use
indoor use
outdoor use
- 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: 20–100 ml HDPE
Bottles: 0,5–5 litres HDPE or PET
Jerry can: 1–80 litres HDPE
Drum: 10–210 litres HDPE
IBC: 1 000 litres HDPE
4.1.1. Use-specific instructions
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
Food and feed area disinfectants (disinfectant for all washable hard surfaces in institutional and industrial areas)
Product type
PT04: Food and feed area
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Field(s) of use
indoor use
outdoor use
—
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: 20–100 ml HDPE
Bottles: 0,5–5 litres HDPE or PET
Jerry can: 1–80 litres HDPE
Drum: 10–210 litres HDPE
IBC: 1 000 litres HDPE
4.2.1. Use-specific instructions
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 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/m 2 or 20 ml/m 2 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.
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.
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 litre)
Contact time
5 minutes
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 2
7.1. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
U2 DESODOR 4D+
Market area: EU
4D+
Market area: EU
DESODOR 4D+
Market area: EU
Authorisation number
EU-0029486-0002 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 % (w/w)
Sodium octyl ether carboxylate
Non-Active substance
53563-70-5
13,5 % (w/w)
D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides
Non-Active substance
110615-47-9
1,76 % (w/w)
7.2. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
KING FLASH GERM
Market area: EU
KingFlash germ
Market area: EU
KING FLASH germ’
Market area: EU
FLASH GERM
Market area: EU
Authorisation number
EU-0029486-0003 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 % (w/w)
Sodium octyl ether carboxylate
Non-Active substance
53563-70-5
27 % (w/w)
D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides
Non-Active substance
110615-47-9
3,52 % (w/w)