ANNEX II

Summary of product characteristics for a biocidal product

Ecolab UA Lactic Acid single product dossier

Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Authorisation number: EU-0027463-0000

R4BP asset number: EU-0027463-0000

1. ADMINISTRATIVE INFORMATION

1.1. Trade name(s) of the product

Trade name(s) GEL NETTOYANT DESINFECTANT WC Maxx Into Des

1.2. Authorisation holder

Name and address of the authorisation holder Name Ecolab Deutschland GmbH Address Ecolab Allee 1, 40789 Monheim am Rhein Germany Authorisation number EU-0027463-0000 R4BP asset number EU-0027463-0000 Date of the authorisation 24 November 2022 Expiry date of the authorisation 31 October 2032

1.3. Manufacturer(s) of the product

Name of manufacturer Ecolab Europe GmbH Address of manufacturer Richtistrasse 7, 8304 Wallisellen, Switzerland Location of manufacturing sites AFP GmbH, 21337 Lueneburg, Germany ACIDEKA S.A. Capuchinos de Basurto 6, 4a planta, 48013 Bilbao, Bizkaia, Spain ADIEGO HNOS, Adiego CTRA DE VALENCIA, 50410 CUARTE DE HUERVA, Spain ALLIED PRODUCTS, Allied Hygiene Unit 11, Belvedere Industrial Estate Fishers Way, DA17 6BS Belvedere Kent, United Kingdom Arkema GmbH Morschheimer Strasse 19, D-67292 Krichbeimbolanden, Germany AZELIS DENMARK, Lundtoftegårdsvej 95, 2800 Kgs. Lyngby, Denmark BELINKA-LJUBLJANA, Belinka Zasavska Cesta 95, 1001 Ljubljana, Slovenia BENTUS LABORATORIES, Radio street 24 BLd 1, 105005 Moscow, Russian Federation BIO PRODUCTiONS Ltd, 72 Victoria Road, RH15 9LH West Sussex, United Kingdom BIOXAL SA, Route des Varennes – Secteur A – BP 30072, 71103 Chalon sur Saöne Cedex, France BORES S.R.L., Bores Srl Via Pioppa 179, 44020 Pontegradella, Italy BRENNTAG ARDENNES, Route de Tournes CD n 2, 08090 Cliron, France BRENNTAG CEE – GUNTRAMSDORF, Blending Bahnstr 13A, 2353 Guntramsdorf, Austria BRENNTAG Kleinkarlbach, Humboldtring 15, 45472 Muehlheim, Germany BRENNTAG KAISERSLAUTERN, Merkurstr. 47, 67663 Kaiserslautern, Germany BRENNTAG NORDIC – HASLEV, Høsten Teglværksvej 47, 4690 Haslev, Denmark BRENNTAG NORMANDLY, 12 Sente des Jumelles BP 11, 76710 Montville, France BRENNTAG PL-ZGIERZ, ul. Kwasowa 5, 95-100 Zgierz, Poland BRENNTAG QUIMICA – Calle Gutemberg n° 22,. Poligono Industrial El Lomo, 28906 Madrid, Spain BRENNTAG SCHWEIZERHALL, Elsaesserstr. 231, CH-4056 Basel, Switzerland BUDICH INTERNATIONAL GmbH, Dieselstrasse 10, 32120 Hiddenhause, Germany CALDIC DEUTSCHLAND CHEMIE B.V., Karlshof 10 D, 40231 Deusseldorf, Germany COLEP BAD SCHMIEDEBERG, Kemberger Str. 3, 06905 Bad Schmiedeberg, Germany LANA S.A. Condado de Trevino 46, 09080 Burgos, Spain COMERCIAL GODO, França 13, 08700 Barcelona, Spain COURTOIS SARL, Route de Pacy, 27730 Bueil, France DAN-MOR Natural products and Chemicals Ltd, Hailian street 29, 30600 Akiva, Israel DENTECK BV, Heliumstraat 8, 2718 SL Zoetermeer, Netherlands DETERGENTS BURGUERA S.L., Joan Ballester, 50, 07630 Campos (illes Baleares), Spain ECL BIEBESHEIM, Justus-von-Liebig-Straße 11, 64584 Biebesheim am Rhein, Germany ECL CELRA, Celra C/Tramuntana s/n Poligona Industrial Celra, 17460 Girona, Spain ECL CHALONS, AVENUE DU GENERAL PATTON, 51000 Chalons en Champagne, France ECL CISTERNA, Via Ninfina II, 04012 Cisterna di Latina, Italy ECL FAWLEY, Fawley Cadland Road, Hythe, SO45 3NP Hampshire, South Hampton, United Kingdom ECL LEEDS, Lotherton Way Garforth, LS25 2JY Leeds, United Kingdom ECL MANDRA, 25TH KM OLD NATIONAL ROAD OF ATHENS TO THIVA, GR 19600, 19600 Mandra, Greece ECL MARIBOR, Vajngerlova 4, SI-2001 Maribor, Slovenia ECL MICROTEK B.V. – Gesinkkampstraat 19, 7051 HR Varsseveld, Netherlands ECL MICROTEK MOSTA, F20 MOSTA TECHNOPARK, 3000 MOSTA MST, Malta ECL MULLINGAR, Forest Park Zone C Mullingar Industrial Estate, N91 Mullingar, Ireland ECL NIEWEGEIN, Brugwal 11A, 3432 NZ Nieuwegein, Netherlands ECL ROVIGO ESOFORM, Viale del Lavoro 10, 45100 Rovigo, Italy ECL ROZZANO, Via A. Grandi„ 20089 Rozzano MI, Italy ECL TESJOKI, NLC Tesjoki Kivikummuntie 1, 07955 Tesjoki, Finland ECL TESSENDERLO, Industriezone Ravenshout 4, 3980 Tessenderlo, Belgium ECL WEAVERGATE, NLC Weavergate Northwich, CHheshire West and Chester, CW8 4EE Weavergate, United Kingdom ECOLAB LTD BAGLAN/SWINDON, Plot 7a Baglan Energy Park, Baglan, Port Talbot, SA11 2HZ Baglan, United Kingdom FERDINAND EIERMACHER, Westring 24, 48356 Nordwalde, Germany F.E.L.T., B.P 64 10 rue du Vertuquet, 59531 Neuville En Ferrain, France Gallows Green Services Ltd. Cod Beck Mill Industrial Estate Dalton Lane Thirsk North Yorkshire, YO7 3HR North Yorkshire, United Kingdom GERDISA GERMAN RGUEZ DROGAS IND., Gerdisa Pol Industrial Miralcampo parc.37, 19200 Azuqueca de Henares Guadalajara, Spain GIRASOL NATURAL PRODUCTS BV, De Veldoven 12-14, 3342 GR Hendrik-Ido-Ambacht, Netherlands HENKEL ENGELS, 48 Pr. Stroitelei, 413116 Saratov, Russian Federation IMECO GmbH & Co. KG, Boschstraße 5, D-63768 Hösbach, Germany INNOVATE GmbH, Am Hohen Stein 11, 06618 Naumburg, Germany INTERFILL LCC-TOSNO, Moskovskoye shosse 1, 187000 Tosno – Leningradskaya oblast, Russian Federation JODEL- PRODUCTOS QUIMICOS, Jodel Zona Inustrial, 2050 Aveiras de Cima, Portugal KLEIMANN GmbH, Am Trieb 13, 72820 Sonnenbühl, Germany LA ANTIGUA LAVANDERA S.L., Apartado de Correos, 58, 41500 Sevilla, Spain LABORATOIRES ANIOS, Pavé du moulin, 59260 Lille-Hellemmes, Spain LABORATOIRES ANIOS, Rue de Lille 3330, 59262 Sainghin-en-Mélantois, France LICHTENHELDT GmbH, Lichtenheldt Industriestrasse 7-9, 23812 Wahlstedt, Germany LONZA GmbH, Morianstr.32, 42103 Wuppertal, Germany MULTIFILL BV, Constructieweg 25A, 3641 SB Mijdrecht, Netherlands NOPA NORDISK PARFUMERIVARE, Hvedevej 2-22, DK-8900 Randers, Denmark PLANOL GmbH, Maybachstr 17, 63456 Hanau, Germany PLUM A/S, Frederik Plums Vej 2, DK 5610 Assens, Denmark PRODUCTOS LA CORBERANA S.L.„ 46612 Corbera (Valencia), Spain THE PROTON GROUP LTD, Ripley Drive, Normanton Industrial Estate, Wakefield, WF6 1QT Wakefield, United Kingdom QUIMICAS MORALES S.L., Misiones, 11, 05005 Las Palmas de Fran Canaria, Spain RNM PRODUCTOS QUIMICOS, Lda Rua da Fabrica, 123, 4765-080 Carreira Vila Nova de Famalicao Carreira Vila Nova de Famalicao, Portugal ROQUETTE & BARENTZ, Route De La Gorgue, F-62136 Lestrem, France RUTPEN LTD, MEMBURY AIRFIELD LAMBOURN BERKS, RG16 7TJ Membury, United Kingdom Solimix, Montseny 17-19 Pol. Ind. Sant Pere Molanta, 08799 Olerdola Barcelona, Spain STAUB & Co, Industriestraße 3, D-86456 Gablingen, Germany STOCKMEIER CHEMIE EILENBURG GmbH & Co.Kg, Gustav-Adolf-Ring 5, 04838 Ellenburg, Germany SYNERLOGIC BV, L.J. Costerstraat 5, 6827 Arnhem, Netherlands UNIVAR Ltd, Argyle House, Epsom Avenue„ SK9 3RN Wilmslow, United Kingdom UNIVAR SPA, Via Caldera 21, 20-153 Milano, Italy Van Dam Bodegraven B.V, Beneluxweg 6-8, 2410 AA Bodegraven, Netherlands Pal International Ltd., Sandhurst Street, – Leicester, United Kingdom CARBON CHEMICALS GROUP LTD, P43 R772 Ringaskiddy, County Cork, Ireland BRENNTAG DUISBURG, Am Röhrenwerk, 4647529 Duisberg, Germany BRENNTAG Glauchau, Bochstrasse, 08371 Glauchau, Germany BRENNTAG Hamburg, Hannoversche Str 40, 21079 Hamburg, Germany BRENNTAG Heilbronn, Dieselstrasse, 574076 Heilbronn, Germany BRENNTAG Lohfelden, Am Fieseler Werk, 934253 Lohfelden, Germany BRENNTAG Nordic – VEJLE, Strandgade 35, 7100 Vejle, Denmark KOMPAK NEDERLAND BV, 433651 Bavel, Netherlands

1.4. Manufacturer(s) of the active substance(s)

Active substance L-(+)-lactic acid Name of manufacturer Purac Biochem bv Address of manufacturer Arkelsedijk 46, 4206 AC Gorinchem, Netherlands Location of manufacturing sites Arkelsedijk 46, 4206 AC Gorinchem, Netherlands

2. PRODUCT COMPOSITION AND FORMULATION

2.1. Qualitative and quantitative information on the composition of the product

Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid Active Substance 79-33-4 201-196-2 13,2 D-Glucopyranose, oligomers, decyl octyl glycosides D-Glucopyranose, oligomers, decyl octyl glycosides Non-active substance 68515-73-1 500-220-1 3,25 Alcohols, C8-10 (even numbered), ethoxylated (< 2,5-EO) Alcohols, C8-10, ethoxylated Non-active substance 71060-57-6 615-247-5 1,0

2.2. Type of formulation

AL – Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS

Hazard statements Causes severe skin burns and eye damage. Corrosive to the respiratory tract. Precautionary statements Do 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 description

Table 1.

Use # 1 – Toilet bowl disinfectant

Product type PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact description of the authorised use Not relevant Target organism(s) (including development stage) Common name: Bacteria Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor Indoor – disinfection of hard surface on the inside of toilet bowl in institutional and healthcare area. Application method(s) Method: Pouring Detailed description: Pouring directly onto surface Application rate(s) and frequency Application Rate: Ready to use (RTU) – in an amount sufficient to cover the whole inner toilet bowl surface. Contact time – 15 minutes. Dilution (%): Ready-to-use Number and timing of application: Daily use Category(ies) of users Professional Pack sizes and packaging material 750, 1000 mL HDPE bottles with a dosing plug and PP/LDPE cap.

4.1.1. Use-specific instructions for use

See general directions for use

4.1.2. Use-specific risk mitigation measures

See general directions 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 directions for use

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions 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 directions for use

5. GENERAL DIRECTIONS FOR USE (1)

5.1. Instructions for use

Lift 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 measures

Do 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 environment

IF 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 packaging

Dispose 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 storage

Keep 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

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(1) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.