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)
Date: 2022-04-01
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: Belgium, biocide, chemical product, chlorine, decontamination, market approval, pharmaceutical product








L_2022105EN.01000701.xml










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.