Commission Implementing Regulation (EU) 2023/2704 of 28 November 2023 granting a Union authorisation for the single biocidal product GHC Chlor
Date: 2023-11-28
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: Germany, biocide, chemical product, chlorine, decontamination, drinking water, market approval, pharmaceutical product








L_202302704EN.000101.fmx.xml












Official Journal of the European Union


EN
Series L













2023/2704


30.11.2023







            COMMISSION IMPLEMENTING REGULATION (EU) 2023/2704
of 28 November 2023
         
granting a Union authorisation for the single biocidal product ‘GHC Chlor’
         
(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 10 December 2018, GHC Gerling, Holz & Co. Handels GmbH submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for authorisation of the same single biocidal product, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named ‘GHC Chlor’ of product-types 2 (disinfectants and algaecides not intended for direct application to humans or animals) and 5 (drinking water) as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-EN045705-33 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference single biocidal product ‘Arche Chlorine’, recorded in the Register under case number BC-UQ045679-98.












(2)


‘GHC Chlor’ contains active chlorine released from chlorine 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-types 2 and 5.












(3)


On 3 August 2021, the Agency submitted to the Commission its opinion (3) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘GHC Chlor’ in accordance with Article 6(1) and (2) of Implementing Regulation (EU) No 414/2013.












(4)


In its opinion, the Agency concludes that the differences, proposed by GHC Gerling, Holz & Co. Handels GmbH, between the same biocidal product and the related reference biocidal product are limited to information which can be the subject of an administrative change in accordance with Article 11 of Commission Implementing Regulation (EU) No 354/2013 (4), and that based on the assessment of Arche Chlorine and subject to compliance with the draft SPC, the same single biocidal product meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012.












(5)


On 15 June 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.












(6)


The Commission also considers that the request made by Germany to adjust the conditions of the Union authorisation of the single biocidal product ‘Arche Chlorine’ for its territory in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012 also applies for the uses 2, 3 and 4 of ‘GHC Chlor’. This adjustment is justified in recitals 7 to 9 of Commission Implementing Regulation (EU) 2023/754 (5) granting a Union authorisation for the single biocidal product ‘Arche Chlorine’ in accordance with 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 the same single biocidal product ‘GHC Chlor’ with the adjustments of the SPC as requested by Germany for its territory for the uses 2, 3 and 4 in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012.












(8)


The expiry date of this authorisation is aligned to the expiry date of the reference single biocidal product ‘Arche Chlorine’.












(9)


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-0027044-0000 is granted to GHC Gerling, Holz & Co. Handels GmbH for the making available on the market and use of the same single biocidal product ‘GHC Chlor’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
For the territory of the Federal Republic of Germany, adjustments to the terms and conditions apply for the uses 2, 3 and 4 of ‘GHC Chlor’ as laid down in the summary of product characteristics in the Annex.
The Union authorisation is valid from 20 December 2023 until 30 April 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, 28 November 2023.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1.

(2)  Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4).

(3)  ECHA opinion of 3 August 2021 on the Union authorisation of the same single biocidal product ‘GHC Chlor’ (https://echa.europa.eu/opinions-on-union-authorisation).

(4)  Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4).

(5)  Commission Implementing Regulation (EU) 2023/754 of 12 April 2023 granting a Union authorisation for the single biocidal product ‘Arche Chlorine’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 100, 13.4.2023, p. 83).




ANNEX
Summary of product characteristics for a biocidal product

GHC Chlor


Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)


Product type 5 – Drinking water (Disinfectants)


Authorisation number: EU-0027044-0000


R4BP asset number: EU-0027044-0000

1.   ADMINISTRATIVE INFORMATION
1.1.   Trade name(s) of the product







Trade name(s)


Chlor
GHC Chlor
Chlorine
GHC Chlorine
Chlore
GHC Chlore
хлор
GHC хлор
Klor
GHC Klor
χλώριο
GHC χλώριο
Chloor
GHC Chloor
Chlor kapalný
GHC Chlor kapalný
Kloor
GHC Kloor
Kloori
GHC Kloori
Klór
GHC Klór
Cloro
GHC Cloro
Hlors
GHC Hlors
Chloras
GHC Chloras
Klorur
GHC Klorur
Clor
GHC Clor
Chlór
GHC Chlór
BOC Chlorine
Chlor flüssig > 99,8 %
CHLORGAS FLUESSIG (99,8 %)
trave Chlor




1.2.   Authorisation holder








Name and address of the authorisation holder


Name


GHC Gerling, Holz & Co. Handels GmbH




Address


Ruhrstraße 113, 22761 Hamburg, Germany




Authorisation number


EU-0027044-0000





R4BP asset number



EU-0027044-0000




Date of the authorisation


20 December 2023




Expiry date of the authorisation


30 April 2033




1.3.   Manufacturer(s) of the product







Name of manufacturer


GHC Gerling, Holz & Co. Handels GmbH




Address of manufacturer


Ruhrstraße 113, 22761 Hamburg, Germany




Location of manufacturing sites







Ruhrstraße 113, 22761 Hamburg, Germany




Kinzigheimer Weg 109, 63450 Hanau, Germany




Siemensstraße 20, 41542 Dormagen, Germany




Breitenau 15, 85232 Bergkirchen, Germany




Löbejüner Straße 21, 06193 Wettin-Löbejün OT Merbit, Germany




Waldstraße 13, 64584 Biebesheim, Germany




Am Haupttor/Bau 3651, 06237 Leuna, Germany

















Name of manufacturer


GHC Invest s.r.o.




Address of manufacturer


Korunovační 103/6, 170 00 Praha 7, Czech Republic




Location of manufacturing sites







Korunovační 103/6, 170 00 Praha 7, Czech Republic




Tovární 157, 277 11 Neratovice, Czech Republic




Na Letišti 415/104, 750 02 Bochoř okres Přerov, Czech Republic




Minická 635, 278 01 Kralupy nad Vltavou, Czech Republic








1.4.   Manufacturer(s) of the active substance(s)







Active substance


Active chlorine released from chlorine




Name of manufacturer


Nobian Industrial Chemicals BV




Address of manufacturer


Velperweg 76, 6824 BM Arnhem, Netherlands




Location of manufacturing sites







Hauptstraße 47, 49479 Ibbenbüren, Germany




Elektrolysestr. 1, 06749 Bitterfeld, Germany




Industriepark Höchst Geb. B598, 65926 Frankfurt am Main Germany

















Active substance


Active chlorine released from chlorine




Name of manufacturer


Arkema France




Address of manufacturer


85 route Nationale, 38560 Jarrie, France




Location of manufacturing sites


85 route Nationale, 38560 Jarrie, France













Active substance


Active chlorine released from chlorine




Name of manufacturer


CABB GmbH




Address of manufacturer


Ludwig Hermann Str. 100, 86368 Gersthofen, Germany




Location of manufacturing sites


Ludwig Hermann Str. 100, 86368 Gersthofen, Germany













Active substance


Active chlorine released from chlorine




Name of manufacturer


Donau Chemie AG




Address of manufacturer


Klagenfurter Str. 17, 9371 Brückl, Austria




Location of manufacturing sites


Klagenfurter Str. 17, 9371 Brückl, Austria













Active substance


Active chlorine released from chlorine




Name of manufacturer


Inovyn Chlorvinyls Limited




Address of manufacturer


South Parade WA7, 4JE Runcorn, United Kingdom




Location of manufacturing sites


South Parade WA7, 4JE Runcorn, United Kingdom













Active substance


Active chlorine released from chlorine




Name of manufacturer


Métaux Spéciaux (MSSA S.A.S.)




Address of manufacturer


111 rue de la Volta, 73600 Saint-Marcel, France




Location of manufacturing sites


111 rue de la Volta, 73600 Saint-Marcel, France













Active substance


Active chlorine released from chlorine




Name of manufacturer


PCC Rokita SA




Address of manufacturer


ul. Sienkiewicza 4, 56-120 Brzeg Dolny, Poland




Location of manufacturing sites


ul. Sienkiewicza 4, 56-120 Brzeg Dolny, Poland













Active substance


Active chlorine released from chlorine




Name of manufacturer


PPC SAS




Address of manufacturer


95 rue du Général de Gaulle, 68800 Thann Cedex, France




Location of manufacturing sites


95 rue du Général de Gaulle, 68800 Thann Cedex, France













Active substance


Active chlorine released from chlorine




Name of manufacturer


Vencorex France SAS




Address of manufacturer


Rue Lavoisier, 38800 Le Pont de Claix, France




Location of manufacturing sites


Rue Lavoisier, 38800 Le Pont de Claix, France




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 chlorine


 


Active Substance


 


 


100,0 




chlorine


chlorine


Non-active substance


7782-50-5


231-959-5


100,0 




2.2.   Type of formulation

GA – Gas
3.   HAZARD AND PRECAUTIONARY STATEMENTS






Hazard statements


May cause or intensify fire; oxidiser
Causes skin irritation.
Causes serious eye irritation.
Toxic if inhaled.
May cause respiratory irritation.
Very toxic to aquatic life.
Contains gas under pressure; may explode if heated




Precautionary statements


Keep away from clothing and other combustible materials.
Do not breathe gas.
Avoid release to the environment.
Wear protective gloves.
Wear protective clothing.
Wear eye protection.
Wear face protection.
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.
Collect spillage.
Store in a well-ventilated place.Keep container tightly closed.
Store locked up.
Protect from sunlight.Store in a well-ventilated place.
In case of fire: Stop leak if safe to do so.
Dispose of contents to local regulation.
Keep valves and fittings free from oil and grease.
Call a doctor if you feel unwell.
Avoid breathing gas.
Wash hands thoroughly after handling.
Use only outdoors or in a well-ventilated area.
IF ON SKIN: Wash with plenty of water.
Call a Poison center/doctor.
Specific treatment (see reference to supplemental first aid instruction on this label).
If skin irritation occurs:Get medical attention.
If eye irritation persists:Get medical attention.
Take off contaminated clothing.And wash it before reuse.




4.   AUTHORISED USE(S)
4.1.   Use description


Table 1


Use # 1 – Disinfection of waste water after the waste water plant







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)


Scientific name: bacteria
Common name: Bacteria
Development stage:
Scientific name: viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor
Outdoor
Disinfection of waste water after the waste water plant, by shock dosing (in case of contamination).




Application method(s)


Method: Closed system
Detailed description:
Automated dosing system.




Application rate(s) and frequency


Application Rate: Shock dosing: 477 mg/l active chlorine (AC) under dirty conditions.
Dilution (%): –
Number and timing of application:
Contact time: 30 minutes




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Cylinder: 4,8-140 l (6-175 kg Cl2)
Drum: 400-1 000  l (500-1 250  kg Cl2)
Railway tanks: 43 000 -44 000  l (53 750 -55 000  kg Cl2)
Carbon/stainless steel




4.1.1.   Use-specific instructions for use

Connect the chlorine cylinder or drum to the automated dosing system, closed dosing system. Set up the parameters of the system to obtain an active chlorine concentration in the water according to the application rate indicated above.
4.1.2.   Use-specific risk mitigation measures

Reduce residual concentrations of active chlorine by active carbon filtration or addition of reducing agents (e.g. ascorbic acid or sodium ascorbate) before discharging the waste water to surface water. Alternatively, water can be retained in a buffer before discharge.
Regular water quality assessments should be performed to assure the effluent meets all required quality standards.
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 Section 5 – General directions for use.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See Section 5 – 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 Section 5 – General directions for use.
4.2.   Use description


Table 2


Use # 2 – Disinfection of drinking water at drinking water suppliers







Product type


PT05 – Drinking water (Disinfectants)




Where relevant, an exact description of the authorised use


/




Target organism(s) (including development stage)


Scientific name: bacteria
Common name: Bacteria
Development stage:
Scientific name: viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor
Outdoor
Disinfection at the drinking water suppliers and their water distribution systems, by continuous dosing.




Application method(s)


Method: Closed system
Detailed description:
Automated dosing system
Adjustment applicable in the territory of the Federal Republic of Germany in accordance with Article 44(5) of Regulation (EU) No 528/2012:
In accordance with the list of treatment substances and disinfection processes of paragraph 11 of the German Drinking Water Ordinance (1), the technical rules for dosing set out in the Deutscher Verein des Gas Wasserfaches e.V (2) – working sheets W 229, W 296, W 623 and the minimum contact time of W 229 apply (3). (See section 6 for further references)




Application rate(s) and frequency


Application Rate: 0,5 mg/l active chlorine (AC) as residual concentration in the system
Dilution (%): –
Number and timing of application:
Frequency: continuous dosing
Adjustment applicable in the territory of the Federal Republic of Germany in accordance with Article 44(5) of Regulation (EU) No 528/2012:
In accordance with the list of treatment substances and disinfection processes of paragraph 11 of the German Drinking Water Ordinance (See section 6 for further reference) (4)
Application rate:
Maximum addition 1,2 mg/l free Cl2

Concentration range after completion of treatment: maximum 0,3 mg/l free Cl2, minimum 0,1 mg/l free Cl2 (including the amounts before treatment and from other treatments) as residual concentration in the system
In exceptional cases an addition of up to 6 mg/l free Cl2 and concentration of up to 0,6 mg/l free Cl2 after treatment is acceptable as residual concentration in the system, if disinfection cannot be ensured by other means or if disinfection is temporarily impaired by ammonium.




Category(ies) of users


Professional




Pack sizes and packaging material


Cylinder: 4,8-140 l (6-175 kg Cl2)
Drum: 400-1 000  l (500-1 250  kg Cl2)
Railway tanks: 43 000 -44 000  l (53 750 -55 000  kg Cl2)
Carbon/stainless steel




4.2.1.   Use-specific instructions for use

Connect the chlorine cylinder or drum to the automated, closed dosing system. Set up the parameters of the system to obtain an active chlorine concentration in the water according to the application rate indicated above.
Please note that some Member States after primary disinfection, request to maintain a residual level of available chlorine in drinking water in the pipes as a precautionary measure. This additional amount, claimed by the applicant as ‘Secondary disinfection: 0,1 to 0,5 mg/l available chlorine (residual)’ has been considered as ‘covered by the primary disinfection’.
4.2.2.   Use-specific risk mitigation measures

Ensure that the concentration of chlorine in the drinking water does not exceed national chlorine limits before consumption.
Ensure that the concentration of chlorate present in the drinking water does not exceed the parametric values set in Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (OJ L 435, 23.12.2020, p. 1).
4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See Section 5 – General directions for use
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See Section 5 – General directions for use
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See Section 5 – General directions for use
4.3.   Use description


Table 3


Use # 3 – Disinfection of water in reservoirs







Product type


PT05 – Drinking water (Disinfectants)




Where relevant, an exact description of the authorised use


/




Target organism(s) (including development stage)


Scientific name: bacteria
Common name: Bacteria
Development stage:
Scientific name: viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor
Outdoor
Disinfection of water (with water coming from tap water network), in reservoirs/tanks, by continuous dosing.




Application method(s)


Method: Closed system
Detailed description:
Automated dosing system. The disinfection is carried out in the inlet of the reservoir, in order to assure proper distribution of the disinfectant in the water.
Adjustment applicable in the territory of the Federal Republic of Germany in accordance with Article 44(5) of Regulation (EU) No 528/2012:
In accordance with the list of treatment substances and disinfection processes of paragraph 11 of the German Drinking Water Ordinance (1), the technical rules for dosing set out in the Deutscher DeutscherVerein des Gas Wasserfaches e.V (2) – working sheets W 229, W 296, W 623 and the minimum contact time of W 229 apply (3). (See section 6 for further references)




Application rate(s) and frequency


Application Rate: 0,5 mg/l Active Chlorine (AC) as residual concentration in the system.
Dilution (%): –
Number and timing of application:
Frequency: continuous dosing
Adjustment applicable in the territory of the Federal Republic of Germany in accordance with Article 44(5) of Regulation (EU) No 528/2012:
In accordance with the list of treatment substances and disinfection processes of paragraph 11 of the German Drinking Water Ordinance (1). (See section 6 for further reference) (4).
Application rate: maximum addition 1,2 mg/l free Cl2;
Concentration range after completion of treatment: maximum 0,3 mg/l free Cl2, min 0,1 mg/L free Cl2 (including the amounts before treatment and from other treatments)
In exceptional cases an addition of up to 6 mg/l free Cl2 and concentration up to 0,6 mg/l free Cl2 after treatment is acceptable, if disinfection cannot be ensured by other means or if disinfection is temporarily impaired by the presence of ammonium.




Category(ies) of users


Professional




Pack sizes and packaging material


Cylinder: 4,8-140 l (6-175 kg Cl2)
Drum: 400-1 000  l (500-1 250  kg Cl2)
Railway tanks: 43 000 -44 000  l (53 750 -55 000  kg Cl2)
Carbon/stainless steel




4.3.1.   Use-specific instructions for use

Connect the chlorine cylinder or drum to the automated, closed dosing system. Set up the parameters of the system to obtain a continuous active chlorine concentration in the water according to the application rate indicated above.
4.3.2.   Use-specific risk mitigation measures

Ensure that the concentration of chlorine in the drinking water does not exceed national chlorine limit before consumption.
Ensure that the concentration of chlorate present in the drinking water does not exceed the parametric values set in Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (OJ L 435, 23.12.2020, p. 1).
4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See Section 5 – General directions for use
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See Section 5 – General directions for use
4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See Section 5 – General directions for use
4.4.   Use description


Table 4


Use # 4 – Disinfection of water in collective systems







Product type


PT05 – Drinking water (Disinfectants)




Where relevant, an exact description of the authorised use


/




Target organism(s) (including development stage)


Scientific name: bacteria
Common name: Bacteria
Development stage:
Scientific name: viruses
Common name: Viruses
Development stage:
Scientific name: legionella pneumophila
Common name: Bacteria
Development stage:




Field(s) of use


Indoor
Outdoor
In Public institutions, healthcare facilities
Disinfection of drinking water in collective drinking water systems by continuous dosing




Application method(s)


Method: Closed system
Detailed description:
Automated dosing system
Adjustment applicable in the territory of the Federal Republic of Germany in accordance with Article 44(5) of Regulation (EU) No 528/2012:
In accordance with the list of treatment substances and disinfection processes of paragraph 11 of the German Drinking Water Ordinance, the requirements set out in the Deutscher Verein des Gas Wasserfaches e.V (2) – working sheets W 229, W 296, W 623 and the minimum contact time of W 229 apply (3). (See section 6 for further references).




Application rate(s) and frequency


Application Rate: 1 mg/l active chlorine (AC) as residual concentration in the system
Dilution (%): –
Number and timing of application:
Frequency: continuous dosing
Adjustment applicable in the territory of the Federal Republic of Germany in accordance with Article 44(5) of Regulation (EU) No 528/2012:
In accordance with the list of treatment substances and disinfection processes of paragraph 11 of the German Drinking Water Ordinance (1). (See section 6 for further reference) (4)
Application rate: maximum addition 1,2 mg/l free Cl2;
Concentration range after completion of treatment: maximum 0,3 mg/l free Cl2, min 0,1 mg/L free Cl2 (including the amounts before treatment and from other treatments)
In exceptional cases an addition of up to 6 mg/l free Cl2 and concentration up to 0,6 mg/l free Cl2 after treatment is acceptable, if disinfection cannot be ensured by other means or if disinfection is temporarily impaired by the presence of ammonium.




Category(ies) of users


Professional




Pack sizes and packaging material


Cylinder: 4,8-140 l (6-175 kg Cl2)
Drum: 400-1 000  l (500-1 250  kg Cl2)
Railway tanks: 43 000 -44 000  l (53 750 -55 000  kg Cl2)
Carbon/stainless steel




4.4.1.   Use-specific instructions for use

Connect the chlorine cylinder or drum to the automated, closed dosing system. Set up the parameters of the system to obtain a continuous active chlorine concentration in the water according to the application rate indicated above.
4.4.2.   Use-specific risk mitigation measures

Ensure that the concentration of chlorine in the drinking water does not exceed national chlorine limit before consumption.
Ensure that the concentration of chlorate present in the drinking water does not exceed the parametric values set in Directive (EU) 2020/2184 of 16 December 2020 on the quality of water intended for human consumption (OJ L 435, 23.12.2020, p. 1).
4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See Section 5 – General directions for use
4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See Section 5 – General directions for use
4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See Section 5 – General directions for use
4.5.   Use description


Table 5


Use # 5 – Disinfection of drinking water for animals







Product type


PT05 – Drinking water (Disinfectants)




Where relevant, an exact description of the authorised use


/




Target organism(s) (including development stage)


Scientific name: bacteria
Common name: Bacteria
Development stage:
Scientific name: viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor
Outdoor
Disinfection of drinking water for animals (with water coming from tap water network) in agricultural areas, by continuous dosing.




Application method(s)


Method: Closed system
Detailed description:
Automated dosing system




Application rate(s) and frequency


Application Rate: 0,5 mg/l active chlorine (AC) as residual concentration in the system.
Dilution (%): –
Number and timing of application:
Frequency: continuous dosing




Category(ies) of users


Professional




Pack sizes and packaging material


Cylinder: 4,8-140 l (6-175 kg Cl2)
Drum: 400-1 000  l (500-1 250  kg Cl2)
Railway tanks: 43 000 -44 000  l (53 750 -55 000  kg Cl2)
Carbon/stainless steel




4.5.1.   Use-specific instructions for use

Connect the chlorine cylinder or drum to the automated, closed dosing system. Set up the parameters of the system to obtain a continuous active chlorine concentration in the water according to the application rate indicated above.
4.5.2.   Use-specific risk mitigation measures

For food commodities, ensure that the concentration of chlorate present in food does not exceed the MRL values set in Commission Regulation (EU) 2020/749 of 4 June 2020 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlorate in or on certain products (OJ L 178, 8.6.2020, p. 7).
4.5.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See Section 5 – General directions for use
4.5.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See Section 5 – General directions for use
4.5.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See Section 5 – General directions for use
5.   GENERAL DIRECTIONS FOR USE (1)

5.1.   Instructions for use

–
5.2.   Risk mitigation measures

For connecting or disconnecting the product containers as well as for maintenance or repair of the gas pipe system, the following risk mitigation measures (RMMs) are mandatory:






—


an alarm system (trigger value corresponding to the acute exposure concentration (AEC): 0,5 mg active chlorine/m3 (or lower according to national legislation) which initiates safety procedures like wearing respiratory protective equipment (RPE) according to CEN standard EN14387: Respiratory protective devices – Gas filter(s) and combined filter(s) – Requirements, testing, marking (or equivalent);










—


application of local exhaust ventilation (LEV) (according to the national legislation) and low-pressure/vacuum are in place to avoid chlorine emission;










—


the electrochemical sensors used for measurements to detect various chlorinated species in addition to chlorine itself;










—


sensors to measure exposure also when the operators are using RPE according to CEN standard EN141 or equivalent.




5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Avoid breathing this toxic gas as much as possible. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Immediately call 112/ambulance for medical assistance.
Information for healthcare personnel/doctor:






 


Immediately initiate life support measures, thereafter call a POISON CENTRE.










 


IF SWALLOWED: Not applicable.










 


IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.










 


IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. 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 of unused product and the packaging in accordance with local requirements.
Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) or down the drains.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Storage conditions:






 


Airtight pressure tanks: Due to its chemical and physical properties, chlorine gas is always stored in dedicated carbon/steel recipients with special, dedicated valves. Chlorine packages for use within the EU should be constructed and labelled according to Directive 2010/35/EU of the European Parliament and of the Council (5) and the Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) done at Geneva on 30 September 1957. See section 6 for further reference. Maximum filling 1,25 kg/l (80 % of volume approx.).










 


Keep containers with chlorine tightly closed and store in a cool, dry and well-ventilated place. Tightly screw on the valve outlet protection seal and the valve protection cap when storing. Prevent cylinders from falling over. Protect from heat and direct sunlight, the temperature of the container should never be below 15 °C or above 50 °C.










 


Chlorine should be kept away from reactive products (materials to avoid: reducing agents, combustible materials, metals in powder, acetylene, hydrogen, ammonia, hydrocarbons and organic materials).




6.   OTHER INFORMATION
With respect to the ‘Category(ies) of users’ note:
Professionals (including industrial users) means trained professionals if this is required by national legislation.






(1)


German Drinking Water Ordinance: Trinkwasserverordnung in der Fassung der Bekanntmachung vom 10. März 2016 (BGBl. I S. 459), die zuletzt durch Artikel 1 der Verordnung vom 22. September 2021 (BGBl. I S. 4343) geändert worden ist; list of treatment substances and disinfection processes of paragraph 11 of the German Drinking Water Ordinance: Bekanntmachung des Umweltbundesamtes der Liste der Aufbereitungsstoffe und Desinfektionsverfahren gemäß § 11 der Trinkwasserverordnung – 21. Änderung – (Stand: Dezember 2019).










(2)


Deutscher Verein des Gas- und Wasserfaches e.V. (German Technical and Scientific Association for Gas and Water).










(3)


Part II, Lfd. Nr.4 of the list of treatment substances and disinfection processes of paragraph 11 of the German Drinking Water Ordinance.










(4)


Part I c, Lfd. Nr.2 of the list of treatment substances and disinfection processes of paragraph 11 of the German Drinking Water Ordinance.










(5)


Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC (OJ L 165, 30.6.2010, p. 1).






(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.



ELI: http://data.europa.eu/eli/reg_impl/2023/2704/oj
ISSN 1977-0677 (electronic edition)