COMMISSION IMPLEMENTING REGULATION (EU) 2024/2205

| Official Journal of the European Union | EN L series ---|---|--- * * * | 2024/2205 | 5.9.2024 ---|---|--- COMMISSION IMPLEMENTING REGULATION (EU) 2024/2205 of 4 September 2024 granting a Union authorisation for the biocidal product family ‘SICO Biocidal Product Family’ 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 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5), first subparagraph, thereof, Whereas: (1) | On 30 April 2019, SICO submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for Union authorisation of the same biocidal product family, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named ‘SICO Biocidal Product Family’, of product-types 2 and 4, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-TA051413-55 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ later authorised by Commission Implementing Regulation (EU) 2023/1758 (3), recorded in the Register under case number BC-HC051278-51. ---|--- (2) | The same biocidal product family ‘SICO Biocidal Product Family’ contains L-(+)-lactic acid as the active substances, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2 and 4. ---|--- (3) | On 19 September 2022, the Agency submitted to the Commission its opinion (4) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘SICO Biocidal Product Family’ in accordance with Article 6(1) and (2) of Implementing Regulation (EU) No 414/2013. ---|--- (4) | In its opinion, the Agency concludes that the proposed differences between ‘SICO Biocidal Product Family’ and the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ are limited to information which can be the subject of an administrative change in accordance with Article 11 of Commission Implementing Regulation (EU) No 354/2013 (5), and that based on the assessment of the related reference biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ and subject to compliance with the draft SPC, ‘SICO Biocidal Product Family’ meets the conditions laid down in Article 19(1) and (6) of Regulation (EU) No 528/2012. ---|--- (5) | On 20 November 2023, the Agency transmitted to the Commission the revised SPCs of ‘SICO Biocidal Product Family’ in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. ---|--- (6) | The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same biocidal product family ‘SICO Biocidal Product Family’. ---|--- (7) | The expiry date of this authorisation is aligned to the expiry date of the authorisation of the related reference biocidal product family ‘SALVECO SALVESAFE PRODUCTS’. ---|--- (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, ---|--- HAS ADOPTED THIS REGULATION: Article 1 A Union authorisation with authorisation number EU-0029486-0000 is hereby granted to SICO for the making available on the market and use of the same biocidal product family ‘SICO Biocidal Product Family’ in accordance with the summary of the biocidal product characteristics set out in the Annex. The Union authorisation is valid from 25 September 2024 until 30 September 2033. Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 4 September 2024. For the Commission The President Ursula VON DER LEYEN * * * (1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj. (2) Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4), ELI: http://data.europa.eu/eli/reg_impl/2013/414/oj. (3) Commission Implementing Regulation (EU) 2023/1758 of 11 September 2023 granting a Union authorisation for the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 224, 12.9.2023, p. 34), ELI: http://data.europa.eu/eli/reg_impl/2023/1758/oj. (4) ECHA opinion of 19.9.2022 on the Union authorisation of the same biocidal product family ‘SICO Biocidal Product Family’, https://echa.europa.eu/opinions-on-union-authorisation. (5) Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4), ELI: http://data.europa.eu/eli/reg_impl/2013/354/oj. * * * ANNEX SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY SICO Biocidal Product Family Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area Authorisation number: EU-0029486-0000 R4BP asset number: EU-0029486-0000 PART I FIRST INFORMATION LEVEL 1\. ADMINISTRATIVE INFORMATION 1.1. Family name Name | SICO Biocidal Product Family ---|--- 1.2. Product type(s) Product type(s) | PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area ---|--- 1.3. Authorisation holder Name and address of the authorisation holder | Name | SICO ---|---|--- Address | 577 RUE DU POMMARIN BP16 VOREPPE 38340 MOIRANS CEDEX FR Authorisation number | EU-0029486-0000 R4BP asset number | EU-0029486-0000 Date of the authorisation | 25 September 2024 Expiry date of the authorisation | 30 September 2033 1.4. Manufacturer(s) of the product Name of manufacturer | SALVECO S.A.S ---|--- Address of manufacturer | Avenue Pierre Mendès-France F-88100 SAINT DIE DES VOSGES France Location of manufacturing sites | SALVECO S.A.S site 1 Avenue Pierre Mendès-France F-88100 SAINT DIE DES VOSGES France Name of manufacturer | S.I.C.O ---|--- Address of manufacturer | 577 Rue du Pommarin F-38340 VOREPPE France Location of manufacturing sites | S.I.C.O site 1 577 Rue du Pommarin F-38340 VOREPPE France S.I.C.O site 2 53 Avenue de l’Europe F-38522 SAINT-EGREVE France S.I.C.O site 3 436 Rue Emile Romanet F-38340 VOREPPE France 1.5. Manufacturer(s) of the active substance(s) Active substance | L-(+)-lactic acid ---|--- Name of manufacturer | PURAC BIOCHEM BV Address of manufacturer | Gran Vial 19-25 08160 Montmelo Spain Location of manufacturing sites | PURAC BIOCHEM BV site 1 Gran Vial 19-25 08160 Montmelo Spain Active substance | L-(+)-lactic acid ---|--- Name of manufacturer | JUNGBUNGZLAUER S.A Address of manufacturer | Z.I Portuaire BP 32 67390 Marckolsheim France Location of manufacturing sites | JUNGBUNGZLAUER S.A site 1 Z.I Portuaire BP 32 67390 Marckolsheim France 2\. PRODUCT FAMILY COMPOSITION AND FORMULATION 2.1. Qualitative and quantitative information on the composition of the family Common name | IUPAC name | Function | CAS number | EC number | Content (%) ---|---|---|---|---|--- L-(+)-lactic acid | | active substance | 79-33-4 | 201-196-2 | 0,627–31,33 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 0–28,8 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 0–8,23 % (w/w) 2.2. Type(s) of formulation Formulation type(s) | SL – Soluble Concentrate ---|--- PART II SECOND INFORMATION LEVEL –META SPC(S) 1\. META SPC 1 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 1 identifier Identifier | Meta SPC: meta-SPC2 ---|--- 1.2. Suffix to the authorisation number Number | 1-1 ---|--- 1.3. Product type(s) Product type(s) | PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area ---|--- 2\. META SPC 1 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 1 Common name | IUPAC name | Function | CAS number | EC number | Content (%) ---|---|---|---|---|--- L-(+)-lactic acid | | active substance | 79-33-4 | 201-196-2 | 15,66–31,33 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 13,5–27 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 3,52–8,23 % (w/w) 2.2. Type(s) of formulation of the meta SPC 1 Formulation type(s) | SL – Soluble Concentrate ---|--- 3\. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1 Hazard statements | H315: Causes skin irritation. H318: Causes serious eye damage. EUH208: Contains Eucalyptol, Carvone and Limonene. May produce an allergic reaction. EUH208: Contains Methyl salicylate and Eugenol (Pure fragrance). May produce an allergic reaction. EUH208: Contains Eucalyptol (Eucalyptus leaves fragrance). May produce an allergic reaction. ---|--- Precautionary statements | P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P264: Wash hands thoroughly after handling. P280: Wear protective gloves, protective clothing and eye protection. P302 + P352: IF ON SKIN: Wash with plenty of water. P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER or doctor. P321: Specific treatment (see supplemental first aid instruction on this label). P332 + P313: If skin irritation occurs: Get medical advice. P362 + P364: Take off contaminated clothing and wash it before reuse. 4\. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in domestic, institutional and industrial areas) Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Scientific name: Viruses Common name: Enveloped viruses Development stage: no data Field(s) of use | indoor use outdoor use in domestic, institutional and industrial area. Application method(s) | Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping Detailed description: - without mechanical action. Application rate(s) and frequency | Application rate: - Dilution (%): 0,299 % to 1,496 % Number and timing of application: Mandatory target organisms: | — | Bacteria: 0,299 % to 1,496 % w/w L-(+)-lactic acid, 5 minutes, 20 °C ---|--- Other target organisms: — | Enveloped viruses and yeasts: 0,299 % to 1,496 % w/w L-(+)-lactic acid, 5 minutes, 20 °C ---|--- Minimum in use concentration of surfactants shall be 0,29 % for any future product included in this meta SPC. Category(ies) of users | professional ; general public (non-professional) Pack sizes and packaging material | Package size for non-professional is restricted to maximum 3 litres and packaging above 1 litre should be equipped with a handle Refill caps: 20–100 ml HDPE Bottles: 0,5–5 litres HDPE or PET Jerry can: 1–80 litres HDPE (only for professional users) Drum: 10–210 litres HDPE (only for professional users) IBC: 1 000 litres HDPE (only for professional users) 4.1.1. Use-specific instructions See general instructions for use 4.1.2. Use-specific risk mitigation measures See general instructions for use 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 instructions for use 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general instructions for use 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general instructions for use 4.2. Use description Table 2 Food and feed area disinfectants (disinfectant for all washable hard surfaces in domestic, institutional and food industry areas) Product type | PT04: Food and feed area ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Field(s) of use | indoor use outdoor use | — | in domestic, institutional and food industry areas (general disinfection) ---|--- Application method(s) | Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping Detailed description: - without mechanical action Application rate(s) and frequency | Application rate: - Dilution (%): 0,299 % to 1,496 % Number and timing of application: Mandatory target organisms: | — | Bacteria and yeast: 0,299 % to 1,496 % w/w L-(+)-lactic acid, 5 minutes, 20 °C ---|--- Minimum in use concentration of surfactants shall be 0,29 % for any future product included in this meta SPC. Category(ies) of users | professional ; general public (non-professional) Pack sizes and packaging material | Package size for non-professional is restricted to maximum 3 litres and packaging above 1 litre should be equipped with a handle Refill caps: 20–100 ml HDPE Bottles: 0,5–5 litres HDPE or PET Jerry can: 1–80 litres HDPE (only for professional users) Drum: 10–210 litres HDPE (only for professional users) IBC: 1 000 litres HDPE (only for professional users) 4.2.1. Use-specific instructions See general instructions for use 4.2.2. Use-specific risk mitigation measures See general instructions for use 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 instructions for use 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general instructions for use 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general instructions for use 5\. GENERAL DIRECTIONS FOR USE OF THE META SPC 1 5.1. Instructions for use — | Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays/m2 or 20 ml/m2 or fully cover the object to be disinfected). ---|--- — | Apply only on non-porous surfaces. ---|--- — | Inform the authorisation holder if the treatment is ineffective. ---|--- — | Comply with the instructions for use. ---|--- — | Each product label shall give information on how the dilution should be made in order to guarantee the efficacy of the product. Since the concentration of L-(+)-lactic acid in products within this meta SPC can range from 15,66 % to 31,33 %, it is not possible to indicate all product dilution here. | Example for a product containing 15,66 % L-(+)-lactic acid Bacterial and yeasticidal activity | Dilution of the product 0,299 % (20 ml product, add water up to 1 litre) | Contact time 5 minutes ---|---|--- The authorisation holder shall indicate on the label the relevant volume of product to be diluted in water on the label of each specific product. 5.2. Risk mitigation measures — | Wash hands after use of the concentrate product. ---|--- — | Avoid contact with eyes. ---|--- — | Avoid splashes and spills during mixing and load ing (dilution). ---|--- — | For outdoor uses, do not apply the product in case rain is expected within 24 hours. ---|--- — | For outdoor uses by spray, avoid transfer to other areas by wind (drift). ---|--- For professional use only: — | Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titles of the EN standards are available in Section 6. – PPE material to be specified by the authorisation holder within the product information. ---|--- For non-professional use only: — | A child-proof closure is required. ---|--- — | Keep out of reach of children and non-target animals or pets. ---|--- 5.3. 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. ---|--- — | IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation or rash occur: 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. ---|--- Call 112 or an ambulance for medical assistance. Information to healthcare personnel or doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (Ph > 11), amines and acids like acetic acid, formic acid or propionic acid. — | IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an 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 — | Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains. ---|--- — | Dispose of unused product, its packaging and all other waste, in accordance with local regulations. ---|--- 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage — | Keep out of reach of children and non-target animals or pets. ---|--- — | Shelf-life: 2 years. ---|--- — | Protect from frost. ---|--- 6\. OTHER INFORMATION P280 is not applicable for the non-professional user. The full titles of the EN standards referenced in section 5.2 ‘Risk mitigation measures’ are: | EN 374 – Protective gloves against dangerous chemicals and micro-organisms ---|--- | EN 16321 – Eye and face protection for occupational use ---|--- | EN 14605 – Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) ---|--- 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) | 5 EN 1 DETERGENT DEGRAISSANT DETARTRANT DESINFECTANT DESODORISANT | Market area: EU ---|---|--- NETTOYANT DESINFECTANT ANTI-CALCAIRE CONCENTRE DILUTION 2 % | Market area: EU DETERGENT DEGRAISSANT DETARTRANT DESINFECTANT DESODORISANT DILUTION 2 % | Market area: EU 5D CONCENTRE DILUTION 2 % | Market area: EU 5 EN 1 CONCENTRE PARFUME | Market area: EU FLASH GERM 5 EN 1 | Market area: EU FLASH GERM CONCENTRE PARFUME DILUTION 2 % | Market area: EU FLASH GERM PARFUME | Market area: EU Authorisation number | | EU-0029486-0001 1-1 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | active substance | 79-33-4 | 201-196-2 | 15,66 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 13,5 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 4,11 % (w/w) 1\. META SPC 2 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 2 identifier Identifier | Meta SPC: meta-SPC3 ---|--- 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 PT04: Food and feed area ---|--- 2\. META SPC 2 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 2 Common name | IUPAC name | Function | CAS number | EC number | Content (%) ---|---|---|---|---|--- L-(+)-lactic acid | | active substance | 79-33-4 | 201-196-2 | 7,83 –31,33 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 6,75 –27 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 1,32 –3,52 % (w/w) 2.2. Type(s) of formulation of the meta SPC 2 Formulation type(s) | SL – Soluble Concentrate ---|--- 3\. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 Hazard statements | H315: Causes skin irritation. H318: Causes serious eye damage. ---|--- Precautionary statements | P264: Wash hands thoroughly after handling. P280: Wear protective gloves, protective clothing and eye protection. P302 + P352: IF ON SKIN: Wash with plenty of water. P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER or doctor. P321: Specific treatment (see supplemental first aid instruction on this label). P332 + P313: If skin irritation occurs: Get medical advice. P362 + P364: Take off contaminated clothing and wash it before reuse. 4\. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in institutional, and industrial areas) Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Scientific name: Viruses Common name: Enveloped viruses Development stage: no data Field(s) of use | indoor use outdoor use \- in institutional and industrial area Application method(s) | Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping Detailed description: - without mechanical action Application rate(s) and frequency | Application rate: - Dilution (%): 0,299 % Number and timing of application: Mandatory target organisms: | — | Bacteria and yeasts: 0,299 % w/w L-(+)-lactic acid, 5 minutes, 20 °C ---|--- Other target organisms: — | Enveloped viruses: 0,299 % w/w L-(+)-lactic acid, 5 minutes, 20 °C ---|--- Minimum in use concentration of surfactants shall be 0,29 % for any future product included in this meta SPC. Category(ies) of users | professional Pack sizes and packaging material | Refill caps: 20–100 ml HDPE Bottles: 0,5–5 litres HDPE or PET Jerry can: 1–80 litres HDPE Drum: 10–210 litres HDPE IBC: 1 000 litres HDPE 4.1.1. Use-specific instructions See general instructions for use 4.1.2. Use-specific risk mitigation measures See general instructions for use 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 instructions for use 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general instructions for use 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general instructions for use 4.2. Use description Table 2 Food and feed area disinfectants (disinfectant for all washable hard surfaces in institutional and industrial areas) Product type | PT04: Food and feed area ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Field(s) of use | indoor use outdoor use | — | in institutional and industrial area (general) ---|--- Application method(s) | Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping Detailed description: - without mechanical action Application rate(s) and frequency | Application rate: - Dilution (%): 0,299 % Number and timing of application: Mandatory target organisms: | — | Bacteria and yeast: 0,299 % w/w L-(+)-lactic acid, 5 minutes, 20 °C ---|--- Minimum in use concentration of surfactants shall be 0,29 % for any future product included in this meta SPC. Category(ies) of users | professional Pack sizes and packaging material | Refill caps: 20–100 ml HDPE Bottles: 0,5–5 litres HDPE or PET Jerry can: 1–80 litres HDPE Drum: 10–210 litres HDPE IBC: 1 000 litres HDPE 4.2.1. Use-specific instructions See general instructions for use 4.2.2. Use-specific risk mitigation measures See general instructions for use 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 instructions for use 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general instructions for use 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general instructions for use 5\. GENERAL DIRECTIONS FOR USE OF THE META SPC 2 5.1. Instructions for use — | Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays/m2 or 20 ml/m2 or fully cover the object to be disinfected). ---|--- — | Apply only on non-porous surfaces. ---|--- — | Inform the authorisation holder if the treatment is ineffective. ---|--- — | Each product label shall give information on how the dilution should be made in order to guarantee the efficacy of the product. Since the concentration of L-(+)-lactic acid in products within this meta SPC can range from 7,83 % to 31,33 %, it is not possible to indicate all product dilution here. ---|--- The authorisation holder shall indicate on the label the relevant volume of product to be diluted in water on the label of each specific product. Example for a product containing 7,83 % L-(+)-lactic acid Bacterial and yeasticidal activity | Dilution of the product 0,299 % (40 ml product, add water up to 1 litre) | Contact time 5 minutes ---|---|--- 5.2. Risk mitigation measures — | Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titless of the EN standard are available under section 6. ---|--- — | PPE material to be specified by the authorisation holder within the product information. ---|--- — | Wash hands after use of the concentrate product. ---|--- — | Avoid contact with eyes. ---|--- — | Avoid splashes and spills during mixing and loading (dilution). ---|--- — | For outdoor uses, do not apply the product in case rain is expected within 24 hours. ---|--- — | For outdoor uses by spray, avoid transfer to other areas by wind (drift). ---|--- 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment — | IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice. ---|--- — | IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. ---|--- Call 112 or an ambulance for medical assistance. Information to healthcare personnel or a doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. — | IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an 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 — | Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains. ---|--- — | Dispose of unused product, its packaging and all other waste, in accordance with local regulations. ---|--- 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage — | Shelf-life: 2 years. ---|--- — | Protect from frost. ---|--- 6\. OTHER INFORMATION The full titles of the EN standards referenced in section 5.2 ‘Risk mitigation measures’ are: | EN 374 - Protective gloves against dangerous chemicals and micro-organisms ---|--- | EN 16321 - Eye and face protection for occupational use ---|--- | EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) ---|--- 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) | U2 DESODOR 4D+ | Market area: EU ---|---|--- 4D+ | Market area: EU DESODOR 4D+ | Market area: EU Authorisation number | EU-0029486-0002 1-2 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | active substance | 79-33-4 | 201-196-2 | 15,66 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 13,5 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 1,76 % (w/w) 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | KING FLASH GERM | Market area: EU ---|---|--- KingFlash germ | Market area: EU KING FLASH germ’ | Market area: EU FLASH GERM | Market area: EU Authorisation number | EU-0029486-0003 1-2 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | active substance | 79-33-4 | 201-196-2 | 31,33 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 27 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 3,52 % (w/w) * * * ELI: http://data.europa.eu/eli/reg_impl/2024/2205/oj ISSN 1977-0677 (electronic edition) * * *