Commission Implementing Regulation (EU) 2023/2200 of 19 October 2023 granting a Union authorisation for the biocidal product family HCl Disinfecting Toilet Bowl Cleaner in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Date: 2023-10-19
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, decontamination, inorganic acid, market approval








L_202302200EN.000101.fmx.xml












Official Journal of the European Union


EN
Series L













2023/2200


20.10.2023







            COMMISSION IMPLEMENTING REGULATION (EU) 2023/2200
of 19 October 2023
         
granting a Union authorisation for the biocidal product family ‘HCl Disinfecting Toilet Bowl Cleaner’ 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 2 May 2018, SC Johnson Europe SARL 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 ‘HCl Disinfecting Toilet Bowl Cleaner’ of product-type 2, 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-LA039435-53 in the Register for Biocidal Products.












(2)


‘HCl Disinfecting Toilet Bowl Cleaner’ contains hydrochloric acid 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 2.












(3)


On 25 May 2022, 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 15 December 2022, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘HCl Disinfecting Toilet Bowl Cleaner’ and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012.












(5)


The opinion concludes that ‘HCl Disinfecting Toilet Bowl Cleaner’ 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 10 January 2023, 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 ‘HCl Disinfecting Toilet Bowl Cleaner’.












(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-0030299-0000 is granted to SC Johnson Europe SARL for the making available on the market and use of the biocidal product family ‘HCl Disinfecting Toilet Bowl Cleaner’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 9 November 2023 to 31 October 2033.


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, 19 October 2023.


For the Commission


The President

Ursula VON DER LEYEN
            





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

(2)  ECHA opinion of 24 November 2022 on the Union authorisation of ‘HCl Disinfecting Toilet Bowl Cleaner’ (ECHA/BPC/370/2022), https://echa.europa.eu/opinions-on-union-authorisation




ANNEX
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
HCl Disinfecting Toilet Bowl Cleaner
Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Authorisation number: EU-0030299-0000
R4BP asset number: EU-0030299-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION
1.1.   Family name







Name


HCl Disinfecting Toilet Bowl Cleaner




1.2.   Product type(s)







Product type(s)


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


SC Johnson Europe Sàrl




Address


Z.A. la Piece 8, 1180 Rolle, Switzerland




Authorisation number


EU-0030299-0000





R4BP asset number



EU-0030299-0000




Date of the authorisation


9 November 2023




Expiry date of the authorisation


31 October 2033




1.4.   Manufacturer(s) of the biocidal products







Name of manufacturer


SC Johnson Europlant BV




Address of manufacturer


PO Box 38, 3640 AA Mijdrecht, Netherlands




Location of manufacturing sites


Groot Mijdrechtstraat 81, 3641 RV Mijdrecht, Netherlands




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







Active substance


Hydrochloric acid




Name of manufacturer


SC Johnson Europe Sàrl




Address of manufacturer


Z.A. la Piece 8, 1180 Rolle, Switzerland




Location of manufacturing sites


Ludwigstraße 12, D-47495 Rheinberg, Germany




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




Hydrochloric acid


Hydrochloric acid


Active Substance


 


231-595-7


6,0 


6,0 




2,2'-(octadec-9-enylimino)bisethanol


2-[(2-hydroxyethyl)[(9E)-octadec-9-en-1-yl]amino]ethan-1-ol


Non-active substance


25307-17-9


246-807-3


2,14 


2,14 




Alcohols, C13-15-branched and linear, ethoxylated


Alcohols, C13-15-branched and linear, ethoxylated (1-2,5 mol EO)


Non-active substance


157627-86-6


 


1,0 


1,0 




Diphenyl ether


1,1'-Oxybis-benzene


Non-active substance


101-84-8


202-981-2


0,0 


0,0045 




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


100 % Limescale




1.2.   Suffix to the authorisation number







Number


1-1




1.3.   Product type(s)







Product type(s)


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




Hydrochloric acid


Hydrochloric acid


Active Substance


 


231-595-7


6,0 


6,0 




2,2'-(octadec-9-enylimino)bisethanol


2-[(2-hydroxyethyl)[(9E)-octadec-9-en-1-yl]amino]ethan-1-ol


Non-active substance


25307-17-9


246-807-3


2,14 


2,14 




Alcohols, C13-15-branched and linear, ethoxylated


Alcohols, C13-15-branched and linear, ethoxylated (1-2,5 mol EO)


Non-active substance


157627-86-6


 


1,0 


1,0 




Diphenyl ether


1,1'-Oxybis-benzene


Non-active substance


101-84-8


202-981-2


0,0 


0,0045 




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


May be corrosive to metals.
Causes severe skin burns and eye damage.
Harmful to aquatic life with long lasting effects.




Precautionary statements


If medical advice is needed, have product container or label at hand.
Keep out of reach of children.
Do not breathe vapours.
Wash hands thoroughly after handling.
Immediately call a POISON CENTER or doctor/physician.
IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
IF INHALED:Remove person to fresh air and keep comfortable for breathing.
Wash contaminated clothing before reuse.
Keep only in original packaging.
Store locked up.
Avoid release to the environment.
Dispose of contents to hazardous or special waste collection point in accordance with local regulations.




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


Table 1


Use # 1 – Bactericide – disinfection of toilet bowl above the water line – non-professionals







Product type


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


—




Target organism(s) (including development stage)


Common name: Bacteria
Development stage: not applicable




Field(s) of use


Indoor
Toilet bowl disinfectant




Application method(s)


Method: Pouring
Detailed description:
Apply product under the toilet bowl rim to cover the surface (above the waterline) completely.




Application rate(s) and frequency


Application Rate: 60 ml for one use in the toilet bowl.
Dilution (%): The product is ready-to-use.
Number and timing of application:
Daily use.
Contact time: minimum 5 minutes.




Category(ies) of users


General public (non-professional)




Pack sizes and packaging material


BOTTLE: High-density polyethylene, 750 ml, opaque.
CAP: Polypropylene.
INSERT: Linear low-density polyethylene.
Child resistant fastening.




4.1.1.   Use-specific instructions for use

See general instructions for use.
4.1.2.   Use-specific risk mitigation measures

See general risk mitigation measures.
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 instructions for use.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general instructions 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 instructions for use.
5.   GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1
5.1.   Instructions for use

Lift the toilet seat. To remove the cap, squeeze the two textured side surfaces and unscrew completely. Tip bottle to fill neck. To disinfect above the water line, squeeze evenly to coat entire bowl direct (60 ml) of liquid gel under the rim and allow to sit for at least 5 minutes. Brush the entire bowl and flush. Replace cap and close tightly until an audible click is heard. Daily use. Comply with the instructions for use.
5.2.   Risk mitigation measures

The packaging is designed to minimise consumer exposure. The product has a swan neck with a nozzle that targets the product accurately when squeezed under the rim of the toilet.
Usage instructions contain the additional warnings: Store locked up. Avoid contact with skin and eyes. Apply only into the rim of the toilet to avoid skin contact. Avoid splashing. Wash hands thoroughly after handling. Keep only in original container.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

If medical advice is needed, have product container or label at hand.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
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.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms:Call a Poison Centre or a doctor.
5.4.   Instructions for safe disposal of the product and its packaging

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life is 4 years at room temperature.
Keep out of reach of children and non-target animals/pets.
6.   OTHER INFORMATION
Additional labelling: -
Do not mix with bleach or any other household cleaners.
For use in toilet bowls only.
< 5 % non-ionic surfactants, disinfectants, perfume.
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)


Duck® 100 % Anti-Limescale


Market area: EU




 


Duck® 100 % Limescale Marine


Market area: EU




Duck® 100 % Limescale Remover Marine


Market area: EU




Duck® 100 % Anticalcar – detergent lichid pentru toaletă


Market area: EU




Duck® 100 % Anticalcare Marine


Market area: EU




Duck® 100 % Disincrostante


Market area: EU




Duck® 100 % Kalkfri – Marine


Market area: EU




Duck® 100 % Kalkfjerner – Marine


Market area: EU




Duck® 100 % Κατά των Αλάτων


Market area: EU




Duck® 100 % κατά των αλάτων – Marine


Market area: EU




Duck® 100 % против котлен камък


Market area: EU




Duck® 100 % Odstraňovač vodného kameňa


Market area: EU




Duck® 100 % odstraňovač vodného kameňa – Marine


Market area: EU




Duck® 100 % odstraňovač vodního kamene


Market area: EU




Duck® 100 % odstraňovač vodního kamene – Marine


Market area: EU




Duck® 100 % przeciw kamieniowi Marine – żel do czyszczenia i dezynfekcji toalet


Market area: EU




Duck® 100 %-tni uništavač kamenca Marine


Market area: EU




Duck® 100 % vízkőoldó – WC tisztító folyadék


Market area: EU




Duck® 100 % vízkőoldó marine – WC tisztító fertőtlenítő folyadék


Market area: EU




Canard® 100 % Anti-tartre


Market area: EU




Canard® 100 % Détartrant Marine


Market area: EU




Canard® 100 % Détartrant Marine/Canard® 100 % Kalkaanslagvernietiger Marine


Market area: EU




WC-Ente® 100 % Anti-Kalk


Market area: EU




WC Ente® 100 % ANTI-KALK Marine


Market area: EU




WC-EEND® Nr. 1 Ontkalker toiletreiniger Marine


Market area: EU




Pato® 100 % Anti-cal


Market area: EU




Pato® 100 % Anti-cal Marine


Market area: EU




Pato® 100 % Anticalcário


Market area: EU




Pato® 100 % Anticalcário Marine


Market area: EU




00 null null® Urinstein & Kalklöser


Market area: EU




00 null null® Urinstein & Kalklöser – Marine


Market area: EU




Authorisation number


EU-0030299-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrochloric acid


Hydrochloric acid


Active Substance


 


231-595-7


6,0 




2,2'-(octadec-9-enylimino)bisethanol


2-[(2-hydroxyethyl)[(9E)-octadec-9-en-1-yl]amino]ethan-1-ol


Non-active substance


25307-17-9


246-807-3


2,14 




Alcohols, C13-15-branched and linear, ethoxylated


Alcohols, C13-15-branched and linear, ethoxylated (1-2,5 mol EO)


Non-active substance


157627-86-6


 


1,0 




Diphenyl ether


1,1'-Oxybis-benzene


Non-active substance


101-84-8


202-981-2


0,0045 




7.2.   Trade name(s), authorisation number and specific composition of each individual product











Trade name(s)


Duck® 100 % Limescale Citrus


Market area: EU




 


Duck® 100 % Limescale Remover Citrus


Market area: EU




Duck® 100 % Anticalcare Citrus


Market area: EU




Duck® 100 % Anticalcar Citrus – detergent lichid pentru toaletă


Market area: EU




Duck® 100 % Kalkfri – Citrus


Market area: EU




Duck® 100 % Kalkfjerner – Citrus


Market area: EU




Duck® 100 % κατά των αλάτων – Citrus


Market area: EU




Duck® 100 % против котлен камък – Цитрус


Market area: EU




Duck® 100 % odstraňovač vodného kameňa – Citrus


Market area: EU




Duck® 100 % odstraňovač vodního kamene – Citrus


Market area: EU




Duck® 100 % przeciw kamieniowi Citrus – żel do czyszczenia i dezynfekcji toalet


Market area: EU




Duck® 100 %-tni uništavač kamenca Citrus


Market area: EU




Duck® 100 % vízkőoldó Citrus – WC tisztító fertőtlenítő folyadék


Market area: EU




Canard® 100 % Anti-tartre Citrus


Market area: EU




Canard® 100 % Détartrant Citrus


Market area: EU




Canard® 100 % anti-tartre – Fraîcheur Citron


Market area: EU




Canard® 100 % Détartrant Citrus/Canard® 100 % Kalkaanslagvernietiger Citrus


Market area: EU




WC Ente® 100 % ANTI-KALK Citrus


Market area: EU




WC-EEND® Nr. 1 Ontkalker toiletreiniger Citrus


Market area: EU




Pato® 100 % Anti-cal Citrus


Market area: EU




Pato® 100 % Anticalcário Citrus


Market area: EU




00 null null® Urinstein & Kalklöser – Citrus


Market area: EU




Authorisation number


EU-0030299-0002 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrochloric acid


Hydrochloric acid


Active Substance


 


231-595-7


6,0 




2,2'-(octadec-9-enylimino)bisethanol


2-[(2-hydroxyethyl)[(9E)-octadec-9-en-1-yl]amino]ethan-1-ol


Non-active substance


25307-17-9


246-807-3


2,14 




Alcohols, C13-15-branched and linear, ethoxylated


Alcohols, C13-15-branched and linear, ethoxylated (1-2,5 mol EO)


Non-active substance


157627-86-6


 


1,0 






(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.



ELI: http://data.europa.eu/eli/reg_impl/2023/2200/oj
ISSN 1977-0677 (electronic edition)