Commission Implementing Regulation (EU) 2023/2747 of 8 December 2023 amending Implementing Regulation (EU) 2022/1391 granting a Union authorisation for the biocidal product family Lactic acid based products – CID Lines NV in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Official Journal EN of the European Union L series 2023/2747 11.12.2023 COMMISSION IMPLEMENTING REGULATION (EU) 2023/2747 of 8 December 2023 amending Implementing Regulation (EU) 2022/1391 granting a Union authorisation for the biocidal product family ‘Lactic acid based products – CID Lines NV’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (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 48(1), point (a), thereof, Whereas: (1) On 26 July 2022, a Union authorisation was granted to CID Lines NV for the making available on the market and use of the biocidal product family ‘Lactic acid-based products – CID Lines NV’ by Commission Implementing Regulation (EU) 2022/1391(2). In Annex I to Implementing Regulation (EU) 2022/1391 the authorisation holder was required to conduct a long-term storage stability test at ambient temperature of ‘Lactic acid-based products – CID Lines NV’ in commercial packaging in which the products in the family will be made available on the market and to submit the results of the test to the Agency by 1 March 2023. (2) The authorisation holder provided the required data on 28 February 2023 to the European Chemicals Agency (ECHA), recorded under the case number BC-RC051007-54. The evaluating competent authority of Belgium submitted the conclusions of its evaluation to ECHA on 9 March 2023. (3) On 30 June 2023, ECHA submitted the opinion of the Biocidal Products Committee(3) to the Commission concluding that the submitted data confirms the shelf life of 2 years for the products of the biocidal product family ‘CID Lines – Lactic acid-based products’, except for the packaging Wipe 4, 2L (105 wipes) from meta SPC 7 for which a two-year shelf life could not be confirmed. (4) The Commission concurs with the opinion of ECHA and considers it therefore appropriate to amend the Union authorisation of the biocidal product family ‘Lactic acid-based products – CID LINES NV’. (5) Since the shelf life of 2 years could not be confirmed for the packaging Wipe 4, 2L (105 wipes) of the biocidal product family, the conditions of Article 19 of Regulation (EU) No 528/2012 are not met for this packaging type for the duration of the shelf life. (6) The packaging Wipe 4, 2L (105 wipes) should therefore be removed from the entry ‘Pack sizes and packaging material’ in tables 13, 14, 15, 16, 17 and 18 of meta SPC 7 in Annex II to Implementing Regulation (EU) 2022/1391. (1) OJ L 167, 27.6.2012, p. 1. (2) Commission Implementing Regulation (EU) 2022/1391 of 26 July 2022 granting a Union authorisation for the biocidal product family ‘Lactic acid based products – CID Lines NV’ (OJ L 211, 12.8.2022, p. 1). (3) Opinion of the evaluation of post authorisation conditions for the Union authorisation of Lactic acid based products – CID Lines NV’. ECHA/BPC/384/2023 of 7 June 2023. ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 1/76EN OJ L, 11.12.2023 (7) On 4 August 2023, the Commission informed the authorisation holder of its intention to amend the Union authorisation for the biocidal product family ‘Lactic acid-based products – CID Lines NV’ and gave the opportunity to submit comments or additional information in accordance with Article 48(2) of Regulation (EU) No 528/2012. In its response received on the same day, the authorisation holder agreed with the intended amendment of the authorisation for the packaging Wipe 4, 2L (105 wipes) in meta SPC 7 for which a two-year shelf life could not be confirmed. (8) In order to enhance clarity and ease the access of users and interested parties to the final version of the SPC which is to be published in the Register of Biocidal Products, Annex II to Implementing Regulation (EU) 2022/1391 should be replaced in its entirety. (9) Implementing Regulation (EU) 2022/1391 should therefore be amended accordingly, HAS ADOPTED THIS REGULATION: Article 1 Annex II to Implementing Regulation (EU) 2022/1391 is replaced by the text in the Annex to this Regulation. 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, 8 December 2023. For the Commission The President Ursula VON DER LEYEN 2/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 ANNEX ‘ANNEX II Summary of product characteristics for a biocidal product family Lactic acid based products – CID LINES NV Product type 1 – Human hygiene (Disinfectants) Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Product type 3 – Veterinary hygiene (Disinfectants) Product type 4 – Food and feed area (Disinfectants) Authorisation number: EU-0027740-0000 R4BP asset number: EU-0027740-0000 PART I FIRST INFORMATION LEVEL 1. ADMINISTRATIVE INFORMATION 1.1. Family name Name Lactic acid based products – CID LINES NV 1.2. Product type(s) Product type(s) PT01 – Human hygiene (Disinfectants) PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT03 – Veterinary hygiene (Disinfectants) PT04 – Food and feed area (Disinfectants) 1.3. Authorisation holder Name and address of the authorisation holder Name CID LINES NV Address Waterpoortstraat 2, 8900 Ieper Belgium Authorisation number EU-0027740-0000 R4BP asset number EU-0027740-0000 Date of the authorisation 31 December 2023 Expiry date of the authorisation 31 August 2032 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 3/76EN OJ L, 11.12.2023 1.4. Manufacturer(s) of the biocidal products Name of manufacturer CID LINES NV Address of manufacturer Waterpoortstraat 2, 8900 Ieper Belgium Location of manufacturing sites Waterpoortstraat 2, 8900 Ieper Belgium 1.5. Manufacturer(s) of the active substance(s) Active substance L-(+)-lactic acid Name of manufacturer Purac Biochem bv Address of manufacturer Arkelsedijk 46, 4206 Gorinchem Netherlands Location of manufacturing sites Arkelsedijk 46, 4206 Gorinchem Netherlands Active substance L-(+)-lactic acid Name of manufacturer Jungbunzlauer S.A. Address of manufacturer Z.I. et Portuaire, B.P. 32, 67390 Marckolsheim France Location of manufacturing sites Z.I. et Portuaire, B.P. 32, 67390 Marckolsheim France 2. PRODUCT FAMILY COMPOSITION AND FORMULATION 2.1. Qualitative and quantitative information on the composition of the family Content (%) Common name IUPAC name Function CAS number EC number Min Max L-(+)-lactic acid Active Substance 79-33-4 201-196-2 2,0 70,0 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 0,0 12,0 sulphate mono- substance C12-14-alkyl esters, sodium salts Sodium lauryl ether Alcohols, Non-active 68891-38-3 500-234-8 0,0 8,4 sulfate C12-14, substance ethoxylated, sulfates, sodium salts Sulfonic acids, Sulfonic acids, Non-active 97489-15-1 307-055-2 0,0 2,25 C14-17-sec- C14-17-sec- substance alkane, sodium alkane, sodium salts salts C6 alkyl glucoside Hexyl Non-active 54549-24-5 259-217-6 0,0 2,4 D-Glucoside substance 4/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 Isopropanol Propan-2-ol Non-active 67-63-0 200-661-7 0,0 5,0 substance Methanesulfonic Methanesulfonic Non-active 75-75-2 200-898-6 0,0 19,5 acid acid substance Sulphuric acid Sulphuric acid Non-active 7664-93-9 231-639-5 0,0 10,5 substance Butyldiglycol 2-(2-butoxye- Non-active 112-34-5 203-961-6 0,0 10,0 thoxy)ethanol substance 2.2. Type(s) of formulation Formulation(s) AL – Any other liquid SL – Soluble concentrate WI – Wipes PART II SECOND INFORMATION LEVEL – META SPC(S) META SPC 1 1. META SPC 1 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 1 identifier Identifier Meta SPC 1: Ready to use hygienic handwash (PT1) 1.2. Suffix to the authorisation number Number 1-1 1.3. Product type(s) Product type(s) PT01 – Human hygiene (Disinfectants) 2. META SPC 1 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 1 Content (%) Common name IUPAC name Function CAS number EC number Min Max L-(+)-lactic acid Active Substance 79-33-4 201-196-2 3,6 3,6 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 5/76EN OJ L, 11.12.2023 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 5,0 5,0 sulphate mono- substance C12-14-alkyl esters, sodium salts Isopropanol Propan-2-ol Non-active 67-63-0 200-661-7 4,0 4,0 substance 2.2. Type(s) of formulation of the meta SPC 1 Formulation(s) AL – Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1 Hazard statements Causes serious eye damage. Precautionary statements Wear eyes/face protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a doctor. 4. AUTHORISED USE(S) OF THE META SPC 1 4.1. Use description Table 1 Use # 1 – Hygienic handwash for professional use Product type PT01 – Human hygiene (Disinfectants) Where relevant, an exact description Not relevant of the authorised use Target organism(s) (including Scientific name: Other: Bacteria development stage) Common name: Bacteria Development stage: Scientific name: Other: Yeast Common name: Yeasts Development stage: Field(s) of use Indoor Food and feed industry, Public field and Kitchens: Hygienic handwash Application method(s) Method: - Detailed description: - 6/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 Application rate(s) and frequency Application Rate: 10 mL of undiluted product (that is four pushes for both hands together) Dilution (%): - Number and timing of application: Apply 10 mL of undiluted product (that is four pushes for both hands together) and wash your hands for at least one minute according to the recommended hand washing procedure, before rinse and dry. Category(ies) of users Professional Pack sizes and packaging material 50 mL, 75 mL, 100 mL, 150 mL, 500 mL, 1L, 5L, 10L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000L, 1 100L HDPE (High Density Polyethylene) 4.1.1. Use-specific instructions for use see general directions for use for Meta SPC 1 4.1.2. Use-specific risk mitigation measures / 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 Meta SPC 1 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for Meta SPC 1 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 Meta SPC 1 5. GENERAL DIRECTIONS FOR USE(1)OF THE META SPC 1 5.1. Instructions for use Wet your hands with clean, running water at room temperature Turn off the tap Apply 10 mL of undiluted product and rub your hands for at least one minute according to the recommended hand washing procedure, before rinse and dry. For professional use only 5.2. Risk mitigation measures / 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment 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 INHALED: If symptoms occur call a POISON CENTRE or a doctor. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Immediately call 112/ambulance for medical assistance. (1) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1. ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 7/76EN OJ L, 11.12.2023 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. 5.4. Instructions for safe disposal of the product and its packaging The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use. The shelf-life of the products is two years. 6. OTHER INFORMATION / 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) Kenosan Hand Scrub Market area: EU Authorisation EU-0027740-0001 1-1 number Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid Active Substance 79-33-4 201-196-2 3,6 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 5,0 sulphate mono- substance C12-14-alkyl esters, sodium salts Isopropanol Propan-2-ol Non-active 67-63-0 200-661-7 4,0 substance META SPC 2 1. META SPC 2 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 2 identifier Identifier Meta SPC 2: Ready to use Algaecide 8/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 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 (Disinfectants) 2. META SPC 2 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 2 Content (%) Common name IUPAC name Function CAS number EC number Min Max L-(+)-lactic acid Active Substance 79-33-4 201-196-2 2,0 2,0 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 0,6 0,9 sulphate mono- substance C12-14-alkyl esters, sodium salts 2.2. Type(s) of formulation of the meta SPC 2 Formulation(s) AL – Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 Hazard statements Causes serious eye irritation. Precautionary statements If medical advice is needed, have product container or label at hand. Keep out of reach of children. Read carefully and follow all instructions. Wash hands thoroughly after handling. Wear eyes/face protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. If skin irritation occurs:Get medical advice. If eye irritation persists:Get medical advice. Take off contaminated clothing.And wash it before reuse. ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 9/76EN OJ L, 11.12.2023 4. AUTHORISED USE(S) OF THE META SPC 2 4.1. Use description Table 2 Use # 1 – Ready to use algaecide for professional use Product type PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: other: bacteria stage) Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: Scientific name: unicellular green algae and blue-green algae Common name: cyanobacteria Development stage: Field(s) of use Indoor Outdoor Public field: Ready-to-use algaecide, on hard/non-porous surfaces without prior cleaning. Application method(s) Method: By brushing, by spraying (low pressure) or pouring Detailed description: / Application rate(s) and frequency Application Rate: 100 mL/m2 Dilution (%): - Number and timing of application: Active against bacteria, yeasts and unicellular green algae and blue- green algae (cyanobacteria): With undiluted product at 20 – 25 °C In 3h contact time 100 mL/m2 The biocidal product is not intended to be used on surfaces that come into contact with food and feed. Category(ies) of users Professional Pack sizes and packaging material 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000L, 1 100L 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000kg, 1 100kg HDPE (High Density Polyethylene) 4.1.1. Use-specific instructions for use see general directions for use for Meta SPC 2 10/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 4.1.2. Use-specific risk mitigation measures / 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 for Meta SPC 2 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 2 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 for Meta SPC 2 4.2. Use description Table 3 Use # 2 – Ready to use algaecide for non-professional use Product type PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: other: bacteria stage) Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: Scientific name: unicellular green algae and blue-green algae Common name: Cyanobacteria Development stage: Field(s) of use Indoor Outdoor Public field: Ready-to-use algaecide, on hard/non-porous surfaces without prior cleaning. Application method(s) Method: By brushing, by spraying (low pressure) or pouring Detailed description: / Application rate(s) and frequency Application Rate: 100 mL/m2 Dilution (%): - Number and timing of application: Active against bacteria, yeasts and unicellular green algae and blue- green algae (cyanobacteria): With undiluted product at 20 – 25 °C ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 11/76EN OJ L, 11.12.2023 In 3h contact time 100 mL/m2 The biocidal product is not intended to be used on surfaces that come into contact with food and feed. Category(ies) of users General public (non-professional) Pack sizes and packaging material 1 L, 5 L, 10 L 1 kg, 5 kg, 10 kg HDPE (High Density Polyethylene) 4.2.1. Use-specific instructions for use see general directions for use for Meta SPC 2 4.2.2. Use-specific risk mitigation measures / 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 for Meta SPC 2 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 2 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 for Meta SPC 2 5. GENERAL DIRECTIONS FOR USE(2)OF THE META SPC 2 5.1. Instructions for use Comply with the instructions for use The surfaces to be disinfected must be wet enough in order to be kept wet during the approved contact time for optimal disinfection. The following precautionary sentence shall be added on the product label: “Make sure to wet surfaces completely”. The required contact time has to be respected until further treatments (for example brushing the surfaces). Use 100 mL solution/m2 5.2. Risk mitigation measures / 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for five minutes. 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 medical advice is needed, have product container or label at hand (2) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2. 12/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 5.4. Instructions for safe disposal of the product and its packaging The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use. The shelf-life of the products is two years. Keep out of reach of children and non-target animals/pets. 6. OTHER INFORMATION / 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) RTU Algaecide Market area: EU Authorisation EU-0027740-0002 1-2 number Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid Active Substance 79-33-4 201-196-2 2,0 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 0,6 sulphate mono- substance C12-14-alkyl esters, sodium salts META SPC 3 1. META SPC 3 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 3 identifier Identifier Meta SPC 3: concentrated algaecide and hard surface disinfection in food industry 1.2. Suffix to the authorisation number Number 1-3 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 13/76EN OJ L, 11.12.2023 1.3. Product type(s) Product type(s) PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT04 – Food and feed area (Disinfectants) 2. META SPC 3 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 3 Content (%) Common name IUPAC name Function CAS number EC number Min Max L-(+)-lactic acid Active Substance 79-33-4 201-196-2 70,0 70,0 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 6,0 6,0 sulphate mono- substance C12-14-alkyl esters, sodium salts 2.2. Type(s) of formulation of the meta SPC 3 Formulation(s) SL – Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3 Hazard statements Causes severe skin burns and eye damage. Causes serious eye damage. Precautionary statements Do not breathe vapours. Wash hands thoroughly after handling. Wear protective gloves. Wear protective clothing. Wear eyes/face protection. IF SWALLOWED:Rinse mouth.Do NOT induce vomiting. IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water. IF INHALED:Remove person to fresh air and keep comfortable for breathing. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a doctor. Wash contaminated clothing before reuse. Store locked up. Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. 14/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 4. AUTHORISED USE(S) OF THE META SPC 3 4.1. Use description Table 4 Use # 1 – concentrated algaecide Product type PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Scientific name: unicellular green algae and blue-green algae development stage) Common name: Cyanobacteria Development stage: Field(s) of use Indoor Outdoor Food and feed industry; Public field: Concentrated algaecide, on hard/non-porous surfaces without prior cleaning. Application method(s) Method: By spraying (low pressure) or pouring Detailed description: / Application rate(s) and Application Rate: 100 mL/m2 frequency Dilution (%): 0,5 % Number and timing of application: Active against unicellular green algae and blue-green algae (cyanobacteria): 100 mL/m2 Dilute the product to 0,5 % in water, to reach an in use concentration of 0,35 % Lactic acid. at 20– 25 °C In 3h contact time Category(ies) of users Professional Pack sizes and packaging 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000L, 1 100L material 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000kg, 1 100kg HDPE (High Density Polyethylene) 4.1.1. Use-specific instructions for use see general directions for use for Meta SPC 3 4.1.2. Use-specific risk mitigation measures see general directions for use for Meta SPC 3 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 for Meta SPC 3 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 15/76EN OJ L, 11.12.2023 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 3 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 for Meta SPC 3 4.2. Use description Table 5 Use # 2 – Disinfection of hard/non-porous surfaces in the food industry (for example processing machines) Product type PT04 – Food and feed area (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor in Food/feed industry: Disinfection of hard/non-porous surfaces (for example processing machines) without prior cleaning Application method(s) Method: Spraying or soaking Detailed description: Spraying Soaking (the bath is intended to be used only once) Application rate(s) and Application Rate: 100 mL/m2 frequency Dilution (%): 4 % Number and timing of application: Active against bacteria and yeasts at +40 °C: Dilute the product to 4 % in water, to reach an in use concentration of 2,8 % Lactic acid. In five seconds contact time 100 mL/m2 Category(ies) of users Professional Pack sizes and packaging 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000L, 1 100L material 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000kg, 1 100kg HDPE (High Density Polyethylene) 4.2.1. Use-specific instructions for use see general directions for use for Meta SPC 3 16/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 4.2.2. Use-specific risk mitigation measures see general directions for use for Meta SPC 3 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 for Meta SPC 3 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 3 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 for Meta SPC 3 5. GENERAL DIRECTIONS FOR USE(3)OF THE META SPC 3 5.1. Instructions for use Disinfection cycle: — Products must be diluted in potable water before use. — Final rinsing (with potable water): if required. The surfaces to be disinfected must be wet enough in order to be kept wet during the approved contact time for optimal disinfection. The following precautionary sentence shall be added on the product label: “Make sure to wet surfaces completely”. 5.2. Risk mitigation measures Gloves and goggles are needed during mixing and loading of the concentrated products. Wear protective coverall (to be specified by the authorisation holder within the product information). 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment IF 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 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. Immediately call 112/ambulance for medical assistance. 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. 5.4. Instructions for safe disposal of the product and its packaging The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use. The shelf-life of the products is two years. 6. OTHER INFORMATION / (3) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3. ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 17/76EN OJ L, 11.12.2023 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Concentrated Algaecide Market area: EU Kenosan Lactic CONC Market area: EU Authorisation EU-0027740-0003 1-3 number Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid Active Substance 79-33-4 201-196-2 70,0 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 6,0 sulphate mono- substance C12-14-alkyl esters, sodium salts META SPC 4 1. META SPC 4 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 4 identifier Identifier Meta SPC 4: Concentrated surface disinfectants for sanitary hygiene and kitchens (PT2-PT4) 1.2. Suffix to the authorisation number Number 1-4 1.3. Product type(s) Product type(s) PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT04 – Food and feed area (Disinfectants) 18/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 2. META SPC 4 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 4 Content (%) Common name IUPAC name Function CAS number EC number Min Max L-(+)-lactic acid Active Substance 79-33-4 201-196-2 16,0 16,0 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 5,0 5,0 sulphate mono- substance C12-14-alkyl esters, sodium salts 2.2. Type(s) of formulation of the meta SPC 4 Formulation(s) SL – Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4 Hazard statements Causes skin irritation. Causes serious eye damage. Contains eucalyptus globulus oil (CAS-No 8000-48-4). May produce an allergic reaction. Precautionary statements If medical advice is needed, have product container or label at hand. Keep out of reach of children. Read carefully and follow all instructions. Wash hands thoroughly after handling. Wear protective gloves. Wear eyes/face protection. IF ON SKIN:Wash with plenty of water. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a doctor. If skin irritation occurs:Get medical advice. Take off contaminated clothing.And wash it before reuse. 4. AUTHORISED USE(S) OF THE META SPC 4 4.1. Use description Table 6 Use # 1 – Hard surface disinfection for sanitary hygiene, other than in healthcare, for professional use (PT2) Product type PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 19/76EN OJ L, 11.12.2023 Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Scientific name: other: bacteria development stage) Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: Field(s) of use Indoor Public field (NOT in HEALTHCARE) Disinfection of hard/non-porous surfaces (for sanitary hygiene) by spraying without prior cleaning Application method(s) Method: By spraying (with wiping if needed, only after the end of the preconised contact time) Detailed description: / Application rate(s) and Application Rate: 250 mL/m2 diluted product frequency Dilution (%): 20 % Number and timing of application: Active against bacteria and yeasts at room temperature Dilute the product 20 % in water, to reach an in use concentration of 3,2 % Lactic acid. In 15 minutes contact time 250 mL/m2 diluted product Category(ies) of users Professional Pack sizes and packaging 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000L, 1 100L material 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000kg, 1 100kg HDPE (High Density Polyethylene) 4.1.1. Use-specific instructions for use Comply with the instructions for use 4.1.2. Use-specific risk mitigation measures Gloves and goggles are needed during handling of the products 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 for Meta SPC 4 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 4 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 for Meta SPC 4 20/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 4.2. Use description Table 7 Use # 2 – Hard surface disinfection for hygiene in kitchens, for professional use (PT4) Product type PT04 – Food and feed area (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Scientific name: other: bacteria development stage) Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: Field(s) of use Indoor in food/feed areas: Disinfection of hard/non-porous surfaces (for general hygiene) by spraying without prior cleaning Application method(s) Method: By spraying (with wiping if needed, only after the end of the preconised contact time) Detailed description: / Application rate(s) and Application Rate: 100 mL/m2 frequency Dilution (%): 20 % Number and timing of application: Active against bacteria and yeasts at room temperature Dilute the product 20 % in water, to reach an in use concentration of 3,2 % Lactic acid. In 15 minutes contact time 100 mL/m2 Category(ies) of users Professional Pack sizes and packaging 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000L, 1 100L material 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000kg, 1 100kg HDPE (High Density Polyethylene) 4.2.1. Use-specific instructions for use Comply with the instructions for use 4.2.2. Use-specific risk mitigation measures Gloves and goggles are needed during handling of the products. 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 for Meta SPC 4 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 21/76EN OJ L, 11.12.2023 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 4 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 for Meta SPC 4 4.3. Use description Table 8 Use # 3 – Disinfection of toilet bowls, for professional use (PT2) Product type PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Scientific name: other: bacteria development stage) Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: Field(s) of use Indoor Public field Disinfection of hard/non-porous inside surfaces of toilets, without prior cleaning Application method(s) Method: By pouring (with brushing – only after the end of the preconised contact time) Detailed description: / Application rate(s) and Application Rate: 250 mL/m2 frequency Dilution (%): - Number and timing of application: Active against bacteria and yeasts at room temperature: With the undiluted product (with 16 % Lactic acid) In five minutes contact time Category(ies) of users Professional Pack sizes and packaging 500 mL, 700 mL, 750 mL, 1L, 1.5 L, 2 L material HDPE (High Density Polyethylene) Toilet Duck 4.3.1. Use-specific instructions for use Comply with the instructions for use 4.3.2. Use-specific risk mitigation measures Gloves and goggles are needed during handling of the products. 22/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 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 for Meta SPC 4 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 4 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 for Meta SPC 4 4.4. Use description Table 9 Use # 4 – Disinfection of toilet bowls, for non-professional use (PT2) Product type PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Scientific name: other: bacteria development stage) Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: Field(s) of use Indoor Public field Disinfection of hard/non-porous inside surfaces of toilets, without prior cleaning Application method(s) Method: By pouring (with brushing – only after the end of the preconised contact time) Detailed description: / Application rate(s) and Application Rate: 250 mL/m2 frequency Dilution (%): - Number and timing of application: Active against bacteria and yeasts at room temperature: With the undiluted product (with 16 % Lactic acid) In five minutes contact time Category(ies) of users General public (non-professional) Pack sizes and packaging 500 mL, 700 mL, 750 mL, 1L, 1.5 L, 2 L material HDPE (High Density Polyethylene) Toilet Duck 4.4.1. Use-specific instructions for use Comply with the instructions for use ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 23/76EN OJ L, 11.12.2023 4.4.2. Use-specific risk mitigation measures Avoid contact with eyes A child proof closure is required The product must be fitted with a pouring spout, the product must be poured gently on the wall of the toilet bowl to avoid the formation of splashes. Wash hands after application 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 If medical advice is needed, have product container or label at hand 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 4 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep out of reach of children and non-target animals/pets. 5. GENERAL DIRECTIONS FOR USE(4)OF THE META SPC 4 5.1. Instructions for use The surfaces to be disinfected must be wet enough in order to be kept wet during the preconised contact time for optimal disinfection. The following precautionary sentence shall be added on the product label: “Make sure to wet surfaces completely”. 5.2. Risk mitigation measures / 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment 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 skin irritation occurs: Get medical advice. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Immediately call 112/ambulance for medical assistance. 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 INHALED: If symptoms occur call a POISON CENTRE or a doctor. 5.4. Instructions for safe disposal of the product and its packaging The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use. The shelf-life of the products is two years. 6. OTHER INFORMATION / (4) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4. 24/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Sanifresh Market area: EU Milcho Des Market area: EU Kenolens Market area: EU Kenolux S100 Market area: EU SANI-CAL Market area: EU Sani Super Market area: EU Scrub Market area: EU MiQro Sani Des Market area: EU Authorisation EU-0027740-0004 1-4 number Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid Active Substance 79-33-4 201-196-2 16,0 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 5,0 sulphate mono- substance C12-14-alkyl esters, sodium salts META SPC 5 1. META SPC 5 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 5 identifier Identifier Meta SPC 5: Concentrated pre-dips (PT3) 1.2. Suffix to the authorisation number Number 1-5 1.3. Product type(s) Product type(s) PT03 – Veterinary hygiene (Disinfectants) ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 25/76EN OJ L, 11.12.2023 2. META SPC 5 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 5 Content (%) Common name IUPAC name Function CAS number EC number Min Max L-(+)-lactic acid Active Substance 79-33-4 201-196-2 8,0 8,0 Sodium lauryl ether Alcohols, Non-active 68891-38-3 500-234-8 8,4 8,4 sulfate C12-14, substance ethoxylated, sulfates, sodium salts Sulfonic acids, Sulfonic acids, Non-active 97489-15-1 307-055-2 2,25 2,25 C14-17-sec- C14-17-sec- substance alkane, sodium alkane, sodium salts salts 2.2. Type(s) of formulation of the meta SPC 5 Formulation(s) SL – Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5 Hazard statements Causes serious eye damage. Precautionary statements Wear eyes/face protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a doctor. 4. AUTHORISED USE(S) OF THE META SPC 5 4.1. Use description Table 10 Use # 1 – Teat disinfection, before milking Product type PT03 – Veterinary hygiene (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Scientific name: other: bacteria development stage) Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: 26/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 Field(s) of use Indoor Veterinary field Teat disinfection before milking with concentrated product (to be diluted before disinfection procedure), without prior cleaning Application method(s) Method: By dipping, by spraying with spray flacon or spray installation and by wiping with a towel Detailed description: By dipping By spraying with spray flacon or spray installation By wiping with a towel soaking with the diluted product Application rate(s) and Application Rate: 5 – 15 mL frequency Dilution (%): 40 % Number and timing of application: Active against bacteria and yeasts: Dilution: 40 % The product must be diluted with RT potable water. In one minute contact time Category(ies) of users Professional Pack sizes and packaging 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000L, 1 100L material 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000kg, 1 100kg HDPE (High Density Polyethylene) 4.1.1. Use-specific instructions for use Application rates: Dilution: 40 % (with 3,2 % LA) – The product must be diluted with RT potable water. — 5 mL per cow per application for use by dipping — 7.5 mL per cow per application for use by spray flacon — 15 mL per cow per application for use by spray installation — For use by wiping with a towel: prepare 10 L working solution for 25 towels. Use one towel per cow. 4.1.2. Use-specific risk mitigation measures see general directions for use for Meta SPC 5 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 for Meta SPC 5 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 5 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 for Meta SPC 5 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 27/76EN OJ L, 11.12.2023 4.2. Use description Table 11 Use # 2 – Intact skin wash/disinfection (of the udder of dairy and beef cattle before calving and of the udder of sows before farrowing) Product type PT03 – Veterinary hygiene (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Scientific name: other: bacteria development stage) Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: Field(s) of use Indoor Veterinary field Application method(s) Method: Spraying Detailed description: / Application rate(s) and Application Rate: 5 – 20 mL frequency Dilution (%): 40 % Number and timing of application: Active against bacteria and yeasts: Dilution: 40 % The product must be diluted with Room Temperature potable water. In one minute contact time 1) dairy and beef cattle on the udder before calving: 5 mL (1 spray) on each teat 2) sows on the udder before farrowing: 20 mL The animals should be kept standing on a clean floor for at least five minutes. Category(ies) of users Professional Pack sizes and packaging 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000L, 1 100L material 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000kg, 1 100kg HDPE (High Density Polyethylene) 4.2.1. Use-specific instructions for use see general directions for use for Meta SPC 5 28/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 4.2.2. Use-specific risk mitigation measures see general directions for use for Meta SPC 5 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 for Meta SPC 5 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 5 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 for Meta SPC 5 5. GENERAL DIRECTIONS FOR USE(5)OF THE META SPC 5 5.1. Instructions for use See use specific instructions for use 5.2. Risk mitigation measures Chemical goggles need to be worn. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Immediately call 112/ambulance for medical assistance. 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 INHALED: If symptoms occur call a POISON CENTRE or a doctor. 5.4. Instructions for safe disposal of the product and its packaging The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use. The shelf-life of the products is two years. 6. OTHER INFORMATION / (5) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 5. ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 29/76EN OJ L, 11.12.2023 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Kenopro Lactic Market area: EU HCP Foam Concentrate Market area: EU Kenopro Lactic Market area: EU Reconet+ Market area: EU Kenopure Market area: EU MIROX Pre Lac Market area: EU Milchsäure Pre Market area: EU Milchsäure Pref Market area: EU Lactocid Pre Market area: EU Milcho Pre Market area: EU Preactive Market area: EU Precoop Market area: EU Lactipré Market area: EU Prelacti Market area: EU Prelak Market area: EU Power Prep Market area: EU Multicleaner Market area: EU Kenopure Strong Market area: EU Semex Pre Market area: EU MEPA Pure Market area: EU MEPA Foam Market area: EU Eco Lac Foam Market area: EU Authorisation EU-0027740-0005 1-5 number Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid Active Substance 79-33-4 201-196-2 8,0 Sodium lauryl ether Alcohols, C12-14, Non-active 68891-38-3 500-234-8 8,4 sulfate ethoxylated, substance sulfates, sodium salts Sulfonic acids, Sulfonic acids, Non-active 97489-15-1 307-055-2 2,25 C14-17-sec-alkane, C14-17-sec- substance sodium salts alkane, sodium salts 30/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 META SPC 6 1. META SPC 6 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 6 identifier Identifier Meta SPC 6: Ready to use Pre-dips (PT3) 1.2. Suffix to the authorisation number Number 1-6 1.3. Product type(s) Product type(s) PT03 – Veterinary hygiene (Disinfectants) 2. META SPC 6 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 6 Content (%) Common name IUPAC name Function CAS number EC number Min Max L-(+)-lactic acid Active Substance 79-33-4 201-196-2 3,6 3,6 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 5,25 5,25 sulphate mono- substance C12-14-alkyl esters, sodium salts 2.2. Type(s) of formulation of the meta SPC 6 Formulation(s) AL – Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6 Hazard statements Causes serious eye damage. Precautionary statements Wear eye/face protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a doctor. ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 31/76EN OJ L, 11.12.2023 4. AUTHORISED USE(S) OF THE META SPC 6 4.1. Use description Table 12 Use # 1 – Teat disinfection, before milking Product type PT03 – Veterinary hygiene (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Scientific name: other: bacteria development stage) Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: Field(s) of use Indoor Veterinary field Application method(s) Method: By dipping, by spraying with spray flacon or spray installation, by wiping with a towel Detailed description: By dipping By spraying with spray flacon or spray installation By wiping with a towel soaking with the diluted product Application rate(s) and Application Rate: Active against bacteria and yeasts: (Ready-To-Use) RTU In one frequency minute contact time. The product must “return” to room temperature before use. Dilution (%): - Number and timing of application: Active against bacteria and yeasts: RTU (with 3,6 % Lactic acid) In one minute contact time The product must “return” to RT before use Category(ies) of users Professional Pack sizes and packaging 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000L, 1 100L material 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000kg, 1 100kg HDPE (High Density Polyethylene) 4.1.1. Use-specific instructions for use Application rates: — 5 mL per cow per application for use by dipping — 7,5 mL per cow per application for use by spray flacon 32/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 — 15 mL per cow per application for use by spray installation — One towel per cow for use by wiping 4.1.2. Use-specific risk mitigation measures see general directions for use for Meta SPC 6 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 for Meta SPC 6 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 6 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 for Meta SPC 6 5. GENERAL DIRECTIONS FOR USE(6)OF THE META SPC 6 5.1. Instructions for use / 5.2. Risk mitigation measures Chemical goggles need to be worn. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Immediately call 112/ambulance for medical assistance. 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 INHALED: If symptoms occur call a POISON CENTRE or a doctor. 5.4. Instructions for safe disposal of the product and its packaging The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use. The shelf-life of the products is two years. 6. OTHER INFORMATION / (6) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 6. ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 33/76EN OJ L, 11.12.2023 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Kenopure R Market area: EU Kenopure RTU Market area: EU HCP Foam RTU Market area: EU Kenoxypure RTU Market area: EU Kenopurox RTU Market area: EU Kenopure Ox RTU Market area: EU Kenopure Plus RTU Market area: EU Kenopure Extra RTU Market area: EU Kenopure oxylac RTU Market area: EU Kenoxylac predip RTU Market area: EU Kenoxilac predip RTU Market area: EU Kenopure H O RTU Market area: EU 2 2 Oxy Kenopure RTU Market area: EU Preactive RTU Market area: EU Precoop RTU Market area: EU Lactipré RTU Market area: EU Prelacti RTU Market area: EU Prelak RTU Market area: EU Power Prep RTU Market area: EU Prelacta Foam Market area: EU Authorisation EU-0027740-0006 1-6 number Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid Active Substance 79-33-4 201-196-2 3,6 34/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 5,25 sulphate mono- substance C12-14-alkyl esters, sodium salts META SPC 7 1. META SPC 7 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 7 identifier Identifier Meta SPC 7: Ready to use wipes (PT2, PT4) 1.2. Suffix to the authorisation number Number 1-7 1.3. Product type(s) Product type(s) PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT04 – Food and feed area (Disinfectants) 2. META SPC 7 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 7 Content (%) Common name IUPAC name Function CAS number EC number Min Max L-(+)-lactic acid Active Substance 79-33-4 201-196-2 2,0 2,0 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 0,6 0,9 sulphate mono- substance C12-14-alkyl esters, sodium salts ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 35/76EN OJ L, 11.12.2023 2.2. Type(s) of formulation of the meta SPC 7 Formulation(s) WI – Wipes 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7 Hazard statements Causes serious eye irritation. Precautionary statements If medical advice is needed, have product container or label at hand. Keep out of reach of children. Read carefully and follow all instructions. Wash hands thoroughly after handling. Wear eyes/face protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. If skin irritation occurs:Get medical advice. If eye irritation persists:Get medical advice. Take off contaminated clothing.And wash it before reuse. 4. AUTHORISED USE(S) OF THE META SPC 7 4.1. Use description Table 13 Use # 1 – Hard surface disinfection in Food and Feed industry, for professional use (PT4) Product type PT04 – Food and feed area (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Scientific name: other: bacteria development stage) Common name: Bacteria Development stage: Scientific name: other: yeasts Common name: Yeasts Development stage: Scientific name: other: viruses Common name: Viruses Development stage: Field(s) of use Indoor Food/feed areas Disinfection of hard/non-porous surfaces and objects, with prior cleaning Application method(s) Method: With pre-impragnated wipes Detailed description: / 36/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 Application rate(s) and Application Rate: Active against bacteria, yeasts and viruses: With pre-impregnated frequency wipes at room temperature in two minutes contact time Dilution (%): - Number and timing of application: Active against bacteria, yeasts and viruses: With pre-impregnated wipes at room temperature in two minutes contact time Category(ies) of users Professional Pack sizes and packaging Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes material 4.1.1. Use-specific instructions for use see general directions for use for Meta SPC 7 4.1.2. Use-specific risk mitigation measures / 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 for Meta SPC 7 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 7 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 for Meta SPC 7 4.2. Use description Table 14 Use # 2 – Hard surface disinfection in food and feed area, for non-professional use (PT4) Product type PT04 – Food and feed area (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Scientific name: other: bacteria development stage) Common name: Bacteria Development stage: Scientific name: other: yeasts Common name: Yeasts Development stage: Scientific name: other: viruses Common name: Viruses Development stage: ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 37/76EN OJ L, 11.12.2023 Field(s) of use Indoor Food/feed areas Disinfection of hard/non-porous surfaces and objects, with prior cleaning Application method(s) Method: With pre-impragnated wipes Detailed description: Wipes Application rate(s) and Application Rate: One wipe/m2 frequency Dilution (%): - Number and timing of application: Active against bacteria, yeasts and viruses: With pre-impregnated wipes at room temperature in two minutes contact time Category(ies) of users General public (non-professional) Pack sizes and packaging Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes material 4.2.1. Use-specific instructions for use Comply with the instructions for use 4.2.2. Use-specific risk mitigation measures / 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 If medical advice is needed, have product container or label at hand 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 7 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep out of reach of children and non-target animals/pets. 4.3. Use description Table 15 Use # 3 – Hard surface disinfection, use in healthcare, for professional use (PT2) Product type PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Scientific name: other: bacteria development stage) Common name: Bacteria Development stage: Scientific name: other: yeasts Common name: Yeasts Development stage: 38/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 Scientific name: other: viruses Common name: Viruses Development stage: Field(s) of use Indoor Public field: Disinfection of hard/non-porous surfaces (walls, floors and other surfaces in indoor spaces, including bathrooms and toilets) with prior cleaning Application method(s) Method: With pre-impregnated wipes Detailed description: / Application rate(s) and Application Rate: Active against bacteria, yeasts and viruses: With pre-impregnated frequency wipes at room temperature in two minutes contact time Dilution (%): - Number and timing of application: Active against bacteria, yeasts and viruses: With pre-impregnated wipes at room temperature in two minutes contact time Category(ies) of users Professional Pack sizes and packaging Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes material 4.3.1. Use-specific instructions for use see general directions for use for Meta SPC 7 4.3.2. Use-specific risk mitigation measures / 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 for Meta SPC 7 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 7 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 for Meta SPC 7 4.4. Use description Table 16 Use # 4 – Hard surface disinfection, use in healthcare, for non-professional use (PT2) Product type PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 39/76EN OJ L, 11.12.2023 Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Scientific name: other: bacteria development stage) Common name: Bacteria Development stage: Scientific name: other: yeasts Common name: Yeasts Development stage: Scientific name: other: viruses Common name: Viruses Development stage: Field(s) of use Indoor Public field: Disinfection of hard/non-porous surfaces (walls, floors and other surfaces in indoor spaces, including bathrooms and toilets) in healthcare area with prior cleaning Application method(s) Method: With pre-impregnated wipes Detailed description: / Application rate(s) and Application Rate: Active against bacteria, yeasts and viruses: With pre-impregnated frequency wipes at room temperature in two minutes contact time Dilution (%): - Number and timing of application: Active against bacteria, yeasts and viruses: With pre-impregnated wipes at room temperature in two minutes contact time Category(ies) of users General public (non-professional) Pack sizes and packaging Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes material 4.4.1. Use-specific instructions for use Comply with the instructions for use 4.4.2. Use-specific risk mitigation measures / 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 If medical advice is needed, have product container or label at hand 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 7 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep out of reach of children and non-target animals/pets. 40/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 4.5. Use description Table 17 Use # 5 – Hard surface disinfection, use other than in healthcare, for professional use (PT2) Product type PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Scientific name: other: bacteria development stage) Common name: Bacteria Development stage: Scientific name: other: yeasts Common name: Yeasts Development stage: Scientific name: other: viruses Common name: Viruses Development stage: Field(s) of use Indoor Public field: Disinfection of hard/non-porous surfaces (walls, floors and other surfaces in indoor spaces, including bathrooms and toilets) with prior cleaning Application method(s) Method: With pre-impregnated wipes Detailed description: / Application rate(s) and Application Rate: Active against bacteria, yeasts and viruses: With pre-impregnated frequency wipes at room temperature in two minutes contact time Dilution (%): - Number and timing of application: Active against bacteria, yeasts and viruse: With pre-impregnated wipes at room temperature in two minutes contact time Category(ies) of users Professional Pack sizes and packaging Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes material 4.5.1. Use-specific instructions for use see general directions for use for Meta SPC 7 4.5.2. Use-specific risk mitigation measures / 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 for Meta SPC 7 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 41/76EN OJ L, 11.12.2023 4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 7 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 for Meta SPC 7 4.6. Use description Table 18 Use # 6 – Hard surface disinfection, use other than in healthcare, for non-professional use (PT2) Product type PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Scientific name: other: bacteria development stage) Common name: Bacteria Development stage: Scientific name: other: yeasts Common name: Yeasts Development stage: Scientific name: other: viruses Common name: Viruses Development stage: Field(s) of use Indoor Public field: Disinfection of hard/non-porous surfaces (walls, floors and other surfaces in indoor spaces, including bathrooms and toilets) with prior cleaning Application method(s) Method: With pre-impregnated wipes Detailed description: / Application rate(s) and Application Rate: Active against bacteria, yeasts and viruses: With pre-impregnated frequency wipes at room temperature in two minutes contact time Dilution (%): - Number and timing of application: Active against bacteria, yeasts and viruses: With pre-impregnated wipes at room temperature in two minutes contact time Category(ies) of users General public (non-professional) Pack sizes and packaging Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes material 4.6.1. Use-specific instructions for use Comply with the instructions for use 42/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 4.6.2. Use-specific risk mitigation measures / 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 If medical advice is needed, have product container or label at hand. 4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 7 4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep out of reach of children and non-target animals/pets. 5. GENERAL DIRECTIONS FOR USE(7)OF THE META SPC 7 5.1. Instructions for use Comply with the instructions for use First clean thoroughly the surfaces and materials to be disinfected and dry the surface or materials. Disinfect the dry surface with a wipe. Make sure the surface remains completely wetted during the required contact time. 5.2. Risk mitigation measures / 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor. IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for five minutes. 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 medical advice is needed, have product container or label at hand 5.4. Instructions for safe disposal of the product and its packaging The packing and content must be eliminated as dangerous waste product under the fullresponsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use. Store at ambient temperature. Do not store below 0 °C and above 40 °C. The shelf-life of the products is two years. Keep out of reach of children and non-target animals/pets 6. OTHER INFORMATION / (7) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 7. ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 43/76EN OJ L, 11.12.2023 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Kenopure wipes Market area: EU EP-460 Wipes Market area: EU Sani Wipes Market area: EU Lactides Wipes Market area: EU Keno Lac Wipes Market area: EU KL Wipes Market area: EU Kenolux Wipes Market area: EU Power Des Wipes Market area: EU Keno L Wipes Market area: EU Keno Des Wipes Market area: EU RĘCZNIKI PAPIEROWE MYJĄCO- Market area: EU DEZYNFEKUJĄCE FARMA RĘCZNIKI PAPIEROWE MYJĄCO- Market area: EU DEZYNFEKUJĄCE VITTRA Ręczniki myjąco-dezynfekujące Market area: EU AGROD Authorisation EU-0027740-0007 1-7 number Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid Active Substance 79-33-4 201-196-2 2,0 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 0,6 sulphate mono- substance C12-14-alkyl esters, sodium salts META SPC 8 1. META SPC 8 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 8 identifier Identifier Meta SPC 8: Ready to use post-dips by dipping (PT3) 1.2. Suffix to the authorisation number Number 1-8 44/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 1.3. Product type(s) Product type(s) PT03 – Veterinary hygiene (Disinfectants) 2. META SPC 8 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 8 Content (%) Common name IUPAC name Function CAS number EC number Min Max L-(+)-lactic acid Active Substance 79-33-4 201-196-2 3,6 7,5 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 1,3 1,3 sulphate mono- substance C12-14-alkyl esters, sodium salts Isopropanol Propan-2-ol Non-active 67-63-0 200-661-7 1,0 3,0 substance 2.2. Type(s) of formulation of the meta SPC 8 Formulation(s) AL – Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8 Hazard statements Causes serious eye damage. Precautionary statements Wear eyes/face protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a doctor. 4. AUTHORISED USE(S) OF THE META SPC 8 4.1. Use description Table 19 Use # 1 – Teat disinfection after milking by dipping Product type PT03 – Veterinary hygiene (Disinfectants) Where relevant, an exact Not relevant description of the authorised use ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 45/76EN OJ L, 11.12.2023 Target organism(s) (including Scientific name: other: bacteria development stage) Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: Field(s) of use Indoor Veterinary field: (Ready-To-Use) RTU post-dip for teat disinfection, after milking, without prior cleaning Application method(s) Method: By dipping Detailed description: / Application rate(s) and Application Rate: Active against bacteria and yeasts: RTU In five minutes contact frequency time. The product must “return” to RT before use. Dilution (%): - Number and timing of application: Active against bacteria and yeasts: RTU (with 3.6 – 7,5 % Lactic acid depending on the product considered) In five minutes contact time The product must “return” to room temperature before use Category(ies) of users Professional Pack sizes and packaging 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000L, 1 100L material 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000kg, 1 100kg HDPE (High Density Polyethylene) 4.1.1. Use-specific instructions for use see general directions for use for Meta SPC 8 4.1.2. Use-specific risk mitigation measures see general directions for use for Meta SPC 8 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 for Meta SPC 8 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 8 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 for Meta SPC 8 46/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 5. GENERAL DIRECTIONS FOR USE(8)OF THE META SPC 8 5.1. Instructions for use Apply the product immediately after each milking, two or three times per day. Ensure that the teat is completely covered to three quarter of its length. Fill the dipping cup with the desired amount of product, but do not use more fluid than necessary. Assume 5 mL per cow per treatment. Respect a contact time of five minutes. The product must be brought to a temperature above 20 °C before use. In order to ensure optimal teat disinfection, the animals should be kept standing for at least five minutes. 5.2. Risk mitigation measures Chemical goggles need to be worn. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Immediately call 112/ambulance for medical assistance. 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 INHALED: If symptoms occur call a POISON CENTRE or a doctor. 5.4. Instructions for safe disposal of the product and its packaging The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use. The shelf-life of the products is two years. 6. OTHER INFORMATION / 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Kenolac Market area: EU Kenolac Red Market area: EU Kenodip 200 Market area: EU Stalosan Lac Dip Market area: EU HCP Dip Market area: EU PEZERK LV PLUS Market area: EU (8) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 8. ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 47/76EN OJ L, 11.12.2023 MIROX Dip Lac Market area: EU Milchsäure Dip Market area: EU Milchsäure Tauche Market area: EU Lactocid Dip Market area: EU GAHERLAC Market area: EU Lactidip Market area: EU Lacticoop Market area: EU Lactactiv Market area: EU Laktotop Market area: EU Superlac Market area: EU MilchsäureFilmdip Super Market area: EU MEPA Lac Market area: EU Eco Lac Market area: EU BluGard Dip Market area: EU Blu-Gard Dip Market area: EU Authorisation EU-0027740-0008 1-8 number Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid Active Substance 79-33-4 201-196-2 3,6 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 1,3 sulphate mono- substance C12-14-alkyl esters, sodium salts Isopropanol Propan-2-ol Non-active 67-63-0 200-661-7 1,0 substance 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Kenolac Forte W Market area: EU Authorisation EU-0027740-0009 1-8 number Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid Active Substance 79-33-4 201-196-2 7,5 48/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 1,3 sulphate mono- substance C12-14-alkyl esters, sodium salts Isopropanol Propan-2-ol Non-active 67-63-0 200-661-7 3,0 substance META SPC 9 1. META SPC 9 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 9 identifier Identifier Meta SPC 9: Ready to use post-dips by spraying (PT3) 1.2. Suffix to the authorisation number Number 1-9 1.3. Product type(s) Product type(s) PT03 – Veterinary hygiene (Disinfectants) 2. META SPC 9 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 9 Content (%) Common name IUPAC name Function CAS number EC number Min Max L-(+)-lactic acid Active Substance 79-33-4 201-196-2 3,6 7,5 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 0,5 1,3 sulphate mono- substance C12-14-alkyl esters, sodium salts Isopropanol Propan-2-ol Non-active 67-63-0 200-661-7 3,0 3,0 substance 2.2. Type(s) of formulation of the meta SPC 9 Formulation(s) AL – Any other liquid ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 49/76EN OJ L, 11.12.2023 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9 Hazard statements Causes serious eye damage. Precautionary statements Wear eye/face protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a doctor. 4. AUTHORISED USE(S) OF THE META SPC 9 4.1. Use description Table 20 Use # 1 – Teat disinfection after milking by spraying or dipping Product type PT03 – Veterinary hygiene (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Scientific name: other: bacteria development stage) Common name: Bacteria Development stage: Scientific name: other yeast Common name: Yeasts Development stage: Field(s) of use Indoor Veterinary field: RTU spray or dip for teat disinfection, after milking, without prior cleaning Application method(s) Method: by spraying or dipping Detailed description: By spraying or dipping Application rate(s) and Application Rate: Active against bacteria and yeasts: RTU In five minutes contact frequency time. The product must “return” to RT before use. Dilution (%): - Number and timing of application: Active against bacteria and yeasts: RTU (with 3.6 – 7,5 % Lactic acid depending on the product considered) In five minutes contact time The product must return to Room temperature before use Category(ies) of users Professional Pack sizes and packaging 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000L, 1 100L material 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000kg, 1 100kg HDPE (High Density Polyethylene) 50/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 4.1.1. Use-specific instructions for use see general directions for use for Meta SPC 9 4.1.2. Use-specific risk mitigation measures see general directions for use for Meta SPC 9 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 for Meta SPC 9 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 9 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 for Meta SPC 9 5. GENERAL DIRECTIONS FOR USE(9)OF THE META SPC 9 5.1. Instructions for use Apply the product immediately after each milking, two or three times per day. Ensure that the teat is completely covered to three quarter of its length. Fill the dipping cup or spraying flacon with the desired amount of the product, but do not use more fluid that necessary. Assume 5 mL per cow per treatment. Respect a contact time of five minutes. The product must be brought to a temperature above 20 °C before use. In order to ensure optimal teat disinfection, the animals should be kept standing for at least five minutes. 5.2. Risk mitigation measures Chemical goggles need to be worn. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Immediately call 112/ambulance for medical assistance. 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 INHALED: If symptoms occur call a POISON CENTRE or a doctor. 5.4. Instructions for safe disposal of the product and its packaging The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use. The shelf-life of the products is two years. (9) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 9. ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 51/76EN OJ L, 11.12.2023 6. OTHER INFORMATION / 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 9 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Kenolac SD Market area: EU HCP Spray Market area: EU Lactospray Market area: EU Zitzentop Market area: EU Lactosilk Market area: EU Milchsäure Spray Bühning Market area: EU Lacto SP Market area: EU Stalosan Lac Spray Market area: EU MIROX Spray Lac Market area: EU Milchsäure Sprühe Market area: EU Lactocid Spray Market area: EU Milcho Spray Market area: EU GAHERLAC SPRAY Market area: EU Lactispray Market area: EU Lacticoop Spray Market area: EU Lactactiv Spray Market area: EU Laktotop Spray Market area: EU Superlac Spray Market area: EU Robolac Market area: EU MEPA Lac SD Market area: EU Eco Lac SD Market area: EU Lely Quaress Circum Market area: EU BluGard Spray Market area: EU Blu-Gard Spray Market area: EU Authorisation EU-0027740-0010 1-9 number Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid Active Substance 79-33-4 201-196-2 3,6 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 1,3 sulphate mono- substance C12-14-alkyl esters, sodium salts 52/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 Isopropanol Propan-2-ol Non-active 67-63-0 200-661-7 3,0 substance 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Kenolac Forte SD Market area: EU Authorisation EU-0027740-0011 1-9 number Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid Active Substance 79-33-4 201-196-2 7,5 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 1,3 sulphate mono- substance C12-14-alkyl esters, sodium salts Isopropanol Propan-2-ol Non-active 67-63-0 200-661-7 3,0 substance 7.3. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Valiant ULTRA EVERYDAY Market area: EU Authorisation EU-0027740-0018 1-9 number Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid Active Substance 79-33-4 201-196-2 4,0 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 1,3 sulphate mono- substance C12-14-alkyl esters, sodium salts Isopropanol Propan-2-ol Non-active 67-63-0 200-661-7 3,0 substance ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 53/76EN OJ L, 11.12.2023 META SPC 10 1. META SPC 10 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 10 identifier Identifier Meta SPC 10: Ready to use post-dips by spraying and dipping (PT3) 1.2. Suffix to the authorisation number Number 1-10 1.3. Product type(s) Product type(s) PT03 – Veterinary hygiene (Disinfectants) 2. META SPC 10 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 10 Content (%) Common name IUPAC name Function CAS number EC number Min Max L-(+)-lactic acid Active Substance 79-33-4 201-196-2 3,6 3,6 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 0,05 0,05 sulphate mono- substance C12-14-alkyl esters, sodium salts 2.2. Type(s) of formulation of the meta SPC 10 Formulation(s) AL – Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 10 Hazard statements Flammable liquid and vapour. Causes serious eye damage. Contains menthan-3-one (CAS-No 14073-97-3). May produce an allergic reaction. Precautionary statements Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking. Wear eyes/face protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a doctor. 54/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 In case of fire:Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide to extinguish. Store in a well-ventilated place.Keep cool. Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. 4. AUTHORISED USE(S) OF THE META SPC 10 4.1. Use description Table 21 Use # 1 – Teat disinfection after milking by spraying or dipping Product type PT03 – Veterinary hygiene (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Scientific name: other: bacteria development stage) Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: Field(s) of use Indoor Veterinary field: RTU spray/dip for teat disinfection, after milking, without prior cleaning Application method(s) Method: By spraying or dipping Detailed description: / Application rate(s) and Application Rate: Active against bacteria and yeasts: RTU In five minutes contact frequency time. The product must “return” to RT before use Dilution (%): - Number and timing of application: Active against bacteria and yeasts: RTU (with 3,6 % Lactic acid) In five minutes contact time Category(ies) of users Professional Pack sizes and packaging 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000L, 1 100L material 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000kg, 1 100kg HDPE (High Density Polyethylene) ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 55/76EN OJ L, 11.12.2023 4.1.1. Use-specific instructions for use Application rates: — 7.5 mL per cow working solution for use by spraying with flacon — 15 mL per cow working solution for use by spraying in installation — 15 mL per cow by for use by spraying with robot — 2.5-5 mL per cow for use by dipping/foaming 4.1.2. Use-specific risk mitigation measures see general directions for use for Meta SPC 10 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 for Meta SPC 10 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 10 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 for Meta SPC 10 5. GENERAL DIRECTIONS FOR USE(10)OF THE META SPC 10 5.1. Instructions for use Apply the product immediately after each milking, two or three times per day. Ensure that the teat is completely covered to three quarter of its length. Fill the dipping cup or spraying flacon with the desired amount of product, but do not use more fluid that necessary. The product must be brought to a temperature above 20 °C before use. In order to ensure optimal teat disinfection, the animals should be kept standing for at least five minutes. 5.2. Risk mitigation measures Chemical goggles need to be worn. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. 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 skin irritation occurs: Get medical advice. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Immediately call 112/ambulance for medical assistance. 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 5.4. Instructions for safe disposal of the product and its packaging The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations. (10) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 10. 56/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use. The shelf-life of the products is two years. 6. OTHER INFORMATION / 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 10 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Kenocool Market area: EU PEZERK LI PLUS Market area: EU Milcho Dip Market area: EU Authorisation EU-0027740-0012 1-10 number Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid Active Substance 79-33-4 201-196-2 3,6 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 0,05 sulphate mono- substance C12-14-alkyl esters, sodium salts META SPC 11 1. META SPC 11 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 11 identifier Identifier Meta SPC 11: Concentrated Surface and equipment disinfectants (PT3 and PT4) 1.2. Suffix to the authorisation number Number 1-11 1.3. Product type(s) Product type(s) PT04 – Food and feed area (Disinfectants) PT03 – Veterinary hygiene (Disinfectants) ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 57/76EN OJ L, 11.12.2023 2. META SPC 11 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 11 Content (%) Common name IUPAC name Function CAS number EC number Min Max L-(+)-lactic acid Active Substance 79-33-4 201-196-2 24,0 24,0 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 12,0 12,0 sulphate mono- substance C12-14-alkyl esters, sodium salts Isopropanol Propan-2-ol Non-active 67-63-0 200-661-7 5,0 5,0 substance 2.2. Type(s) of formulation of the meta SPC 11 Formulation(s) SL – Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 11 Hazard statements Causes skin irritation. Causes serious eye damage. Precautionary statements Wash hands thoroughly after handling. Wear protective gloves. Wear eyes/face protection. IF ON SKIN:Wash with plenty of water. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a doctor. Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. 4. AUTHORISED USE(S) OF THE META SPC 11 4.1. Use description Table 22 Use # 1 – Hard surface disinfection in food and feed industry Product type PT04 – Food and feed area (Disinfectants) Where relevant, an exact Not relevant description of the authorised use 58/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 Target organism(s) (including Scientific name: other: bacteria development stage) Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: Field(s) of use Indoor in Food/feed industry + Public field: Disinfection of hard/non-porous surfaces by spraying or soaking with prior cleaning Application method(s) Method: By spraying or by immersion Detailed description: Spraying Immersion (the bath is intended to be used only once) Application rate(s) and Application Rate: 100 mL/m2 frequency Dilution (%): 1 % or 3 % Number and timing of application: Active against bacteria and yeasts at room temperature: — 3 % (with 0,72 % Lactic acid) in two minutes contact time — 1 % (with 0,24 % Lactic acid) in 15 minutes contact time Category(ies) of users Professional Pack sizes and packaging 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000L, 1 100L material 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000kg, 1 100kg HDPE (High Density Polyethylene) 4.1.1. Use-specific instructions for use see general directions for use for Meta SPC 11 4.1.2. Use-specific risk mitigation measures see general directions for use for Meta SPC 11 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 for Meta SPC 11 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 11 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 for Meta SPC 11 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 59/76EN OJ L, 11.12.2023 4.2. Use description Table 23 Use # 2 – Equipment disinfection by soaking in food and feed industry Product type PT04 – Food and feed area (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Scientific name: other: bacteria development stage) Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: Field(s) of use Indoor Indoor – in Food/feed industry + Public field: Disinfection of hard/non-porous surfaces (for example processing machines) by spraying or soaking without prior cleaning Application method(s) Method: By spraying or immersion Detailed description: / Application rate(s) and Application Rate: 100 mL/m2 frequency Dilution (%): 8 % or 15 % Number and timing of application: Active against bacteria and yeasts at +7 °C: — By soaking: 15 % (with 3,6 % Lactic acid) in 30 seconds contact time — By spraying: 8 % (with 1,92 % Lactic acid) in two minutes contact time Category(ies) of users Professional Pack sizes and packaging 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000L, 1 100L material 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000kg, 1 100kg HDPE (High Density Polyethylene) 4.2.1. Use-specific instructions for use see general directions for use for Meta SPC 11 4.2.2. Use-specific risk mitigation measures see general directions for use for Meta SPC 11 60/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 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 for Meta SPC 11 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 11 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 for Meta SPC 11 4.3. Use description Table 24 Use # 3 – Hard surface disinfection for veterinary hygiene Product type PT03 – Veterinary hygiene (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor Veterinary field: Disinfection of hard/non-porous surfaces by spraying or soaking with prior cleaning Application method(s) Method: By spraying or immersion Detailed description: Spraying Immersion (the bath is intended to be used only once) Application rate(s) and Application Rate: Active against bacteria and yeasts at +10 °C: 4 % in 30 minutes frequency contact time Dilution (%): 4 % Number and timing of application: Active against bacteria and yeasts at +10 °C: 4 % (with 0,96 % Lactic acid) in 30 minutes contact time Category(ies) of users Professional Pack sizes and packaging 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000L, 1 100L material 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000kg, 1 100kg HDPE (High Density Polyethylene) ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 61/76EN OJ L, 11.12.2023 4.3.1. Use-specific instructions for use Animal houses must be empty of animals during disinfection. The product is used to disinfect animal housings of pigs, cows, poultry. Clean the surfaces thoroughly with a detergent before disinfection. Rinse with clean water and remove surplus water. Mixing and loading: container is opened manually and emptied into the reservoir or connected to a pump, which pumps the product into the reservoir of the spraying device which is then filled up with water in order to achieve the correct concentration of use. Apply the product by spraying or immersion. Use as much solution as needed to keep the surfaces wet during the complete contact time. It is not necessary to spray during the complete contact time. 4.3.2. Use-specific risk mitigation measures see general directions for use for Meta SPC 11 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 for Meta SPC 11 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 11 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 for Meta SPC 11 5. GENERAL DIRECTIONS FOR USE(11)OF THE META SPC 11 5.1. Instructions for use Disinfection procedures by spraying: The surfaces to be disinfected must be wet enough in order to be kept wet during the preconised contact time for optimal disinfection. The following precautionary sentence shall be added on the product label: “Make sure to wet surfaces completely”. Products must be diluted in potable water before use. 5.2. Risk mitigation measures Gloves and goggles are needed during mixing and loading. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. 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 skin irritation occurs: Get medical advice. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Immediately call 112/ambulance for medical assistance. 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 5.4. Instructions for safe disposal of the product and its packaging The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations. (11) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 11. 62/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use. The shelf-life of the products is two years. 6. OTHER INFORMATION / 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 11 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Kenosan Lactic Market area: EU Lacto Des Market area: EU Bio Des 100 Market area: EU Bio Lac Market area: EU Authorisation EU-0027740-0013 1-11 number Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid Active Substance 79-33-4 201-196-2 24,0 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 12,0 sulphate mono- substance C12-14-alkyl esters, sodium salts Isopropanol Propan-2-ol Non-active 67-63-0 200-661-7 5,0 substance META SPC 12 1. META SPC 12 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 12 identifier Identifier Meta SPC 12: Inner surface disinfectants by CIP with and without circulation and crate wash (PT4) 1.2. Suffix to the authorisation number Number 1-12 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 63/76EN OJ L, 11.12.2023 1.3. Product type(s) Product type(s) PT04 – Food and feed area (Disinfectants) 2. META SPC 12 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 12 Content (%) Common name IUPAC name Function CAS number EC number Min Max L-(+)-lactic acid Active Substance 79-33-4 201-196-2 22,0 22,0 C6 alkyl glucoside Hexyl Non-active 54549-24-5 259-217-6 2,4 2,4 D-Glucoside substance Methanesulfonic Methanesulfonic Non-active 75-75-2 200-898-6 0,0 10,5 acid acid substance Sulphuric acid Sulphuric acid Non-active 7664-93-9 231-639-5 0,0 10,5 substance 2.2. Type(s) of formulation of the meta SPC 12 Formulation(s) SL – Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 12 Hazard statements Causes severe skin burns and eye damage. May be corrosive to metals. Precautionary statements Keep only in original packaging. Do not breathe vapours. Wash hands thoroughly after handling. Wear protective gloves. Wear protective clothing. Wear eyes/face protection. IF SWALLOWED:Rinse mouth.Do NOT induce vomiting. IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water. IF INHALED:Remove person to fresh air and keep comfortable for breathing. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a doctor. Absorb spillage to prevent material damage. Wash contaminated clothing before reuse. Store locked up. Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. 64/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 4. AUTHORISED USE(S) OF THE META SPC 12 4.1. Use description Table 25 Use # 1 – Inner surface disinfection by CIP with circulation Product type PT04 – Food and feed area (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor in Food and feed industry: Disinfection of hard/non-porous inner surfaces by CIP procedures (with circulation) Application method(s) Method: CIP procedures Detailed description: / Application rate(s) and Application Rate: at +50 °C frequency Dilution (%): 1 to 4 % Number and timing of application: At +50 °C Active against bacteria and yeasts: — with prior cleaning: 2 % (with 0,44 % Lactic acid) in two minutes contact time/1 % in 30 minutes contact time — without prior cleaning: 4 % (with 0,88 % Lactic acid) in two minutes contact time Or 1 % (0,22 % Lactic acid) in 30 minutes contact time — in milky conditions: 2 % (with 0,44 % Lactic acid) in 15 minutes contact time Category(ies) of users Professional Pack sizes and packaging 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000L, 1 100L material 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000kg, 1 100kg HDPE (High Density Polyethylene) 4.1.1. Use-specific instructions for use see general directions for use for Meta SPC 12 4.1.2. Use-specific risk mitigation measures see general directions for use for Meta SPC 12 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 65/76EN OJ L, 11.12.2023 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 for Meta SPC 12 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 12 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 for Meta SPC 12 4.2. Use description Table 26 Use # 2 – Inner surface disinfection by CIP without circulation Product type PT04 – Food and feed area (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Scientific name: other: bacteria development stage) Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: Field(s) of use Indoor in Food and feed industry: Disinfection of hard/non-porous inner surfaces by CIP procedures (without circulation) Application method(s) Method: CIP procedures Detailed description: / Application rate(s) and Application Rate: At +50 °C frequency Dilution (%): 2 % or 4 % Number and timing of application: At +50 °C Active against bacteria and yeasts: — with prior cleaning: 2 % (with 0,44 % Lactic acid) in two minutes contact time — without prior cleaning: 4 % (with 0,88 % Lactic acid) in two minutes contact time Or 2 % (with 0,44 % Lactic acid) in 30 minutes contact time Category(ies) of users Professional Pack sizes and packaging 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000L, 1 100L material 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000kg, 1 100kg HDPE (High Density Polyethylene) 66/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 4.2.1. Use-specific instructions for use see general directions for use for Meta SPC 12 4.2.2. Use-specific risk mitigation measures see general directions for use for Meta SPC 12 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 for Meta SPC 12 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 12 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 for Meta SPC 12 4.3. Use description Table 27 Use # 3 – Crate wash Product type PT04 – Food and feed area (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Common name: Bacteria development stage) Development stage: Common name: Yeasts Development stage: Field(s) of use Indoor Indoor – in Food and feed industry disinfection of hard/non-porous surfaces in crate washers Application method(s) Method: Crate wash Detailed description: / Application rate(s) and Application Rate: At +50 °C frequency Dilution (%): 2 % or 4 % Number and timing of application: At +50 °C Active against bacteria and yeasts: — With prior cleaning: 2 % (with 0,44 % Lactic acid) in two minutes contact — without prior cleaning: 4 % (with 0,88 % Lactic acid) in two minutes contact Category(ies) of users Professional ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 67/76EN OJ L, 11.12.2023 Pack sizes and packaging 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000L, 1 100L material 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000kg, 1 100kg HDPE (High Density Polyethylene) 4.3.1. Use-specific instructions for use see general directions for use for Meta SPC 12 4.3.2. Use-specific risk mitigation measures see general directions for use for Meta SPC 12 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 for Meta SPC 12 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 12 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 for Meta SPC 12 5. GENERAL DIRECTIONS FOR USE(12)OF THE META SPC 12 5.1. Instructions for use Products must be diluted in potable water before use. 5.2. Risk mitigation measures Gloves and goggles are needed during mixing and loading. Wear protective coverall (to be specified by the authorisation holder within the product information). 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment IF 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 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. Immediately call a Call 112/ambulance for medical assistance. 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 5.4. Instructions for safe disposal of the product and its packaging The packing and content must be eliminated as dangerous waste product under the whole responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations. (12) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 12. 68/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use. The shelf-life of the products is 2 years. 6. OTHER INFORMATION / 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 12 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Pho Cid L Market area: EU Tornax 100 Market area: EU Tornax Des Market area: EU Lacto CIP Market area: EU Pho Cid Eco Market area: EU Authorisation EU-0027740-0014 1-12 number Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid Active Substance 79-33-4 201-196-2 22,0 C6 alkyl glucoside Hexyl Non-active 54549-24-5 259-217-6 2,4 D-Glucoside substance Methanesulfonic Methanesulfonic Non-active 75-75-2 200-898-6 10,5 acid acid substance 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Pho Cid LS Market area: EU Authorisation EU-0027740-0015 1-12 number Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid Active Substance 79-33-4 201-196-2 22,0 C6 alkyl glucoside Hexyl Non-active 54549-24-5 259-217-6 2,4 D-Glucoside substance Sulphuric acid Sulphuric acid Non-active 7664-93-9 231-639-5 10,5 substance ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 69/76EN OJ L, 11.12.2023 META SPC 13 1. META SPC 13 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 13 identifier Identifier Meta SPC 13: Hard surface disinfectants (PT4) 1.2. Suffix to the authorisation number Number 1-13 1.3. Product type(s) Product type(s) PT04 – Food and feed area (Disinfectants) 2. META SPC 13 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 13 Content (%) Common name IUPAC name Function CAS number EC number Min Max L-(+)-lactic acid Active Substance 79-33-4 201-196-2 11,0 11,0 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 4,5 4,5 sulphate mono- substance C12-14-alkyl esters, sodium salts Methanesulfonic Methanesulfonic Non-active 75-75-2 200-898-6 10,5 19,5 acid acid substance 2.2. Type(s) of formulation of the meta SPC 13 Formulation(s) SL – Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 13 Hazard statements May be corrosive to metals. Causes severe skin burns and eye damage. Precautionary statements Keep only in original packaging. Do not breathe vapours. Wash hands thoroughly after handling. Wear protective gloves. Wear protective clothing. Wear eyes/face protection. 70/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 IF SWALLOWED:Rinse mouth.Do NOT induce vomiting. IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water. IF INHALED:Remove person to fresh air and keep comfortable for breathing. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a doctor. Absorb spillage to prevent material damage. Wash contaminated clothing before reuse. Store locked up. Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. 4. AUTHORISED USE(S) OF THE META SPC 13 4.1. Use description Table 28 Use # 1 – Hard surface disinfection (PT4) Product type PT04 – Food and feed area (Disinfectants) Where relevant, an exact Not relevant description of the authorised use Target organism(s) (including Scientific name: other: bacteria development stage) Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: Field(s) of use Indoor Food/feed areas Disinfection of hard/non-porous surfaces by foaming Application method(s) Method: By foaming Detailed description: / Application rate(s) and Application Rate: At room temperature in 30 minutes contact time Active against frequency bacteria and yeasts: – with prior cleaning: 1 % – without prior cleaning: 5 % Dilution (%): 1 or 5 % Number and timing of application: At room temperature in 30 minutes contact time Active against bacteria and yeasts: — with prior cleaning: 1 % (with 0,11 % Lactic acid) — without prior cleaning: 5 % (with 0,55 % Lactic acid) ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 71/76EN OJ L, 11.12.2023 Category(ies) of users Professional Pack sizes and packaging 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000L, 1 100L material 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000kg, 1 100kg HDPE (High Density Polyethylene) 4.1.1. Use-specific instructions for use see general directions for use for Meta SPC 13 4.1.2. Use-specific risk mitigation measures see general directions for use for Meta SPC 13 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 for Meta SPC 13 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 13 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 for Meta SPC 13 5. GENERAL DIRECTIONS FOR USE(13)OF THE META SPC 13 5.1. Instructions for use The surfaces to be disinfected must be wet enough in order to be kept wet during the preconised contact time for optimal disinfection. The following precautionary sentence shall be added on the product label: “Make sure to wet surfaces completely”. Products must be diluted in potable water before use. 5.2. Risk mitigation measures Gloves and goggles are needed during mixing and loading. Wear protective coverall (to be specified by the authorisation holder within the product information). 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment IF 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 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. Immediately call 112/ambulance for medical assistance. 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 (13) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 13. 72/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 5.4. Instructions for safe disposal of the product and its packaging The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use. The shelf-life of the products is two years. 6. OTHER INFORMATION / 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 13 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Tornax L Market area: EU Lacto Cid Market area: EU Authorisation EU-0027740-0016 1-13 number Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid Active Substance 79-33-4 201-196-2 11,0 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 4,5 sulphate mono- substance C12-14-alkyl esters, sodium salts Methanesulfonic Methanesulfonic Non-active 75-75-2 200-898-6 10,5 acid acid substance META SPC 14 1. META SPC 14 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 14 identifier Identifier Meta SPC 14: Ready to use hygienic handrub (PT1) 1.2. Suffix to the authorisation number Number 1-14 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 73/76EN OJ L, 11.12.2023 1.3. Product type(s) Product type(s) PT01 – Human hygiene (Disinfectants) 2. META SPC 14 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 14 Content (%) Common name IUPAC name Function CAS number EC number Min Max L-(+)-lactic acid Active Substance 79-33-4 201-196-2 3,6 3,6 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 2,0 2,0 sulphate mono- substance C12-14-alkyl esters, sodium salts Isopropanol Propan-2-ol Non-active 67-63-0 200-661-7 4,0 4,0 substance Butyldiglycol 2-(2-butoxye- Non-active 112-34-5 203-961-6 10,0 10,0 thoxy)ethanol substance 2.2. Type(s) of formulation of the meta SPC 14 Formulation(s) AL – Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 14 Hazard statements Causes serious eye damage. Precautionary statements Wear eye/face protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a doctor. 4. AUTHORISED USE(S) OF THE META SPC 14 4.1. Use description Table 29 Use # 1 – Hygienic handrub, for professional use (PT1) Product type PT01 – Human hygiene (Disinfectants) Where relevant, an exact Not relevant description of the authorised use 74/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/ojEN OJ L, 11.12.2023 Target organism(s) (including Scientific name: other: bacteria development stage) Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: Field(s) of use Indoor in Food/feed industry; Public field; Kitchens Hygienic handrub, on visibly clean hands Application method(s) Method: By rubbing the hands Detailed description: / Application rate(s) and Application Rate: 6 mL of product frequency Dilution (%): - Number and timing of application: Active against bacteria and yeasts: RTU (with 3,6 % Lactic acid) 6 mL (that is three pushes for both hands together) One minute contact time Category(ies) of users Professional Pack sizes and packaging 50 mL, 75 mL, 100 mL, 150 mL, 500 mL, 1L, 5L, 10L, 20 L, 25 L, 30 L, 60 L, 200 material L, 220 L, 600 L, 1 000L, 1 100L HDPE (High Density Polyethylene) 4.1.1. Use-specific instructions for use see general directions for use for Meta SPC 14 4.1.2. Use-specific risk mitigation measures / 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 for Meta SPC 14 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging see general directions for use for Meta SPC 14 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 for Meta SPC 14 5. GENERAL DIRECTIONS FOR USE(14)OF THE META SPC 14 5.1. Instructions for use Apply 6 ml of the product undiluted. Respect a contact time of 1 minute. Rinse thoroughly after disinfection. For professional use only (14) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 14. ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj 75/76EN OJ L, 11.12.2023 5.2. Risk mitigation measures / 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment 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 INHALED: If symptoms occur call a POISON CENTRE or a doctor. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Immediately call 112/ambulance for medical assistance. 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 5.4. Instructions for safe disposal of the product and its packaging The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use. The shelf-life of the products is two years. 6. OTHER INFORMATION / 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 14 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Kenosan Hand Rub Market area: EU Authorisation EU-0027740-0017 1-14 number Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid Active Substance 79-33-4 201-196-2 3,6 Sodium Lauryl Sulfuric acid, Non-active 85586-07-8 287-809-4 2,0 sulphate mono- substance C12-14-alkyl esters, sodium salts Isopropanol Propan-2-ol Non-active 67-63-0 200-661-7 4,0 substance Butyldiglycol 2-(2-butoxye- Non-active 112-34-5 203-961-6 10,0’ thoxy)ethanol substance 76/76 ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj