Commission Implementing Regulation (EU) 2022/2108 of 3 November 2022 granting a Union authorisation for the single biocidal product ‘Ecolab UA Lactic acid single product dossier’ (Text with EEA relevance)
Commission Implementing Regulation (EU) 2022/2108of 3 November 2022granting a Union authorisation for the single biocidal product Ecolab UA Lactic acid single product dossier(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., and in particular Article 44(5), first paragraph, thereof,Whereas:(1)On 16 April 2019, Ecolab Deutschland GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a single biocidal product named "Ecolab UA Lactic acid single product dossier" of product-type 2, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Latvia had agreed to evaluate the application. The application was recorded under case number BC-XS050968-91 in the Register for Biocidal Products.(2)"Ecolab UA Lactic acid single product dossier" contains L-(+)-lactic acid, as active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-type 2.(3)On 24 March 2021, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency ("the Agency").(4)On 4 November 2021, the Agency submitted to the Commission an opinionECHA opinion of 12 October 2021 on the Union authorisation of the biocidal product "Ecolab UA Lactic acid single product dossier" (ECHA/BPC/294/2021), https://echa.europa.eu/it/opinions-on-union-authorisation., the draft summary of the biocidal product characteristics ("SPC") of "Ecolab UA Lactic acid single product dossier" and the final assessment report on the single biocidal product, in accordance with Article 44(3) of Regulation (EU) No 528/2012.(5)The opinion concludes that "Ecolab UA Lactic acid single product dossier" is a single biocidal product, that it is eligible for Union authorisation in accordance with Article 42(1) of Regulation (EU) No 528/2012 and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) of that Regulation.(6)On 22 November 2021, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.(7)The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for "Ecolab UA Lactic acid single product dossier".(8)In its opinion, the Agency recommends that the Commission request the authorisation holder to conduct a shelf-life study of "Ecolab UA Lactic acid single product dossier" in commercial packaging in which the product is to be made available on the market, as a condition of the authorisation. The study should show relevant data demonstrating satisfactory chemical and physical properties prior to and after storage. The Commission agrees with that recommendation and considers that the submission of the results of that study should be a condition relating to the making available on the market and use of the single biocidal product pursuant to Article 22(1) of Regulation (EU) No 528/2012. Given the fact that that study is already being conducted, the authorisation holder should submit the results of that study to the Agency by 3 months after the date of entry into force of this Regulation. The Commission also considers that the fact that data is to be provided after the authorisation is granted does not affect the conclusion on the fulfilment of the condition under Article 19(1), point (d), of Regulation (EU) No 528/2012 on the basis of the existing data.(9)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-0027463-0000 is granted to Ecolab Deutschland GmbH for the making available on the market and use of the single biocidal product "Ecolab UA Lactic acid single product dossier" subject to compliance with the terms and conditions set out in Annex I and in accordance with the summary of the biocidal product characteristics set out in Annex II.The Union authorisation is valid from 24 November 2022 to 31 October 2032.
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, 3 November 2022.For the CommissionThe PresidentUrsula von der LeyenANNEX ITERMS AND CONDITIONS (EU-0027463-0000)The authorisation holder shall conduct a shelf life study (24 months) of "Ecolab UA Lactic acid single product dossier" in commercial packaging in which the product is to be made available on the market. The specification proposed and properties tested shall be in accordance with Guidance on the Biocidal Products Regulation Volume I: Identity of the active substance/physico-chemical properties/analytical methodology – Information Requirements, Evaluation and Assessment. Parts A+B+C, Version 2.1, March 2022, section 2.6.4 Storage stability, stability and shelf-lifehttps://echa.europa.eu/documents/10162/2324906/bpr_guidance_vol_i_parts_abc_en.pdf/31b245e5-52c2-f0c7-04db-8988683cbc4b. All relevant properties shall be determined prior to and after storage.By 24 February 2023 the authorisation holder shall submit the results of the study to the Agency.ANNEX IISummary of product characteristics for a biocidal productEcolab UA Lactic Acid single product dossierProduct type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)Authorisation number: EU-0027463-0000R4BP asset number: EU-0027463-00001.ADMINISTRATIVE INFORMATION1.1.Trade name(s) of the product
Trade name(s)GEL NETTOYANT DESINFECTANT WCMaxx Into Des
1.2.Authorisation holder
Name and address of the authorisation holderNameEcolab Deutschland GmbH
AddressEcolab Allee 1, 40789 Monheim am Rhein Germany
Authorisation numberEU-0027463-0000
R4BP asset numberEU-0027463-0000
Date of the authorisation24 November 2022
Expiry date of the authorisation31 October 2032
1.3.Manufacturer(s) of the product
Name of manufacturerEcolab Europe GmbH
Address of manufacturerRichtistrasse 7, 8304 Wallisellen, Switzerland
Location of manufacturing sitesAFP GmbH, 21337 Lueneburg, GermanyACIDEKA S.A. Capuchinos de Basurto 6, 4a planta, 48013 Bilbao, Bizkaia, SpainADIEGO HNOS, Adiego CTRA DE VALENCIA, 50410 CUARTE DE HUERVA, SpainALLIED PRODUCTS, Allied Hygiene Unit 11, Belvedere Industrial Estate Fishers Way, DA17 6BS Belvedere Kent, United KingdomArkema GmbH Morschheimer Strasse 19, D-67292 Krichbeimbolanden, GermanyAZELIS DENMARK, Lundtoftegårdsvej 95, 2800 Kgs. Lyngby, DenmarkBELINKA-LJUBLJANA, Belinka Zasavska Cesta 95, 1001 Ljubljana, SloveniaBENTUS LABORATORIES, Radio street 24 BLd 1, 105005 Moscow, Russian FederationBIO PRODUCTiONS Ltd, 72 Victoria Road, RH15 9LH West Sussex, United KingdomBIOXAL SA, Route des Varennes – Secteur A – BP 30072, 71103 Chalon sur Saöne Cedex, FranceBORES S.R.L., Bores Srl Via Pioppa 179, 44020 Pontegradella, ItalyBRENNTAG ARDENNES, Route de Tournes CD n 2, 08090 Cliron, FranceBRENNTAG CEE – GUNTRAMSDORF, Blending Bahnstr 13A, 2353 Guntramsdorf, AustriaBRENNTAG Kleinkarlbach, Humboldtring 15, 45472 Muehlheim, GermanyBRENNTAG KAISERSLAUTERN, Merkurstr. 47, 67663 Kaiserslautern, GermanyBRENNTAG NORDIC – HASLEV, Høsten Teglværksvej 47, 4690 Haslev, DenmarkBRENNTAG NORMANDLY, 12 Sente des Jumelles BP 11, 76710 Montville, FranceBRENNTAG PL-ZGIERZ, ul. Kwasowa 5, 95-100 Zgierz, PolandBRENNTAG QUIMICA – Calle Gutemberg n° 22,. Poligono Industrial El Lomo, 28906 Madrid, SpainBRENNTAG SCHWEIZERHALL, Elsaesserstr. 231, CH-4056 Basel, SwitzerlandBUDICH INTERNATIONAL GmbH, Dieselstrasse 10, 32120 Hiddenhause, GermanyCALDIC DEUTSCHLAND CHEMIE B.V., Karlshof 10 D, 40231 Deusseldorf, GermanyCOLEP BAD SCHMIEDEBERG, Kemberger Str. 3, 06905 Bad Schmiedeberg, GermanyLANA S.A. Condado de Trevino 46, 09080 Burgos, SpainCOMERCIAL GODO, França 13, 08700 Barcelona, SpainCOURTOIS SARL, Route de Pacy, 27730 Bueil, FranceDAN-MOR Natural products and Chemicals Ltd, Hailian street 29, 30600 Akiva, IsraelDENTECK BV, Heliumstraat 8, 2718 SL Zoetermeer, NetherlandsDETERGENTS BURGUERA S.L., Joan Ballester, 50, 07630 Campos (illes Baleares), SpainECL BIEBESHEIM, Justus-von-Liebig-Straße 11, 64584 Biebesheim am Rhein, GermanyECL CELRA, Celra C/Tramuntana s/n Poligona Industrial Celra, 17460 Girona, SpainECL CHALONS, AVENUE DU GENERAL PATTON, 51000 Chalons en Champagne, FranceECL CISTERNA, Via Ninfina II, 04012 Cisterna di Latina, ItalyECL FAWLEY, Fawley Cadland Road, Hythe, SO45 3NP Hampshire, South Hampton, United KingdomECL LEEDS, Lotherton Way Garforth, LS25 2JY Leeds, United KingdomECL MANDRA, 25TH KM OLD NATIONAL ROAD OF ATHENS TO THIVA, GR 19600, 19600 Mandra, GreeceECL MARIBOR, Vajngerlova 4, SI-2001 Maribor, SloveniaECL MICROTEK B.V. – Gesinkkampstraat 19, 7051 HR Varsseveld, NetherlandsECL MICROTEK MOSTA, F20 MOSTA TECHNOPARK, 3000 MOSTA MST, MaltaECL MULLINGAR, Forest Park Zone C Mullingar Industrial Estate, N91 Mullingar, IrelandECL NIEWEGEIN, Brugwal 11A, 3432 NZ Nieuwegein, NetherlandsECL ROVIGO ESOFORM, Viale del Lavoro 10, 45100 Rovigo, ItalyECL ROZZANO, Via A. Grandi„ 20089 Rozzano MI, ItalyECL TESJOKI, NLC Tesjoki Kivikummuntie 1, 07955 Tesjoki, FinlandECL TESSENDERLO, Industriezone Ravenshout 4, 3980 Tessenderlo, BelgiumECL WEAVERGATE, NLC Weavergate Northwich, CHheshire West and Chester, CW8 4EE Weavergate, United KingdomECOLAB LTD BAGLAN/SWINDON, Plot 7a Baglan Energy Park, Baglan, Port Talbot, SA11 2HZ Baglan, United KingdomFERDINAND EIERMACHER, Westring 24, 48356 Nordwalde, GermanyF.E.L.T., B.P 64 10 rue du Vertuquet, 59531 Neuville En Ferrain, FranceGallows Green Services Ltd. Cod Beck Mill Industrial Estate Dalton Lane Thirsk North Yorkshire, YO7 3HR North Yorkshire, United KingdomGERDISA GERMAN RGUEZ DROGAS IND., Gerdisa Pol Industrial Miralcampo parc.37, 19200 Azuqueca de Henares Guadalajara, SpainGIRASOL NATURAL PRODUCTS BV, De Veldoven 12-14, 3342 GR Hendrik-Ido-Ambacht, NetherlandsHENKEL ENGELS, 48 Pr. Stroitelei, 413116 Saratov, Russian FederationIMECO GmbH & Co. KG, Boschstraße 5, D-63768 Hösbach, GermanyINNOVATE GmbH, Am Hohen Stein 11, 06618 Naumburg, GermanyINTERFILL LCC-TOSNO, Moskovskoye shosse 1, 187000 Tosno – Leningradskaya oblast, Russian FederationJODEL- PRODUCTOS QUIMICOS, Jodel Zona Inustrial, 2050 Aveiras de Cima, PortugalKLEIMANN GmbH, Am Trieb 13, 72820 Sonnenbühl, GermanyLA ANTIGUA LAVANDERA S.L., Apartado de Correos, 58, 41500 Sevilla, SpainLABORATOIRES ANIOS, Pavé du moulin, 59260 Lille-Hellemmes, SpainLABORATOIRES ANIOS, Rue de Lille 3330, 59262 Sainghin-en-Mélantois, FranceLICHTENHELDT GmbH, Lichtenheldt Industriestrasse 7-9, 23812 Wahlstedt, GermanyLONZA GmbH, Morianstr.32, 42103 Wuppertal, GermanyMULTIFILL BV, Constructieweg 25A, 3641 SB Mijdrecht, NetherlandsNOPA NORDISK PARFUMERIVARE, Hvedevej 2-22, DK-8900 Randers, DenmarkPLANOL GmbH, Maybachstr 17, 63456 Hanau, GermanyPLUM A/S, Frederik Plums Vej 2, DK 5610 Assens, DenmarkPRODUCTOS LA CORBERANA S.L.„ 46612 Corbera (Valencia), SpainTHE PROTON GROUP LTD, Ripley Drive, Normanton Industrial Estate, Wakefield, WF6 1QT Wakefield, United KingdomQUIMICAS MORALES S.L., Misiones, 11, 05005 Las Palmas de Fran Canaria, SpainRNM PRODUCTOS QUIMICOS, Lda Rua da Fabrica, 123, 4765-080 Carreira Vila Nova de Famalicao Carreira Vila Nova de Famalicao, PortugalROQUETTE & BARENTZ, Route De La Gorgue, F-62136 Lestrem, FranceRUTPEN LTD, MEMBURY AIRFIELD LAMBOURN BERKS, RG16 7TJ Membury, United KingdomSolimix, Montseny 17-19 Pol. Ind. Sant Pere Molanta, 08799 Olerdola Barcelona, SpainSTAUB & Co, Industriestraße 3, D-86456 Gablingen, GermanySTOCKMEIER CHEMIE EILENBURG GmbH & Co.Kg, Gustav-Adolf-Ring 5, 04838 Ellenburg, GermanySYNERLOGIC BV, L.J. Costerstraat 5, 6827 Arnhem, NetherlandsUNIVAR Ltd, Argyle House, Epsom Avenue„ SK9 3RN Wilmslow, United KingdomUNIVAR SPA, Via Caldera 21, 20-153 Milano, ItalyVan Dam Bodegraven B.V, Beneluxweg 6-8, 2410 AA Bodegraven, NetherlandsPal International Ltd., Sandhurst Street, – Leicester, United KingdomCARBON CHEMICALS GROUP LTD, P43 R772 Ringaskiddy, County Cork, IrelandBRENNTAG DUISBURG, Am Röhrenwerk, 4647529 Duisberg, GermanyBRENNTAG Glauchau, Bochstrasse, 08371 Glauchau, GermanyBRENNTAG Hamburg, Hannoversche Str 40, 21079 Hamburg, GermanyBRENNTAG Heilbronn, Dieselstrasse, 574076 Heilbronn, GermanyBRENNTAG Lohfelden, Am Fieseler Werk, 934253 Lohfelden, GermanyBRENNTAG Nordic – VEJLE, Strandgade 35, 7100 Vejle, DenmarkKOMPAK NEDERLAND BV, 433651 Bavel, Netherlands
1.4.Manufacturer(s) of the active substance(s)
Active substanceL-(+)-lactic acid
Name of manufacturerPurac Biochem bv
Address of manufacturerArkelsedijk 46, 4206 AC Gorinchem, Netherlands
Location of manufacturing sitesArkelsedijk 46, 4206 AC Gorinchem, Netherlands
2.PRODUCT COMPOSITION AND FORMULATION2.1.Qualitative and quantitative information on the composition of the product
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
L-(+)-lactic acidActive Substance79-33-4201-196-213,2
D-Glucopyranose, oligomers, decyl octyl glycosidesD-Glucopyranose, oligomers, decyl octyl glycosidesNon-active substance68515-73-1500-220-13,25
Alcohols, C8-10 (even numbered), ethoxylated (< 2,5-EO)Alcohols, C8-10, ethoxylatedNon-active substance71060-57-6615-247-51,0
2.2.Type of formulationAL – Any other liquid3.HAZARD AND PRECAUTIONARY STATEMENTS
Hazard statementsCauses severe skin burns and eye damage.Corrosive to the respiratory tract.
Precautionary statementsDo not breathe vapours.Wash hands thoroughly after handling.Wear protective gloves.IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.IF INHALED:Remove person to fresh air and keep comfortable for breathing.Immediately call a POISON CENTER or doctor/physician.Specific treatment (see first aid instruction on this label).Wash contaminated clothing before reuse.Store locked up.Dispose of contents to according with national regulations.Dispose of container to according with national regulations.
4.AUTHORISED USE(S)4.1.Use descriptionTable 1.Use # 1 – Toilet bowl disinfectant
Product typePT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised useNot relevant
Target organism(s) (including development stage)Common name: BacteriaDevelopment stage:Common name: YeastsDevelopment stage:
Field(s) of useIndoorIndoor – disinfection of hard surface on the inside of toilet bowl in institutional and healthcare area.
Application method(s)Method: PouringDetailed description:Pouring directly onto surface
Application rate(s) and frequencyApplication Rate: Ready to use (RTU) – in an amount sufficient to cover the whole inner toilet bowl surface. Contact time – 15 minutes.Dilution (%): Ready-to-useNumber and timing of application:Daily use
Category(ies) of usersProfessional
Pack sizes and packaging material750, 1000 mL HDPE bottles with a dosing plug and PP/LDPE cap.
4.1.1.Use-specific instructions for useSee general directions for use4.1.2.Use-specific risk mitigation measuresSee general directions for use4.1.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general directions for use4.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use4.1.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use5.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.5.1.Instructions for useLift up the toilet seat and carefully direct the nozzle under the toilet rim. Squeeze and apply slowly all around the inside of the bowl, allowing enough liquid to cover the whole inner toilet bowl surface. Leave for 15 minutes. Flush the toilet afterwards.May not be used with bleach or other cleaning agents.Inform the registration holder if the treatment is ineffective.5.2.Risk mitigation measuresDo not breathe vapour.Avoid contact with eyes and skin.Do not brush the product in toilet bowl.Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).Wash hands thoroughly after handling.5.3.Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentIF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a Poison Centre or a doctor.IF ON SKIN: Immediately wash with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.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/ambulance for medical assistance.Information to healthcare personnel/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. Do NOT induce vomiting. Give something to drink, if exposed person is able to swallow. Call 112/ambulance for medical assistance.When asking for medical advice keep packaging or label at hand and call a POISON CENTER or doctor/physician.5.4.Instructions for safe disposal of the product and its packagingDispose the product and its packaging in accordance with applicable national regulations.5.5.Conditions of storage and shelf-life of the product under normal conditions of storageKeep away from strong bases. Keep out of reach of children.Store in original container tightly closed.Store between + 5 °C and + 40 °C. Protect from frost.Shelf life: 24 months.6.OTHER INFORMATION-