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Date: 2023-12-07 Category: Not Applicable State: Union Government Country: Europe

Commission Implementing Regulation (EU) 2023/2727 of 30 November 2023 granting a Union authorisation for the single biocidal product PPC Chlorine liquid

Issued by European Commission · Directorate-General for Health and Food Safety

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Executive Summary & Key Takeaways

Executive Summary: This document is a Commission Implementing Regulation (EU) 2023/2727, granting Union authorisation to Vynova PPC SAS for the single biocidal product "PPC Chlorine liquid". The authorisation is valid from 27 December 2023 until 30 April 2033. The regulation specifies conditions for the product's use and placing on the market, including adjustments for use in Germany. Key Points / Main Content: * **Authorisation:** * Union authorisation EU0027045-0000 is granted to Vynova PPC SAS for PPC Chlorine liquid. * The authorisation is valid from December 27, 2023, to April 30, 2033. * **Product Information:** * Trade name: PPC Chlorine Liquid. * Product types: Disinfectants and algaecides (PT02), and drinking water disinfectants (PT05). * Active substance: Active chlorine released from chlorine. * Formulation type: Gas. * **Authorised Uses:** * Disinfection of wastewater (PT02). * Disinfection of drinking water at suppliers (PT05). * Disinfection of water in reservoirs (PT05). * Disinfection of water in collective systems (PT05). * Disinfection of drinking water for animals (PT05). * **Specific Instructions & Risk Mitigation Measures:** * Closed dosing systems are required for application. * Specific instructions and risk mitigation measures are detailed for each use, including concentration limits and water quality assessments. * For wastewater disinfection, reducing agents or active carbon filtration should be used. * For drinking water disinfection, chlorine and chlorate concentrations must be within national and EU limits. * **Adjustments for Germany:** * Specific adjustments to the terms and conditions apply in Germany for uses 2, 3, and 4, referencing German Drinking Water Ordinance and technical rules. * **General Directions for Use:** * Mandatory risk mitigation measures include alarm systems, local exhaust ventilation, and respiratory protective equipment. * First aid instructions and emergency measures are provided. * Disposal must be in accordance with local requirements. * Storage requires airtight pressure tanks and specific conditions to avoid hazards. * **Hazard and Precautionary Statements:** * The product is an oxidiser, causes skin and eye irritation, is toxic if inhaled, and is very toxic to aquatic life. * Precautionary measures include wearing protective gear, avoiding release to the environment, and proper storage. Impact Analysis: Vynova PPC SAS: * Impact: Granted authorisation to market and use PPC Chlorine liquid within the EU, subject to the conditions outlined in the regulation. * Action Required: Ensure compliance with the Summary of Product Characteristics (SPC) in the Annex, including specific conditions for different uses and risk mitigation measures. Drinking Water Suppliers, Wastewater Treatment Plants, Agricultural Facilities, Public Institutions & Healthcare Facilities * Impact: Can use PPC Chlorine liquid for disinfection purposes under the authorised uses, but must adhere to specific conditions and risk mitigation measures. * Action Required: Implement the instructions for use, risk mitigation measures, and ensure compliance with concentration limits and water quality standards. Federal Republic of Germany: * Impact: Specific adjustments to the terms and conditions of the authorisation apply within its territory for uses 2, 3, and 4. * Action Required: Ensure compliance with the German Drinking Water Ordinance and relevant technical rules when PPC Chlorine liquid is used for drinking water disinfection. European Chemicals Agency (ECHA): * Impact: ECHA's opinion was considered during the decision to grant authorisation. * Action Required: No specific action outlined in this document. Standing Committee on Biocidal Products: * Impact: The measures in the regulation are in accordance with their opinion. * Action Required: No specific action outlined in this document.

Key Entities Referenced

European Union: A political and economic union of member states located primarily in Europe. European Commission: The executive branch of the European Union responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU. Regulation EU No 528/2012: A regulation of the European Parliament and of the Council concerning the making available on the market and use of biocidal products. European Chemicals Agency: An agency of the European Union that implements EU chemicals legislation. PPC Chlorine liquid: A single biocidal product containing active chlorine released from chlorine, used as a disinfectant and algaecide. Vynova PPC SAS: The company that submitted the application for authorization of PPC Chlorine liquid. Federal Republic of Germany: A country in Europe to whose territory adjustments to the terms and conditions apply for certain uses of PPC Chlorine liquid Arche Chlorine: A reference single biocidal product to PPC Chlorine liquid.
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Official Journal EN of the European Union L series 2023/2727 7.12.2023 COMMISSION IMPLEMENTING REGULATION (EU) 2023/2727 of 30 November 2023 granting a Union authorisation for the single biocidal product ‘PPC Chlorine liquid’ (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 2012concerning the making available on the market and use of biocidal products(1), and in particular Article 44(5), first subparagraph, thereof, Whereas: (1) On 29 April 2019, Vynova PPC SAS 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 ‘PPC Chlorine liquid’ 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-LA051328-54 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference single biocidal product ‘Arche Chlorine’, authorised by Commission Implementing Regulation (EU) 2023/754(3)and recorded in the Register under case number BC-UQ045679-98. (2) ‘PPC Chlorine liquid’ 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(4)and the draft summary of the biocidal product characteristics (‘SPC’) of ‘PPC Chlorine liquid’ 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 Vynova PPC SAS, 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(5), 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 31 July 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. (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) 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). (4) ECHA opinion of 3 August 2021 on the Union authorisation of the same single biocidal product ‘PPC Chlorine liquid’, https://echa. europa.eu/opinions-on-union-authorisation. (5) 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). ELI: http://data.europa.eu/eli/reg_impl/2023/2727/oj 1/14EN OJ L, 7.12.2023 (6) The Commission 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 ‘PPC Chlorine liquid’. That adjustment is justified in recitals 7 to 9 of the Implementing Regulation (EU) 2023/754. (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 ‘PPC Chlorine liquid’ 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 should be 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-0027045-0000 is granted to Vynova PPC SAS for the making available on the market and use of the same single biocidal product ‘PPC Chlorine liquid’ 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 ‘PPC Chlorine liquid’ as laid down in the summary of product characteristics in the Annex. The Union authorisation is valid from 27 December 2023until 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, 30 November 2023. For the Commission The President Ursula VON DER LEYEN 2/14 ELI: http://data.europa.eu/eli/reg_impl/2023/2727/ojEN OJ L, 7.12.2023 ANNEX Summary of product characteristics for a biocidal product PPC Chlorine Liquid 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-0027045-0000 R4BP asset number: EU-0027045-0000 1. ADMINISTRATIVE INFORMATION 1.1. Trade name(s) of the product Trade name(s) PPC Chlorine Liquid 1.2. Authorisation holder Name and address of the authorisation Name Vynova PPC SAS holder Address 95 rue du Général de Gaulle BP 60090, 68802 THANN CEDEX France Authorisation number EU-0027045-0000 R4BP asset number EU-0027045-0000 Date of the authorisation 27 December 2023 Expiry date of the authorisation 30 April 2033 1.3. Manufacturer(s) of the product Name of manufacturer Vynova PPC SAS Address of manufacturer 95 rue du Général de Gaulle, 68802 Thann Cedex France Location of manufacturing sites 95 rue du Général de Gaulle, 68802 Thann Cedex France 1.4. Manufacturer(s) of the active substance(s) Active substance Active chlorine released from chlorine Name of manufacturer Vynova PPC SAS Address of manufacturer 95 rue du Général de Gaulle, 68802 Thann Cedex France Location of manufacturing sites 95 rue du Général de Gaulle, 68802 Thann Cedex France ELI: http://data.europa.eu/eli/reg_impl/2023/2727/oj 3/14EN OJ L, 7.12.2023 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 Active 100,0 released from Substance chlorine chlorine chlorine Non-active 7782-50-5 231-959-5 100,0 substance 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. 4/14 ELI: http://data.europa.eu/eli/reg_impl/2023/2727/ojEN OJ L, 7.12.2023 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 Scientific name: bacteria development stage) 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 Application Rate: Shock dosing: 477 mg/l active chlorine (AC) under dirty frequency conditions. Dilution (%): - Number and timing of application: Contact time: 30 minutes Category(ies) of users Industrial Professional Pack sizes and packaging Cylinder: 4,8 - 140 l (6-175 kg Cl ) 2 material Drum: 400-1 000l (500-1 250kg Cl ) 2 Railway tanks: 43 000- 44 000l (53 750- 55 000kg 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. ELI: http://data.europa.eu/eli/reg_impl/2023/2727/oj 5/14EN OJ L, 7.12.2023 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 Scientific name: bacteria development stage) 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 Ordinance1, the technical rules for dosing set out in the Deutscher Verein des Gas Wasserfaches e.V2 -working sheets W 229, W 296, W 623 and the minimum contact time of W 229 apply3. (See section 6 for further references) 6/14 ELI: http://data.europa.eu/eli/reg_impl/2023/2727/ojEN OJ L, 7.12.2023 Application rate(s) and Application Rate: 0,5 mg/l active chlorine (AC) as residual concentration in the frequency 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 (including the amounts before treatment and from other 2 treatments) as residual concentration in the system In exceptional cases an addition of up to 6 mg/l free Cl and concentration of up to 2 0,6 mg/l free Cl after treatment is acceptable as residual concentration in the 2 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 Cylinder: 4,8 - 140 l (6-175 kg Cl ) 2 material Drum: 400-1 000l (500-1 250kg Cl ) 2 Railway tanks: 43 000- 44 000l (53 750- 55 000kg 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. ELI: http://data.europa.eu/eli/reg_impl/2023/2727/oj 7/14EN OJ L, 7.12.2023 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 2020on 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 Scientific name: bacteria development stage) 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 Ordinance1, the technical rules for dosing set out in the Deutscher DeutscherVerein des Gas Wasserfaches e.V2-working sheets W 229, W 296, W 623 and the minimum contact time of W 229 apply3. (See section 6 for further references) 8/14 ELI: http://data.europa.eu/eli/reg_impl/2023/2727/ojEN OJ L, 7.12.2023 Application rate(s) and Application Rate: 0,5 mg/l Active Chlorine (AC) as residual concentration in the frequency 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 Ordinance1. (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 (including the amounts before treatment and from other 2 treatments) In exceptional cases an addition of up to 6 mg/l free Cl and concentration up to 0,6 2 mg/l free Cl after treatment is acceptable, if disinfection cannot be ensured by other 2 means or if disinfection is temporarily impaired by the presence of ammonium. Category(ies) of users Professional Pack sizes and packaging Cylinder: 4,8 - 140 l (6-175 kg Cl ) 2 material Drum: 400-1 000l (500-1 250kg Cl ) 2 Railway tanks: 43 000- 44 000l (53 750- 55 000kg 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 2020on 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 ELI: http://data.europa.eu/eli/reg_impl/2023/2727/oj 9/14EN OJ L, 7.12.2023 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 Scientific name: bacteria development stage) 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.V2 -working sheets W 229, W 296, W 623 and the minimum contact time of W 229 apply3. (See section 6 for further references) 10/14 ELI: http://data.europa.eu/eli/reg_impl/2023/2727/ojEN OJ L, 7.12.2023 Application rate(s) and Application Rate: 1 mg/l active chlorine (AC) as residual concentration in the system frequency 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 Ordinance1. (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 (including the amounts before treatment and from other 2 treatments) In exceptional cases an addition of up to 6 mg/l free Cl and concentration up to 0,6 2 mg/l free Cl after treatment is acceptable, if disinfection cannot be ensured by other 2 means or if disinfection is temporarily impaired by the presence of ammonium. Category(ies) of users Professional Pack sizes and packaging Cylinder: 4,8 - 140 l (6-175 kg Cl ) 2 material Drum: 400-1 000l (500-1 250kg Cl ) 2 Railway tanks: 43 000- 44 000l (53 750- 55 000kg 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 2020on 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 ELI: http://data.europa.eu/eli/reg_impl/2023/2727/oj 11/14EN OJ L, 7.12.2023 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 Scientific name: bacteria development stage) 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 Application Rate: 0,5 mg/l active chlorine (AC) as residual concentration in the frequency system. Dilution (%): - Number and timing of application: Frequency: continuous dosing Category(ies) of users Professional Pack sizes and packaging Cylinder: 4,8 - 140 l (6-175 kg Cl ) 2 material Drum: 400-1 000l (500-1 250kg Cl ) 2 Railway tanks: 43 000- 44 000l (53 750– 55 000kg Cl ) 2 Carbon/stainless steel 12/14 ELI: http://data.europa.eu/eli/reg_impl/2023/2727/ojEN OJ L, 7.12.2023 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 2020amending 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. (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/2023/2727/oj 13/14EN OJ L, 7.12.2023 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 Council5 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 2010on 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). 14/14 ELI: http://data.europa.eu/eli/reg_impl/2023/2727/oj

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