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EU Authorisation for HCl Toilet Cleaner

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0% found this document useful (0 votes)
35 views11 pages

EU Authorisation for HCl Toilet Cleaner

Uploaded by

Ega Eng
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Official Journal EN

of the European Union L series

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,

(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

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EN OJ L, 20.10.2023

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

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OJ L, 20.10.2023 EN

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 Name SC Johnson Europe Sàrl


holder
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

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EN OJ L, 20.10.2023

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

Content (%)
Common name IUPAC name Function CAS number EC number
Min Max

Hydrochloric acid Hydrochloric Active 231-595-7 6,0 6,0


acid Substance
2,2'-(octadec- 2-[(2-hydro­ Non-active 25307-17-9 246-807-3 2,14 2,14
9-enylimino) xyethyl)[(9E)- substance
bisethanol octadec-9-en-
1-yl]amino]
ethan-1-ol
Alcohols, Alcohols, Non-active 157627-86-6 1,0 1,0
C13-15-branched C13-15-bran­ substance
and linear, ched and
ethoxylated linear,
ethoxylated
(1-2,5 mol EO)
Diphenyl ether 1,1'-Oxybis- Non-active 101-84-8 202-981-2 0,0 0,0045
benzene substance

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

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OJ L, 20.10.2023 EN

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

Content (%)
Common name IUPAC name Function CAS number EC number
Min Max

Hydrochloric acid Hydrochloric Active 231-595-7 6,0 6,0


acid Substance
2,2'-(octadec- 2-[(2-hydro­ Non-active 25307-17-9 246-807-3 2,14 2,14
9-enylimino) xyethyl)[(9E)- substance
bisethanol octadec-9-en-
1-yl]amino]
ethan-1-ol
Alcohols, Alcohols, Non-active 157627-86-6 1,0 1,0
C13-15-branched C13-15-bran­ substance
and linear, ched and
ethoxylated linear,
ethoxylated
(1-2,5 mol EO)
Diphenyl ether 1,1'-Oxybis- Non-active 101-84-8 202-981-2 0,0 0,0045
benzene substance

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.

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EN OJ L, 20.10.2023

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 Common name: Bacteria
stage) 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.

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OJ L, 20.10.2023 EN

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.

(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.

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EN OJ L, 20.10.2023

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 Market area: EU
Marine
Duck® 100 % Anticalcar – Market area: EU
detergent lichid pentru toaletă
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 – Market area: EU
Marine
Duck® 100 % против котлен камък Market area: EU
Duck® 100 % Odstraňovač Market area: EU
vodného kameňa

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OJ L, 20.10.2023 EN

Duck® 100 % odstraňovač Market area: EU


vodného kameňa – Marine

Duck® 100 % odstraňovač Market area: EU


vodního kamene

Duck® 100 % odstraňovač Market area: EU


vodního kamene – Marine

Duck® 100 % przeciw kamieniowi Market area: EU


Marine – żel do czyszczenia i
dezynfekcji toalet

Duck® 100 %-tni uništavač Market area: EU


kamenca Marine

Duck® 100 % vízkőoldó – WC Market area: EU


tisztító folyadék

Duck® 100 % vízkőoldó marine – Market area: EU


WC tisztító fertőtlenítő folyadék

Canard® 100 % Anti-tartre Market area: EU

Canard® 100 % Détartrant Marine Market area: EU

Canard® 100 % Détartrant Market area: EU


Marine/Canard® 100 %
Kalkaanslagvernietiger Marine

WC-Ente® 100 % Anti-Kalk Market area: EU

WC Ente® 100 % ANTI-KALK Market area: EU


Marine

WC-EEND® Nr. 1 Ontkalker Market area: EU


toiletreiniger Marine

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 Market area: EU


– Marine

Authorisation EU-0030299-0001 1-1


number

Common name IUPAC name Function CAS number EC number Content (%)

Hydrochloric acid Hydrochloric Active 231-595-7 6,0


acid Substance

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EN OJ L, 20.10.2023

2,2'-(octadec- 2-[(2-hydroxye­ Non-active 25307-17-9 246-807-3 2,14


9-enylimino) thyl)[(9E)- substance
bisethanol octadec-9-en-
1-yl]amino]
ethan-1-ol

Alcohols, Alcohols, Non-active 157627-86-6 1,0


C13-15-branched C13-15-bran­ substance
and linear, ched and linear,
ethoxylated ethoxylated
(1-2,5 mol EO)

Diphenyl ether 1,1'-Oxybis- Non-active 101-84-8 202-981-2 0,0045


benzene substance

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 Market area: EU


Citrus

Duck® 100 % Anticalcare Citrus Market area: EU

Duck® 100 % Anticalcar Citrus – Market area: EU


detergent lichid pentru toaletă

Duck® 100 % Kalkfri – Citrus Market area: EU

Duck® 100 % Kalkfjerner – Citrus Market area: EU

Duck® 100 % κατά των αλάτων – Market area: EU


Citrus

Duck® 100 % против котлен камък Market area: EU


– Цитрус

Duck® 100 % odstraňovač Market area: EU


vodného kameňa – Citrus

Duck® 100 % odstraňovač Market area: EU


vodního kamene – Citrus

Duck® 100 % przeciw kamieniowi Market area: EU


Citrus – żel do czyszczenia i
dezynfekcji toalet

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OJ L, 20.10.2023 EN

Duck® 100 %-tni uništavač Market area: EU


kamenca Citrus

Duck® 100 % vízkőoldó Citrus – Market area: EU


WC tisztító fertőtlenítő folyadék

Canard® 100 % Anti-tartre Citrus Market area: EU

Canard® 100 % Détartrant Citrus Market area: EU

Canard® 100 % anti-tartre – Market area: EU


Fraîcheur Citron

Canard® 100 % Détartrant Market area: EU


Citrus/Canard® 100 %
Kalkaanslagvernietiger Citrus

WC Ente® 100 % ANTI-KALK Market area: EU


Citrus

WC-EEND® Nr. 1 Ontkalker Market area: EU


toiletreiniger Citrus

Pato® 100 % Anti-cal Citrus Market area: EU

Pato® 100 % Anticalcário Citrus Market area: EU

00 null null® Urinstein & Kalklöser Market area: EU


– Citrus

Authorisation EU-0030299-0002 1-1


number
Common name IUPAC name Function CAS number EC number Content (%)
Hydrochloric acid Hydrochloric Active 231-595-7 6,0
acid Substance
2,2'-(octadec- 2-[(2-hydroxye­ Non-active 25307-17-9 246-807-3 2,14
9-enylimino) thyl)[(9E)- substance
bisethanol octadec-9-en-
1-yl]amino]
ethan-1-ol
Alcohols, Alcohols, Non-active 157627-86-6 1,0
C13-15-branched C13-15-bran­ substance
and linear, ched and linear,
ethoxylated ethoxylated
(1-2,5 mol EO)

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