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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

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) 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 productsOJ 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 414/2013Commission 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) 2023/1758Commission 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 opinionECHA 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 354/2013Commission 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 1A 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 2This 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 CommissionThe PresidentUrsula von der LeyenANNEXSUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILYSure Lactic FamilyProduct type(s)PT02: Disinfectants and algaecides not intended for direct application to humans or animalsPT03: Veterinary hygienePT04: Food and feed areaAuthorisation number: EU-0029485-0000R4BP asset number: EU-0029485-0000PART IFIRST INFORMATION LEVEL1.ADMINISTRATIVE INFORMATION1.1.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 animalsPT03: Veterinary hygienePT04: Food and feed area

1.3.Authorisation holder

Name and address of the authorisation holder	Name	Diversey Europe Operations B.V.
Name and address of the authorisation holder	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) ItalyDiversey Europe Operations B.V. site 2 Rembrandtlaan 414 7545 ZW Enschede Netherlands (the)Diversey Europe Operations B.V. site 3Cotes 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) SpainDiversey 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 1Constructieweg 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 1Westkanaaldijk 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 1Charnowo 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 1Lhotsko 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 1Via 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 1Via 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 1Gran 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 1Z.I Portuaire BP 32 67390 Marckolsheim France

2.PRODUCT FAMILY COMPOSITION AND FORMULATION2.1.Qualitative and quantitative information on the composition of the family

Common 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 ConcentrateAL – Any other liquid

PART IISECOND INFORMATION LEVEL – META SPC(S)1.META SPC 1 ADMINISTRATIVE INFORMATION1.1.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 animalsPT03: Veterinary hygienePT04: Food and feed area

2.META SPC 1 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 1

Common 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 SPC4.1.Use description

Table 1Disinfectants 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: BacteriaCommon name: BacteriaDevelopment stage: no dataScientific name: YeastsCommon name: YeastsDevelopment stage: no dataScientific name: VirusesCommon name: Enveloped virusesDevelopment stage: no data
Field(s) of use	Indoor useOutdoor useIn 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 °COther target organisms:Enveloped viruses: 0,299 % w/w L-(+)-lactic acid, 5 minutes, 20 °CThe 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 PETJerry can: 1-80 litres HDPEDrum: 10-210 litres HDPEIBC: 1000 litres HDPESoft container: 1,5, 2,5 litres low-density polyethylene (LDPE)

4.1.1.Use-specific instructionsApply 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 measuresSee 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 environmentSee general instructions for use.4.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee 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 storageSee general instructions for use.4.2.Use description

Table 2Food 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: BacteriaCommon name: BacteriaDevelopment stage: no dataScientific name: YeastsCommon name: YeastsDevelopment stage: no dataScientific name: VirusCommon name: Enveloped viruses onlyDevelopment stage: no data
Field(s) of use	Indoor useOutdoor useIn 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 °COther target organisms:Enveloped viruses: 0,299 % w/w L-(+)-lactic acid, 5 minutes, 20 °CThe 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 PETJerry can: 1-80 litres HDPEDrum: 10-210 litres HDPEIBC: 1000 litres HDPESoft container: 1,5, 2,5 litres LDPE

4.2.1.Use-specific instructionsApply 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 measuresSee general instructions for use4.2.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general instructions for use4.2.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general instructions for use4.2.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general instructions for use4.3.Use description

Table 3Disinfectants 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: BacteriaCommon name: BacteriaDevelopment stage: no dataScientific name: YeastCommon name: YeastsDevelopment stage: no data
Field(s) of use	Indoor useOutdoor 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 °CThe 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 PETJerry can: 1-80 litres HDPEDrum: 10-210 litres HDPEIBC: 1000 litres HDPESoft container: 1,5, 2,5 litres LDPE

4.3.1.Use-specific instructionsClean 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 measuresSee general instructions for use4.3.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general instructions for use4.3.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general instructions for use4.3.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general instructions for use5.GENERAL DIRECTIONS FOR USE OF THE META SPC 15.1.Instructions for useApply only on non-porous surfaces.Inform the authorisation holder if the treatment is ineffective.5.2.Risk mitigation measuresWear 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 environmentIF 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 acidIF 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 packagingDo 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 storageShelf-life: 2 years.Protect from frost.6.OTHER INFORMATIONThe full titles of the EN standards referenced in section 5.2 "Risk mitigation measures" are:EN 374 – Protective gloves against dangerous chemicals and micro-organismsEN 16321 – Eye and face protection for occupational useEN 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 17.1.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