LegalizeCommission 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)
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.
ANNEX
SALVECO SALVESAFE PRODUCTS
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
PT03: Veterinary hygiene
Authorisation number EU-0028967-0000
R4BP asset number EU-0028967-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
| Name | SALVECO SALVESAFE PRODUCTS |
|---|---|
| Product type(s) | PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area PT03: Veterinary hygiene |
| --- | --- |
| Name and address of the authorisation holder | Name |
| --- | --- |
| Address | Avenue Pierre Mendès-France Z.A. Hellieule 4 F 88100 SAINT DIE DES VOSGES FR |
| Authorisation number | |
| R4BP asset number | |
| Date of the authorisation | |
| Expiry date of the authorisation | |
| 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 |
| Name of manufacturer | IDEAL Chimic |
| --- | --- |
| Address of manufacturer | Route de St-Julien 34 1227 Carouge Switzerland |
| Location of manufacturing sites | Route de St-Julien 34 1227 Carouge Switzerland |
| 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
| 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) | ||
| Formulation type(s) | SL – Soluble Concentrate AL – Any other liquids | ||||
| --- | --- |
PART II
SECOND INFORMATION LEVEL - META SPC(S)
1. META SPC 1 ADMINISTRATIVE INFORMATION
| Identifier | Meta SPC: meta-SPC1 |
|---|---|
| Number | 1-1 |
| --- | --- |
| 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
| 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) | ||
| 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. |
|---|---|
| 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
| 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, 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: - 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 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) |
See general instructions for use.
See general instructions for use.
See general instructions for use.
See general instructions for use.
See general instructions for use.
| 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: - 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 – 100 ml 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) |
See general instructions for use.
See general instructions for use.
See general instructions for use.
See general instructions for use.
See general instructions for use.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1
— 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 Dilution of the product Contact time Bacterial and yeasticidal activity 0,299 % (20 ml product, add water up to 1 liter) 5 minutes
The authorisation holder shall indicate on the label the relevant volume of product to be diluted in water for each specific product.
— 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.
— 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.
— 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.
— 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:
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
| 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 % (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 | 8,23 % (w/w) | ||
| 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 % (w/w) | |
| Sodium octyl ether carboxylate | Non-Active substance | 53563-70-5 | 18 % (w/w) | ||
| D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | Non-Active substance | 110615-47-9 | 5,49 % (w/w) | ||
| 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 % (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) | ||
| 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 % (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) |
1. META SPC 2 ADMINISTRATIVE INFORMATION
| Identifier | Meta SPC: meta-SPC2 |
|---|---|
| Number | 1-2 |
| --- | --- |
| 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
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