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Document 32026R0741
Commission Implementing Regulation (EU) 2026/741 of 30 March 2026 amending Implementing Regulation (EU) 2022/2127 as regards administrative changes to the Union authorisation of the biocidal product family Ecolab UA BPF 1-Propanol
Commission Implementing Regulation (EU) 2026/741 of 30 March 2026 amending Implementing Regulation (EU) 2022/2127 as regards administrative changes to the Union authorisation of the biocidal product family Ecolab UA BPF 1-Propanol
Commission Implementing Regulation (EU) 2026/741 of 30 March 2026 amending Implementing Regulation (EU) 2022/2127 as regards administrative changes to the Union authorisation of the biocidal product family Ecolab UA BPF 1-Propanol
C/2026/2027
OJ L, 2026/741, , ELI: http://data.europa.eu/eli/reg_impl/2026/741/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
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Official Journal |
EN L series |
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2026/741 |
31.3.2026 |
COMMISSION IMPLEMENTING REGULATION (EU) 2026/741
of 30 March 2026
amending Implementing Regulation (EU) 2022/2127 as regards administrative changes to the Union authorisation of the biocidal product family ‘Ecolab UA BPF 1-Propanol’
(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 50(2) thereof,
Whereas:
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(1) |
On 4 November 2022, Commission Implementing Regulation (EU) 2022/2127 (2) granted a Union authorisation, under number EU-0028430-0000, to Ecolab Deutschland GmbH for the making available on the market and use of the biocidal product family ‘Ecolab UA BPF 1-Propanol’. The Annex to that Implementing Regulation provides the summary of product characteristics for that biocidal product family. |
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(2) |
On 26 March 2025, Ecolab Deutschland GmbH submitted to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013 (3), a notification of administrative changes to the Union authorisation for the biocidal product family ‘Ecolab UA BPF 1-Propanol’, as referred to in Title 1 of the Annex to that Regulation. The notification was recorded in the Register for Biocidal Products (‘Register’) under case number BC-EM105048-46. The notified proposed changes to that authorisation concern the addition of trade names and changes in the address of the biocidal product manufacturer. |
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(3) |
On 16 April 2025, the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, an opinion (4) on the notified administrative changes to the Union authorisation for the biocidal product family ‘Ecolab UA BPF 1-Propanol’, together with a revised summary of product characteristics in all the official languages of the Union. In its opinion, the Agency concluded that the proposed changes are administrative changes as referred to in Article 50(3), point (a), of Regulation (EU) No 528/2012 and as specified in Title 1, Sections 1 and 2, of the Annex to Implementing Regulation (EU) No 354/2013, and that, after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met. |
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(4) |
The Commission concurs with the opinion of the Agency and therefore considers it appropriate to amend the Union authorisation for the biocidal product family ‘Ecolab UA BPF 1-Propanol’ to introduce the administrative changes requested by Ecolab Deutschland GmbH. |
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(5) |
Except for the amendments regarding the proposed administrative changes, all other information included in the summary of product characteristics of ‘Ecolab UA BPF 1-Propanol’, as set out in the Annex to Implementing Regulation (EU) 2022/2127, remains unchanged. |
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(6) |
In order to enhance clarity and to ease the access of users and interested parties to the consolidated version of the summary of product characteristics which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2022/2127 should be replaced in its entirety. Due to a change in the format used for the generation of the summary of biocidal product characteristics in the Register in February 2024, the summary of product characteristics in that Annex should also include some minor editorial and layout changes. |
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(7) |
Implementing Regulation (EU) 2022/2127 should therefore be amended accordingly, |
HAS ADOPTED THIS REGULATION:
Article 1
The Annex to Implementing Regulation (EU) 2022/2127 is replaced by the text set out in the Annex to this Regulation.
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, 30 March 2026.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.
(2) 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 (OJ L 285, 7.11.2022, p. 4, ELI: http://data.europa.eu/eli/reg_impl/2022/2127/oj).
(3) Commission 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).
(4) ECHA opinion UAD-C-1816957-17-00/F of 16 April 2025 on administrative changes of the Union authorisation of the biocidal product family ‘Ecolab UA BPF 1-Propanol’, BPC and ECHA opinions – ECHA.
ANNEX
Summary of product characteristics for a biocidal product family
Ecolab UA BPF 1-Propanol
Product type(s)
PT01: Human hygiene
Authorisation number EU-0028430-0000
R4BP asset number EU-0028430-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
1.1. Family name
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Name |
Ecolab UA BPF 1-Propanol |
1.2. Product type(s)
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Product type(s) |
PT01: Human hygiene |
1.3. Authorisation holder
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Name and address of the authorisation holder |
Name |
Ecolab Deutschland GmbH |
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Address |
Ecolab Allee 1 40789 Monheim am Rhein Germany |
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Authorisation number |
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EU-0028430-0000 |
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R4BP asset number |
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EU-0028430-0000 |
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Date of the authorisation |
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27 November 2022 |
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Expiry date of the authorisation |
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31 October 2032 |
1.4. Manufacturer(s) of the product
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Name of manufacturer |
Ecolab Europe GmbH |
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Address of manufacturer |
Hofwiesenstrasse 349 8050 Zürich Switzerland |
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Location of manufacturing sites |
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1.5. Manufacturer(s) of the active substance(s)
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Active substance |
Propan-1-ol |
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Name of manufacturer |
BASF SE |
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Address of manufacturer |
Carl-Bosch-Str. 38 67056 Ludwigshafen Germany |
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Location of manufacturing sites |
BASF SE site 1 Carl-Bosch-Str. 38 67056 Ludwigshafen Germany |
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Active substance |
Propan-1-ol |
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Name of manufacturer |
OQ Corporation |
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Address of manufacturer |
2001 FM 3057 TX 77414 Bay City United States (the) |
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Location of manufacturing sites |
OQ Corporation site 1 2001 FM 3057 TX 77414 Bay City United States (the) |
2. PRODUCT FAMILY COMPOSITION AND FORMULATION
2.1. Qualitative and quantitative information on the composition of the family
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Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
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Propan-1-ol |
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Active substance |
71-23-8 |
200-746-9 |
70,35 - 75,38 % (w/w) |
2.2. Type(s) of formulation
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Formulation type(s) |
AL Any other liquid |
PART II
SECOND INFORMATION LEVEL META SPC(S)
1. META SPC 1 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 1 identifier
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Identifier |
Meta SPC: meta SPC 1 |
1.2. Suffix to the authorisation number
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Number |
1-1 |
1.3. Product type(s)
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Product type(s) |
PT01: Human hygiene |
2. META SPC 1 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 1
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Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
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Propan-1-ol |
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Active substance |
71-23-8 |
200-746-9 |
70,35 - 75,38 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 1
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Formulation type(s) |
AL Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
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Hazard statements |
H226: Flammable liquid and vapour. H318: Causes serious eye damage. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. |
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Precautionary statements |
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P280: Wear face protection. P280: Wear eye protection. 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/doctor. P261: Avoid breathing vapours. P312: Call a POISONCENTRE/doctor if you feel unwell. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1.
Hand disinfection
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Product type |
PT01: Human hygiene |
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Where relevant, an exact description of the authorised use |
Hygienic handrub |
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Target organism(s) (including development stage) |
Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Tuberculosis bacilli Common name: Tuberculosis bacilli Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: no data Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: no data |
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Field(s) of use |
indoor use Indoor Hand disinfection Food processing areas (industry, institutional and hospital kitchen areas (no contact with patients)) Hygienic handrub, on visibly clean hands |
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Application method(s) |
Method: Manual or automatic pump Detailed description: Manual (elbow lever or touchless) Authomatic (by pump) |
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Application rate(s) and frequency |
Application Rate: 3 ml Ready to use Number and timing of application: 10 times per day |
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Category(ies) of users |
industrial professional |
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Pack sizes and packaging material |
100-20 000 ml 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 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:
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— |
30 seconds bacteria/yeast/ tuberculosis bacilli / enveloped viruses |
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— |
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
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Trade name(s) |
Skinman Sensitive |
Market area: EU |
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P3-Manodes LI |
Market area: EU |
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Epicare DES |
Market area: EU |
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Manodes LI |
Market area: EU |
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Keystone Hand Des |
Market area: EU |
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Sysco Hand Des |
Market area: EU |
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Authorisation number |
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EU-0028430-0001 1-1 |
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Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
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Propan-1-ol |
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Active substance |
71-23-8 |
200-746-9 |
70,35 % (w/w) |
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ELI: http://data.europa.eu/eli/reg_impl/2026/741/oj
ISSN 1977-0677 (electronic edition)