Commission Implementing Regulation (EU) 2024/2409 of 13 September 2024 granting a Union authorisation for the single biocidal product Hydroflex IPA 70 Biocide in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Date: 2024-09-13
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, biocide, chemical product, decontamination, food safety, market approval, pharmaceutical product








L_202402409EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2024/2409


16.9.2024







            COMMISSION IMPLEMENTING REGULATION (EU) 2024/2409
of 13 September 2024
         
granting a Union authorisation for the single biocidal product ‘Hydroflex IPA 70 Biocide’ 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 20 September 2023, Hydroflex Group GmbH submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for Union authorisation of the same single biocidal product, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named ‘Hydroflex IPA 70 Biocide’, of product-types 2 and 4, as described in Annex V to Regulation (EU) No 528/2012, referring to the single biocidal product “Isopropanol 70 Biocide” (authorisation number EU-0027707-0022), which is a part of the related reference biocidal product family ‘Brenntag GmbH Propan-2-ol Product Family’. The application was recorded under case number BC-BX088801-11 in the Register for Biocidal Products. The application also indicated the authorisation number of the related reference biocidal product family ‘Brenntag GmbH Propan-2-ol Product Family’ authorised by Commission Implementing Regulation (EU) 2022/2252 (3), with authorisation number EU-0027707-0000.












(2)


The single biocidal product ‘Hydroflex IPA 70 Biocide’ contains propan-2-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-types 2 and 4.












(3)


On 12 January 2024, the Agency submitted to the Commission its opinion (4) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘Hydroflex IPA 70 Biocide’ in accordance with Article 6 of Implementing Regulation (EU) No 414/2013.












(4)


In its opinion, the Agency concludes that the proposed differences between the single biocidal product ‘Hydroflex IPA 70 Biocide’ and the related single biocidal product “Isopropanol 70 Biocide”, which is a part of the related reference biocidal product family ‘Brenntag GmbH Propan-2-ol Product Family’, are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 (5), and that based on the assessment of the related reference biocidal product family ‘Brenntag GmbH Propan-2-ol Product Family’ and subject to compliance with the draft SPC, the same single biocidal product ‘Hydroflex IPA 70 Biocide’ meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012.












(5)


On 4 April 2024, the Agency transmitted to the Commission the revised SPC of ‘Hydroflex IPA 70 Biocide’ in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.












(6)


The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same single biocidal product ‘Hydroflex IPA 70 Biocide’.












(7)


The expiry date of the authorisation should be aligned with the expiry date of the authorisation of the related reference biocidal product family ‘Brenntag GmbH Propan-2-ol Product Family’.












(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-0032170-0000 is granted to Hydroflex Group GmbH for the making available on the market and use of the same single biocidal product ‘Hydroflex IPA 70 Biocide’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 6 October 2024 until 30 November 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, 13 September 2024.


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) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4, ELI: http://data.europa.eu/eli/reg_impl/2013/414/oj).

(3)  Commission Implementing Regulation (EU) 2022/2252 of 11 November 2022 granting a Union authorisation for the biocidal product family ‘Brenntag GmbH Propan-2-ol Product Family’ (OJ L 297, 17.11.2022, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2022/2252/oj)

(4)  European Chemicals Agency opinion of 12 January 2024 on the Union authorisation of the same single biocidal product ‘Hydroflex IPA 70 Biocide’, https://echa.europa.eu/opinions-on-union-authorisation


(5)  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).




ANNEX
Summary of product characteristics for a biocidal product

Hydroflex IPA 70 Biocide

Product type(s)

PT02: Disinfectants and algaecides not intended for direct application to humans or animals


PT04: Food and feed area


Authorisation number:
EU-0032170-0000


R4BP asset number:
EU-0032170-0000

1.   ADMINISTRATIVE INFORMATION

1.1.   Trade name(s) of the product







Trade name(s)


Hydroflex IPA 70 Biocide




1.2.   Authorisation holder








Name and address of the authorisation holder


Name


Hydroflex Group GmbH




Address


Kiesacker 19 35418 Buseck DE




Authorisation number


 


EU-0032170-0000





R4BP asset number



 


EU-0032170-0000




Date of the authorisation


 


6 October 2024




Expiry date of the authorisation


 


30 November 2032




1.3.   Manufacturer(s) of the product

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







Active substance


Propan-2-ol




Name of manufacturer


ExxonMobil




Address of manufacturer


4999 Scenic Highway LA 70897 Baton Rouge, Louisiana United States (the)




Location of manufacturing sites


4999 Scenic Highway LA 70897 Baton Rouge, Louisiana United States (the)













Active substance


Propan-2-ol




Name of manufacturer


Shell Nederland Raffinaderij B.V.




Address of manufacturer


Vondelingenweg 601, Vodelingenenplaat 3196 KK Rotterdam Netherlands (the)




Location of manufacturing sites


Vondelingenweg 601, Vodelingenenplaat 3196 KK Rotterdam Netherlands (the)













Active substance


Propan-2-ol




Name of manufacturer


INEOS Solvents Germany GmbH




Address of manufacturer


Römerstrasse 733 47443 Moers Germany




Location of manufacturing sites







Römerstrasse 733 47443 Moers Germany




Shamrockstraße 88 44623 Herne Germany








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 (%)




Propan-2-ol


 


active substance


67-63-0


200-661-7


70 % (w/w)




2.2.   Type(s) of formulation

Meta SPC 2: Ready-to-Use trigger spray
3.   HAZARD AND PRECAUTIONARY STATEMENTS







Hazard statements


H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.




Precautionary statements


P101: If medical advice is needed, have product container or label at hand.
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P233: Keep container tightly closed.
P261: Avoid breathing vapours.
P261: Avoid breathing spray.
P271: Use only outdoors or in a well-ventilated area.
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.
P312: Call a POISON CENTER/doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical advice.
P337+P313: If eye irritation persists: Get medical attention.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to in accordance with local regulations.
P501: Dispose of container to in accordance with local regulations.




4.   AUTHORISED USE(S)

4.1.   Use description


Table 1


Use 1 – Liquid Spray – Small surface disinfection – Professional user







Product type


PT02: Disinfectants and algaecides not intended for direct application to humans or animals




Where relevant, an exact description of the authorised use


Not relevant.




Target organism(s) (including development stage)


Scientific name: Bacteria (incl. Mycobacteria),
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -




Field(s) of use


indoor use
Disinfection of small non-porous surfaces, materials, equipment and furniture in private, public, healthcare, industrial areas and in areas for professional activities.




Application method(s)


Method: spraying
Detailed description: -




Application rate(s) and frequency


Application rate: For surface disinfection a ready-to-use spray solution (20 ml/m2) is applied on surfaces at room temperature.
Dilution (%): -
Number and timing of application:
Application according to requirements, one application per use, 4 times per day.
Small surface disinfection(other than healthcare):
Bactericidal and yeasticidal: contact time at least 1 min
In healthcare area:
Bactericidal and yeasticidal: contact time at least 5 min




Category(ies) of users


professional




Pack sizes and packaging material








—


Bottle HD-PE: 0,1L–2,5L; (Screw caps (HD-PE) or caps (PP) or pump caps (PP) or trigger spray caps (PP) or safety caps (PP))










—


Can HD-PE: 5L-60L; (Screw caps (PE/LDPE/HD-PE) or safety caps (HD-PE)










—


Drum HD-PE: 200L; (Plastic plug with venting system (HD-PE) or Plastic plug for tap (HD-PE) or plastic tap (HD-PE) or seal caps (HD-PE))










—


IBC container HD-PE: 1 000 L; (Screw caps (HD-PE)








4.1.1.   Use-specific instructions







1)


Apply the ready-to-use product to the surface by spraying. Make sure to wet surfaces completely and wait for 1 minute (general surface disinfection) or 5 minutes (surfaces in healthcare area)










2)


For use at room temperature.










3)


Application according to requirements, one application per use, 4 times per day.




4.1.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be considered for refilling procedure unless it can be replaced by technical and/or organisational measures:
The use of eye protection during refilling of the product is recommended.
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.
4.2.   Use description


Table 2


Use 2 – Liquid Spray - Disinfection for small food contact surfaces – Professional user







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -




Field(s) of use


indoor use
Disinfection of small non-porous surfaces in food sector or food processing industries (including breweries, dairy industry and meat industry).




Application method(s)


Method: spraying
Detailed description: -




Application rate(s) and frequency


Application rate: For surface disinfection a ready-to-use spray solution (20 ml/m2) is applied on surfaces at room temperature.
Dilution (%): -
Number and timing of application:
Application according to requirements, one application per use, 4 times per day.
Small surface disinfection:
Bactericidal and yeasticidal: contact time at least 1 min
In Breweries/meat industry:
Bactericidal and yeasticidal: contact time at least 5 min
In dairy industry:
Bactericidal and yeasticidal: contact time at least 15 min




Category(ies) of users


professional




Pack sizes and packaging material








—


Bottle HD-PE: 0,1L–2,5L; (Screw caps (HD-PE) or caps (PP) or pump caps (PP) or trigger spray caps (PP) or safety caps (PP))










—


Can HD-PE: 5L-60L; (Screw caps (PE/LDPE/HD-PE) or safety caps (HD-PE)










—


Drum HD-PE: 200L; (Plastic plug with venting system (HD-PE) or Plastic plug for tap (HD-PE) or plastic tap (HD-PE) or seal caps (HD-PE))










—


IBC container HD-PE: 1 000 L;(Screw caps (HD-PE)








4.2.1.   Use-specific instructions







1)


Apply the ready-to-use product to the surface by spraying. Make sure to wet surfaces completely and wait for at least 1 min (general surface disinfection), 5 min (surface disinfection in breweries or meat industry) or at least 15 min (surface disinfection in dairy industry).










2)


For use at room temperature.










3)


Application according to requirements, one application per use, 4 times per day.




4.2.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be considered for disinfection of food processing machinery and refilling procedure unless it can be replaced by technical and / or organisational measures: The use of eye protection during handling of the product is recommended.
4.2.3.   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.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.2.5.   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







1)


Products must be shaken before use.










2)


Do not apply more than 20 mL/m2.










3)


Used wipes must be disposed in a closed container.




5.2.   Risk mitigation measures







1)


Avoid contact with eyes.










2)


For refilling a funnel must be applied.










3)


The product must only be applied for disinfection of small surfaces.










4)


Keep out of reach of children and pets.










5)


Use only in well-ventilated areas.










6)


Keep children and pets away from rooms where disinfection is taking place.










7)


Provide adequate ventilation before children and pets enter treated rooms.




5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment







1)


IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.










2)


IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.




5.4.   Instructions for safe disposal of the product and its packaging







1)


Product: Disposal together with normal waste is not allowed. Special disposal required according to local regulations.










2)


Do not let product enter drains.










3)


Contact waste disposal services.










4)


Contaminated packaging: Empty contaminated packaging thoroughly. They can be recycled after thorough and proper cleaning. Packaging that cannot be cleaned are to be disposed of in the same manner as the product.










5)


Do not burn, or use a cutting torch on, the empty drum. Risk of explosion.




5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage







1)


Store in a well-ventilated place.










2)


Keep cool.










3)


Keep container tightly closed.










4)


Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.










5)


Shelf-life: 24 months




6.   OTHER INFORMATION

The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.


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



ELI: http://data.europa.eu/eli/reg_impl/2024/2409/oj
ISSN 1977-0677 (electronic edition)