Commission Implementing Regulation (EU) 2025/2048 of 10 October 2025 granting a Union authorisation for the biocidal product family 3025 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
A Union authorisation with authorisation number EU-0034603-0000 is hereby granted to Schuelke & Mayr GmbH for the making available on the market and use of the biocidal product family ‘3025’ in accordance with the summary of the biocidal product characteristics set out in the Annex. The Union authorisation is valid from 5 November 2025 until 30 September 2030.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
ANNEX SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY 3025 Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area Authorisation number: EU-0034603-0000 R4BP asset number: EU-0034603-0000 PART I FIRST INFORMATION LEVEL 1. ADMINISTRATIVE INFORMATION 1.1. Family name Name 3025 1.2. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area 1.3. Authorisation holder Name and address of the authorisation holder Name Schuelke & Mayr GmbH Address Robert-Koch-Str. 2 22851 Norderstedt DE Authorisation number EU-0034603-0000 R4BP asset number EU-0034603-0000 Date of the authorisation 5 November 2025 Expiry date of the authorisation 30 September 2030 1.4. Manufacturer(s) of the product Name of manufacturer Schülke & Mayr GmbH Address of manufacturer Robert-Koch-Strasse 2 22851 Norderstedt Germany Location of manufacturing sites Schülke & Mayr GmbH Robert-Koch-Strasse 2 22851 Norderstedt Germany Name of manufacturer Vink Chemicals GmbH & Co. KG Address of manufacturer Eichenhöhe 29 21255 Kakenstorf Germany Location of manufacturing sites Vink Chemicals GmbH & Co. KG Eichenhöhe 29 21255 Kakenstorf Germany Name of manufacturer Vink Chemicals Memmingen GmbH Address of manufacturer Luitpoldstrasse 32 87700 Memmingen Germany Location of manufacturing sites Vink Chemicals Memmingen GmbH Luitpoldstrasse 32 87700 Memmingen Germany 1.5. Manufacturer(s) of the active substance(s) Active substance Glutaraldehyde Name of manufacturer Union Carbide Corporation Address of manufacturer Route 25 25112 Institute, West Virginia United States (the) Location of manufacturing sites Union Carbide Corporation Route 25 25112 Institute, West Virginia United States (the) Active substance Glutaraldehyde Name of manufacturer BASF SE Address of manufacturer Carl-Bosch-Strasse 38 67056 Ludwigshafen Germany Location of manufacturing sites BASF SE Carl-Bosch-Strasse 38 67056 Ludwigshafen Germany Active substance C(M)IT/MIT (3:1) Name of manufacturer Dow Chemical Company Ltd. Tyneside Works Address of manufacturer Ellison Street – Tyne & Wear NE32 3DJ Jarrow United Kingdom of Great Britain and Northern Ireland (the) Location of manufacturing sites Dow Chemical Company Ltd. Tyneside Works Ellison Street – Tyne & Wear NE32 3DJ Jarrow United Kingdom of Great Britain and Northern Ireland (the) Active substance C(M)IT/MIT (3:1) Name of manufacturer Jiangsu FOPIA Chemicals Co. Ltd Address of manufacturer Touzeng Village 224555 Binhuai Town, Binhai County, Yancheng City, Jiangsu China Location of manufacturing sites Jiangsu FOPIA Chemicals Co. Ltd Touzeng Village 224555 Binhuai Town, Binhai County, Yancheng City, Jiangsu China Active substance C(M)IT/MIT (3:1) Name of manufacturer Dalian Bio-Chem Company Limited Address of manufacturer No. 32 Wuwu Road, 11th Floor, Anda Business Mansion, Zhongshan District 116001 Dalian, Liaoning China Location of manufacturing sites Dalian Bio-Chem Company Limited site 1 No.325 Shunle Street, Lvshun Development Zone, 116052 Dalian, Liaoning China Dalian Bio-Chem Company Limited Dalian Songmudao Chemical Industry Zone, Puwan New District 116308 Dalian, Liaoning China 2. PRODUCT FAMILY COMPOSITION AND FORMULATION 2.1. Qualitative and quantitative information on the composition of the family Common name IUPAC name Function CAS number EC number Content (%) Glutaraldehyde 1,5-pentanedial Active substance 111-30-8 203-856-5 10 -10 % (w/w) C(M)IT/MIT (3:1) Reaction mass of 5-chloro-2-methyl-2h-isothiazol-3-one and 2-methyl-2h-isothiazol-3-one (3:1) Active substance 55965-84-9 0,28 -0,28 % (w/w) Alcohols C8-C10, ethoxylated, propoxylated Non-active substance 68603-25-8 0,5 -10 % (w/w) 2.2. Type(s) of formulation Formulation type(s) SL Soluble concentrate PART II SECOND INFORMATION LEVEL META SPC(S) 1. META SPC 1 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 1 identifier Identifier Meta SPC: meta-SPC 1 – 3025 1.2. Suffix to the authorisation number Number 1-1 1.3. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area 2. META SPC 1 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 1 Common name IUPAC name Function CAS number EC number Content (%) Glutaraldehyde 1,5-pentanedial Active substance 111-30-8 203-856-5 10 -10 % (w/w) C(M)IT/MIT (3:1) Reaction mass of 5-chloro-2-methyl-2h-isothiazol-3-one and 2-methyl-2h-isothiazol-3-one (3:1) Active substance 55965-84-9 0,28 -0,28 % (w/w) Alcohols C8-C10, ethoxylated, propoxylated Non-active substance 68603-25-8 10 -10 % (w/w) 2.2. Type(s) of formulation of the meta SPC 1 Formulation type(s) SL Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1 Hazard statements H317: May cause an allergic skin reaction. H318: Causes serious eye damage. H332: Harmful if inhaled. H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled. H410: Very toxic to aquatic life with long lasting effects. H335: May cause respiratory irritation. Precautionary statements P261: Avoid breathing vapours. P271: Use only outdoors or in a well-ventilated area. P272: Contaminated work clothing should not be allowed out of the workplace. P273: Avoid release to the environment. P280: Wear protective gloves/protective clothing/eye protection/face protection. P284: [In case of inadequate ventilation] wear respiratory protection. P302+P352: IF ON SKIN: Wash with plenty of soap and water. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P312: Call a POISON CENTER/doctor if you feel unwell. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P321: Specific treatment required (see instructions on this label). P310: Immediately call a POISON CENTER/doctor. P333+P313: If skin irritation or rash occurs: Get medical advice. P333+P313: If skin irritation or rash occurs: Get medical attention. P362+P364: Take off contaminated clothing and wash it before reuse. P391: Collect spillage. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P405: Store locked up. P342+P311: If experiencing respiratory symptoms: Call a POISON CENTER/doctor/.... P501: Dispose of contents to an approved waste disposal plant. P501: Dispose of container to an approved waste disposal plant. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #1-1: surface disinfection in industrial production areas, immersion and circulation (CIP) (PT 2) Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the authorised use n/a Target organism(s) (including development stage) Common name: yeasts Common name: viruses Common name: fungi Common name: bacteria Common name: enveloped viruses Field(s) of use Indoor use Hard non-porous surface disinfection in industrial production areas by immersion, disinfection of equipment and containers by immersion in an aqueous dilution of the product, and by circulation (cleaning in place, CIP), disinfection of inner surfaces of pipes, tanks, fillers, mixers and other machines. Application method(s) Method: Surface disinfection by immersion and circulation (CIP) Detailed description: n.a. Application rate(s) and frequency Use at room temperature under clean conditions. Use the product with the following dilution and contact time: Bacteria & enveloped viruses: 1 % (v/v), 15 minutes; 2 % (v/v), 5 minutes; Yeasts: 1 % (v/v), 15 minutes. Fungi (immersion): 1 % (v/v), 60 min; 2 % (v/v), 30 minutes; Fungi (CIP): 1 % (v/v), 60 minutes; 2 % (v/v), 15 minutes. Viruses: 3 % (v/v), 60 minutes. Immersion: up to 180 litre per disinfection bath Number and timing of application: Application frequency (CIP): 2 times a day Application frequency (immersion): 1 time a day Category(ies) of users Industrial Professional Pack sizes and packaging material 5-30 litre canister (HDPE)(high density polyethylene) 200 litre drum (HDPE) 500-1 000 litre (Intermediate Bulk Container) IBC container (HDPE, embedded in steel framework) 4.1.1. Use-specific instructions for use Thoroughly clean and rinse the surface. Dry the surface before applying the disinfection product. Immersion: The working solution is prepared by dosing the required quantity of the product into water. This is done manually by using an appropriate package size or by using a measuring cup or canister pump for correct dilution in water for the activity needed. Immerse equipment completely in working solution for the specified contact time. The disinfection bath can only be used once. CIP: The required quantities of the product and water are pumped into the closed system by an automatic dosage system to a final concentration as needed for the respective activity. Volume of product needed to disinfect the surface depends on the size of the closed system. Circulate the working solution in the closed system for the specified contact time. 4.1.2. Use-specific risk mitigation measures During handling of the undiluted product: Wear protective gloves (e.g. butyl rubber) compliant with the requirements of the European Standard EN 374 or equivalent, protective clothing (coveralls) (type 6, EN 13034 or equivalent) and eye/face protection (EN 166 or equivalent) and respiratory protection equipment (RPE) with Assigned Protection Factor (APF 10) (EN 12941 or equivalent). For immersion: Application: no personal protective equipment (PPE) needed. For CIP applications: Application: closed system; no PPE needed. Regarding the personal protective equipment listed in this section, this is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See Section 6 for the full references to this act and the European 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 general direction for use. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general direction for use. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general direction for use. 4.2. Use description Table 2 Use #1-2: surface disinfection in industrial production areas of food and feed, circulation (CIP) (PT 4) Product type PT04: Food and feed area Where relevant, an exact description of the authorised use n/a Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Common name: viruses Common name: enveloped viruses Field(s) of use Indoor use Hard non-porous surface disinfection in industrial production areas of food and feed by circulation (cleaning in place, CIP), disinfection of inner surfaces of pipes, tanks, fillers, mixers and other machines. Application method(s) Method: surface disinfection by circulation (CIP) Detailed description: n.a. Application rate(s) and frequency Use at room temperature under clean conditions. Use the product with the following dilution and contact time: Bacteria, yeasts & enveloped viruses: 1 % (v/v), 15 minutes. Fungi: 1 % (v/v), 60 minutes; 2 % (v/v), 15 minutes. Viruses: 3 % (v/v), 60 minutes. Number and timing of application: Application frequency (CIP): 2 times a day Category(ies) of users Industrial Professional Pack sizes and packaging material 5-30 litre canister (HDPE) 200 litre drum (HDPE) 500-1 000 litre IBC container (HDPE, embedded in steel framework) 4.2.1. Use-specific instructions for use Thoroughly clean and rinse the surface. Dry the surface before applying the disinfection product. CIP: The required quantities of the product and water are pumped into the closed system by an automatic dosage system to a final concentration as needed for the respective activity. Volume of product needed to disinfect the surface depends on the size of the closed system. Circulate the working solution in the closed system for the specified contact time. Rinse treated pipes/machinery with drinking water after application. 4.2.2. Use-specific risk mitigation measures During handling of the undiluted product: Wear protective gloves (e.g. butyl rubber) compliant with the requirements of the European Standard EN 374 or equivalent, protective clothing (coveralls) (type 6, EN 13034 or equivalent) and eye/face protection (EN 166 or equivalent) and respiratory protection equipment (RPE) with Assigned Protection Factor (APF 10) (EN 12941 or equivalent). Application: closed system; no personal protective equipment (PPE) needed. Regarding the personal protective equipment listed in this section, this is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See Section 6 for the full references to this act and the European Standards. 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 general directions for use. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See 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 general directions for use. 4.3. Use description Table 3 Use #1-4: surface disinfection in industrial production areas, wiping, mopping, immersion and circulation (PT2) Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the authorised use n/a Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Common name: enveloped viruses Common name: viruses Field(s) of use Indoor use Hard non-porous surface disinfection in industrial production areas by wiping of work surfaces, machines, equipment, utensils etc., by mopping of floors and walls, by immersion, disinfection of equipment and containers by immersion in an aqueous dilution of the product, and by circulation (cleaning in place, CIP), disinfection of inner surfaces of pipes, tanks, fillers, mixers and other machines. Application method(s) Method: Surface disinfection by wiping, mopping, immersion and CIP Detailed description: n.a. Application rate(s) and frequency Application Rate: Wiping and mopping: 40 ml/m 2 . Use at room temperature under clean conditions. Use the product with the following dilution and contact time: Bacteria & enveloped viruses: 1 % (v/v), 15 minutes; 2 % (v/v), 5 minutes. Yeasts: 1 % (v/v), 15 minutes. Fungi: (mopping, wiping and immersion): 1 % (v/v), 60 minutes; 2 % (v/v), 30 minutes; Fungi (CIP): 1 % (v/v), 60 minutes; 2 % (v/v), 15 minutes. Viruses: 3 % (v/v), 60 minutes. Immersion: up to 180 litres per disinfection bath Number and timing of application: Application frequency (CIP): 2 times a day Application frequency (wiping, mopping, immersion): 1 time a day Category(ies) of users Industrial Professional Pack sizes and packaging material 5-30 litre canister (HDPE) 200 litre drum (HDPE) 500-1 000 litre IBC container (HDPE, embedded in steel framework) 4.3.1. Use-specific instructions for use Thoroughly clean and rinse the surface. Dry the surface before applying the disinfection product. Wiping and mopping: At the end of workshift, the working solution is prepared by dosing the required quantity of the product into water. This is done manually by using an appropriate package size or by using a measuring cup or canister pump for correct dilution in water for the activity needed. Soak a clean dry wipe or mop in freshly prepared working solution and wipe or mop the surface until it is completely wetted. Keep the surface wet and allow to take effect for the specified contact time. Immersion: The working solution is prepared by dosing the required quantity of the product into water. This is done manually by using an appropriate package size or by using a measuring cup or canister pump for correct dilution in water for the activity needed. Immerse equipment completely in working solution for the specified contact time. The disinfection bath can only be used once. CIP: The required quantities of product and water are pumped into the closed system by an automatic dosage system to a final concentration as needed for the respective activity. Volume of product needed to disinfect the surface depends on the size of the closed system. Circulate the working solution in the closed system for the specified contact time. 4.3.2. Use-specific risk mitigation measures During handling of the undiluted product: Wear protective gloves (e.g. butyl rubber) compliant with the requirements of the European Standard EN 374 or equivalent, protective clothing (coveralls) (type 6, EN 13034 or equivalent) and eye/face protection (EN 166 or equivalent) and respiratory protection equipment (RPE) with Assigned Protection Factor (APF 10) (EN 12941 or equivalent). For wiping: In small rooms: ≤ 80 m 3 , wear gloves (EN 374 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≤ 3 % in-use dilution are used. In large rooms: > 80 m 3 , wear gloves (EN 374 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≤ 3 % in-use dilution is used. For mopping: In small rooms: ≤ 80 m 3 , wear gloves (EN 374 or equivalent) and RPE with APF 10 if (EN 12941 or equivalent) ≤ 2 % in-use dilution are used. In small rooms: ≤ 80 m 3 , wear gloves (EN 374 or equivalent), coverall (type 6, EN 13034 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if 3 % in-use dilution are used. In large rooms: > 80 m 3 , wear gloves (EN 374 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≤ 1 % in-use dilution is used. In large rooms: > 80 m 3 , wear gloves (EN 374 or equivalent), coverall (type 6, EN 13034 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≥ 1,5% in-use dilution is used. For immersion: Application: personal protective equipment (PPE) needed. For CIP applications: Application: closed system; no PPE needed. The following secondary exposure control measure applies to all application methods: PPE specified for the user shall also be worn by persons working in the vicinity of the application or who may otherwise be exposed to the biocidal product. Professional users must ensure that no bystanders are present in the treatment area during application. If bystanders have to be present, the users have to ensure that those wear the same PPE as themselves. The room shall be sealed and re-entry prevented after disinfection took place. It shall be indicated that a ventilation process after disinfection is running (information of other workers). Re-entry is only permitted once the air concentration of the active substance has dropped below the reference value (Adverse Effect Concentration (AEC) inhalation of 0,0106 mg/m 3 ). Unprotected persons should be kept away from treated areas until surfaces are dry. Regarding the personal protective equipment listed in this section, this is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See Section 6 for the full references to this act and the European Standards. 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 general directions for use. 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See 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 general directions for use. 4.4. Use description Table 4 Use #1-7: surface disinfection in industrial productions areas wiping, mopping, immersion and circulation (CIP) clean and dirty (PT2) Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the authorised use n/a Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Common name: enveloped viruses Common name: viruses Field(s) of use Indoor use Hard non-porous surface disinfection in industrial production areas by wiping of work surfaces, machines, equipment, utensils etc., by mopping of floors and walls, by immersion, disinfection of equipment and containers by immersion in an aqueous dilution of the product, and by circulation (cleaning in place, CIP), disinfection of inner surfaces of pipes, tanks, fillers, mixers and other machines. Application method(s) Method: Surface disinfection by wiping, mopping, immersion and CIP Detailed description: n.a. Application rate(s) and frequency Application Rate: Wiping and mopping: 40 ml/m 2 . Use at room temperature. Disinfection with prior cleaning: Use the product with the following dilution and contact time: Bacteria & enveloped viruses:1 % (v/v), 15 minutes; 2 % (v/v), 5 minutes. Yeasts: 1 % (v/v), 15 minutes. Fungi (mopping, wiping and immersion): 1 % (v/v), 60 minutes; 2 % (v/v), 30 minutes; Fungi (CIP): 1 % (v/v), 60 minutes; 2 % (v/v), 15 minutes. Viruses: 3 % (v/v), 60 minutes. Disinfection without prior cleaning: Use the product with the following dilution and contact time: Bacteria & enveloped viruses (mopping, wiping and immersion): 0,5 % (v/v), 2 hours; 1 % (v/v), 15 minutes; 3 % (v/v), 5 minutes; Bacteria & enveloped viruses (CIP): 0,5 % (v/v), 30 minutes; 1 % (v/v), 15 minutes; 3 % (v/v), 5 minutes. Yeasts: 0,5 % (v/v), 2 hours; 1 % (v/v), 60 minutes; 2 % (v/v), 15 minutes; 3 % (v/v), 5 minutes. Fungi (mopping, wiping and immersion): 1 % (v/v), 2 hours; Fungi (CIP): 1 % (v/v), 60 minutes; 3 % (v/v), 15 minutes. Viruses: 3 % (v/v), 60 minutes. Immersion: up to 180 litres per disinfection bath Number and timing of application: Application frequency (CIP): 2 times a day Application frequency (wiping, mopping, immersion): 1 time a day Category(ies) of users Industrial Professional Pack sizes and packaging material 5-30 litre canister (HDPE) 200 litre drum (HDPE) 500-1 000 litre IBC container (HDPE, embedded in steel framework) 4.4.1. Use-specific instructions for use For disinfection with prior cleaning: thoroughly clean and rinse the surface. Dry the surface before applying the disinfection product. Wiping and mopping: At the end of work-shift, the working solution is prepared by dosing the required quantity of the product into water. This is done manually by using an appropriate package size or by using a measuring cup or canister pump for correct dilution in water for the activity needed. Soak a clean dry wipe or mop in freshly prepared working solution and wipe or mop the surface until it is completely wetted. Keep the surface wet and allow to take effect for the specified contact time. Immersion: The working solution is prepared by dosing the required quantity of the product into water. This is done manually by using an appropriate package size or by using a measuring cup or canister pump for correct dilution in water for the activity needed. Immerse equipment completely in working solution for the specified contact time. The disinfection bath can only be used once. CIP: The required quantities of product and water are pumped into the closed system by an automatic dosage system to a final concentration as needed for the respective activity. Volume of product needed to disinfect the surface depends on the size of the closed system. Circulate the working solution in the closed system for the specified contact time. 4.4.2. Use-specific risk mitigation measures During handling of the undiluted product: Wear protective gloves (e.g. butyl rubber) compliant with the requirements of the European Standard EN 374 or equivalent, protective clothing (coveralls) (type 6, EN 13034 or equivalent) and eye/face protection (EN 166 or equivalent) and respiratory protection equipment (RPE) with Assigned Protection Factor (APF 10) (EN 12941 or equivalent). For wiping: In small rooms: ≤ 80 m 3 , wear gloves (EN 374 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≤ 3 % in-use dilution are used. In large rooms: > 80 m 3 , wear gloves (EN 374 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≤ 3 % in-use dilution is used. For mopping: In small rooms: ≤ 80 m 3 , wear gloves (EN 374 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≤ 2 % in-use dilution are used. In small rooms: ≤ 80 m 3 , wear gloves (EN 374 or equivalent), coverall (type 6, EN 13034 or equivalent) and RPE with APF 10 (EN 12941) if 3 % in-use dilution are used. In large rooms: > 80 m 3 , wear gloves (EN 374 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≤ 1 % in-use dilution is used. In large rooms: > 80 m 3 , wear gloves (EN 374 or equivalent), coverall (type 6, EN 13034 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≥ 1,5% in-use dilution is used. For immersion: Application: no personal protective equipment (PPE) needed. For CIP applications: Application: closed system; no PPE needed. The following secondary exposure control measure applies to all application methods: PPE specified for the user shall also be worn by persons working in the vicinity of the application or who may otherwise be exposed to the biocidal product. Professional users must ensure that no bystanders are present in the treatment area during application. If bystanders have to be present, the users have to ensure that those wear the same PPE as themselves. The room shall be sealed and re-entry prevented after disinfection took place. It shall be indicated that a ventilation process after disinfection is running (information of other workers). Re-entry is only permitted once the air concentration of the active substance has dropped below the reference value (Adverse Effect Concentration (AEC) inhalation of 0,0106 mg/m 3 ). Unprotected persons should be kept away from treated areas until surfaces are dry. Regarding the personal protective equipment listed in this section, this is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See Section 6 for the full references to this act and the European Standards. 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 general directions for use. 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See 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 general directions for use. 4.5. Use description Table 5 Use # 1-8: surface disinfection in industrial production areas, wiping, mopping, spraying, immersion and circulation (CIP) (PT 2) Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the authorised use n/a Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Common name: enveloped viruses Common name: viruses Field(s) of use Indoor use Hard non-porous surface disinfection in industrial production areas by wiping of work surfaces, machines, equipment, utensils etc., by mopping of floors and walls, by spraying (tanks) by immersion, disinfection of equipment and containers by immersion in an aqueous dilution of the product, and by circulation (cleaning in place, CIP), disinfection of inner surfaces of pipes, tanks, fillers, mixers and other machines. Application method(s) Method: Surface disinfection by wiping, mopping, spraying, immersion and CIP Detailed description: n.a. Application rate(s) and frequency Application Rate: Wiping, mopping and spraying: 40 ml/m 2 . Use at room temperature under clean conditions. Use the product with the following dilution and contact time: Bacteria & enveloped viruses: 1 % (v/v), 15 minutes; 2 % (v/v), 5 minutes. Yeasts: 1 % (v/v), 15 minutes. Fungi (mopping, wiping, spraying and immersion): 1 % (v/v), 60 minutes; 2 % (v/v), 30 minutes; Fungi (CIP): 1 % (v/v), 60 minutes; 2 % (v/v), 15 minutes. Viruses: 3 % (v/v), 60 minutes. Immersion: up to 180 litres per disinfection bath Number and timing of application: Application frequency (CIP): 2 times a day Application frequency (wiping, mopping, spraying, immersion): 1 time a day Category(ies) of users Industrial Professional Pack sizes and packaging material 5-30 litre canister (HDPE) 200 litre drum (HDPE) 500-1 000 litre IBC container (HDPE, embedded in steel framework) 4.5.1. Use-specific instructions for use Thoroughly clean and rinse the surface. Dry the surface before applying the disinfection product. Wiping and mopping: At the end of work-shift, the working solution is prepared by dosing the required quantity of the product into water. This is done manually by using an appropriate package size or by using a measuring cup/canister pump for correct dilution in water for the activity needed. Soak a clean dry wipe/mop in freshly prepared working solution and wipe/mop the surface until it is completely wetted. Keep the surface wet and allow to take effect for the specified contact time. Spraying (tanks): The working solution is prepared by dosing the required quantity of the product into water. This is done manually by using an appropriate package size or by using a measuring cup/canister pump for correct dilution in water for the activity needed. Working solution is sprayed onto the inner surface of tanks by using a spraying device until it is completely wetted. Keep the surface wet and allow to take effect for the specified contact time. Immersion: The working solution is prepared by dosing the required quantity of the product into water. This is done manually by using an appropriate package size or by using a measuring cup/canister pump for correct dilution in water for the activity needed. Immerse equipment completely in working solution for the specified contact time. The disinfection bath can only be used once. CIP: The required quantities of product and water are pumped into the closed system by an automatic dosage system to a final concentration as needed for the respective activity. Volume of product needed to disinfect the surface depends on the size of the closed system. Circulate the working solution in the closed system for the specified contact time. 4.5.2. Use-specific risk mitigation measures During handling of the undiluted product: Wear protective gloves (e.g. butyl rubber) compliant with the requirements of the European Standard EN 374 or equivalent, protective clothing (coveralls) (type 6, EN 13034 or equivalent) and eye/face protection (EN 166 or equivalent) and respiratory protection equipment (RPE) with Assigned Protection Factor (APF 10) (EN 12941 or equivalent). For wiping: In small rooms: ≤ 80 m 3 , wear gloves (EN 374 or equivalent) and RPE with APF 10 if (EN 12941 or equivalent) ≤ 3 % in-use dilution are used. In large rooms: > 80 m 3 , wear gloves (EN 374 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≤ 3 % in-use dilution is used. For mopping: In small rooms: ≤ 80 m 3 , wear gloves (EN 374 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≤ 2 % in-use dilution are used. In small rooms: ≤ 80 m 3 , wear gloves (EN 374 or equivalent), coverall (type 6, EN 13034 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if 3 % in-use dilution are used. In large rooms: > 80 m 3 , wear gloves (EN 374 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≤ 1 % in-use dilution is used. In large rooms: > 80 m 3 , wear gloves (EN 374 or equivalent), coverall (type 6, EN 13034 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≥ 1 % in-use dilution is used. For spraying in tanks: Wear gloves (EN 374), coverall (type 6, EN 13034 or equivalent) and RPE APF 10 (EN 12941 or equivalent) when products with < 1 % in-use dilution are used. Wear gloves (EN 374), coverall (type 6, EN 13034 or equivalent) and RPE APF 20 (EN 12942 or equivalent) when products with 1 %-2 % in-use dilution are used. Wear gloves (EN 374), coverall (type 6, EN 13034 or equivalent) and RPE APF 40 (EN 12942 or equivalent) when products with 3 % in-use dilution are used. For immersion: Application: no personal protective equipment (PPE) needed. For CIP applications: Application: closed system; no PPE needed. The following secondary exposure control measure applies to all application methods: PPE specified for the user shall also be worn by persons working in the vicinity of the application or who may otherwise be exposed to the biocidal product. Professional users must ensure that no bystanders are present in the treatment area during application. If bystanders have to be present, the users have to ensure that those wear the same PPE as themselves. The room shall be sealed and re-entry prevented after disinfection took place. It shall be indicated that a ventilation process after disinfection is running (information of other workers). Re-entry is only permitted once the air concentration of the active substance has dropped below the reference value (Adverse Effect Concentration (AEC) inhalation of 0,0106 mg/m 3 ). Unprotected persons should be kept away from treated areas until surfaces are dry. Regarding the personal protective equipment listed in this section, this is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See Section 6 for the full references to this act and the European Standards. 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 general directions for use. 4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See 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 general directions for use. 4.6. Use description Table 6 Use # 1-11 surface disinfection in industrial production areas, wiping, mopping, spraying, immersion and circulation (CIP) clean and dirty (PT 2) Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the authorised use n/a Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Common name: enveloped viruses Common name: viruses Field(s) of use Indoor use Hard non-porous surface disinfection in industrial production areas by wiping of work surfaces, machines, equipment, utensils etc., by mopping of floors and walls, by spraying (tanks) by immersion, disinfection of equipment and containers by immersion in an aqueous dilution of the product, and by circulation (cleaning in place, CIP), disinfection of inner surfaces of pipes, tanks, fillers, mixers and other machines. Application method(s) Method: Surface disinfection by wiping, mopping, spraying, immersion and CIP Detailed description: n.a. Application rate(s) and frequency Application Rate: Wiping, mopping and spraying: 40 ml/m 2 . Use at room temperature. Disinfection with prior cleaning: Use the product with the following dilution and contact time: Bacteria & enveloped viruses: 1 % (v/v), 15 minutes; 2 % (v/v), 5 minutes. Yeasts: 1 % (v/v), 15 minutes. Fungi (mopping, wiping, spraying and immersion): 1 % (v/v), 60 minutes; 2 % (v/v), 30 minutes; Fungi (CIP): 1 % (v/v), 60 minutes; 2 % (v/v), 15 minutes. Viruses: 3 % (v/v), 60 minutes. Disinfection without prior cleaning: Use the product with the following dilution and contact time: Bacteria & enveloped viruses (mopping, wiping, spraying and immersion): 0,5 % (v/v), 2 hours; 1 % (v/v), 15 minutes; 3 % (v/v), 5 minutes; Bacteria & enveloped viruses (CIP): 0,5 % (v/v), 30 minutes; 1 % (v/v), 15 minutes; 3 % (v/v), 5 minutes. Yeasts: 0,5 % (v/v), 2 hours; 1 % (v/v), 60 minutes; 2 % (v/v), 15 minutes; 3 % (v/v), 5 minutes. Fungi (mopping, wiping, spraying and immersion): 1 % (v/v), 2 hours; Fungi (CIP): 1 % (v/v), 60 minutes; 3 % (v/v), 15 minutes. Viruses: 3 % (v/v), 60 minutes. Immersion: up to 180 litres per disinfection bath Number and timing of application: Application frequency (CIP): 2 times a day Application frequency (wiping, mopping, spraying, immersion): 1 time a day Category(ies) of users Industrial Professional Pack sizes and packaging material 5-30 litres canister (HDPE) 200 litres drum (HDPE) 500-1 000 litres IBC container (HDPE, embedded in steel framework) 4.6.1. Use-specific instructions for use For disinfection with prior cleaning: thoroughly clean and rinse the surface. Dry the surface before applying the disinfection product. Wiping and mopping: At the end of work-shift, the working solution is prepared by dosing the required quantity of the product into water. This is done manually by using an appropriate package size or by using a measuring cup/canister pump for correct dilution in water for the activity needed. Soak a clean dry wipe/mop in freshly prepared working solution and wipe/mop the surface until it is completely wetted. Keep the surface wet and allow to take effect for the specified contact time. Spraying (tanks): The working solution is prepared by dosing the required quantity of the product into water. This is done manually by using an appropriate package size or by using a measuring cup/canister pump for correct dilution in water for the activity needed. Working solution is sprayed onto the inner surface of tanks by using a spraying device until it is completely wetted. Keep the surface wet and allow to take effect for the specified contact time. Immersion: The working solution is prepared by dosing the required quantity of the product into water. This is done manually by using an appropriate package size or by using a measuring cup/canister pump for correct dilution in water for the activity needed. Immerse equipment completely in working solution for the specified contact time. The disinfection bath can only be used once. CIP: The required quantities of product and water are pumped into the closed system by an automatic dosage system to a final concentration as needed for the respective activity. Volume of product needed to disinfect the surface depends on the size of the closed system. Circulate the working solution in the closed system for the specified contact time. 4.6.2. Use-specific risk mitigation measures During handling of the undiluted product: Wear protective gloves (e.g. butyl rubber) compliant with the requirements of the European Standard EN 374 or equivalent, protective clothing (coveralls) (type 6, EN 13034 or equivalent) and eye/face protection (EN 166 or equivalent) and respiratory protection equipment (RPE) with Assigned Protection Factor (APF 10) (EN 12941 or equivalent). For wiping: In small rooms: ≤ 80 m 3 , wear gloves (EN 374 or equivalent) and RPE with APF 10 if (EN 12941 or equivalent) ≤ 3 % in-use dilution are used. In large rooms: > 80 m 3 , wear gloves (EN 374 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≤ 3 % in-use dilution is used. For mopping: In small rooms: ≤ 80 m 3 , wear gloves (EN 374 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≤ 2 % in-use dilution are used. In small rooms: ≤ 80 m 3 , wear gloves (EN 374 or equivalent), coverall (type 6, EN 13034 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if 3 % in-use dilution are used. In large rooms: > 80 m 3 , wear gloves (EN 374 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≤ 1 % in-use dilution is used. In large rooms: > 80 m 3 , wear gloves (EN 374 or equivalent), coverall (type 6, EN 13034 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≥ 1 % in-use dilution is used. For spraying in tanks: Wear gloves (EN 374 or equivalent), coverall (type 6, EN 13034 or equivalent) and RPE APF 10 (EN 12941 or equivalent) when products with <1 % in-use dilution are used. Wear gloves (EN 374 or equivalent), coverall (type 6, EN 13034 or equivalent) and RPE APF 20 (EN 12942 or equivalent) when products with 1 %-2 % in-use dilution are used. Wear gloves (EN 374 or equivalent), coverall (type 6, EN 13034 or equivalent) and RPE APF 40 (EN 12942 or equivalent) when products with 3 % in-use dilution are used. For immersion: Application: no personal protective equipment (PPE) needed. For CIP applications: Application: closed system; no PPE needed. The following secondary exposure control measure applies to all application methods: PPE specified for the user shall also be worn by persons working in the vicinity of the application or who may otherwise be exposed to the biocidal product. Professional users must ensure that no bystanders are present in the treatment area during application. If bystanders have to be present, the users have to ensure that those wear the same PPE as themselves. The room shall be sealed and re-entry prevented after disinfection took place. It shall be indicated that a ventilation process after disinfection is running (information of other workers). Re-entry is only permitted once the air concentration of the active substance has dropped below the reference value (Adverse Effect Concentration (AEC) inhalation of 0,0106 mg/m 3 ). Unprotected persons should be kept away from treated areas until surfaces are dry. Regarding the personal protective equipment listed in this section, this is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See Section 6 for the full references to this act and the European Standards. 4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use. 4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use. 4.7. Use description Table 7 Use #1-12 surface disinfection in industrial production areas of food and feed, circulation (CIP) clean and dirty (PT 4) Product type PT04: Food and feed area Where relevant, an exact description of the authorised use n/a Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Common name: enveloped viruses Common name: viruses Field(s) of use Indoor use Hard non-porous surface disinfection in industrial production areas by circulation (cleaning in place, CIP), disinfection of inner surfaces of pipes, tanks, fillers, mixers and other machines. Application method(s) Method: surface disinfection by circulation (CIP) Detailed description: n.a. Application rate(s) and frequency Use at room temperature. Disinfection with prior cleaning: Use the product with the following dilution and contact time: Bacteria, yeasts & enveloped viruses: 1 % (v/v), 15 minutes. Fungi: 1 % (v/v), 60 minutes; 2 % (v/v), 15 minutes. Viruses: 3 % (v/v), 60 minutes. Disinfection without prior cleaning: Use the product with the following dilution and contact time: Bacteria, yeasts & enveloped viruses: 3 % (v/v), 5 minutes. Fungi: 3 % (v/v), 15 minutes. Viruses: 3 % (v/v), 60 minutes. Number and timing of application: Application frequency (CIP): 2 times a day Category(ies) of users Industrial Professional Pack sizes and packaging material 5-30 litres canister (HDPE) 200 litres drum (HDPE) 500-1 000 litres IBC container (HDPE, embedded in steel framework) 4.7.1. Use-specific instructions for use For disinfection with prior cleaning: thoroughly clean and rinse the surface. Dry the surface before applying the disinfection product. The required quantities of product and water are pumped into the closed system by an automatic dosage system to a final concentration as needed for the respective activity. Volume of product needed to disinfect the surface depends on the size of the closed system. Circulate the working solution in the closed system for the specified contact time. Rinse treated pipes/machinery with drinking water after application. 4.7.2. Use-specific risk mitigation measures During handling of the undiluted product: Wear protective gloves (e.g. butyl rubber) compliant with the requirements of the European Standard EN 374 or equivalent, protective clothing (coveralls) (type 6, EN 13034 or equivalent) and eye/face protection (EN 166 or equivalent) and respiratory protection equipment (RPE) with Assigned Protection Factor (APF 10) (EN 12941 or equivalent). Application: closed system; no personal protective equipment (PPE) needed. Regarding the personal protective equipment listed in this section, this is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See Section 6 for the full references to this act and the European Standards. 4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use. 4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1 5.1. Instructions for use Please see use-specific instructions for use. 5.2. Risk mitigation measures See use-specific risk mitigation measures. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Particulars of likely direct or indirect effects Harmful if inhaled. May cause an allergic skin reaction. Causes serious eye damage. May cause allergy or asthma symptoms or breathing difficulties if inhaled. Corrosive to the respiratory tract. Precautions Avoid breathing vapours. Environmental precautions: Avoid release to the environment. First aid instructions IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. 5.4. Instructions for safe disposal of the product and its packaging Waste water emission to reprocessing plant and final release of purified liquid to STP (sewage treatment plant). Emissions to surface water, soil and groundwater via STP. Dispose of contents/container to an approved waste disposal plant. Dispose of waste and residues in accordance with local authority requirements. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Conditions for safe storage, including any incompatibilities Requirements for storage areas and containers: Store at temperature not exceeding 40 °C in the original container. Further information on storage conditions: Keep away from heat. Keep away from direct sunlight. Keep container tightly closed. Store in a well-ventilated place. Advice on common storage: Do not store near food, drink and feed. Shelf-life: 24 months. Conditions to avoid: Protect from frost, heat and sunlight. 6. OTHER INFORMATION The full titles of the EN standards referenced in Section 4.2 ‘Risk mitigation measures’ are: EN ISO 374 – Protective gloves against dangerous chemicals and micro-organisms EN ISO 166 – Personal eye protection standard EN 13034 – Protective clothing against liquid chemicals – Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6) EN ISO 12941 – Respiratory protective devices – Powered filtering devices incorporating a loose fitting respiratory interface – Requirements, testing, marking EN 12942 – Respiratory protective devices. Powered filtering devices incorporating full face masks, half masks or quarter masks. Requirements, testing, marking Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) ( OJ L 131, 5.5.1998, p. 11 ). With respect to the ‘Category (ies) of users’ note: Professionals (including industrial users) means trained professionals if this is required by national legislation. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) buraton 3025 Market area: EU buraton GA Market area: EU disinfectant GA Market area: EU concentrate GA Market area: EU system CIP GA Market area: EU power CIP GA Market area: EU industry CIP GA Market area: EU Anlagen CIP GA Market area: EU arcana GA cip Market area: EU Authorisation number EU-0034603-0001 1-1 Common name IUPAC name Function CAS number EC number Content (%) Glutaraldehyde 1,5-pentanedial Active substance 111-30-8 203-856-5 10 % (w/w) C(M)IT/MIT (3:1) Reaction mass of 5-chloro-2-methyl-2h-isothiazol-3-one and 2-methyl-2h-isothiazol-3-one (3:1) Active substance 55965-84-9 0,28 % (w/w) Alcohols C8-C10, ethoxylated, propoxylated Non-active substance 68603-25-8 10 % (w/w) 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) perform classic concentrate GA Market area: EU perform sterile concentrate GA Market area: EU Authorisation number EU-0034603-0002 1-1 Common name IUPAC name Function CAS number EC number Content (%) Glutaraldehyde 1,5-pentanedial Active substance 111-30-8 203-856-5 10 % (w/w) C(M)IT/MIT (3:1) Reaction mass of 5-chloro-2-methyl-2h-isothiazol-3-one and 2-methyl-2h-isothiazol-3-one (3:1) Active substance 55965-84-9 0,28 % (w/w) Alcohols C8-C10, ethoxylated, propoxylated Non-active substance 68603-25-8 10 % (w/w) 7.3. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) grotanol 3025 Market area: EU Authorisation number EU-0034603-0003 1-1 Common name IUPAC name Function CAS number EC number Content (%) Glutaraldehyde 1,5-pentanedial Active substance 111-30-8 203-856-5 10 % (w/w) C(M)IT/MIT (3:1) Reaction mass of 5-chloro-2-methyl-2h-isothiazol-3-one and 2-methyl-2h-isothiazol-3-one (3:1) Active substance 55965-84-9 0,28 % (w/w) Alcohols C8-C10, ethoxylated, propoxylated Non-active substance 68603-25-8 10 % (w/w) 1. META SPC 2 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 2 identifier Identifier Meta SPC: meta-SPC 2 – parmetol SL 60 1.2. Suffix to the authorisation number Number 1-2 1.3. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals 2. META SPC 2 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 2 Common name IUPAC name Function CAS number EC number Content (%) Glutaraldehyde 1,5-pentanedial Active substance 111-30-8 203-856-5 10 -10 % (w/w) C(M)IT/MIT (3:1) Reaction mass of 5-chloro-2-methyl-2h-isothiazol-3-one and 2-methyl-2h-isothiazol-3-one (3:1) Active substance 55965-84-9 0,28 -0,28 % (w/w) 2.2. Type(s) of formulation of the meta SPC 2 Formulation type(s) SL Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 Hazard statements H332: Harmful if inhaled. H317: May cause an allergic skin reaction. H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled. H410: Very toxic to aquatic life with long lasting effects. H335: May cause respiratory irritation. H318: Causes serious eye damage. Precautionary statements P261: Avoid breathing vapours. P271: Use only outdoors or in a well-ventilated area. P272: Contaminated work clothing should not be allowed out of the workplace. P273: Avoid release to the environment. P280: Wear protective gloves/protective clothing/eye protection/face protection. P284: [In case of inadequate ventilation] wear respiratory protection. P302+P352: IF ON SKIN: Wash with plenty of soap and water. P321: Specific treatment required (see instructions on this label). P312: Call a POISON CENTER /doctor if you feel unwell. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P333+P313: If skin irritation or rash occurs: Get medical advice. P333+P313: If skin irritation or rash occurs: Get medical attention. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER/doctor. P362+P364: Take off contaminated clothing and wash it before reuse. P391: Collect spillage. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P342+P311: If experiencing respiratory symptoms: Call a POISON CENTER/doctor. P405: Store locked up. P501: Dispose of contents to an approved waste disposal plant. P501: Dispose of container to an approved waste disposal plant. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Use #2-8: surface disinfection in industrial production areas, wiping, mopping, spraying, immersion and circulation (PT2) Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the authorised use n/a Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Common name: enveloped viruses Common name: viruses Field(s) of use Indoor use Hard non-porous surface disinfection in industrial production areas by wiping of work surfaces, machines, equipment, utensils etc., by mopping of floors and walls, by spraying (tanks), by immersion, disinfection of equipment and containers by immersion in an aqueous dilution of the product, and by circulation (cleaning in place, CIP), disinfection of inner surfaces of pipes, tanks, fillers, mixers and other machines. Application method(s) Method: Surface disinfection by wiping, mopping, spraying, immersion and CIP Detailed description: n.a. Application rate(s) and frequency Application Rate: Wiping, mopping and spraying: 40 ml/m 2 . Use at room temperature under clean conditions. Use the product with the following dilution and contact time: Bacteria & enveloped viruses: 1 % (v/v), 15 minutes; 2 % (v/v), 5 minutes. Yeasts: 1 % (v/v), 15 minutes. Fungi (mopping, wiping, spraying and immersion): 1 % (v/v), 60 minutes; 2 % (v/v), 30 minutes; Fungi (CIP): 1 % (v/v), 60 minutes; 2 % (v/v), 15 minutes. Viruses: 3 % (v/v), 60 minutes. Immersion: up to 180 litres per disinfection bath Number and timing of application: Application frequency (CIP): 2 times a day Application frequency (wiping, mopping, spraying, immersion): 1 time a day Category(ies) of users Industrial Professional Pack sizes and packaging material 5-30 litres canister (HDPE) 200 litres drum (HDPE) 500-1 000 litres IBC container (HDPE, embedded in steel framework) 4.1.1. Use-specific instructions for use Thoroughly clean and rinse the surface. Dry the surface before applying the disinfection product. Wiping and mopping: At the end of work-shift, the working solution is prepared by dosing the required quantity of the product into water. This is done manually by using an appropriate package size or by using a measuring cup or canister pump for correct dilution in water for the activity needed. Soak a clean dry wipe or mop in freshly prepared working solution and wipe or mop the surface until it is completely wetted. Keep the surface wet and allow to take effect for the specified contact time. Spraying (tanks): The working solution is prepared by dosing the required quantity of the product into water. This is done manually by using an appropriate package size or by using a measuring cup or canister pump for correct dilution in water for the activity needed. Working solution is sprayed onto the inner surface by using a spraying device until it is completely wetted. Keep the surface wet and allow to take effect for the specified contact time. Immersion: The working solution is prepared by dosing the required quantity of the product into water. This is done manually by using an appropriate package size or by using a measuring cup or canister pump for correct dilution in water for the activity needed. Immerse equipment completely in working solution for the specified contact time. The disinfection bath can only be used once. CIP: The required quantities of product and water are pumped into the closed system by an automatic dosage system to a final concentration as needed for the respective activity. Volume of product needed to disinfect the surface depends on the size of the closed system. Circulate the working solution in the closed system for the specified contact time. 4.1.2. Use-specific risk mitigation measures During handling of the undiluted product: Wear protective gloves (e.g. butyl rubber) compliant with the requirements of the European Standard EN 374 or equivalent, protective clothing (coveralls) (type 6, EN 13034 or equivalent) and eye/face protection (EN 166 or equivalent) and respiratory protection equipment (RPE) with Assigned Protection Factor (APF 10) (EN 12941 or equivalent). For wiping: In small rooms: ≤ 80 m 3 , wear gloves (EN 374 or equivalent) and RPE with APF 10 if (EN 12941 or equivalent) ≤ 3 % in-use dilution are used. In large rooms: > 80 m 3 , wear gloves (EN 374 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≤ 3 % in-use dilution is used. For mopping: In small rooms: ≤ 80 m 3 , wear gloves (EN 374 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≤ 2 % in-use dilution are used. In small rooms: ≤ 80 m 3 , wear gloves (EN 374 or equivalent), coverall (type 6, EN 13034 or equivalent) and RPE with APF 10 (EN 12941) if 3 % in-use dilution are used. In large rooms: > 80 m 3 , wear gloves (EN 374 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≤ 1 % in-use dilution is used. In large rooms: > 80 m 3 , wear gloves (EN 374 or equivalent), coverall (type 6, EN 13034 or equivalent) and RPE with APF 10 (EN 12941) if ≥ 1 % in-use dilution is used. For spraying in tanks: Wear gloves (EN 374), coverall (type 6, EN 13034 or equivalent) and RPE APF 10 (EN 12941 or equivalent) when products with <1 % in-use dilution are used. Wear gloves (EN 374), coverall (type 6, EN 13034 or equivalent) and RPE APF 20 (EN 12942 or equivalent) when products with 1 %-2 % in-use dilution are used. Wear gloves (EN 374), coverall (type 6, EN 13034 or equivalent) and RPE APF 40 (EN 12942 or equivalent) when products with 3 % in-use dilution are used. For immersion: Application: no personal protective equipment (PPE) needed. For CIP applications: Application: closed system; no PPE needed. The following secondary exposure control measure applies to all application methods: PPE specified for the user shall also be worn by persons working in the vicinity of the application or who may otherwise be exposed to the biocidal product. Professional users must ensure that no bystanders are present in the treatment area during application. If bystanders have to be present, the users have to ensure that those wear the same PPE as themselves. The room shall be sealed and re-entry prevented after disinfection took place. It shall be indicated that a ventilation process after disinfection is running (information of other workers). Re-entry is only permitted once the air concentration of the active substance has dropped below the reference value (Adverse Effect Concentration (AEC) inhalation of 0,0106 mg/m 3 ). Unprotected persons should be kept away from treated areas until surfaces are dry. Regarding the personal protective equipment listed in this section, this is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See Section 6 for the full references to this act and the European 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 general directions for use. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use. 4.2. Use description Table 2 Use # 2-11: surface disinfection in industrial production areas, wiping, mopping, spraying, immersion and circulation (CIP) clean and dirty (PT 2) Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the authorised use n/a Target organism(s) (including development stage) Common name: bacteria Common name: yeasts Common name: fungi Common name: enveloped viruses Common name: viruses Field(s) of use Indoor use Hard non-porous surface disinfection in industrial production areas by wiping of work surfaces, machines, equipment, utensils etc., by mopping of floors and walls, by spraying (tanks), by immersion, disinfection of equipment and containers by immersion in an aqueous dilution of the product, and by circulation (cleaning in place, CIP), disinfection of inner surfaces of pipes, tanks, fillers, mixers and other machines. Application method(s) Method: Surface disinfection by wiping, mopping, spraying, immersion and CIP Detailed description: n.a. Application rate(s) and frequency Application Rate: Wiping, mopping and spraying: 40 ml/m 2 . Use at room temperature. Disinfection with prior cleaning: Use the product with the following dilution and contact time: Bacteria & enveloped viruses: 1 % (v/v), 15 minutes; 2 % (v/v), 5 minutes. Yeasts: 1 % (v/v), 15 minutes. Fungi (mopping, wiping, spraying and immersion): 1 % (v/v), 60 minutes; 2 % (v/v), 30 minutes; Fungi (CIP): 1 % (v/v), 60 minutes; 2 % (v/v), 15 minutes. Viruses: 3 % (v/v), 60 minutes. Disinfection without prior cleaning: Use the product with the following dilution and contact time: Bacteria & enveloped viruses (mopping, wiping, spraying and immersion): 0,5 % (v/v), 2 hours; 1 % (v/v), 15 minutes; 3 % (v/v), 5 minutes; Bacteria & enveloped viruses (CIP): 1 % (v/v), 15 minutes; 3 % (v/v), 5 minutes. Yeasts: 1 % (v/v), 60 minutes; 2 % (v/v), 15 minutes; 3 % (v/v), 5 minutes. Fungi (mopping, wiping, spraying and immersion): 1 % (v/v), 2 hours; Fungi (CIP): 1 % (v/v), 60 minutes; 3 % (v/v), 15 minutes. Viruses: 3 % (v/v), 60 minutes. Immersion: up to 180 litres per disinfection bath Number and timing of application: Application frequency (CIP): 2 times a day Application frequency (wiping, mopping, spraying, immersion): 1 time a day Category(ies) of users Industrial Professional Pack sizes and packaging material 5-30 litres canister (HDPE) 200 litres drum (HDPE) 500-1 000 litres IBC container (HDPE, embedded in steel framework) 4.2.1. Use-specific instructions for use For disinfection with prior cleaning: thoroughly clean and rinse the surface. Dry the surface before applying the disinfection product. Wiping and mopping: At the end of work-shift, the working solution is prepared by dosing the required quantity of the product into water. This is done manually by using an appropriate package size or by using a measuring cup or canister pump for correct dilution in water for the activity needed. Soak a clean dry wipe or mop in freshly prepared working solution and wipe or mop the surface until it is completely wetted. Keep the surface wet and allow to take effect for the specified contact time. Spraying (tanks): The working solution is prepared by dosing the required quantity of the product into water. This is done manually by using an appropriate package size or by using a measuring cup/canister pump for correct dilution in water for the activity needed. Working solution is sprayed onto the inner surface by using a standard cleaning lance (at a distance of approximately 1,5 meters to the surface) until it is completely wetted. Keep the surface wet and allow to take effect for the specified contact time. Immersion: The working solution is prepared by dosing the required quantity of the product into water. This is done manually by using an appropriate package size or by using a measuring cup or canister pump for correct dilution in water for the activity needed. Immerse equipment completely in working solution for the specified contact time. The disinfection bath can only be used once. CIP: The required quantities of product and water are pumped into the closed system by an automatic dosage system to a final concentration as needed for the respective activity. Volume of product needed to disinfect the surface depends on the size of the closed system. Circulate the working solution in the closed system for the specified contact time. 4.2.2. Use-specific risk mitigation measures During handling of the undiluted product: Wear protective gloves (e.g. butyl rubber) compliant with the requirements of the European Standard EN 374 or equivalent, protective clothing (coveralls) (type 6, EN 13034 or equivalent) and eye/face protection (EN 166 or equivalent) and respiratory protection equipment (RPE) with Assigned Protection Factor (APF 10) (EN 12941 or equivalent). For wiping: In small rooms: ≤ 80 m 3 , wear gloves (EN 374 or equivalent) and RPE with APF 10 if (EN 12941 or equivalent) ≤ 3 % in-use dilution are used. In large rooms: > 80 m 3 , wear gloves (EN 374 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≤ 3 % in-use dilution is used. For mopping: In small rooms: ≤ 80 m 3 , wear gloves (EN 374 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≤ 2 % in-use dilution are used. In small rooms: ≤ 80 m 3 , wear gloves (EN 374 or equivalent), coverall (type 6, EN 13034 or equivalent) and RPE with APF 10 (EN 12941) if 3 % in-use dilution are used. In large rooms: > 80 m 3 , wear gloves (EN 374 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≤ 1 % in-use dilution is used. In large rooms: > 80 m 3 , wear gloves (EN 374 or equivalent), coverall (type 6, EN 13034 or equivalent) and RPE with APF 10 (EN 12941 or equivalent) if ≥ 1 % in-use dilution is used. For spraying in tanks: Wear gloves (EN 374 or equivalent), coverall (type 6, EN 13034 or equivalent) and RPE APF 10 (EN 12941 or equivalent) when products with <1 % in-use dilution are used. Wear gloves (EN 374 or equivalent), coverall (type 6, EN 13034 or equivalent) and RPE APF 20 (EN 12942 or equivalent) when products with 1 %-2 % in-use dilution are used. Wear gloves (EN 374 or equivalent), coverall (type 6, EN 13034 or equivalent) and RPE APF 40 (EN 12942 or equivalent) when products with 3 % in-use dilution are used. For immersion: Application: no personal protective equipment (PPE) needed. For CIP applications: Application: closed system; no PPE needed. The following secondary exposure control measure applies to all application methods: PPE specified for the user shall also be worn by persons working in the vicinity of the application or who may otherwise be exposed to the biocidal product. Professional users must ensure that no bystanders are present in the treatment area during application. If bystanders have to be present, the users have to ensure that those wear the same personal protective equipment (PPE) as themselves. The room shall be sealed and re-entry prevented after disinfection took place. It shall be indicated that a ventilation process after disinfection is running (information of other workers). Re-entry is only permitted once the air concentration of the active substances has dropped below the reference value (Adverse Effect Concentration (AEC) inhalation of 0,0106 mg/m 3 ). Unprotected persons should be kept away from treated areas until surfaces are dry. Regarding the personal protective equipment listed in this section, this is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See Section 6 for the full references to this act and the European Standards. 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 general directions for use. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See 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 general directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2 5.1. Instructions for use Please see use-specific instructions for use. 5.2. Risk mitigation measures See use-specific risk mitigation measures. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Particulars of likely direct or indirect effects Harmful if inhaled. May cause an allergic skin reaction. Causes serious eye damage. May cause allergy or asthma symptoms or breathing difficulties if inhaled. Corrosive to the respiratory tract. Precautions Avoid breathing vapours. Environmental precautions: Do not flush into surface water. First aid instructions IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. 5.4. Instructions for safe disposal of the product and its packaging Waste water emission to reprocessing plant and final release of purified liquid to STP (sewage treatment plant). Emissions to surface water, soil and groundwater via STP. Dispose of contents/ container to an approved waste disposal plant. Dispose of waste and residues in accordance with local authority requirements. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Conditions for safe storage, including any incompatibilities Requirements for storage areas and containers: Store at temperature not exceeding 40 °C in the original container. Further information on storage conditions: Keep away from heat. Keep away from direct sunlight. Keep container tightly closed. Store in a well-ventilated place. Advice on common storage: Do not store near food, drink and feed. Shelf-life: 24 months. Conditions to avoid: Protect from frost, heat and sunlight. 6. OTHER INFORMATION The full titles of the EN standards referenced in Section 4.2 ‘Risk mitigation measures’ are: EN ISO 374 – Protective gloves against dangerous chemicals and micro-organisms EN ISO 166 – Personal eye protection standard EN 13034 – Protective clothing against liquid chemicals – Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6) EN ISO 12941 – Respiratory protective devices – Powered filtering devices incorporating a loose fitting respiratory interface – Requirements, testing, marking EN 12942 – Respiratory protective devices. Powered filtering devices incorporating full face masks, half masks or quarter masks. Requirements, testing, marking Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) ( OJ L 131, 5.5.1998, p. 11 ). With respect to the ‘Category (ies) of users’ note: Professionals (including industrial users) means trained professionals if this is required by national legislation. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) parmetol SL 60 Market area: EU Authorisation number EU-0034603-0004 1-2 Common name IUPAC name Function CAS number EC number Content (%) Glutaraldehyde 1,5-pentanedial Active substance 111-30-8 203-856-5 10 % (w/w) C(M)IT/MIT (3:1) Reaction mass of 5-chloro-2-methyl-2h-isothiazol-3-one and 2-methyl-2h-isothiazol-3-one (3:1) Active substance 55965-84-9 0 ,28 % (w/w)
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