Commission Implementing Regulation (EU) 2022/2127 of 4 November 2022 granting a Union authorisation for the biocidal product family ‘Ecolab UA BPF 1-Propanol’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
Date: 2022-11-04
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, decontamination, market approval, pharmaceutical product








L_2022285EN.01000401.xml










7.11.2022   


EN


Official Journal of the European Union


L 285/4








            COMMISSION IMPLEMENTING REGULATION (EU) 2022/2127
of 4 November 2022
         
granting a Union authorisation for the biocidal product family ‘Ecolab UA BPF 1-Propanol’ 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 (1), and in particular Article 44(5), first subparagraph, thereof,

Whereas:







(1)


On 26 March 2019, Ecolab Deutschland GmbH submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘Ecolab UA BPF 1-Propanol’ of product-type 1, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Sweden had agreed to evaluate the application. The application was recorded under case number BC-RS050191-24 in the Register for Biocidal Products.












(2)


‘Ecolab UA BPF 1-Propanol’ contains propan-1-ol as the active substance included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-type 1.












(3)


On 9 September 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 Agency.












(4)


On 24 March 2022, the Agency submitted its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Ecolab UA BPF 1-Propanol’ and the final assessment report on the biocidal product family, to the Commission in accordance with Article 44(3) of Regulation (EU) No 528/2012.












(5)


The opinion concludes that ‘Ecolab UA BPF 1-Propanol’ is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.












(6)


On 12 April 2022, 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 BPF 1-Propanol’.












(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-0028430-0000 is granted to Ecolab Deutschland GmbH for the making available on the market and use of the biocidal product family ‘Ecolab UA BPF 1-Propanol’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 27 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, 4 November 2022.


For the Commission


The President

Ursula VON DER LEYEN
            





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

(2)  ECHA opinion of 1 March 2021 on the Union authorisation of ‘Ecolab UA BPF 1-Propanol’ (ECHA/BPC/315/2022), https://echa.europa.eu/bpc-opinions-on-union-authorisation




ANNEX
Summary of product characteristics for a biocidal product family

Ecolab UA BPF 1-Propanol


Product type 1 – Human hygiene (Disinfectants)


Authorisation number: EU-0028430-0000


R4BP asset number: EU-0028430-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION
1.1.   Family name







Name


Ecolab UA BPF 1-Propanol




1.2.   Product type(s)







Product type(s)


PT01 – Human hygiene (Disinfectants)




1.3.   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-0028430-0000





R4BP asset number



EU-0028430-0000




Date of the authorisation


27 November 2022




Expiry date of the authorisation


31 October 2032




1.4.   Manufacturer(s) of the biocidal products







Name of manufacturer


Ecolab Europe GmbH




Address of manufacturer


Richtistrasse 7, 8304 Walliselen Switzerland




Location of manufacturing sites







Richtistrasse 7, 8304 Walliselen Switzerland




AFP GmbH, Otto-Brenner-Straße 16, 21337 Lüneburg Germany




Acideka S.A., Edificio Feria. Capuchinos de Basurto 6. 4a planta, 48013 Bilbao Spain




Adiego, Adiego Ctra De Valencia KM 5, 900, 50410 Cuarte de Huerva Zaragoza Spain




Allied Products, Allied Hygiene Unit 11, Belvedere Industrial Estate, Fishers Way, Belvedere, Kent, DA17 6BS Belvedere United Kingdom




Arkema GmbH, Morschheimer Straße 19, D-67292 Krichbeimbolanden Germany




Azelis Denmark, Lundtoftegårdsvej 95, 2800 Kgs Lyngby Denmark




Belinka-Ljublijana, Belinka Zasavska Cesta, 95 1001 Ljubljana Slovenia




Radio street 24 Bld 1, 105005 Moscow Russian Federation




Bio Productions Ltd inc. Starpro, 72 Victoria Road Victoria Industrial Estate, West Sussex, RH15 9LH Burgess Hill United Kingdom




Bioxal SA, Route des Varennes – Secteur A, BP 30072 71103 Cedex France




Bores Srl, Via Pioppa 179, 44030 Pontegradella (FE) Italy




Brenntag Ardennes, Route de Tournes, CD n 2, 08090 Cliron France




Brenntag CEE – Guntramsdorf, Blending Bahnstr. 13 A, 2353 Guntramsdorf Austria




Brenntag GmbH, Humboldtring 15, 45472 Mülheim Germany




Brenntag Kaiserslautern, Merkurstr. 47, 67663 Kaiserslautern Germany




Brenntag Nordic – Haslev, Høsten Teglværksvej 47, 4690 Haslev Denmark




Brenntag Nordic – Vejle, Strandgade 35, 7100 Vejle Denmark




Brenntag Normandy, 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 Getafe Madrid Spain




Brenntag Schweizerhall, Elsaesserstr. 231, CH-4056 Basel Schweiz Switzerland




Brenntag SRL, Str. Gării nr 1, 077040 Chiaina, Ilfov Romania




Budich International GmbH, Dieselstraße 10, 32120 Hiddenhause Germany




Caldic Deutschland Chemie B.V, Karlshof 10, D 40231 Düsseldorf Germany




The Carbon Group„ P43 R772, County Cork Ringaskiddy Ireland




Colep Bad Schmiedeberg, Kemberger Str. 3, 06905 Bad Schmiedeberg Germany




Comercial Farmaceutica Castel LANA S.A., ‘Cofarcas’ Condado de Trevino 46 P.I Villalonquejar, 09080 Burgos Spain




Comercial Godo, França 13, 08700 Igaulada Barcelona Spain




Courtois Sarl, ZA Sous Le Beer, Route de Pacy, 27730 Bueil France




DAN-MOR (Dr Wipe) Natural products and Chemicals Ltd, Or Akiva Industrial Zone, Hailian street 29, 30600 Akiva Israel




Denteck BV, Heliumstraat 8, 2718 SL Zoetermeer Netherlands




Donauchem Kft (Hungary), Bányalég utca 37-43, H-1225 Budapest Hungary




Detergents Burguera S.L, Joan Ballester 50, 07630 Campos (Illes Baleares) Spain




Champion Technologies Ltd, Minto Avenue, Altens Industrial Estate, AB12 3JZ Aberdeen United Kingdom




ECL Biebesheim, Justus-von-Liebig-Straße 11, 64584 Biebesheim am Rhein Germany




ECL Chalons, Avenue Du General Patton, 51000 Chalons en Champagne France




ECL Cisterna, Nalco italiana Manufacturing Srl. Via Ninfina II, 04012 Cisterna di Latina Italy




Champion Technologies Ltd Fawley, Fawley Cadland Road Hythe, Hampshire, SO45 3NP Southampton United Kingdom




Ecolab Leeds, Lotherton Way, Garforth, LS25 2JY Leeds United Kingdom




ECL Mandra, 25TH KM Old National Road of Athens To Thiva, 19600 Mandra Greece




ECL Maribor, Vajngerlova Ulica 4, 2000 Maribor Slovenia




ECL Microtek B.V., Gesinkkampstraat 19, 7051 HR Varsseveld Netherlands




ECL Microtek Mosta, Sorbonne Centre F20 Mosta Technopark, Mst 3000 Mosta Malta




ECL Microtek Zutphen, Hekkehorst 24, 7027 BN Zutphen Netherlands




Ecolab Ltd (IE) and Ecolab Manufacturing IE Ltd (IE), Forest Park, Zone C Mullingar Ind. Estate N91, Co. Westmeath Mullingar Ireland




ECL Niewegein, Brugwal 11A, 3432 NZ Nieuwegein Netherlands




ECL Rovigo Esoform, Esoform SRL Laboratorio Chimico Farmaceutico Viale del Lavoro 10, 45100 Rovigo Italy




ECL Rozzano, Via A. Grandi, 20089 Milan Italy




ECL Tessenderlo, Havenlaan 4, Ravenshout 4 210 , B-3980 Tessenderlo Belgium




ECL Weavergate/Ecolab Ltd (UK)/Ecolab Manufacturing UK Ltd (UK), Winnington Avenue, CW8 3AA Northwich United Kingdom




Ecolab LTD Baglan/Swindon, Plot 7a Baglan Energy Park, Baglan, SA11 2HZ Port Talbot United Kingdom




Ferdinand Eiermacher GmbH & Co. KG, 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, YO7 3HR Thirsk United Kingdom




Gerdisa German Rodriguez Drogas IND., Gerdisa Poligono Industrial Miralcampo C.Pintura n.-4, 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 Naumberg Germany




Interfill LCC-Tosno, 187000 Moskovskoye shosse 1, 187000 Leningradskaya oblast Russian Federation




Jodel, Jodel Zona Industrial 2050, 2050 Aveiras de Cima Portugal




Kleimann GmbH, Am Trieb 13, 72820 Sonnenbühl Germany




Kompak Nederland BV, 433651 Bavel 0031-161 Bavel Netherlands




La Antigua Lavandera S.L., Ctra. Antigua Sevilla-Alcalá Km.1,5 (SE-410 Apartado de Correos 58, 41500 Alcala De Guadaira Sevilla Spain




Laboratoires Anios, Pavé du moulin, 59260 Lille-Hellemmes France




Laboratoires Anios, 3330 Rue de Lille, 59262 Sainghin-en-Mélantois France




Laboratoires Prodene Klint, Site de Mitry-Mory 2, Rue Denis Papin ZI Mitry-Compans, 77290 Mitry Mory France




Lichtenheldt GmbH, Lichtenheldt Industriestraße 7-9, 23812 Wahlstedt Germany




Lonza GmbH, Morianstr.32, 42103 Wuppertal Germany




Multifill BV, Constructieweg 25-A, 3641 SB Mijdrecht Netherlands




NALCO Finland Manufacturing Oy (Tesjoki), Kivikummuntie 1, 07955 Tesjoki Finland




NALCO Celra, Celra C/Tramuntana s/n Poligona Industrial, 17460 Celra Spain




NOPA Nordisk Parfumerivare, Hvedevej 2-22, DK-8900 Randers Denmark




Nuova Farmec Srl, Via Flemming 7, 37026 Settimo di Pescantina (VR) Verona Italy




Pal International Ltd, Sandhurst Street, LE17 4JA Leicester United Kingdom




Planol GmbH, Maybachstr. 17, 63456 Hanau Germany




Plum A/S, Frederik Plums Vej 2, DK 5610 Assens Denmark




Productos La Corberana S.L., Ctra Corbera Polinyá, s/n° 4, 46612 Valencia Spain




The Proton Group Ltd, Ripley Drive, Normanton Industrial Estate, WF6 1QT Wakefield United Kingdom




Quimicas Morales S.L., Misiones, 11 Urb. El Sebadal, 05005 Las Palmas de Gran Canaria Spain




RNM Productos Quimicos, Lda Rua da Fabrica 123, Segade, 4765-080 Carreira Vila Nova de Famalicao Portugal




RP Adam Ltd (Arpal Group), North Riverside Business Park, Riverside Road„ TD7 5DU Selkirk United Kingdom




Roquette & Barentz, Roquette Freres, Route De La Gorgue, F-62136 Lestrem France




Rutpen Ltd, Membury Airfield, Lambourn, RG16 7TJ Membury United Kingdom




Simagec, Z.I. de Rousset/Peynier, 54 Avenue de la Plaine„ 13790 Rousset France




Solimix, Montseny 17-19 Pol. Ind. Sant Pere, Molanta, 08799 Olerdola Barcelona Spain




Staub & Co. – Silbermann GmbH, Industriestraße 3, D-86456 Gablingen Germany




Stockmeier Chemie, Eilenburg GmbH & Co. Kg, Gustav-Adolf-Ring 5, 04838 Ellenburg Germany




Synerlogic BV (IN2FOOD), L.J. Costerstraat 5, 6827 Arnhem Netherlands




Techtex (Technical Textile Services Ltd), Units 7 & 8, Rhodes Business Park Silburn Way, Middleton, M24 4NE Manchester United Kingdom




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, Postbus 48 NL, 2410 AA Bodegraven Netherlands




McBride, Calle Ramón Esteve, 0 S/N (Pol L’Illa)„ 08650 Botjosa (la) Barcelona Spain




Extruplast, Avenue de la Repentie, 1700 La Rochelle1 France




Brenntag Hungary Kft, Bányalég u. 45, 1225 Budapest Hungary




DR. Becher GmbH, Vor den Specken 3„ 30926 Seelze Germany




Danlind AS, Lægaardvej 90 – 94, DK-7500 Holstebro Denmark




Farmak Moravia a.s, Na Vlčinci 16„ 779 00 Oloumoc Czech Republic




Hydrachem LTD, Gillmans Industrial Estate, Natts Lane, RH14 9EZ Billingshurst United Kingdom




Julius Hoesch GmbH, Birkesdorfer Str. 5, 52353 Düren Germany




Medentech LTD, Whitemill Industrial Estate, Wexford Ireland




MKS GmbH & Co. KG, Am Ockenheimer Graben 43, 55411 Bingen am Rhein Germany




PDI, Aber Park, Aber Road, CH6 5EX Flint United Kingdom




Peenwhite LTD, Midpoint 18 Business Park, Aston Way„ CW10 0HS Middlewich United Kingdom




Jago Pro Sp.z.o.o., Szczakowska 35, 43-600 Jaworzno Poland




Wesso AG, Martin-Luther-Str. 10, 91217 Hersbruck Germany




CID Lines NV, Waterpoorstraat 2, 8900 Leper Belgium








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







Active substance


Propan-1-ol




Name of manufacturer


BASF SE




Address of manufacturer


Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany




Location of manufacturing sites


Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany













Active substance


Propan-1-ol




Name of manufacturer


OQ Corporation




Address of manufacturer


2001 FM 3057, TX 77414 Bay City United States




Location of manufacturing sites


2001 FM 3057, TX 77414 Bay City United States




2.   PRODUCT FAMILY COMPOSITION AND FORMULATION
2.1.   Qualitative and quantitative information on the composition of the family












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Propan-1-ol


 


Active Substance


71-23-8


200-746-9


70,35 


75,38 




2.2.   Type(s) of formulation







Formulation(s)


AL – Any other liquid




PART II

SECOND INFORMATION LEVEL – META SPC(S)


META SPC 1

1.   META SPC 1 ADMINISTRATIVE INFORMATION
1.1.   Meta SPC 1 identifier







Identifier


meta SPC 1




1.2.   Suffix to the authorisation number







Number


1-1




1.3.   Product type(s)







Product type(s)


PT01 – Human hygiene (Disinfectants)




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












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Propan-1-ol


 


Active Substance


71-23-8


200-746-9


70,35 


75,38 




2.2.   Type(s) of formulation of the meta SPC 1







Formulation(s)


AL – Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1






Hazard statements


Flammable liquid and vapour.
Causes serious eye damage.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.




Precautionary statements


Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
Wear face protection.
Wear eye protection.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Immediately call a POISON CENTER/doctor.
Avoid breathing vapours.
Call a POISONCENTRE/doctor if you feel unwell.




4.   AUTHORISED USE(S) OF THE META SPC 1
4.1.   Use description


Table 1.


Use # 1 – Hand disinfection







Product type


PT01 – Human hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


Hygienic hand rub




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Tuberculosis bacilli
Common name: Tuberculosis bacilli
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage:
Scientific name: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage:




Field(s) of use


Indoor
Indoor
Hand disinfection
Food processing areas (industry, institutional and hospital kitchen areas (no contact with patients))
Hygienic hand rub, on visibly clean hands




Application method(s)


Method: Manual or automatic pump
Detailed description:
Manual (elbow lever or touchless) Automatic (by pump)




Application rate(s) and frequency


Application Rate: 3 ml
Dilution (%): Ready to use
Number and timing of application:
10 times per day




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


100-20 000  l HEDP bottle, jerry can.




4.1.1.   Use-specific instructions for use

Refer to general measures (5.1)
4.1.2.   Use-specific risk mitigation measures

Refer to general measures (5.2))
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

Refer to general measures (5.3)
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Refer to general measures (5.4)
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Refer to general measures (5.5)
5.   GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1
5.1.   Instructions for use


Use 1 – Hand disinfection

Hand Disinfection for food processing areas:
Apply 3 ml product on clean and dry hands for:






—


30 seconds bacteria/yeast/tuberculosis bacilli/enveloped viruses










—


60 seconds viruses (limited spectrum virucidal activity)




Keep hands wet during whole contact time
5.2.   Risk mitigation measures

Avoid contact with eyes.
If refilling is needed, gloves and eye protection should be used.
In case of skin dryness, use appropriate skin care lotion.
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. Call a POISON CENTRE or a doctor.
IF SWALLOWED: Rinse mouth.
If symptoms: Call 112/ambulance for medical assistance.
If no symptoms: Call a POISON CENTRE or a doctor.
Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.
IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.
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.
Environmental precautions: do not allow contact with soil, surface or ground water.
5.4.   Instructions for safe disposal of the product and its packaging

Product and product residues: Do not allow the product to enter drains, water courses or the soil. Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of the product in compliance with local regulations. Dispose of wastes in an approved waste disposal facility
Packaging: Bring empty containers to an approved waste handling site for recycling or disposal. Dispose of packaging only if completely empty and closed. Do not re-use empty containers. Dispose of in accordance with local, regional, national regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep away from heat and sources of ignition. Keep in a cool, well-ventilated place. Keep away from oxidizing agents. Keep out of reach of children. Keep container tightly closed. Store in suitable labelled containers. Store between 0 °C to 25 °C.
Shelf life: 4 years
6.   OTHER INFORMATION
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)


Skinman Sensitive


Market area: EU




 


P3-Manodes LI


Market area: EU




Epicare DES


Market area: EU




Manodes LI


Market area: EU




Authorisation number


EU-0028430-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-1-ol


 


Active Substance


71-23-8


200-746-9


70,35 






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