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

• CELEX: Implementing Regulation (EU) 2023/2200
• Articles: 3

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 .

Schedules & Appendices

ANNEX SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY

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.