Commission Implementing Regulation (EU) 2024/1767of 26 June 2024granting 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(Text with EEA relevance)

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 (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 OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj. , and in particular Article 44(5), first subparagraph, thereof, Whereas: (1) On 30 April 2019, Diversey Europe Operations B.V submitted to the European Chemicals Agency (the Agency) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4, ELI: http://data.europa.eu/eli/reg_impl/2013/414/oj). for Union authorisation of the same biocidal product family, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named Sure Lactic Family, of product-types 2, 3 and 4, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-EM051406-41 in the Register for Biocidal Products (the Register). The application also indicated the application number of the related reference biocidal product family SALVECO SALVESAFE PRODUCTS later authorised by Commission Implementing Regulation (EU) 2023/1758 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 (OJ L 224, 12.9.2023, p. 34, ELI: http://data.europa.eu/eli/reg_impl/2023/1758/oj). , recorded in the Register under case number BC-HC051278-51. (2) The same biocidal product family Sure Lactic Family contains L-(+)-lactic acid as the active substances, 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 19 September 2022, the Agency submitted to the Commission its opinion ECHA opinion of 19.9.2022 on the Union authorisation of the same biocidal product family Sure Lactic Family, https://echa.europa.eu/opinions-on-union-authorisation. and the draft summary of the biocidal product characteristics (SPC) of Sure Lactic Family in accordance with Article 6(1) and (2) of Implementing Regulation (EU) No 414/2013. (4) In its opinion, the Agency concludes that the proposed differences between Sure Lactic Family and the biocidal product family SALVECO SALVESAFE PRODUCTS are limited to information which can be the subject of an administrative change in accordance with Article 11 of Commission Implementing Regulation (EU) No 354/2013

Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4, ELI: http://data.europa.eu/eli/reg_impl/2013/354/oj). , and that based on the assessment of the related reference biocidal product family SALVECO SALVESAFE PRODUCTS and subject to compliance with the draft SPC, Sure Lactic Family meets the conditions laid down in Article 19(1) and (6) of Regulation (EU) No 528/2012. (5) On 16 November 2023, the Agency transmitted to the Commission the revised SPCs of Sure Lactic Family in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. (6) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same biocidal product family Sure Lactic Family. (7) The expiry date of this authorisation is aligned to the expiry date of the authorisation of the related reference 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-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.

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, 26 June 2024. For the Commission The President Ursula von der Leyen

Annex

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 NameSure 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 holderNameDiversey Europe Operations B.V.AddressRegulatory team Maarssenbroeksedijk 2 3542 DN Utrecht NLAuthorisation numberEU-0029485-0000R4BP asset numberEU-0029485-0000Date of the authorisation17 July 2024Expiry date of the authorisation30 September 2033 1.4. Manufacturer(s) of the product Name of manufacturerSALVECO S.A.SAddress of manufacturerAvenue Pierre Mendès-France F-88100 Saint-Dié-des-Vosges FranceLocation of manufacturing sitesSALVECO S.A.S site 1 Avenue Pierre Mendès-France F-88100 Saint-Dié-des-Vosges France

Name of manufacturerGESTRA S.A.SAddress of manufacturerAllée Robert Schumann F-88110 Raon-l’Étape FranceLocation of manufacturing sitesGESTRA S.A.S site 1 Allée Robert Schumann F-88110 Raon-l’Étape FranceName of manufacturerDiversey Europe Operations B.V.Address of manufacturerMaarssenbroeksedijk 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 manufacturerMultifill BVAddress of manufacturerConstructieweg 25a 3640 AJ Mijdrecht Netherlands (the)Location of manufacturing sites Multifill BV site 1 Constructieweg 25a 3640 AJ Mijdrecht Netherlands (the) Name of manufacturerOrvema B.V.Address of manufacturerWestkanaaldijk 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 manufacturerAerosol Service Sp. z o.o.Address of manufacturerCharnowo 36 76-270 Ustka PolandLocation of manufacturing sites Aerosol Service Sp. z o.o. site 1 Charnowo 36 76-270 Ustka Poland Name of manufacturerHelichem B.V.Address of manufacturerKozakkenberg 5 5951 DL Belfeld Netherlands (the)Location of manufacturing sitesHelichem B.V. site 1 Kozakkenberg 5 5951 DL Belfeld Netherlands (the)Name of manufacturerCheport spol s.r.o.Address of manufacturerLhotsko 93 76312 Vizovice CzechiaLocation of manufacturing sites Cheport spol s.r.o. site 1 Lhotsko 93 76312 Vizovice Czechia Name of manufacturerEMMEGI DETERGENTS SRLAddress of manufacturerVia Merlo Carlo Giuseppe, 3 20122 Milano ItalyLocation of manufacturing sites EMMEGI DETERGENTS SRL site 1 Via Marconi, 5 25030 Trenzano Italy Name of manufacturerGFL SAAddress of manufacturerVia Sorengo 1 6900 Lugano SwitzerlandLocation 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 substanceL-(+)-lactic acidName of manufacturerPURAC BIOCHEM BVAddress of manufacturerGran Vial 19-25 08160 Montmeló SpainLocation of manufacturing sites PURAC BIOCHEM BV site 1 Gran Vial 19-25 08160 Montmeló Spain Active substanceL-(+)-lactic acidName of manufacturerJUNGBUNGZLAUER S.AAddress of manufacturerZ.I Portuaire BP 32 67390 Marckolsheim FranceLocation 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 nameIUPAC nameFunctionCAS numberEC numberContent (%)L-(+)-lactic acidActive substance79-33-4201-196-20,627 - 31,33 % (w/w)Sodium octyl ether carboxylateNon-active substance53563-70-50,0 – 28,8 % (w/w)D-glucopyranos, oligomeric, C10-16 (even numbered)-alkyl glycosidesNon-active substance110615-47-90,0 – 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 IdentifierMeta SPC: Sure Lactic Meta 1.2. Suffix to the authorisation number Number1-1 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 nameIUPAC nameFunctionCAS numberEC numberContent (%)L-(+)-lactic acidActive substance79-33-4201-196-231,33 - 31,33 % (w/w)Sodium octyl ether carboxylateNon-active substance53563-70-524,93 - 24,93 % (w/w)D-glucopyranos, oligomeric, C10-16 (even numbered)-alkyl glycosidesNon-active substance110615-47-93,52 - 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 typePT02: Disinfectants and algaecides not intended for direct application to humans or animalsWhere 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 usersProfessionalPack sizes and packaging material

Bottles: 0,5-5 litres HDPE or PET Jerry can: 1-80 litres HDPE Drum: 10-210 litres HDPE IBC: 1000 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/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 2 Food and feed area disinfectants (disinfectant for all washable hard surfaces in domestic, institutional and industrial (food industry) areas) Product typePT04: Food and feed areaWhere 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 usersIndustrial; professionalPack sizes and packaging material Bottles: 0,5-5 litres HDPE or PET Jerry can: 1-80 litres HDPE Drum: 10-210 litres HDPE IBC: 1000 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/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 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 typePT03: Veterinary hygieneWhere 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 usersProfessionalPack sizes and packaging material Bottles: 0,5-5 litres HDPE or PET Jerry can: 1-80 litres HDPE Drum: 10-210 litres HDPE IBC: 1000 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/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 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 DisinfectantMarket area: EUSURE™ Ice & ShakeMarket area: EUSuma Shake D10.3Market area: EUSuma Cleaner Disinfectant D10.10Market area: EUSuma Sanides D10.10Market area: EUSuma San Des D10.10Market area: EUTASKI SanidesMarket area: EUTASKI Sani DesMarket area: EUTASKI Sani 3 in 1Market area: EUDivosan Protect ConcMarket area: EUDOMESTOS SaniShield Conc ProfessionalMarket area: EU DOMESTOS KitchenShield Conc ProfessionalMarket area: EUDOMESTOS CleanShield Conc ProfessionalMarket area: EUGLORIX SaniShield Conc ProfessionalMarket area: EUGLORIX KitchenShield Conc ProfessionalMarket area: EUGLORIX CleanShield Conc ProfessionalMarket area: EUKLINEX SaniShield Conc ProfessionalMarket area: EUKLINEX KitchenShield Conc ProfessionalMarket area: EUKLINEX CleanShield Conc ProfessionalMarket area: EULYSOFORM SaniShield Conc ProfessionalMarket area: EULYSOFORM KitchenShield Conc ProfessionalMarket area: EULYSOFORM CleanShield Conc ProfessionalMarket area: EU SAVO SaniShield Conc ProfessionalMarket area: EUSAVO KitchenShield Conc ProfessionalMarket area: EUSAVO CleanShield Conc ProfessionalMarket area: EUCIF SaniShield Conc ProfessionalMarket area: EUCIF KitchenShield Conc ProfessionalMarket area: EUCIF CleanShield Conc ProfessionalMarket area: EUVISS SaniShield Conc ProfessionalMarket area: EUVISS KitchenShield Conc ProfessionalMarket area: EUVISS CleanShield Conc ProfessionalMarket area: EUJIF SaniShield Conc ProfessionalMarket area: EUJIF KitchenShield Conc ProfessionalMarket area: EUJIF CleanShield Conc ProfessionalMarket area: EU

FLORASZEPT SaniShield Conc ProfessionalMarket area: EUFLORASZEPT KitchenShield Conc ProfessionalMarket area: EUFLORASZEPT CleanShield Conc ProfessionalMarket area: EUANDY SaniShield Conc ProfessionalMarket area: EUANDY KitchenShield Conc ProfessionalMarket area: EUANDY CleanShield Conc ProfessionalMarket area: EUSUPERANDY SaniShield Conc ProfessionalMarket area: EUSUPERANDY KitchenShield Conc ProfessionalMarket area: EUSUPERANDY CleanShield Conc ProfessionalMarket area: EUANDYSAN SaniShield Conc ProfessionalMarket area: EUANDYSAN KitchenShield Conc ProfessionalMarket area: EU ANDYSAN CleanShield Conc ProfessionalMarket area: EULIFEBUOY SaniShield Conc ProfessionalMarket area: EULIFEBUOY KitchenShield Conc ProfessionalMarket area: EULIFEBUOY CleanShield Conc ProfessionalMarket area: EUSANO-Cream-CleanMarket area: EUAuthorisation numberEU-0029485-0001 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)L-(+)-lactic acidActive substance79-33-4201-196-231,33Sodium octyl ether carboxylateNon-active substance53563-70-524,93D-glucopyranos, oligomeric, C10-16 (even numbered)-alkyl glycosidesNon-active substance110615-47-93,52