A Union authorisation with authorisation number EU-0026816-0000 is granted to Arche Consortia for the making available on the market and use of the single biocidal product ‘Arche Chlorine’ 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 ‘Arche Chlorine’ as laid down in the summary of product characteristics in the Annex.
The Union authorisation is valid from 3 May 2023 to 30 April 2033.
ANNEXSupplementary provisions
ANNEX
Summary of product characteristics for a biocidal product
Arche Chlorine
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-0026816-0000
R4BP asset number: EU-0026816-0000
1. ADMINISTRATIVE INFORMATION
1.1. Trade name(s) of the product
Trade name(s)
Arche Chlorine
1.2. Authorisation holder
Name and address of the authorisation holder
Name
ARCHE Consortia
Address
Liefkensstraat 35D, 9032 Wondelgem Belgium
Authorisation number
EU-0026816-0000
R4BP asset number
EU-0026816-0000
Date of the authorisation
3 May 2023
Expiry date of the authorisation
30 April 2033
1.3. Manufacturer(s) of the product
Name of manufacturer
PCC Rokita SA
Address of manufacturer
Sienkiewicza 4, 56-120 Brzeg Dolny Poland
Location of manufacturing sites
Sienkiewicza 4, 56-120 Brzeg Dolny Poland
1.4. Manufacturer(s) of the active substance(s)
Active substance
Active chlorine released from chlorine
Name of manufacturer
PCC Rokita SA
Address of manufacturer
Sienkiewicza 4, 56-120 Brzeg Dolny Poland
Location of manufacturing sites
Sienkiewicza 4, 56-120 Brzeg Dolny Poland
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 Cl 2 )
Drum: 400-1 000 l (500-1 250 kg Cl 2 )
Railway tanks: 43 000 -44 000 l (53 750 -55 000 kg Cl 2 )
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 Cl 2 ;
Concentration range after completion of treatment: maximum 0,3 mg/l free Cl 2 , minimum 0,1 mg/l free Cl 2 (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 Cl 2 and concentration of up to 0,6 mg/l free Cl 2 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 Cl 2 )
Drum: 400-1 000 l (500-1 250 kg Cl 2 )
Railway tanks: 43 000 -44 000 l (53 750 -55 000 kg Cl 2 )
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 (recast) ( 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 Cl 2 ;
Concentration range after completion of treatment: maximum 0,3 mg/l free Cl 2 , min 0,1 mg/L free Cl 2 (including the amounts before treatment and from other treatments)
In exceptional cases an addition of up to 6 mg/l free Cl 2 and concentration up to 0,6 mg/l free Cl 2 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 Cl 2 )
Drum: 400-1 000 l (500-1 250 kg Cl 2 )
Railway tanks: 43 000 -44 000 l (53 750 -55 000 kg Cl 2 )
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 (EU) Directive 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (recast) ( 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 Cl 2 ;
Concentration range after completion of treatment: maximum 0,3 mg/l free Cl 2 , min 0,1 mg/L free Cl 2 (including the amounts before treatment and from other treatments)
In exceptional cases an addition of up to 6 mg/l free Cl 2 and concentration up to 0,6 mg/l free Cl 2 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 Cl 2 )
Drum: 400-1 000 l (500-1 250 kg Cl 2 )
Railway tanks: 43 000 -44 000 l (53 750 -55 000 kg Cl 2 )
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 (EU) Directive 2020/2184 of 16 December 2020 on the quality of water intended for human consumption (recast) ( 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 Cl 2 )
Drum: 400-1 000 l (500-1 250 kg Cl 2 )
Railway tanks: 43 000 -44 000 l (53 750 -55 000 kg Cl 2 )
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/m 3 (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.
