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
Commission Implementing Regulation (EU) 2023/2200of 19 October 2023granting 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 productsOJ L 167, 27.6.2012, p. 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 opinionECHA 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, 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 1A 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 2This 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 CommissionThe PresidentUrsula von der LeyenANNEXSUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILYHCl Disinfecting Toilet Bowl CleanerProduct type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)Authorisation number: EU-0030299-0000R4BP asset number: EU-0030299-0000PART IFIRST INFORMATION LEVEL1.ADMINISTRATIVE INFORMATION1.1.Family name
NameHCl 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 holderNameSC Johnson Europe Sàrl
AddressZ.A. la Piece 8, 1180 Rolle, Switzerland
Authorisation numberEU-0030299-0000
R4BP asset numberEU-0030299-0000
Date of the authorisation9 November 2023
Expiry date of the authorisation31 October 2033
1.4.Manufacturer(s) of the biocidal products
Name of manufacturerSC Johnson Europlant BV
Address of manufacturerPO Box 38, 3640 AA Mijdrecht, Netherlands
Location of manufacturing sitesGroot Mijdrechtstraat 81, 3641 RV Mijdrecht, Netherlands
1.5.Manufacturer(s) of the active substance(s)
Active substanceHydrochloric acid
Name of manufacturerSC Johnson Europe Sàrl
Address of manufacturerZ.A. la Piece 8, 1180 Rolle, Switzerland
Location of manufacturing sitesLudwigstraße 12, D-47495 Rheinberg, Germany
2.PRODUCT FAMILY COMPOSITION AND FORMULATION2.1.Qualitative and quantitative information on the composition of the family
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
Hydrochloric acidHydrochloric acidActive Substance231-595-76,06,0
2,2'-(octadec-9-enylimino)bisethanol2-[(2-hydroxyethyl)[(9E)-octadec-9-en-1-yl]amino]ethan-1-olNon-active substance25307-17-9246-807-32,142,14
Alcohols, C13-15-branched and linear, ethoxylatedAlcohols, C13-15-branched and linear, ethoxylated (1-2,5 mol EO)Non-active substance157627-86-61,01,0
Diphenyl ether1,1'-Oxybis-benzeneNon-active substance101-84-8202-981-20,00,0045
2.2.Type(s) of formulation
Formulation(s)AL – Any other liquid
PART IISECOND INFORMATION LEVEL – META SPC(S)META SPC 11.META SPC 1 ADMINISTRATIVE INFORMATION1.1.Meta SPC 1 identifier
Identifier100 % Limescale
1.2.Suffix to the authorisation number
Number1-1
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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 1
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
Hydrochloric acidHydrochloric acidActive Substance231-595-76,06,0
2,2'-(octadec-9-enylimino)bisethanol2-[(2-hydroxyethyl)[(9E)-octadec-9-en-1-yl]amino]ethan-1-olNon-active substance25307-17-9246-807-32,142,14
Alcohols, C13-15-branched and linear, ethoxylatedAlcohols, C13-15-branched and linear, ethoxylated (1-2,5 mol EO)Non-active substance157627-86-61,01,0
Diphenyl ether1,1'-Oxybis-benzeneNon-active substance101-84-8202-981-20,00,0045
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 statementsMay be corrosive to metals.Causes severe skin burns and eye damage.Harmful to aquatic life with long lasting effects.
Precautionary statementsIf 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 14.1.Use description
Table 1Use # 1 – Bactericide – disinfection of toilet bowl above the water line – non-professionals
Product typePT02 – 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: BacteriaDevelopment stage: not applicable
Field(s) of useIndoorToilet bowl disinfectant
Application method(s)Method: PouringDetailed description:Apply product under the toilet bowl rim to cover the surface (above the waterline) completely.
Application rate(s) and frequencyApplication 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 usersGeneral public (non-professional)
Pack sizes and packaging materialBOTTLE: High-density polyethylene, 750 ml, opaque.CAP: Polypropylene.INSERT: Linear low-density polyethylene.Child resistant fastening.
4.1.1.Use-specific instructions for useSee general instructions for use.4.1.2.Use-specific risk mitigation measuresSee 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 environmentSee general instructions for use.4.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee 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 storageSee general instructions for use.5.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1. OF THE META SPC 15.1.Instructions for useLift 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 measuresThe 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 environmentIf 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 packagingAt 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 storageShelf-life is 4 years at room temperature.Keep out of reach of children and non-target animals/pets.6.OTHER INFORMATIONAdditional 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 17.1.Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)Duck® 100 % Anti-LimescaleMarket area: EU
Duck® 100 % Limescale MarineMarket area: EU
Duck® 100 % Limescale Remover MarineMarket area: EU
Duck® 100 % Anticalcar – detergent lichid pentru toaletăMarket area: EU
Duck® 100 % Anticalcare MarineMarket area: EU
Duck® 100 % DisincrostanteMarket area: EU
Duck® 100 % Kalkfri – MarineMarket area: EU
Duck® 100 % Kalkfjerner – MarineMarket area: EU
Duck® 100 % Κατά των ΑλάτωνMarket area: EU
Duck® 100 % κατά των αλάτων – MarineMarket area: EU
Duck® 100 % против котлен камъкMarket area: EU
Duck® 100 % Odstraňovač vodného kameňaMarket area: EU
Duck® 100 % odstraňovač vodného kameňa – MarineMarket area: EU
Duck® 100 % odstraňovač vodního kameneMarket area: EU
Duck® 100 % odstraňovač vodního kamene – MarineMarket area: EU
Duck® 100 % przeciw kamieniowi Marine – żel do czyszczenia i dezynfekcji toaletMarket area: EU
Duck® 100 %-tni uništavač kamenca MarineMarket area: EU
Duck® 100 % vízkőoldó – WC tisztító folyadékMarket area: EU
Duck® 100 % vízkőoldó marine – WC tisztító fertőtlenítő folyadékMarket area: EU
Canard® 100 % Anti-tartreMarket area: EU
Canard® 100 % Détartrant MarineMarket area: EU
Canard® 100 % Détartrant Marine/Canard® 100 % Kalkaanslagvernietiger MarineMarket area: EU
WC-Ente® 100 % Anti-KalkMarket area: EU
WC Ente® 100 % ANTI-KALK MarineMarket area: EU
WC-EEND® Nr. 1 Ontkalker toiletreiniger MarineMarket area: EU
Pato® 100 % Anti-calMarket area: EU
Pato® 100 % Anti-cal MarineMarket area: EU
Pato® 100 % AnticalcárioMarket area: EU
Pato® 100 % Anticalcário MarineMarket area: EU
00 null null® Urinstein & KalklöserMarket area: EU
00 null null® Urinstein & Kalklöser – MarineMarket area: EU
Authorisation numberEU-0030299-0001 1-1
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Hydrochloric acidHydrochloric acidActive Substance231-595-76,0
2,2'-(octadec-9-enylimino)bisethanol2-[(2-hydroxyethyl)[(9E)-octadec-9-en-1-yl]amino]ethan-1-olNon-active substance25307-17-9246-807-32,14
Alcohols, C13-15-branched and linear, ethoxylatedAlcohols, C13-15-branched and linear, ethoxylated (1-2,5 mol EO)Non-active substance157627-86-61,0
Diphenyl ether1,1'-Oxybis-benzeneNon-active substance101-84-8202-981-20,0045
7.2.Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)Duck® 100 % Limescale CitrusMarket area: EU
Duck® 100 % Limescale Remover CitrusMarket area: EU
Duck® 100 % Anticalcare CitrusMarket area: EU
Duck® 100 % Anticalcar Citrus – detergent lichid pentru toaletăMarket area: EU
Duck® 100 % Kalkfri – CitrusMarket area: EU
Duck® 100 % Kalkfjerner – CitrusMarket area: EU
Duck® 100 % κατά των αλάτων – CitrusMarket area: EU
Duck® 100 % против котлен камък – ЦитрусMarket area: EU
Duck® 100 % odstraňovač vodného kameňa – CitrusMarket area: EU
Duck® 100 % odstraňovač vodního kamene – CitrusMarket area: EU
Duck® 100 % przeciw kamieniowi Citrus – żel do czyszczenia i dezynfekcji toaletMarket area: EU
Duck® 100 %-tni uništavač kamenca CitrusMarket area: EU
Duck® 100 % vízkőoldó Citrus – WC tisztító fertőtlenítő folyadékMarket area: EU
Canard® 100 % Anti-tartre CitrusMarket area: EU
Canard® 100 % Détartrant CitrusMarket area: EU
Canard® 100 % anti-tartre – Fraîcheur CitronMarket area: EU
Canard® 100 % Détartrant Citrus/Canard® 100 % Kalkaanslagvernietiger CitrusMarket area: EU
WC Ente® 100 % ANTI-KALK CitrusMarket area: EU
WC-EEND® Nr. 1 Ontkalker toiletreiniger CitrusMarket area: EU
Pato® 100 % Anti-cal CitrusMarket area: EU
Pato® 100 % Anticalcário CitrusMarket area: EU
00 null null® Urinstein & Kalklöser – CitrusMarket area: EU
Authorisation numberEU-0030299-0002 1-1
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Hydrochloric acidHydrochloric acidActive Substance231-595-76,0
2,2'-(octadec-9-enylimino)bisethanol2-[(2-hydroxyethyl)[(9E)-octadec-9-en-1-yl]amino]ethan-1-olNon-active substance25307-17-9246-807-32,14
Alcohols, C13-15-branched and linear, ethoxylatedAlcohols, C13-15-branched and linear, ethoxylated (1-2,5 mol EO)Non-active substance157627-86-61,0