Commission Implementing Regulation (EU) 2024/1767 of 26 June 2024 granting a Union authorisation for the biocidal product family Sure Lactic Family in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
A Union authorisation with authorisation number EU-0029485-0000 is hereby granted to Diversey Europe Operations B.V for the making available on the market and use of the same biocidal product family ‘Sure Lactic Family’ in accordance with the summary of the biocidal product characteristics set out in the Annex. The Union authorisation is valid from 17 July 2024 until 30 September 2033.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
ANNEX SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY Sure Lactic Family Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT03: Veterinary hygiene PT04: Food and feed area Authorisation number: EU-0029485-0000 R4BP asset number: EU-0029485-0000 PART I FIRST INFORMATION LEVEL 1. ADMINISTRATIVE INFORMATION 1.1. Family name Name Sure Lactic Family 1.2. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT03: Veterinary hygiene PT04: Food and feed area 1.3. Authorisation holder Name and address of the authorisation holder Name Diversey Europe Operations B.V. Address Regulatory team Maarssenbroeksedijk 2 3542 DN Utrecht NL Authorisation number EU-0029485-0000 R4BP asset number EU-0029485-0000 Date of the authorisation 17 July 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-Dié-des-Vosges France Location of manufacturing sites SALVECO S.A.S site 1 Avenue Pierre Mendès-France F-88100 Saint-Dié-des-Vosges France Name of manufacturer GESTRA S.A.S Address of manufacturer Allée Robert Schumann F-88110 Raon-l’Étape France Location of manufacturing sites GESTRA S.A.S site 1 Allée Robert Schumann F-88110 Raon-l’Étape France Name of manufacturer Diversey Europe Operations B.V. Address of manufacturer Maarssenbroeksedijk 2 3542DN Utrecht Netherlands (the) Location of manufacturing sites Diversey Europe Operations B.V. site 1 Strada Statale 235 26010 Bagnolo Cremasco (CR) Italy Diversey Europe Operations B.V. site 2 Rembrandtlaan 414 7545 ZW Enschede Netherlands (the) Diversey Europe Operations B.V. site 3 Cotes Park Industrial Estate DE55 4PA Somercotes Alfreton United Kingdom of Great Britain and Northern Ireland (the) Diversey Europe Operations B.V. site 4 AvenidaConde Duque 5, 7 y 9; Poligono Industrial La Postura 28343 Valdemoro (Madrid) Spain Diversey Europe Operations B.V. site 5 Morschheimer Strasse 12 67292 Kirchheimbolanden Germany Name of manufacturer Multifill BV Address of manufacturer Constructieweg 25a 3640 AJ Mijdrecht Netherlands (the) Location of manufacturing sites Multifill BV site 1 Constructieweg 25a 3640 AJ Mijdrecht Netherlands (the) Name of manufacturer Orvema B.V. Address of manufacturer Westkanaaldijk 26-I 3606 AM Maarssen Netherlands (the) Location of manufacturing sites Orvema B.V. site 1 Westkanaaldijk 26-I 3606 AM Maarssen Netherlands (the) Name of manufacturer Aerosol Service Sp. z o.o. Address of manufacturer Charnowo 36 76-270 Ustka Poland Location of manufacturing sites Aerosol Service Sp. z o.o. site 1 Charnowo 36 76-270 Ustka Poland Name of manufacturer Helichem B.V. Address of manufacturer Kozakkenberg 5 5951 DL Belfeld Netherlands (the) Location of manufacturing sites Helichem B.V. site 1 Kozakkenberg 5 5951 DL Belfeld Netherlands (the) Name of manufacturer Cheport spol s.r.o. Address of manufacturer Lhotsko 93 76312 Vizovice Czechia Location of manufacturing sites Cheport spol s.r.o. site 1 Lhotsko 93 76312 Vizovice Czechia Name of manufacturer EMMEGI DETERGENTS SRL Address of manufacturer Via Merlo Carlo Giuseppe, 3 20122 Milano Italy Location of manufacturing sites EMMEGI DETERGENTS SRL site 1 Via Marconi, 5 25030 Trenzano Italy Name of manufacturer GFL SA Address of manufacturer Via Sorengo 1 6900 Lugano Switzerland Location of manufacturing sites GFL SA site 1 Via del Benessere, 4 27010 Siziano PV Italy 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 Montmeló Spain Location of manufacturing sites PURAC BIOCHEM BV site 1 Gran Vial 19-25 08160 Montmeló 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 0,0 – 28,8 % (w/w) D-glucopyranos, oligomeric, C10-16 (even numbered)-alkyl glycosides Non-active substance 110615-47-9 0,0 – 8,23 % (w/w) 2.2. Type(s) of formulation Formulation type(s) SL – Soluble Concentrate AL – Any other liquid PART II SECOND INFORMATION LEVEL – META SPC(S) 1. META SPC 1 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 1 identifier Identifier Meta SPC: Sure Lactic Meta 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 PT03: Veterinary hygiene 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 31,33 - 31,33 % (w/w) Sodium octyl ether carboxylate Non-active substance 53563-70-5 24,93 - 24,93 % (w/w) D-glucopyranos, oligomeric, C10-16 (even numbered)-alkyl glycosides Non-active substance 110615-47-9 3,52 - 3,52 % (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. 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 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 areas Application method(s) Method: Wiping, mopping 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 litres HDPE or PET Jerry can: 1-80 litres HDPE Drum: 10-210 litres HDPE IBC: 1 000 litres HDPE Soft container: 1,5, 2,5 litres low-density polyethylene (LDPE) 4.1.1. Use-specific instructions 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). 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 industrial (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 Scientific name: Virus Common name: Enveloped viruses only Development stage: no data Field(s) of use Indoor use Outdoor use — In domestic, institutional and food industry areas Application method(s) Method: Wiping, mopping 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 litres HDPE or PET Jerry can: 1-80 litres HDPE Drum: 10-210 litres HDPE IBC: 1 000 litres HDPE Soft container: 1,5, 2,5 litres LDPE 4.2.1. Use-specific instructions 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). 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 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 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: Yeast Common name: Yeasts Development stage: no data Field(s) of use Indoor use Outdoor use Application method(s) Method: Wiping, mopping 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 litres HDPE or PET Jerry can: 1-80 litres HDPE Drum: 10-210 litres HDPE IBC: 1 000 litres HDPE Soft container: 1,5, 2,5 litres LDPE 4.3.1. Use-specific instructions — Clean carefully the surfaces before application of the product. — Apply the product by fully wetting all surface for 30 minutes (apply approx. 18 sprays/m 2 or 20 ml/m 2 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 OF THE META SPC 1 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 titles 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 1 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) SURE™ Cleaner Disinfectant Market area: EU SURE™ Ice & Shake Market area: EU Suma Shake D10.3 Market area: EU Suma Cleaner Disinfectant D10.10 Market area: EU Suma Sanides D10.10 Market area: EU Suma San Des D10.10 Market area: EU TASKI Sanides Market area: EU TASKI Sani Des Market area: EU TASKI Sani 3 in 1 Market area: EU Divosan Protect Conc Market area: EU DOMESTOS SaniShield Conc Professional Market area: EU DOMESTOS KitchenShield Conc Professional Market area: EU DOMESTOS CleanShield Conc Professional Market area: EU GLORIX SaniShield Conc Professional Market area: EU GLORIX KitchenShield Conc Professional Market area: EU GLORIX CleanShield Conc Professional Market area: EU KLINEX SaniShield Conc Professional Market area: EU KLINEX KitchenShield Conc Professional Market area: EU KLINEX CleanShield Conc Professional Market area: EU LYSOFORM SaniShield Conc Professional Market area: EU LYSOFORM KitchenShield Conc Professional Market area: EU LYSOFORM CleanShield Conc Professional Market area: EU SAVO SaniShield Conc Professional Market area: EU SAVO KitchenShield Conc Professional Market area: EU SAVO CleanShield Conc Professional Market area: EU CIF SaniShield Conc Professional Market area: EU CIF KitchenShield Conc Professional Market area: EU CIF CleanShield Conc Professional Market area: EU VISS SaniShield Conc Professional Market area: EU VISS KitchenShield Conc Professional Market area: EU VISS CleanShield Conc Professional Market area: EU JIF SaniShield Conc Professional Market area: EU JIF KitchenShield Conc Professional Market area: EU JIF CleanShield Conc Professional Market area: EU FLORASZEPT SaniShield Conc Professional Market area: EU FLORASZEPT KitchenShield Conc Professional Market area: EU FLORASZEPT CleanShield Conc Professional Market area: EU ANDY SaniShield Conc Professional Market area: EU ANDY KitchenShield Conc Professional Market area: EU ANDY CleanShield Conc Professional Market area: EU SUPERANDY SaniShield Conc Professional Market area: EU SUPERANDY KitchenShield Conc Professional Market area: EU SUPERANDY CleanShield Conc Professional Market area: EU ANDYSAN SaniShield Conc Professional Market area: EU ANDYSAN KitchenShield Conc Professional Market area: EU ANDYSAN CleanShield Conc Professional Market area: EU LIFEBUOY SaniShield Conc Professional Market area: EU LIFEBUOY KitchenShield Conc Professional Market area: EU LIFEBUOY CleanShield Conc Professional Market area: EU SANO-Cream-Clean Market area: EU Authorisation number EU-0029485-0001 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 24,93 D-glucopyranos, oligomeric, C10-16 (even numbered)-alkyl glycosides Non-active substance 110615-47-9 3,52
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