CELEX: 32022R0527
Language: en
Date: 2022-04-01 00:00:00
Title: Commission Implementing Regulation (EU) 2022/527 of 1 April 2022 granting a Union authorisation for the single biocidal product ‘ARIEL chlorine Professional System 5 chlorine bleach for white wash’ (Text with EEA relevance)

4.4.2022   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 105/7
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2022/527
         of 1 April 2022
         granting a Union authorisation for the single biocidal product ‘ARIEL chlorine Professional System 5 chlorine bleach for white wash’
         (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 11 December 2018, Procter & Gamble Services Company NV submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a single biocidal product named ‘ARIEL chlorine Professional System 5 chlorine bleach for white wash’ of product type 2, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Belgium had agreed to evaluate the application. The application was recorded under case number BC-ER045796-14 in the Register for Biocidal Products.
                  
               
                     (2)
                  
                  
                     ‘ARIEL chlorine Professional System 5 chlorine bleach for white wash’ contains active chlorine released from sodium hypochlorite 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.
                  
               
                     (3)
                  
                  
                     On 25 November 2020, 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 5 July 2021, the Agency submitted to the Commission an opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘ARIEL chlorine Professional System 5 chlorine bleach for white wash’ 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 ‘ARIEL chlorine Professional System 5 chlorine bleach for white wash’ 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 30 July 2021, 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 ‘ARIEL chlorine Professional System 5 chlorine bleach for white wash’.
                  
               
                     (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-0026814-0000 is granted to Procter & Gamble Services Company NV for the making available on the market and use of the single biocidal product ‘ARIEL chlorine Professional System 5 chlorine bleach for white wash’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
            The Union authorisation is valid from 24 April 2022 until 31 March 2032.
         
         
            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, 1 April 2022.
            
               
                  For the Commission
               
               
                  The President
               
               Ursula VON DER LEYEN
            
         
         
            (1)  OJ L 167, 27.6.2012, p. 1.
         
            (2)  ECHA opinion of 16 June 2021 on the Union authorisation of the biocidal product 'Ariel chlorine Professional System 5 chlorine bleach for white wash’ (ECHA/BPC/282/2021). https://echa.europa.eu/it/opinions-on-union-authorisation
      
      
         
            ANNEX
            Summary of product characteristics for a biocidal product
            
               ARIEL Chlorine Professional System 5 Chlorine Bleach for white wash
            
            
               Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
            
            
               Authorisation number: EU-0026814-0000
            
            
               R4BP asset number: EU-0026814-0000
            
            1.   ADMINISTRATIVE INFORMATION
            
            1.1.   Trade name(s) of the product
            
            
                        Trade name(s)
                     
                     
                        ARIEL Chlorine Professional System 5 Chlorine Bleach for white wash
                     
                  1.2.   Authorisation holder
            
            
                        Name and address of the authorisation holder
                     
                     
                        Name
                     
                     
                        Procter & Gamble Services Company NV
                     
                  
                        Address
                     
                     
                        Temselaan 100, 1853 Brussels Belgium
                     
                  
                        Authorisation number
                     
                     
                        EU-0026814-0000
                     
                  
                        
                           R4BP asset number
                        
                     
                     
                        EU-0026814-0000
                     
                  
                        Date of the authorisation
                     
                     
                        24 April 2022
                     
                  
                        Expiry date of the authorisation
                     
                     
                        31 March 2032
                     
                  1.3.   Manufacturer(s) of the product
            
            
                        Name of manufacturer
                     
                     
                        Sutter Industries S.p.A
                     
                  
                        Address of manufacturer
                     
                     
                        Località Leigozze 1, Borghetto, 15060 Borbera Italy
                     
                  
                        Location of manufacturing sites
                     
                     
                        Località Leigozze 1, Borghetto, 15060 Borbera Italy
                     
                  1.4.   Manufacturer(s) of the active substance(s)
            
            
                        Active substance
                     
                     
                        Active chlorine released from sodium hypochlorite
                     
                  
                        Name of manufacturer
                     
                     
                        ALTAIR CHIMICA S.p.A.
                     
                  
                        Address of manufacturer
                     
                     
                        Via Moie Vecchie n.13, 56048 Saline di Volterra (PI) Italy
                     
                  
                        Location of manufacturing sites
                     
                     
                        Via Moie Vecchie n.13, 56048 Saline di Volterra (PI) Italy
                     
                  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 (%)
                     
                  
                        Active chlorine released from sodium hypochlorite
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                         
                     
                     
                         
                     
                     
                        9,05 
                     
                  
                        Sodium hypochlorite
                     
                     
                        Sodium hypochlorite
                     
                     
                        Non-active substance
                     
                     
                        7681-52-9
                     
                     
                        231-668-3
                     
                     
                        9,5 
                     
                  2.2.   Type of formulation
            
            SL – Soluble concentrate
            3.   HAZARD AND PRECAUTIONARY STATEMENTS
            
            
                        Hazard statements
                     
                     
                        Contact with acids liberates toxic gas.
                        May be corrosive to metals.
                        Causes severe skin burns and eye damage.
                        Very toxic to aquatic life with long lasting effects.
                     
                  
                        Precautionary statements
                     
                     
                        Keep only in original packaging.
                        Do not breathe vapours.
                        Wash hands thoroughly after handling.
                        Avoid release to the environment.
                        Wear protective gloves.
                        Wear eye protection.
                        Wear protective clothing.
                        Immediately call a poison centre or doctor/physician.
                        IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
                        IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
                        IF INHALED: Remove person to fresh air and keep comfortable for breathing.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        Wash contaminated clothing before reuse.
                        Absorb spillage to prevent material damage.
                        Collect spillage.
                        Store locked up.
                        Dispose of contents to in accordance with local regulations.
                        Dispose of container to in accordance with local regulations.
                     
                  4.   AUTHORISED USE(S)
            
            4.1.   Use description
            
            
               Table 1. Use # 1 – Laundry disinfection (machine wash) in the post-wash rinsing phase
            
            
                        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:
                        Common name: Yeasts
                        Development stage:
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        In professional washing machines (such as washing-machines in restaurants, hotels, care-homes and non-healthcare facilities) via closed automatic dosing programs:
                        Disinfection of linen after cleaning. The product can only be used with Procter & Gamble professional automatic dosing equipment. The product is not authorized for manual dosing.
                     
                  
                        Application method(s)
                     
                     
                        Method: Closed system
                        Detailed description:
                        -
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Application Rate: 10,0 mL/L
                     
                  
                        Dilution (%):
                     
                  
                        Number and timing of application:
                     
                  
                        The product is added once via automatic dosing, for disinfection of clean laundry: after the washing/cleaning step delivered by using Ariel S1 Actilift detergent (commercial name of Ariel System S1), the water is drained/extracted. After a refill step with fresh water, the product is added for the main wash/first rinse bath.
                     
                  
                        The product is efficacious on clean items when used at 10 mL/L during 15 min contact time at +40 °C (liquor ratio = 1:5; with 4 kg ballast load)
                     
                  
                        Category(ies) of users
                     
                     
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        10L-20L HDPE canister with moulded handle and safety lock & key cap. UN certified for Dangerous goods.
                     
                  4.1.1.   Use-specific instructions for use
            
            See general directions for use.
            4.1.2.   Use-specific risk mitigation measures
            
            See general directions for use.
            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
            
            See general directions for use.
            5.   GENERAL DIRECTIONS FOR USE (1)
            
            5.1.   Instructions for use
            
            The biocidal product ARIEL Chlorine Professional System 5 chlorine bleach for white wash is intended to be used only during main wash, after pre-wash with Procter & Gamble Professional dosing equipment for disinfection of clean laundry:
            
                        —
                     
                     
                        Step 1 cleaning with Ariel System S1 (can be referred to as prewash or main wash) at 40 °C for 10 min: Wash water is drained, extracted, and refilled with fresh water prior to step 2;
                     
                  
                        —
                     
                     
                        Step 2 disinfection: this can be referred to as main wash (if the first step is a pre-wash) or first rinse bath (if the first step is a main wash). The second step containing ARIEL Chlorine Professional System 5 chlorine bleach for white wash is always performed at 40 °C for 15 min. This is followed by 1-2 rinse and drain phases and finally an extraction by spin.
                     
                  5.2.   Risk mitigation measures
            
            During handling product and during the maintenance of machines (repair broken dosing system):
            
                        —
                     
                     
                        Wear protective chemical resistant gloves (EN374).
                     
                  
                        —
                     
                     
                        Wear eyes protection (EN166)
                     
                  
                        —
                     
                     
                        Wear protective coverall (to be specified by the authorisation holder within the product information).
                     
                  5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            
                        
                           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 with plenty of water. Take off all contaminated clothing and wash it before reuse. Wash with soap and water and continue rinsing 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. Immediately call a Call 112/ambulance for medical assistance.
                     
                  
                        
                           If inhaled
                        
                     
                     
                        :
                     
                     
                        Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
                     
                  5.4.   Instructions for safe disposal of the product and its packaging
            
            
               For containment:
            
            
                        —
                     
                     
                        Scoop absorbed substance into closing containers. Do not use metal containers.
                     
                  
               Methods for cleaning up:
            
            
                        —
                     
                     
                        Small quantities of liquid spill: take up in non-combustible absorbent material and shovel into container for disposal. Large spills: contain released substance, pump into suitable containers. Do not use metal containers.
                     
                  
               Disposal:
            
            
                        —
                     
                     
                        This material and its container must be disposed of in a safe way, in accordance with local/regional/national regulations.
                     
                  
                        —
                     
                     
                        Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.
                     
                  5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage
            
            
               Storage conditions:
            
            
                        —
                     
                     
                        Store in original container.
                     
                  
               Incompatible materials:
            
            
                        —
                     
                     
                        Metals. acids. Reacts with (some) acids: Release of (highly) toxic gases/vapours (chlorine). May be corrosive to metals.
                     
                  
               Prohibitions on mixed storage:
            
            
                        —
                     
                     
                        Keep only in the original container in a cool, well-ventilated place away from (strong) acids.
                     
                  
               Storage area:
            
            
                        —
                     
                     
                        Store in a cool area. Store in a dry area.
                     
                  
                        —
                     
                     
                        Do not store at temperatures above 30 °C.
                     
                  
                        —
                     
                     
                        Protect from frost.
                     
                  
                        —
                     
                     
                        Keep away from direct sunlight.
                     
                  
                        —
                     
                     
                        Shelf life: 12 months
                     
                  6.   OTHER INFORMATION
            
            
               (1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.