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)
Date: 2022-11-03
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, decontamination, market approval, organic acid, pharmaceutical product








L_2022284EN.01005501.xml










4.11.2022   


EN


Official Journal of the European Union


L 284/55








            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)


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 (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 opinion (2), 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 1
A 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 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, 3 November 2022.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1.

(2)  ECHA 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.




ANNEX I

TERMS 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-life (1). 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.


(1)  https://echa.europa.eu/documents/10162/2324906/bpr_guidance_vol_i_parts_abc_en.pdf/31b245e5-52c2-f0c7-04db-8988683cbc4b





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
-


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