Commission Implementing Regulation (EU) 2024/2419 of 13 September 2024 granting a Union authorisation for the single biocidal product Soft Care Med H5 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: biocide, chemical product, decontamination, hygiene product, market approval, pharmaceutical product








L_202402419EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2024/2419


16.9.2024







            COMMISSION IMPLEMENTING REGULATION (EU) 2024/2419
of 13 September 2024
         
granting a Union authorisation for the single biocidal product ‘Soft Care Med H5’ 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 29 March 2019, Diversey Europe Operations B.V. 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 single biocidal product named ‘Soft Care Med H5’ of product-type 1 as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-MF050448-40 in the Register for Biocidal Products.












(2)


‘Soft Care Med H5’ contains propan-1-ol and propan-2-ol as the active substances, both 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 17 July 2023, 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 14 December 2023, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Soft Care Med H5’ 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 ‘Soft Care Med H5’ is a single biocidal product within the meaning of Article 3(1), point (r), 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) of that Regulation.












(6)


On 3 January 2024, 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 ‘Soft Care Med H5’.












(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-0032018-0000 is granted to Diversey Europe Operations B.V. for the making available on the market and use of the single biocidal product ‘Soft Care Med H5’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 6 October 2024 to 30 September 2034.


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)  ECHA opinion of 22 November 2023 on the Union authorisation of the single biocidal product ‘Soft Care Med H5’ (ECHA/BPC/401/2023), https://echa.europa.eu/opinions-on-union-authorisation





ANNEX
Summary of product characteristics for a biocidal product
Soft Care Med H5

Product type(s)

PT01: Human hygiene

Authorisation number: EU-0032018-0000

R4BP asset number: EU-0032018-0000
1.   ADMINISTRATIVE INFORMATION

1.1.   Trade name(s) of the product







Trade name(s)


Soft Care Med H5
Soft Care Med
DivoCare Alco P VR203
DivoCare Alco P
Soft Care Alcoplus
Soft Care Impact Med
PrimeSource MED
Soft Care Alcogel
PrimeSource Alcoplus
PrimeSource Alcogel
PrimeSource Hand Sanitizer
STAPLES Med
STAPLES Alcogel
STAPLES Alcoplus
STAPLES Hand Sanitizer
Optimax Hand Sanitizer
Optimax Med
Optimax Alcogel
Optimax Alcoplus
Trust MED




1.2.   Authorisation holder








Name and address of the authorisation holder


Name


Diversey Europe Operations B.V.




Address


Regulatory team Maarssenbroeksedijk 2 3542 DN Utrecht NL




Authorisation number


 


EU-0032018-0000





R4BP asset number



 


EU-0032018-0000




Date of the authorisation


6 October 2024




Expiry date of the authorisation


30 September 2034




1.3.   Manufacturer(s) of the product







Name of manufacturer


Diversey Europe Operations B.V.




Address of manufacturer


Maarssenbroeksedijk 2 3542 DN Utrecht, Netherlands (the)




Location of manufacturing sites







Diversey Europe Operations B.V. site 1 Strada Statale 235 26010 Bagnolo Cremasco (CR) Italy




Diversey Europe Operations B.V. site 2 Rembrandtlaan 414 7545 ZW Enschede, Netherlands (the)




Diversey Europe Operations B.V. site 3 Cotes Park Industrial Estate DE55 4PA Somercotes, Alfreton, United Kingdom of Great Britain and Northern Ireland (the)




Diversey Europe Operations B.V. site 4 Avenida Conde Duque 5, 7 y 9, Poligono Industrial La Postura 28343 Valdemoro, Madrid, Spain




Diversey Europe Operations B.V. site 5 Morschheimer Strasse 12 67292 Kirchheimbolanden, Germany

















Name of manufacturer


Multifill B.V.




Address of manufacturer


Constructieweg 25a, P.O. Box 367 3640 Mijdrecht, Netherlands (the)




Location of manufacturing sites


Multifill B.V. site 1 Constructieweg 25a, P.O. Box 367 3640 AJ Mijdrecht, Netherlands (the)




1.4.   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


BASF SE site 1 Carl-Bosch-Str. 38 67056 Ludwigshafen, Germany













Active substance


Propan-1-ol




Name of manufacturer


OXEA Corporation




Address of manufacturer


2001 FM 3057 TX 77414 Bay City United States (the)




Location of manufacturing sites


OXEA Corporation site 1 2001 FM 3057 TX 77414 Bay City United States (the)













Active substance


Propan-2-ol




Name of manufacturer


SASOL Solvents Germany, GmbH




Address of manufacturer


Anckelmannsplatz D-20537 Hamburg, Germany




Location of manufacturing sites







SASOL Solvents Germany GmbH site 1 Shamrockstrasse 88 D-44623 Herne, Germany




SASOL Solvents Germany GmbH site 2 Römerstr. 733 D-47443 Moers, Germany

















Active substance


Propan-2-ol




Name of manufacturer


Shell Chemicals Europe B.V.




Address of manufacturer


Postbus 2334 3000 CH Rotterdam, Netherlands (the)




Location of manufacturing sites


Shell Chemicals Europe B.V. site 1 Shell Nederland Chemie BV/Shell Nederland Raffinaderij B.V., Vondelingenweg 601 3196 KK Rotterdam-Pernis, Netherlands (the)













Active substance


Propan-2-ol




Name of manufacturer


Exxon Mobil Chemicals




Address of manufacturer


Hermeslaan 2 1831 Machelen, Belgium




Location of manufacturing sites







Exxon Mobil Chemicals site 1 ExxonMobil’s Baton Rouge Refinery and Chemical Plant, 4045 Scenic Hwy LA 70805 Baton Rouge, United States (the)




Exxon Mobil Chemicals site 2 Esso Refinery Fawley SO45 1TX Southampton, United Kingdom of Great Britain and Northern Ireland (the)

















Active substance


Propan-2-ol




Name of manufacturer


Novapex




Address of manufacturer


21 Chemin de la Sauvegarde - 21 Ecully Parc - CS 33167 69134 Écully Cedex, France




Location of manufacturing sites


Novapex site 1 Novapex SAS Usine de Rousillon, Rue Gaston Monmousseau 38556 Saint Maurice l’Exil, France




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-1-ol


 


active substance


71-23-8


200-746-9


2,96 % (w/w)




Propan-2-ol


 


active substance


67-63-0


200-661-7


70 % (w/w)




2.2.   Type(s) of formulation

AL Any other liquid
3.   HAZARD AND PRECAUTIONARY STATEMENTS







Hazard statements


H225: Highly flammable liquid and vapour.
H336: May cause drowsiness or dizziness.
H319: Causes serious eye irritation.




Precautionary statements


P101: If medical advice is needed, have product container or label at hand.
P102: Keep out of reach of children.
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.
P271: Use only outdoors or in a well-ventilated area.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P312: Call a POISON CENTER if you feel unwell.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice.
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].
P370+P378: In case of fire: Use water to extinguish.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to chemical waste.
P103: Read carefully and follow all instructions.




4.   AUTHORISED USE(S)

4.1.   Use description


Table 1


PT01 - Hygienic hand rub







Product type


PT01: Human hygiene




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Scientific name: no data
Common name: Enveloped viruses
Development stage: no data
Scientific name: no data
Common name: limited spectrum viruses
Development stage: no data
Scientific name: no data
Common name: Tuberculosis bacilli
Development stage: no data




Field(s) of use


indoor use
outdoor use
Ready to use disinfectant hand rub for hands for use in hospitals and other medical areas, institutional and industrial areas, restaurants and large-scale canteen kitchens and recreational areas. Not for domestic use.




Application method(s)


Method: Dispense
Detailed description: For pump or pouch with pump:Dispense ready to use disinfectant by applying the product onto the hands. Rub to completely cover clean hands. For flip top or cap bottle:Pour the ready to use liquid into the palm of one cupped hand. Rub to completely cover clean hands.




Application rate(s) and frequency


Application rate: Adult: 3 ml (the amount of liquid should resemble the size of a large-sized coin) equal to 3 pumps with the dosing system Child under 12 years: 2 ml equal to 2 pumps with the dosing system Child under 6 years: 1 ml equal to 1 pump with the dosing system
Dilution (%): Ready to use
Number and timing of application:
Professional user: Up to 25 applications per day
Non-professional user:






—


Adults: Up to 11 applications per day










—


Children: Up to 3 applications per day








Category(ies) of users


industrial ; professional ; general public (non-professional)




Pack sizes and packaging material


Professional and industrial:






 


Rigid container (flip top) high-density polyethylene (HDPE): 100, 150, 200, 500 ml










 


Rigid container (pump or cap) (HDPE): 0,5, 0,6, 0,7, 0,75, 0,8, 0,9, 1, 1,3, 1,5, 2, 3, 5, 10, 20, 50, 100, 200, 900, 950, 1000 litres










 


Flexible container (pouch with pump or cap) low-density polyethylene (LDPE): 0,8, 1,3, 2,5 litres




Non-professional:






 


Rigid container (flip top) (HDPE): 100, 150, 200, 500 ml










 


Rigid container (pump or cap) (HDPE): 0,5, 0,6, 0,7, 0,75, 0,8, 0,9, 1, 1,3, 1,5, 2, 3, 5 litres










 


Flexible container (pouch with pump or cap) (LDPE): 0,8, 1,3, 2,5 litres








4.1.1.   Use-specific instructions

Comply with the instructions for use.
The product needs to be used on visibly clean hands.
Step 1: Apply the following amount of disinfectant:






—


Adult: 3 ml equal to 3 pumps with the dosing system










—


Child under 12 years: 2 ml equal to 2 pumps with the dosing system










—


Child under 6 years: 1 ml equal to 1 pump with the dosing system




Rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.
Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.
Step 3: Open fingers and rub the finger webs. Reverse and repeat action.
Step 4: Rub palm to palm with fingers interlocked (5 times).
Step 5: Rub thumb of each hand using a rotating movement.
Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.
Keep wet for 30 sec against bacteria, yeast, tuberculosis bacilli and enveloped viruses or 2 minutes against limited spectrum viruses.
Do not rinse.
Repeat if renewed hand disinfection is required.
Children and toddler shall only perform hand disinfection under adult supervision: apply the amount for children/toddler at your own hand first and rub the product at child’s/toddler’s hand until both hands are totally dried (see 6-Step instructions). Make sure that the child/toddler does not touch eyes or mouth before the product has dried.
4.1.2.   Use-specific risk mitigation measures

See general directions for use
Use by children only under supervision of an adult.
Do not use for children under 1 year.
Make sure that the user applies the product in an area where people will not be present for a longer period.
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

Keep out of reach of children and non-target animals/pets
4.2.   Use description


Table 2


PT01 - Surgical hand rub







Product type


PT01: Human hygiene




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Scientific name: no data
Common name: Limited spectrum viruses
Development stage: no data
Scientific name: no data
Common name: Tuberculosis bacilli
Development stage: no data




Field(s) of use


indoor use
Ready to use surgical disinfectant for hands and forearms for use in hospitals and other medical areas.




Application method(s)


Method: Dispense
Detailed description: Dispense ready to use disinfectant by pumping at least 3 times (1 ml per pump) onto the hands (pump or pouch with pump) and rub to completely cover clean hands and arms.
OR
Pour the ready to use liquid into the palm of one cupped hand (flip top or cap bottle) applying sufficiently to completely cover clean hands and arms.




Application rate(s) and frequency


Application rate: Portions of 3 ml up to 12 ml in total
Dilution (%): Ready to use
Number and timing of application:
Up to 4 applications per day




Category(ies) of users


professional




Pack sizes and packaging material


Rigid container (flip top) high-density polyethylene (HDPE): 100, 150, 200, 500 ml
Rigid container (pump or cap) (HDPE): 0,5, 0,6, 0,7, 0,75, 0,8, 0,9, 1, 1,3, 1,5, 2, 3, 5, 10, 20, 50, 100, 200 litres
Flexible container (pouch with pump or cap) low-density polyethylene (LDPE): 0,8, 1,3, 2,5 litres




4.2.1.   Use-specific instructions

The product shall be used on visibly clean hands and arms.
Do not refill or decant products used as surgical hand rub.

For pump or pouch with pump:

Dispense by pumping at least 3 times (1 ml per pump) onto the hands and rub to completely cover clean hands and arms up to the elbow. Repeat the procedure and use multiple portions of 3 ml to keep hands and arms wet for 2 minutes.
Keep wet for 2 minutes against bacteria, yeast, tuberculosis bacteria and limited spectrum viruses.
Do not rinse.
Repeat if renewed hand disinfection is required. (Up to 4 applications per day).

For flip top or cap bottle:

Pour the liquid into the palm of one cupped hand, applying sufficiently to completely cover clean hands and arms up to the elbow. Repeat the procedure and use multiple portions of 3 ml to keep hands and arms wet for 2 minutes.
Keep wet for 2 minutes against bacteria, yeast, tuberculosis bacteria and limited spectrum viruses.
Do not rinse.
Repeat if renewed hand disinfection is required. (Up to 4 applications per day).
4.2.2.   Use-specific risk mitigation measures

See general directions for use
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

See use specific instructions for the individual uses.
5.2.   Risk mitigation measures

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

Inhalation: May cause drowsiness or dizziness.
Skin contact: No known effects or symptoms in normal use.
Eye contact: Causes severe irritation.
Ingestion: Ingestion might lead to nausea and vomiting due to local irritation and systemic effects like drunkenness, drowsiness, sometimes unconsciousness and low blood sugar (especially in children).
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: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

Environmental precautions:

Avoid (direct) release (of undiluted product) to the environment/sewage system.
Dilute spills with water and mop up.
5.4.   Instructions for safe disposal of the product and its packaging

Dispose according to national or local regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

2 years shelf life
Store below 30°C
Store away from heat and direct sunlight.
6.   OTHER INFORMATION



(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/2024/2419/oj
ISSN 1977-0677 (electronic edition)