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Document 32022R2127
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)
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)
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)
C/2022/7825
OJ L 285, 7.11.2022, p. 4–14
(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: This act has been changed. Current consolidated version: 07/11/2022
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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:
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(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. |
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(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. |
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(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. |
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(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. |
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(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. |
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(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. |
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(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’. |
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(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
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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 (Disinfectants) |
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 |
EU-0028430-0000 |
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R4BP asset number |
EU-0028430-0000 |
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Date of the authorisation |
27 November 2022 |
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Expiry date of the authorisation |
31 October 2032 |
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1.4. Manufacturer(s) of the biocidal products
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Name of manufacturer |
Ecolab Europe GmbH |
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Address of manufacturer |
Richtistrasse 7, 8304 Walliselen 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 |
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 |
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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
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Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
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Min |
Max |
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Propan-1-ol |
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Active Substance |
71-23-8 |
200-746-9 |
70,35 |
75,38 |
2.2. Type(s) of formulation
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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
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Identifier |
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 (Disinfectants) |
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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Min |
Max |
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Propan-1-ol |
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Active Substance |
71-23-8 |
200-746-9 |
70,35 |
75,38 |
2.2. Type(s) of formulation of the meta SPC 1
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Formulation(s) |
AL – Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
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Hazard statements |
Flammable liquid and vapour. Causes serious eye damage. May cause drowsiness or dizziness. Repeated exposure may cause skin dryness or cracking. |
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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
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Product type |
PT01 – Human hygiene (Disinfectants) |
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Where relevant, an exact description of the authorised use |
Hygienic hand rub |
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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: |
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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 |
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Application method(s) |
Method: Manual or automatic pump Detailed description: Manual (elbow lever or touchless) Automatic (by pump) |
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Application rate(s) and frequency |
Application Rate: 3 ml Dilution (%): 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 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:
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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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Authorisation number |
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 |
(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.