COMMISSION IMPLEMENTING REGULATION (EU) 2023/1758

12.9.2023 | EN | Official Journal of the European Union | L 224/34 ---|---|---|--- * * * 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 (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 26 April 2019, Salveco SAS submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for a Union authorisation of a biocidal product family named ‘SALVECO SALVESAFE PRODUCTS’ of product-types 2, 3 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of France had agreed to evaluate the application. The application was recorded under case number BC-HC051278-51 in the Register for Biocidal Products. ---|--- (2) | ‘SALVECO SALVESAFE PRODUCTS’ contains L-(+)-lactic acid as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2, 3 and 4. ---|--- (3) | On 7 January 2022, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency. ---|--- (4) | On 5 July 2022, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘SALVECO SALVESAFE PRODUCTS’ and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012. ---|--- (5) | The opinion concludes that ‘SALVECO SALVESAFE PRODUCTS’ is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation. ---|--- (6) | On 20 July 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. ---|--- (7) | The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the 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-0028967-0000 is hereby granted to Salveco SAS for the making available on the market and use of the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ in accordance with the summary of the biocidal product characteristics set out in the Annex. The Union authorisation is valid from 2 October 2023 to 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, 11 September 2023. For the Commission The President Ursula VON DER LEYEN * * * (1) OJ L 167, 27.6.2012, p. 1. (2) ECHA opinion of 15 June 2022 on the Union authorisation of ‘SALVECO SALVESAFE PRODUCTS’ (ECHA/BPC/346/2022), https://echa.europa.eu/opinions-on- union-authorisation. * * * ANNEX SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY SALVECO SALVESAFE PRODUCTS 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-0028967-0000 R4BP asset number: EU-0028967-0000 PART I FIRST INFORMATION LEVEL 1\. ADMINISTRATIVE INFORMATION 1.1. Family name Name | SALVECO SALVESAFE PRODUCTS ---|--- 1.2. Product type(s) Product type(s) | 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 | SALVECO S.A.S. ---|---|--- Address | Avenue Pierre Mendès-France Z.A. Hellieule 4, F 88100 SAINT DIE DES VOSGES France Authorisation number | EU-0028967-0000 R4BP asset number | EU-0028967-0000 Date of the authorisation | 2 October 2023 Expiry date of the authorisation | 30 September 2033 1.4. Manufacturer(s) of the biocidal products 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 | Avenue Pierre Mendès-France, F-88100 SAINT DIE DES VOSGES France Name of manufacturer | GESTRA S.A.S ---|--- Address of manufacturer | Allée Robert Schumann, F-88110 RAON-L’ETAPE France Location of manufacturing sites | Allée Robert Schumann, F-88110 RAON-L’ETAPE 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 | 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 | 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 (%) ---|---|---|---|---|--- Min | Max L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 0,627 | 31,33 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 0,0 | 28,8 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 0,0 | 8,23 2.2. Type(s) of formulation Formulation(s) | SL – Soluble Concentrate AL – Any other liquids ---|--- 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-SPC1 ---|--- 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 (Disinfectants) PT04 - Food and feed area (Disinfectants) ---|--- 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 (%) ---|---|---|---|---|--- Min | Max L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 15,66 | 31,33 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 13,5 | 27,0 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 3,52 | 8,23 2.2. Type(s) of formulation of the meta SPC 1 Formulation(s) | SL – Soluble Concentrate ---|--- 3\. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1 Hazard statements | Causes skin irritation. Causes serious eye damage. ---|--- 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, protective clothing and eye 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 POISON CENTER or doctor. Specific treatment (see supplemental first aid instruction on this label). If skin irritation occurs:Get medical advice. Take off contaminated clothing.And wash it before reuse. 4\. AUTHORISED USE(S) OF THE META SPC 1 4.1. Use description Table 1 Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in domestic, institutional, medical and industrial areas) Product type | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Viruses Common name: Enveloped viruses Development stage: Field(s) of use | Indoor Outdoor In domestic, institutional, medical and industrial areas 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 liters and packaging above 1 liter should be equipped with a handle | | Refill caps: 20 - 100ml high density polyethylene (HDPE) ---|--- | Bottles: 0,5 - 5 liters HDPE or polyethylene terephtalate (PET) ---|--- | Jerry can: 1-80 liters HDPE (only for professional users) ---|--- | Drum: 10-210 liters HDPE (only for professional users) ---|--- | Intermediate bulk container (IBC): 1 000 liters HDPE (only for professional users) ---|--- 4.1.1. Use-specific instructions for use 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 Use # 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 (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Field(s) of use | Indoor Outdoor | — | 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 liters and packaging above 1 liter should be equipped with a handle | | Refill caps: 20 - 100ml high density polyethylene (HDPE) ---|--- | Bottles: 0,5 - 5 liters HDPE or polyethylene terephtalate (PET) ---|--- | Jerry can: 1-80 liters HDPE (only for professional users) ---|--- | Drum: 10-210 liters HDPE (only for professional users) ---|--- | Intermediate bulk container (IBC): 1 000 liters HDPE (only for professional users) ---|--- 4.2.1. Use-specific instructions for use 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 (1) 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 liter) | Contact time 5 minutes ---|---|--- The authorisation holder shall indicate on the label the relevant volume of product to be diluted in water for 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 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). ---|--- 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 texts of the EN standards are available in Section 6. – Personal protective equipment (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 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 — | Keep out of reach of children and non-target animals or pets. ---|--- — | Shelf-life: 2 years. ---|--- — | Protect from frost. ---|--- 6\. OTHER INFORMATION — | P280 (Wear protective gloves/protective clothing/eye protection/face protection) 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) | SALVE FAM1_1 | Market area: EU ---|---|--- Authorisation number | EU-0028967-0001 1-1 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 27,0 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 8,23 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM1_5 | Market area: EU ---|---|--- Authorisation number | EU-0028967-0002 1-1 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 20,89 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 18,0 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 5,49 7.3. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM1_9 | Market area: EU ---|---|--- | OSANIS – Nettoyant désinfectant concentré | Market area: EU Authorisation number | EU-0028967-0003 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 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 13,5 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 4,11 7.4. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM1_13 | Market area: EU ---|---|--- | MILTON - Dégraissant désinfectant | Market area: EU Authorisation number | EU-0028967-0004 1-1 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 27,0 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 3,52 META SPC 2 1\. META SPC 2 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 2 identifier Identifier | meta-SPC2 ---|--- 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) PT04 - Food and feed area (Disinfectants) ---|--- 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 (%) ---|---|---|---|---|--- Min | Max L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 15,66 | 31,33 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 13,5 | 27,0 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 3,52 | 8,23 2.2. Type(s) of formulation of the meta SPC 2 Formulation(s) | SL – Soluble Concentrate ---|--- 3\. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 Hazard statements | Causes skin irritation. Causes serious eye damage. Contains Eucalyptol, Carvone and Limonene. May produce an allergic reaction. Contains Methyl salicylate and Eugenol (Pure fragrance). May produce an allergic reaction. Contains Eucalyptol (Ecalyptus leaves fragrance). 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, protective clothing and eye 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 POISON CENTER or doctor. Specific treatment (see supplemental first aid instruction on this label). If skin irritation occurs:Get medical advice. Take off contaminated clothing.And wash it before reuse. 4\. AUTHORISED USE(S) OF THE META SPC 2 4.1. Use description Table 3 Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in domestic, institutional, medical and industrial areas) Product type | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Viruses Common name: Enveloped viruses Development stage: Field(s) of use | Indoor Outdoor in domestic, institutional, medical 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 liters and packaging above 1 liter should be equipped with a handle Refill caps: 20 - 100 ml HDPE Bottles: 0,5 - 5 liters HDPE or PET Jerry can: 1-80 liters HDPE (only for professional users) Drum: 10-210 liters HDPE (only for professional users) IBC: 1 000 liters HDPE (only for professional users) 4.1.1. Use-specific instructions for use 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 4 Use # 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 (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Field(s) of use | Indoor Outdoor | — | 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 liters and packaging above 1 liter should be equipped with a handle Refill caps: 20 - 100ml HDPE Bottles: 0,5 - 5 liters HDPE or PET Jerry can: 1-80 liters HDPE (only for professional users) Drum: 10-210 liters HDPE (only for professional users) IBC: 1 000 liters HDPE (only for professional users) 4.2.1. Use-specific instructions for use 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 (2) 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. ---|--- — | 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 liter) | 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 2 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM1_2 | Market area: EU ---|---|--- Authorisation number | EU-0028967-0005 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 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 27,0 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 8,23 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM1_3 | Market area: EU ---|---|--- Authorisation number | EU-0028967-0006 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 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 27,0 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 8,23 7.3. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM1_4 | Market area: EU ---|---|--- | MAISON VERTE - Recharge pour spray désinfectant multi-usages | Market area: EU MAISON VERTE PRO - Recharge pour spray désinfectant multi-usages | Market area: EU MAISON VERTE PRO - Recharge pour spray désinfectant salle de bain | Market area: EU SANIVERT - Recharge pour spray désinfectant multi-usages | Market area: EU YOU - Recharge désinfectant toutes surfaces | Market area: EU YOU - Recharge désinfectant WC | Market area: EU SANILAK - Recharge Nettoyant désinfectant multi-usages Eucalyptus | Market area: EU SANILAK - Recharge Nettoyant désinfectant sanitaires Eucalyptus | Market area: EU SANILAK - Recharge Nettoyant désinfectant cuisine Eucalyptus | Market area: EU YOU - Refill All purpose disinfecting cleaner | Market area: EU Authorisation number | EU-0028967-0007 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 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 27,0 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 8,23 7.4. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM1_6 | Market area: EU ---|---|--- Authorisation number | EU-0028967-0008 1-2 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 20,89 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 18,0 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 5,49 7.5. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM1_7 | Market area: EU ---|---|--- Authorisation number | EU-0028967-0009 1-2 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 20,89 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 18,0 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 5,49 7.6. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM1_8 | Market area: EU ---|---|--- Authorisation number | EU-0028967-0010 1-2 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 20,89 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 18,0 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 5,49 7.7. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM1_10 | Market area: EU ---|---|--- | SANILAK - Nettoyant désinfectant concentré Menthe | Market area: EU SANILAK - Recharge Nettoyant désinfectant sols et surfaces Menthe | Market area: EU Authorisation number | EU-0028967-0011 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 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 13,5 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 4,11 7.8. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM1_11 | Market area: EU ---|---|--- Authorisation number | EU-0028967-0012 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 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 13,5 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 4,11 7.9. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM1_12 | Market area: EU ---|---|--- | MAISON VERTE - Recharge pour sol désinfectant multi-surfaces | Market area: EU MAISON VERTE PRO - Recharge pour désinfectant sol | Market area: EU MAISON VERTE PRO - Recharge pour désinfectant Multi-surfaces | Market area: EU SANIVERT - Recharge désinfectant multi-surfaces | Market area: EU YOU - Recharge désinfectant sols & surfaces | Market area: EU SANILAK - Nettoyant désinfectant concentré Eucalyptus | Market area: EU SANILAK - Recharge Nettoyant désinfectant sols et surfaces Eucalyptus | Market area: EU Authorisation number | EU-0028967-0013 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 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 13,5 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 4,11 7.10. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM1_14 | Market area: EU ---|---|--- Authorisation number | EU-0028967-0014 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 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 27,0 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 8,23 7.11. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM1_15 | Market area: EU ---|---|--- | TECH'LAB - Concentré détergent désinfectant sols & surfaces | Market area: EU Authorisation number | EU-0028967-0015 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 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 13,5 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 4,11 7.12. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM1_16 | Market area: EU ---|---|--- Authorisation number | EU-0028967-0016 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 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 13,5 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 4,11 META SPC 3 1\. META SPC 3 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 3 identifier Identifier | meta-SPC3 ---|--- 1.2. Suffix to the authorisation number Number | 1-3 ---|--- 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 Common name | IUPAC name | Function | CAS number | EC number | Content (%) ---|---|---|---|---|--- Min | Max L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 7,83 | 31,33 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 6,75 | 27,0 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 1,32 | 3,52 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 skin irritation. Causes serious eye damage. ---|--- Precautionary statements | Wash hands thoroughly after handling. Wear protective gloves, protective clothing and eye 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 POISON CENTER or doctor. Specific treatment (see supplemental first aid instruction on this label). If skin irritation occurs:Get medical advice. Take off contaminated clothing.And wash it before reuse. 4\. AUTHORISED USE(S) OF THE META SPC 3 4.1. Use description Table 5 Use # 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 (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Viruses Common name: Enveloped viruses Development stage: Field(s) of use | Indoor Outdoor | — | 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 – 100ml HDPE Bottles: 0,5 - 5 liters HDPE or PET Jerry can: 1-80 liters HDPE Drum: 10-210 liters HDPE IBC: 1 000 liters HDPE 4.1.1. Use-specific instructions for use 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 6 Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in institutional and industrial areas) Product type | PT04 - Food and feed area (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Field(s) of use | Indoor Outdoor | — | 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 – 100ml HDPE Bottles: 0,5 - 5 liters HDPE or PET Jerry can: 1-80 liters HDPE Drum: 10-210 liters HDPE IBC: 1 000 liters HDPE 4.2.1. Use-specific instructions for use 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 (3) OF THE META SPC 3 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 auhtorisation 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. | 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 liter) | 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 — | 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 3 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM2_1 | Market area: EU ---|---|--- Authorisation number | EU-0028967-0017 1-3 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 15,66 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 13,5 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 1,76 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM2_2 | Market area: EU ---|---|--- Authorisation number | EU-0028967-0018 1-3 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 27,0 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 3,52 7.3. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM2_6 | Market area: EU ---|---|--- Authorisation number | EU-0028967-0019 1-3 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 7,83 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 6,75 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 1,32 META SPC 4 1\. META SPC 4 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 4 identifier Identifier | meta-SPC4 ---|--- 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) ---|--- 2\. META SPC 4 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 4 Common name | IUPAC name | Function | CAS number | EC number | Content (%) ---|---|---|---|---|--- Min | Max L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 7,83 | 31,33 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 6,75 | 27,0 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 1,32 | 5,28 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 Eucalyptol, Carvone and Limonene (Cool Mint fragrance). May produce an allergic reaction. Contains Methyl salicylate and Eugenol (Pure fragrance). May produce an allergic reaction. ---|--- Precautionary statements | Wash hands thoroughly after handling. Wear protective gloves, protective clothing and eye 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 POISON CENTER or doctor. Specific treatment (see supplemental first aid instruction on this label). 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 7 Use # 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 (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Viruses Common name: Enveloped viruses Development stage: Field(s) of use | Indoor Outdoor | — | 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 – 100ml HDPE Bottles: 0,5 - 5 liters HDPE or PET Jerry can: 1-80 liters HDPE Drum: 10-210 liters HDPE IBC: 1 000 liters HDPE 4.1.1. Use-specific instructions for use 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 8 Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in institutional and industrial areas) Product type | PT04 - Food and feed area (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Field(s) of use | Indoor Outdoor | — | 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 yeast: 0,299% w/w L-(+)-lactic cid, 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 – 100ml HDPE Bottles: 0,5 - 5 liters HDPE or PET Jerry can: 1-80 liters HDPE Drum: 10-210 liters HDPE IBC: 1 000 liters HDPE 4.2.1. Use-specific instructions for use 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 (4) OF THE META SPC 4 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. | 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 liter) | 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 — | 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 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 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 CENTER 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 4 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM2_3 | Market area: EU ---|---|--- | ATOUT-VERT - DD303 | Market area: EU SANILAK - Recharge Nettoyant Désinfectant Multi-usages Menthe | Market area: EU SANILAK - Recharge Nettoyant Désinfectant Sanitaires Menthe | Market area: EU SANILAK - Recharge Nettoyant Désinfectant Cuisine Menthe | Market area: EU Authorisation number | EU-0028967-0020 1-4 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 27,0 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 5,28 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM2_4 | Market area: EU ---|---|--- Authorisation number | EU-0028967-0021 1-4 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 27,0 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 5,28 7.3. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM2_5 | Market area: EU ---|---|--- | ATOUT-VERT - DDP38 | Market area: EU Authorisation number | EU-0028967-0022 1-4 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 7,83 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 6,75 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 1,32 META SPC 5 1\. META SPC 5 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 5 identifier Identifier | meta-SPC5 ---|--- 1.2. Suffix to the authorisation number Number | 1-5 ---|--- 1.3. Product type(s) Product type(s) | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT03 - Veterinary hygiene (Disinfectants) PT04 - Food and feed area (Disinfectants) ---|--- 2\. META SPC 5 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 5 Common name | IUPAC name | Function | CAS number | EC number | Content (%) ---|---|---|---|---|--- Min | Max L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 | 31,33 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 28,8 | 28,8 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 3,52 | 3,52 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 skin irritation. Causes serious eye damage. ---|--- Precautionary statements | Wash hands thoroughly after handling. Wear protective gloves, protective clothing and eye 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 POISON CENTER or doctor. Specific treatment (see supplemental first aid instruction on this label). If skin irritation occurs:Get medical advice. Take off contaminated clothing.And wash it before reuse. 4\. AUTHORISED USE(S) OF THE META SPC 5 4.1. Use description Table 9 Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in institutional, medical, and industrial areas) Product type | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Viruses Common name: Enveloped viruses Development stage: Field(s) of use | Indoor Outdoor | — | In institutional, medical and industrial area ---|--- Application method(s) | Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion except in medical areas, mopping Detailed description: | — | without mechanical action ---|--- Application rate(s) and frequency | Application Rate: - Dilution (%): 0,4485% Number and timing of application: Mandatory target organisms: | — | Bacteria and yeasts: 0,4485% w/w L-(+)-lactic acid, 5 minutes, 20°C ---|--- Other target organisms: — | Enveloped viruses: 0,4485% w/w L-(+)-lactic acid, 5 minutes, 20°C ---|--- The concentrated product is to be diluted at 1,5% v/v before use. Category(ies) of users | Professional Pack sizes and packaging material | Bottles: 0,5 - 5 liters HDPE or PET Jerry can: 1-80 liters HDPE Drum: 10-210 liters HDPE IBC: 1 000 liters HDPE 4.1.1. Use-specific instructions for use 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 10 Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in institutional and industrial (food industry) areas) Product type | PT04 - Food and feed area (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Field(s) of use | Indoor Outdoor | — | In institutional and industrial (food industry (general, meat (except slaughterhouses) and milk industries)) 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 (%): 0,4485% to 0,598% Number and timing of application: General disinfection and meat industries Mandatory target organisms: | — | Bacteria and yeast: 0,4485% to 0,598% w/w L-(+)-lactic acid, 5 minutes, 20°C ---|--- The concentrated product is to be diluted between 1,5% and 2% v/v before use. Milk industries Mandatory target organisms: — | Bacteria and yeast: 0,598% w/w L-(+)-lactic acid, 5 minutes, 20°C ---|--- The concentrated product is to be diluted at 2% v/v before use. Category(ies) of users | Professional Pack sizes and packaging material | Bottles: 0,5 - 5 liters HDPE or PET Jerry can: 1-80 liters HDPE Drum: 10-210 liters HDPE IBC: 1 000 liters HDPE 4.2.1. Use-specific instructions for use 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 4.3. Use description Table 11 Use # 3 – Disinfectants used to disinfect the materials and surfaces associated with the housing of animals (disinfectants for all washable hard surfaces in veterinary area) Product type | PT03 - Veterinary hygiene (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: other: bacteria Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeast Development stage: Field(s) of use | Indoor Outdoor 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 30 minutes, 10°C ---|--- The concentrated product is to be diluted at 1% v/v before use. Category(ies) of users | Professional Pack sizes and packaging material | Bottles: 0,5 - 5 liters HDPE or PET Jerry can: 1-80 liters HDPE Drum: 10-210 liters HDPE IBC: 1 000 liters HDPE 4.3.1. Use-specific instructions for use — | Clean carefully the surfaces before application of the product. ---|--- 4.3.2. Use-specific risk mitigation measures See general instructions for use 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 instructions for use 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general instructions for use 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general instructions for use 5\. GENERAL DIRECTIONS FOR USE (5) OF THE META SPC 5 5.1. Instructions for use — | Apply the product by fully wetting all surface for 5 to 30 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 auhtorisation holder if the treatment is ineffective. ---|--- 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 product is a foaming formulation. ---|--- 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 5 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM3_1 | Market area: EU ---|---|--- | CLEAN DESINFECTANT | Market area: EU GERM D | Market area: EU Authorisation number | EU-0028967-0023 1-5 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 28,8 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 3,52 META SPC 6 1\. META SPC 6 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 6 identifier Identifier | meta-SPC6 ---|--- 1.2. Suffix to the authorisation number Number | 1-6 ---|--- 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 6 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 6 Common name | IUPAC name | Function | CAS number | EC number | Content (%) ---|---|---|---|---|--- Min | Max L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 | 31,33 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 28,8 | 28,8 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 5,28 | 5,28 2.2. Type(s) of formulation of the meta SPC 6 Formulation(s) | SL – Soluble Concentrate ---|--- 3\. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6 Hazard statements | Causes skin irritation. Causes serious eye damage. Contains Eucalyptol and Carvone. May produce an allergic reaction. ---|--- Precautionary statements | Wash hands thoroughly after handling. Wear protective gloves, protective clothing and eye 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 POISON CENTER or doctor. Specific treatment (see supplemental first aid instruction on this label). If skin irritation occurs:Get medical advice. Take off contaminated clothing.And wash it before reuse. 4\. AUTHORISED USE(S) OF THE META SPC 6 4.1. Use description Table 12 Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in medical area) Product type | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Viruses Common name: Enveloped viruses Development stage: Field(s) of use | Indoor Outdoor | — | in medical area ---|--- Application method(s) | Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, mopping Detailed description: | — | without mechanical action ---|--- Application rate(s) and frequency | Application Rate: - Dilution (%): 0,4485% Number and timing of application: Mandatory target organisms: | — | Bacteria and yeast: 0,4485% w/w L-(+)-lactic acid, 5 minutes, 20°C ---|--- Other target organisms: — | Enveloped viruses: 0,4485% w/w L-(+)-lactic acid, 5 minutes, 20°C ---|--- The concentrated product is to be diluted at 1,5 % before use. Category(ies) of users | Professional Pack sizes and packaging material | Bottles: 0,5 - 5 liters HDPE or PET Jerry can: 1-80 liters HDPE Drum: 10-210 liters HDPE IBC: 1 000 liters HDPE 4.1.1. Use-specific instructions for use 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 5\. GENERAL DIRECTIONS FOR USE (6) OF THE META SPC 6 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. ---|--- 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 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 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 6 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM3_2 | Market area: EU ---|---|--- Authorisation number | EU-0028967-0024 1-6 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 28,8 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 5,28 META SPC 7 1\. META SPC 7 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 7 identifier Identifier | meta-SPC7 ---|--- 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) PT03 - Veterinary hygiene (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 Common name | IUPAC name | Function | CAS number | EC number | Content (%) ---|---|---|---|---|--- Min | Max L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 | 31,33 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 24,93 | 24,93 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 3,52 | 3,52 2.2. Type(s) of formulation of the meta SPC 7 Formulation(s) | SL – Soluble Concentrate ---|--- 3\. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7 Hazard statements | Causes skin irritation. Causes serious eye damage. ---|--- Precautionary statements | Wash hands thoroughly after handling. Wear protective gloves, protective clothing and eye 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 POISON CENTER or doctor. Specific treatment (see supplemental first aid instruction on this label). If skin irritation occurs: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 – 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 (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Viruses Common name: Enveloped viruses Development stage: Field(s) of use | Indoor Outdoor | — | In domestic, institutional and industrial area ---|--- Application method(s) | Method: Wiping, moping or brush, spraying, soaking or dipping (immersion) 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 ---|--- The concentrated product is to be diluted at 1% v/v before use. Category(ies) of users | Professional Pack sizes and packaging material | Bottles: 0,5 - 5 liters HDPE or PET Jerry can: 1-80 liters HDPE Drum: 10-210 liters HDPE IBC: 1 000 liters HDPE Soft container: 1,5, 2,5 liters Low density polyethylene (LDPE) 4.1.1. Use-specific 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). 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 14 Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in domestic, institutional and industrial (food industry) areas) Product type | PT04 - Food and feed area (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Virus Common name: Enveloped viruses only Development stage: Field(s) of use | Indoor Outdoor | — | In domestic, institutional and food industry areas ---|--- Application method(s) | Method: Wiping, moping or brush, spraying, soaking or dipping (immersion) 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 ---|--- Other target organisms: — | Enveloped viruses: 0,299% w/w L-(+)-lactic acid, 5 minutes, 20°C ---|--- The concentrated product is to be diluted at 1% v/v before use as indicated on label. Category(ies) of users | Industrial Professional Pack sizes and packaging material | Bottles: 0,5 - 5 liters HDPE or PET Jerry can: 1-80 liters HDPE Drum: 10-210 liters HDPE IBC: 1 000 liters HDPE Soft container: 1,5, 2,5 liters LDPE 4.2.1. Use-specific 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). ---|--- 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 4.3. Use description Table 15 Use # 3 – Disinfectants used to disinfect the materials and surfaces associated with the housing of animals (disinfectants for all washable hard surfaces in veterinary area) Product type | PT03 - Veterinary hygiene (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeast Common name: Yeasts Development stage: Field(s) of use | Indoor Outdoor - Application method(s) | Method: Wiping, moping or brush, spraying, soaking or dipping (immersion) Detailed description: | — | without mechanical action ---|--- Application rate(s) and frequency | Application Rate: - Dilution (%): 0,748% Number and timing of application: Mandatory target organisms: | — | Bacteria and yeast: 0,748% w/w L-(+)-lactic acid, 30 minutes, 10°C ---|--- The concentrated product is to be diluted at 2,5% v/v before use as indicated on label. Category(ies) of users | Professional Pack sizes and packaging material | Bottles: 0,5 - 5 liters HDPE or PET Jerry can: 1-80 liters HDPE Drum: 10-210 liters HDPE IBC: 1 000 liters HDPE Soft container: 1,5, 2,5 liters LDPE 4.3.1. Use-specific instructions for use — | Clean carefully the surfaces before application of the product. ---|--- — | Apply the product by fully wetting all surface for 30 minutes (apply approx. 18 sprays/m2 or 20 ml/m2 or fully cover the object to be disinfected). ---|--- 4.3.2. Use-specific risk mitigation measures See general instructions for use 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 instructions for use 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general instructions for use 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general instructions for use 5\. GENERAL DIRECTIONS FOR USE (7) OF THE META SPC 7 5.1. Instructions for use — | Apply only on non porous surfaces. ---|--- — | Inform the authorisation holder if the treatment is ineffective. ---|--- 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 7 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE 15 | Market area: EU ---|---|--- Authorisation number | EU-0028967-0025 1-7 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 31,33 Sodium octyl ether carboxylate | | Non-active substance | 53563-70-5 | | 24,93 D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-active substance | 110615-47-9 | | 3,52 META SPC 8 1\. META SPC 8 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 8 identifier Identifier | meta-SPC8 ---|--- 1.2. Suffix to the authorisation number Number | 1-8 ---|--- 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 8 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 8 Common name | IUPAC name | Function | CAS number | EC number | Content (%) ---|---|---|---|---|--- Min | Max L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 0,627 | 1,566 2.2. Type(s) of formulation of the meta SPC 8 Formulation(s) | AL – Any other liquids ---|--- 3\. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8 Hazard statements | ---|--- Precautionary statements | 4\. AUTHORISED USE(S) OF THE META SPC 8 4.1. Use description Table 16 Use # 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 (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Viruses Common name: Enveloped viruses Development stage: Field(s) of use | Indoor Outdoor | — | In domestic, institutional and industrial areas. ---|--- Application method(s) | Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion Detailed description: | — | without mechanical action ---|--- Application rate(s) and frequency | Application Rate: - Dilution (%): 0 Number and timing of application: Ready to use products. Contact time:

5 minutes, 20°C Category(ies) of users | Professional General public (non-professional) Pack sizes and packaging material | Package size for non-professional is restricted to maximum 3 liters and packaging above 1 liter should be equipped with a handle. Sprays (SP05): 0,5 liter - 0,75 liter HDPE or PET Bottles: 0,5 - 5 liters HDPE or PET Jerry can: 1-80 liters HDPE (only for professional users) Drum: 10-210 liters HDPE (only for professional users) IBC: 1 000 liters HDPE (only for professional users) 4.1.1. Use-specific instructions for use 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 17 Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in domestic, institutional and industrial areas) Product type | PT04 - Food and feed area (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Field(s) of use | Indoor Outdoor | — | In domestic, institutional and industrial (food industry (general)) areas. ---|--- Application method(s) | Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion>Detailed description: - Application rate(s) and frequency | Application Rate: ->Dilution (%): 0>Number and timing of application:>Ready to use products.>Contact time: 5 minutes, 20°C Category(ies) of users | Professional General public (non-professional) Pack sizes and packaging material | Package size for non-professional is restricted to maximum 3 liters and packaging above 1 liter should be equipped with a handle.>Sprays (SP05): 0,5 liter - 0,75 liter HDPE or PET>Bottles: 0,5 - 5 liters HDPE or PET>Jerry can: 1-80 liters HDPE (only for professional users) Drum: 10-210 liters HDPE (only for professional users) IBC: 1 000 liters HDPE (only for professional users) 4.2.1. Use-specific instructions for use 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 (8) OF THE META SPC 8 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. ---|--- 5.2. Risk mitigation measures — | 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 medical advice is needed, have product container or label at hand ---|--- — | IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. 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 SWALLOWED: If symptoms occur 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 — | 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 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) | SALVE FAM5_1 | Market area: EU ---|---|--- Authorisation number | EU-0028967-0026 1-8 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 0,627 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM5_2 | Market area: EU ---|---|--- Authorisation number | EU-0028967-0027 1-8 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 0,627 7.3. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SANILAK - Nettoyant désinfectant multi-usages Eucalyptus | Market area: EU ---|---|--- | SANILAK - Nettoyant désinfectant sanitaires Eucalyptus | Market area: EU SANILAK - Nettoyant désinfectant cuisine Eucalyptus | Market area: EU SALVE FAM5_3 | Market area: EU Authorisation number | EU-0028967-0028 1-8 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 0,627 7.4. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM5_4 | Market area: EU ---|---|--- | YOU - All purpose disinfecting cleaner | Market area: EU MAISON VERTE - Désinfectant | Market area: EU MAISON VERTE PRO - Désinfectant Multi-usages | Market area: EU MAISON VERTE PRO - Désinfectant Salle de Bain | Market area: EU SANIVERT - Désinfectant | Market area: EU YOU - Nettoyant désinfectant toutes surfaces | Market area: EU YOU - Désinfectant WC détartrant | Market area: EU Authorisation number | EU-0028967-0029 1-8 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 0,627 7.5. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM5_5 | Market area: EU ---|---|--- Authorisation number | EU-0028967-0030 1-8 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 1,566 7.6. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM5_6 | Market area: EU ---|---|--- | SANILAK - Nettoyant désinfectant sols et surfaces | Market area: EU Authorisation number | EU-0028967-0031 1-8 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 1,566 7.7. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM5_7 | Market area: EU ---|---|--- | SANILAK - Nettoyant désinfectant sols et surfaces Eucalyptus | Market area: EU Authorisation number | EU-0028967-0032 1-8 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 1,566 7.8. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM5_8 | Market area: EU ---|---|--- | MAISON VERTE - Désinfectant Multi-surfaces | Market area: EU MAISON VERTE PRO - Désinfectant Sol | Market area: EU MAISON VERTE PRO - Désinfectant Multi-surfaces | Market area: EU SANIVERT - Désinfectant Multi-surfaces | Market area: EU YOU - Désinfectant sols & surfaces | Market area: EU Authorisation number | EU-0028967-0033 1-8 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 1,566 META SPC 9 1\. META SPC 9 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 9 identifier Identifier | meta-SPC9 ---|--- 1.2. Suffix to the authorisation number Number | 1-9 ---|--- 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 9 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 9 Common name | IUPAC name | Function | CAS number | EC number | Content (%) ---|---|---|---|---|--- Min | Max L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 0,627 | 0,627 2.2. Type(s) of formulation of the meta SPC 9 Formulation(s) | AL – Any other liquids ---|--- 3\. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9 Hazard statements | ---|--- Precautionary statements | 4\. AUTHORISED USE(S) OF THE META SPC 9 4.1. Use description Table 18 Use # 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 (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Viruses Common name: Enveloped viruses Development stage: Field(s) of use | Indoor Outdoor | — | 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 (%): - Number and timing of application: Ready to use products. Contact time: 5 minutes, 20°C Category(ies) of users | Professional General public (non-professional) Pack sizes and packaging material | Package size for non-professional is restricted to maximum 3 liters and packaging above 1 liter should be equipped with a handle Sprays (SP05): 0,5 liter - 0,75 liter HDPE or PET Bottles: 0,5 - 5 liters HDPE or PET Jerry can: 1-80 liters HDPE (only for professional users) Drum: 10-210 liters HDPE (only for professional users) 4.1.1. Use-specific instructions for use 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 19 Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in domestic, institutional and industrial areas) Product type | PT04 - Food and feed area (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Field(s) of use | Indoor Outdoor | — | In domestic, institutional and industrial (general) 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 (%): - Number and timing of application: Ready to use products. Contact time: 5 minutes, 20°C Category(ies) of users | Professional General public (non-professional) Pack sizes and packaging material | Package size for non-professional is restricted to maximum 3 liters and packaging above 1 liter should be eqquiped with a handle. Sprays (SP05): 0,5 liter - 0,75 liter HDPE or PET Bottles: 0,5 - 5 liters HDPE or PET Jerry can: 1-80 liters HDPE (only for professional users) Drum: 10-210 liters HDPE (only for professional users) 4.2.1. Use-specific instructions for use 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 (9) OF THE META SPC 9 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). ---|--- — | Comply with the instructions for use. ---|--- — | Apply only on non-porous surfaces ---|--- 5.2. Risk mitigation measures — | 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 medical advice is needed, have product container or label at hand ---|--- — | IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. 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 SWALLOWED: If symptoms occur 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 — | 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 - 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) | SALVE FAM6_1 | Market area: EU ---|---|--- Authorisation number | EU-0028967-0034 1-9 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 0,627 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM6_2 | Market area: EU ---|---|--- | SANILAK - Nettoyant désinfectant multi-usages Menthe | Market area: EU SANILAK - Nettoyant désinfectant sanitaires Menthe | Market area: EU SANILAK - Nettoyant désinfectant cuisine Menthe | Market area: EU Authorisation number | EU-0028967-0035 1-9 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 0,627 7.3. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | SALVE FAM6_3 | Market area: EU ---|---|--- Authorisation number | EU-0028967-0036 1-9 Common name | IUPAC name | Function | CAS number | EC number | Content (%) L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 0,627 * * * (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. (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. (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. (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. (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. (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. (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. (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. (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. * * *