COMMISSION IMPLEMENTING REGULATION (EU) 2025/285

| Official Journal of the European Union | EN L series ---|---|--- * * * | 2025/285 | 13.2.2025 ---|---|--- COMMISSION IMPLEMENTING REGULATION (EU) 2025/285 of 12 February 2025 amending Implementing Regulation (EU) 2023/1758 as regards administrative changes to the Union authorisation of the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ (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 50(2) thereof, Whereas: (1) | On 11 September 2023, Commission Implementing Regulation (EU) 2023/1758 (2) granted a Union authorisation, under number EU-0028967-0000, to Salveco SAS for the making available on the market and use of the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’. The Annex to that Implementing Regulation provides the summary of product characteristics (‘SPC’) for that biocidal product family. ---|--- (2) | On 23 October 2023, 10 January 2024 and 5 February 2024, Salveco SAS submitted to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013 (3), notifications of administrative changes to the Union authorisation for the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’, recorded in the register for biocidal products under case numbers BC-HF089623-38, BC-HR091384-18, and BC-VH092958-06. The notified changes concern the addition of 6 trade names, the addition of a new package size within the already authorised range and the addition of a new product manufacturer. ---|--- (3) | On 14 November 2023 (4), 15 February 2024 (5) and 6 March 2024 (6) the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, opinions on the notified administrative changes to the Union authorisation for the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’, together with a revised summary of the biocidal product characteristics. In the opinions, the Agency concludes that the proposed changes are administrative changes as referred to in Article 50(3), point (a), of Regulation (EU) No 528/2012 and as specified in Title 1, Section 1, of the Annex to Implementing Regulation (EU) No 354/2013, and that after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met. ---|--- (4) | On 6 March 2024, the Agency transmitted to the Commission the revised summary of the biocidal product characteristics of the Union authorisation for the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ in all official languages of the Union, covering all administrative changes applied for, in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013. ---|--- (5) | The Commission concurs with the opinions of the Agency and therefore considers it appropriate to amend the Union authorisation for the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ to introduce the administrative changes requested by Salveco SAS. ---|--- (6) | Except for the amendments regarding the administrative changes, all other information included in the summary of the biocidal product characteristics of ‘SALVECO SALVESAFE PRODUCTS’ as set out in the Annex to Implementing Regulation (EU) 2023/1758 remains unchanged. ---|--- (7) | In order to enhance clarity and to ease the access of users and interested parties to the consolidated version of the summary of the biocidal product characteristics which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2023/1758 should be replaced in its entirety. Due to a change in the format used for the generation of the summary of biocidal product characteristics in the register for biocidal products in 2024, the summary of biocidal product characteristics in that Annex should also include some minor editorial and layout changes. ---|--- (8) | Implementing Regulation (EU) 2023/1758 should therefore be amended accordingly, ---|--- HAS ADOPTED THIS REGULATION: Article 1 The Annex to Implementing Regulation (EU) 2023/1758 is replaced by the Annex to this Regulation. Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 12 February 2025. For the Commission The President Ursula VON DER LEYEN * * * (1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj. (2) Commission Implementing Regulation (EU) 2023/1758 of 11 September 2023 granting a Union authorisation for the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 224, 12.9.2023, p. 34, ELI: http://data.europa.eu/eli/reg_impl/2023/1758/oj). (3) Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p.4, ELI: http://data.europa.eu/eli/reg_impl/2013/354/oj). (4) ECHA Opinion on the administrative change of the Union authorisation of the biocidal product family: SALVECO SALVESAFE PRODUCTS of 14 November 2023, Opinion No UAD-C-1691638-29-00/F, https://echa.europa.eu/opinions-on-union- authorisation. (5) ECHA Opinion on the administrative change of the Union authorisation of the biocidal product family: SALVECO SALVESAFE PRODUCTS of 15 February 2024, Opinion No UAD-C-1712946-30-00/F, https://echa.europa.eu/opinions-on-union- authorisation. (6) ECHA Opinion on the administrative change of the Union authorisation of the biocidal product family: SALVECO SALVESAFE PRODUCTS of 6 March 2024, Opinion No UAD-C-1717922-28-00/F, https://echa.europa.eu/opinions-on-union- authorisation. * * * ANNEX SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY SALVECO SALVESAFE PRODUCTS Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area PT03: Veterinary hygiene 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 PT04: Food and feed area PT03: Veterinary hygiene ---|--- 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 FR 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 product Name of manufacturer | SALVECO S.A.S ---|--- Address of manufacturer | Avenue Pierre Mendès-France F-88100 SAINT DIE DES VOSGES France Location of manufacturing sites | 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 Name of manufacturer | IDEAL Chimic ---|--- Address of manufacturer | Route de St-Julien 34 1227 Carouge Switzerland Location of manufacturing sites | Route de St-Julien 34 1227 Carouge Switzerland 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 (%) ---|---|---|---|---|--- L-(+)-lactic acid | | active substance | 79-33-4 | 201-196-2 | 0,627 - 31,33 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 0 - 28,8 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 0 - 8,23 % (w/w) 2.2. Type(s) of formulation Formulation type(s) | SL – Soluble Concentrate AL – Any other liquids ---|--- PART II SECOND INFORMATION LEVEL - META SPC(S) 1\. META SPC 1 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 1 identifier Identifier | Meta SPC: 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 PT04: Food and feed area ---|--- 2\. META SPC 1 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 1 Common name | IUPAC name | Function | CAS number | EC number | Content (%) ---|---|---|---|---|--- L-(+)-lactic acid | | active substance | 79-33-4 | 201-196-2 | 15,66 - 31,33 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 13,5 - 27 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 3,52 - 8,23 % (w/w) 2.2. Type(s) of formulation of the meta SPC 1 Formulation type(s) | SL – Soluble Concentrate ---|--- 3\. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1 Hazard statements | H315: Causes skin irritation. H318: Causes serious eye damage. ---|--- Precautionary statements | P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P264: Wash hands thoroughly after handling. P280: Wear protective gloves, protective clothing and eye protection. P302+P352: IF ON SKIN: Wash with plenty of water. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER or doctor. P321: Specific treatment (see supplemental first aid instruction on this label). P332+P313: If skin irritation occurs: Get medical advice. P362+P364: Take off contaminated clothing and wash it before reuse. 4\. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in domestic, institutional, medical and industrial areas) Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Scientific name: Viruses Common name: Enveloped viruses Development stage: no data Field(s) of use | indoor use outdoor use In domestic, institutional, 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: - 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 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 See general instructions for use. 4.1.2. Use-specific risk mitigation measures See general instructions for use. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general instructions for use. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general instructions for use. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general instructions for use. 4.2. Use description Table 2 Food and feed area disinfectants (disinfectant for all washable hard surfaces in domestic, institutional and food industry areas Product type | PT04: Food and feed area ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Field(s) of use | indoor use outdoor use | — | in domestic, institutional and food industry areas (general disinfection) ---|--- Application method(s) | Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping Detailed description: | — | without mechanical action ---|--- Application rate(s) and frequency | Application rate: - 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 – 100 ml 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 See general instructions for use. 4.2.2. Use-specific risk mitigation measures See general instructions for use. 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general instructions for use. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general instructions for use. 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general instructions for use. 5\. GENERAL DIRECTIONS FOR USE OF THE META SPC 1 5.1. Instructions for use — | Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected). ---|--- — | Apply only on non-porous surfaces. ---|--- — | Inform the authorisation holder if the treatment is ineffective. ---|--- — | Comply with the instructions for use. ---|--- — | Each product label shall give information on how the dilution should be made in order to guarantee the efficacy of the product. Since the concentration of L-(+)-lactic acid in products within this meta SPC can range from 15,66 % to 31,33 %, it is not possible to indicate all product dilution here. | Example for a product containing 15,66 % L-(+)-lactic acid | Dilution of the product | Contact time ---|---|--- Bacterial and yeasticidal activity | 0,299 % (20 ml product, add water up to 1 liter) | 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 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 27 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 8,23 % (w/w) 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 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 18 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 5,49 % (w/w) 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 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 13,5 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 4,11 % (w/w) 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 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 27 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 3,52 % (w/w) 1\. META SPC 2 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 2 identifier Identifier | Meta SPC: 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 PT04: Food and feed area ---|--- 2\. META SPC 2 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 2 Common name | IUPAC name | Function | CAS number | EC number | Content (%) ---|---|---|---|---|--- L-(+)-lactic acid | | active substance | 79-33-4 | 201-196-2 | 15,66 - 31,33 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 13,5 - 27 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 3,52 - 8,23 % (w/w) 2.2. Type(s) of formulation of the meta SPC 2 Formulation type(s) | SL – Soluble Concentrate ---|--- 3\. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 Hazard statements | H315: Causes skin irritation. H318: Causes serious eye damage. EUH208: Contains Eucalyptol, Carvone and Limonene. May produce an allergic reaction. EUH208: Contains Methyl salicylate and Eugenol (Pure fragrance). May produce an allergic reaction. EUH208: Contains Eucalyptol (Ecalyptus leaves fragrance). May produce an allergic reaction. ---|--- Precautionary statements | P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P264: Wash hands thoroughly after handling. P280: Wear protective gloves, protective clothing and eye protection. P302+P352: IF ON SKIN: Wash with plenty of water. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER or doctor. P321: Specific treatment (see supplemental first aid instruction on this label). P332+P313: If skin irritation occurs: Get medical advice. P362+P364: Take off contaminated clothing and wash it before reuse. 4\. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in domestic, institutional, medical and industrial areas) Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Scientific name: Viruses Common name: Enveloped viruses Development stage: no data Field(s) of use | indoor use outdoor use in domestic, institutional, 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: - 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 See general instructions for use 4.1.2. Use-specific risk mitigation measures See general instructions for use 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general instructions for use 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general instructions for use 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general instructions for use 4.2. Use description Table 2 Food and feed area disinfectants (disinfectant for all washable hard surfaces in domestic, institutional and food industry areas) Product type | PT04: Food and feed area ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Field(s) of use | indoor use outdoor use | — | in domestic, institutional and food industry areas (general disinfection) ---|--- Application method(s) | Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping Detailed description: | — | without mechanical action ---|--- Application rate(s) and frequency | Application rate: - 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 – 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) 4.2.1. Use-specific instructions See general instructions for use 4.2.2. Use-specific risk mitigation measures See general instructions for use 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general instructions for use 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general instructions for use 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general instructions for use 5\. GENERAL DIRECTIONS FOR USE OF THE META SPC 2 5.1. Instructions for use — | Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m2 or 20 ml/m2 or fully cover the object to be disinfected). ---|--- — | Apply only on non porous surfaces. ---|--- — | Inform the authorisation holder if the treatment is ineffective. ---|--- — | 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 | Dilution of the product | Contact time ---|---|--- Bacterial and yeasticidal activity | 0,299 % (20 ml product, add water up to 1 liter) | 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 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 27 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 8,23 % (w/w) 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 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 27 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 8,23 % (w/w) 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 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 27 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 8,23 % (w/w) 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 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 18 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 5,49 % (w/w) 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 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 18 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 5,49 % (w/w) 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 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 18 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 5,49 % (w/w) 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 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 13,5 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 4,11 % (w/w) 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 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 13,5 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 4,11 % (w/w) 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 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 13,5 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 4,11 % (w/w) 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 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 27 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 8,23 % (w/w) 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 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 13,5 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 4,11 % (w/w) 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 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 13,5 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 4,11 % (w/w) 1\. META SPC 3 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 3 identifier Identifier | Meta SPC: 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 PT04: Food and feed area ---|--- 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 (%) ---|---|---|---|---|--- L-(+)-lactic acid | | active substance | 79-33-4 | 201-196-2 | 7,83 - 31,33 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 6,75 - 27 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 1,32 - 3,52 % (w/w) 2.2. Type(s) of formulation of the meta SPC 3 Formulation type(s) | SL – Soluble Concentrate ---|--- 3\. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3 Hazard statements | H315: Causes skin irritation. H318: Causes serious eye damage. ---|--- Precautionary statements | P264: Wash hands thoroughly after handling. P280: Wear protective gloves, protective clothing and eye protection. P302+P352: IF ON SKIN: Wash with plenty of water. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER or doctor. P321: Specific treatment (see supplemental first aid instruction on this label). P332+P313: If skin irritation occurs: Get medical advice. P362+P364: Take off contaminated clothing and wash it before reuse. 4\. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in institutional, and industrial areas) Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Scientific name: Viruses Common name: Enveloped viruses Development stage: no data Field(s) of use | indoor use outdoor use | — | in institutional and industrial area ---|--- Application method(s) | Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping Detailed description: | — | without mechanical action ---|--- Application rate(s) and frequency | Application rate: - 0,299 % Number and timing of application: Mandatory target organisms: | — | Bacteria and yeasts: 0,299 % w/w L-(+)-lactic acid, 5 minutes, 20 °C ---|--- Other target organisms: — | Enveloped viruses: 0,299 % w/w L-(+)-lactic acid, 5 minutes, 20 °C ---|--- Minimum in use concentration of surfactants shall be 0,29 % for any future product included in this meta SPC. Category(ies) of users | professional Pack sizes and packaging material | Refill caps: 20 – 100 ml HDPE Bottles: 0,5 - 5 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 See general instructions for use 4.1.2. Use-specific risk mitigation measures See general instructions for use 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general instructions for use 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general instructions for use 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general instructions for use 4.2. Use description Table 2 Food and feed area disinfectants (disinfectant for all washable hard surfaces in institutional and industrial areas) Product type | PT04: Food and feed area ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Field(s) of use | indoor use outdoor use | — | in institutional and industrial area (general) ---|--- Application method(s) | Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping Detailed description: | — | without mechanical action ---|--- Application rate(s) and frequency | Application rate: - 0,299 % Number and timing of application: Mandatory target organisms: | — | Bacteria and yeast: 0,299 % w/w L-(+)-lactic acid, 5 minutes, 20 °C ---|--- Minimum in use concentration of surfactants shall be 0,29 % for any future product included in this meta SPC. Category(ies) of users | professional Pack sizes and packaging material | Refill caps: 20 – 100 ml HDPE Bottles: 0,5 - 5 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 See general instructions for use 4.2.2. Use-specific risk mitigation measures See general instructions for use 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general instructions for use 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general instructions for use 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general instructions for use 5\. GENERAL DIRECTIONS FOR USE OF THE META SPC 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 | Dilution of the product | Contact time ---|---|--- Bacterial and yeasticidal activity | 0,299 % (40 ml product, add water up to 1 liter) | 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 ---|---|--- Nu-LactiKleen | 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 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 13,5 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 1,76 % (w/w) 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | 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 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 27 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 3,52 % (w/w) 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 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 6,75 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 1,32 % (w/w) 1\. META SPC 4 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 4 identifier Identifier | Meta SPC: 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 PT04: Food and feed area ---|--- 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 (%) ---|---|---|---|---|--- L-(+)-lactic acid | | active substance | 79-33-4 | 201-196-2 | 7,83 - 31,33 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 6,75 - 27 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 1,32 - 5,28 % (w/w) 2.2. Type(s) of formulation of the meta SPC 4 Formulation type(s) | SL – Soluble Concentrate ---|--- 3\. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4 Hazard statements | H315: Causes skin irritation. H318: Causes serious eye damage. EUH208: Contains Eucalyptol, Carvone and Limonene (Cool Mint fragrance). May produce an allergic reaction. EUH208: Contains Methyl salicylate and Eugenol (Pure fragrance). May produce an allergic reaction. ---|--- Precautionary statements | P264: Wash hands thoroughly after handling. P280: Wear protective gloves, protective clothing and eye protection. P302+P352: IF ON SKIN: Wash with plenty of water. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER or doctor. P321: Specific treatment (see supplemental first aid instruction on this label). P332+P313: If skin irritation occurs: Get medical advice. P362+P364: Take off contaminated clothing and wash it before reuse. 4\. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in institutional and industrial areas) Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Scientific name: Viruses Common name: Enveloped viruses Development stage: no data Field(s) of use | indoor use outdoor use | — | In institutional and industrial area ---|--- Application method(s) | Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping Detailed description: | — | without mechanical action ---|--- Application rate(s) and frequency | Application rate: - 0,299 % Number and timing of application: Mandatory target organisms: | — | Bacteria and yeasts: 0,299 % w/w L-(+)-lactic acid, 5 minutes, 20 °C ---|--- Other target organisms: — | Enveloped viruses: 0,299 % w/w L-(+)-lactic acid, 5 minutes, 20 °C ---|--- Minimum in use concentration of surfactants shall be 0,29 % for any future product included in this meta SPC. Category(ies) of users | professional Pack sizes and packaging material | Refill caps: 20 – 100 ml HDPE Bottles: 0,5 - 5 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 See general instructions for use 4.1.2. Use-specific risk mitigation measures See general instructions for use 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general instructions for use 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general instructions for use 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general instructions for use 4.2. Use description Table 2 Food and feed area disinfectants (disinfectant for all washable hard surfaces in institutional and industrial areas) Product type | PT04: Food and feed area ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Field(s) of use | indoor use outdoor use | — | In institutional and industrial area ---|--- 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: - 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 – 100 ml 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 See general instructions for use 4.2.2. Use-specific risk mitigation measures See general instructions for use 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general instructions for use 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general instructions for use 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general instructions for use 5\. GENERAL DIRECTIONS FOR USE OF THE META SPC 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 | Dilution of the product | Contact time ---|---|--- Bacterial and yeasticidal activity | 0,299 % (40 ml product, add water up to 1 liter) | 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 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 27 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 5,28 % (w/w) 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 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 27 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 5,28 % (w/w) 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 DISINSEPT 4 | Market area: EU ASEPTO 4 | Market area: EU DESINSUR 4 | Market area: EU IGIENA 4 | 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 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 6,75 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 1,32 % (w/w) 1\. META SPC 5 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 5 identifier Identifier | Meta SPC: 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 PT04: Food and feed area PT03: Veterinary hygiene ---|--- 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 (%) ---|---|---|---|---|--- L-(+)-lactic acid | | active substance | 79-33-4 | 201-196-2 | 31,33 - 31,33 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 28,8 - 28,8 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 3,52 - 3,52 % (w/w) 2.2. Type(s) of formulation of the meta SPC 5 Formulation type(s) | SL – Soluble Concentrate ---|--- 3\. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5 Hazard statements | H315: Causes skin irritation. H318: Causes serious eye damage. ---|--- Precautionary statements | P264: Wash hands thoroughly after handling. P280: Wear protective gloves, protective clothing and eye protection. P302+P352: IF ON SKIN: Wash with plenty of water. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER or doctor. P321: Specific treatment (see supplemental first aid instruction on this label). P332+P313: If skin irritation occurs: Get medical advice. P362+P364: Take off contaminated clothing and wash it before reuse. 4\. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in institutional, medical, and industrial areas) Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Scientific name: Viruses Common name: Enveloped viruses Development stage: no data Field(s) of use | indoor use outdoor use | — | In institutional, 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: - 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 See general instructions for use 4.1.2. Use-specific risk mitigation measures See general instructions for use 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general instructions for use 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general instructions for use 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general instructions for use 4.2. Use description Table 2 Food and feed area disinfectants (disinfectant for all washable hard surfaces in institutional and industrial (food industry) areas) Product type | PT04: Food and feed area ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Field(s) of use | indoor use outdoor use | — | In 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: - 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 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 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 ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: other: bacteria Common name: Bacteria Development stage: no data Scientific name: other: yeast Common name: Yeast Development stage: no data Field(s) of use | indoor use outdoor use 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: - 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 \- 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 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 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 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 Evo 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 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 28,8 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 3,52 % (w/w) 1\. META SPC 6 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 6 identifier Identifier | Meta SPC: 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 ---|--- 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 (%) ---|---|---|---|---|--- L-(+)-lactic acid | | active substance | 79-33-4 | 201-196-2 | 31,33 - 31,33 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 28,8 - 28,8 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 5,28 - 5,28 % (w/w) 2.2. Type(s) of formulation of the meta SPC 6 Formulation type(s) | SL – Soluble Concentrate ---|--- 3\. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6 Hazard statements | H315: Causes skin irritation. H318: Causes serious eye damage. EUH208: Contains Eucalyptol and Carvone. May produce an allergic reaction. ---|--- Precautionary statements | P264: Wash hands thoroughly after handling. P280: Wear protective gloves, protective clothing and eye protection. P302+P352: IF ON SKIN: Wash with plenty of water. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER or doctor. P321: Specific treatment (see supplemental first aid instruction on this label). P332+P313: If skin irritation occurs: Get medical advice. P362+P364: Take off contaminated clothing and wash it before reuse. 4\. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in medical area) Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Scientific name: Viruses Common name: Enveloped viruses Development stage: no data Field(s) of use | indoor use outdoor use | — | in 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: - 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 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 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 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 28,8 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 5,28 % (w/w) 1\. META SPC 7 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 7 identifier Identifier | Meta SPC: 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 PT04: Food and feed area PT03: Veterinary hygiene ---|--- 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 (%) ---|---|---|---|---|--- L-(+)-lactic acid | | active substance | 79-33-4 | 201-196-2 | 31,33 - 31,33 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 24,93 - 24,93 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 3,52 - 3,52 % (w/w) 2.2. Type(s) of formulation of the meta SPC 7 Formulation type(s) | SL – Soluble Concentrate ---|--- 3\. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7 Hazard statements | H315: Causes skin irritation. H318: Causes serious eye damage. ---|--- Precautionary statements | P264: Wash hands thoroughly after handling. P280: Wear protective gloves, protective clothing and eye protection. P302+P352: IF ON SKIN: Wash with plenty of water. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER or doctor. P321: Specific treatment (see supplemental first aid instruction on this label). P332+P313: If skin irritation occurs: Get medical advice. P362+P364: Take off contaminated clothing and wash it before reuse. 4\. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in domestic, institutional and industrial areas) Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Scientific name: Viruses Common name: Enveloped viruses Development stage: no data Field(s) of use | indoor use outdoor use | — | In domestic, institutional and industrial area ---|--- Application method(s) | Method: Wiping, moping or brush, spraying, soaking or dipping (immersion) Detailed description: | — | without mechanical action ---|--- Application rate(s) and frequency | Application rate: - 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, 2,5 liters Low density polyethylene (LDPE) 4.1.1. Use-specific instructions 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 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 ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Scientific name: Virus Common name: Enveloped viruses only Development stage: no data Field(s) of use | indoor use outdoor use | — | 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: - 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, 2,5 liters LDPE 4.2.1. Use-specific instructions — | 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 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 ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeast Common name: Yeasts Development stage: no data Field(s) of use | indoor use outdoor use - 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: - 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, 2,5 liters LDPE 4.3.1. Use-specific instructions — | 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 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 % (w/w) Sodium octyl ether carboxylate | | Non-Active substance | 53563-70-5 | | 24,93 % (w/w) D-glucopyranose, oligomeric, C10-16 (even numbered)-alkyl glycosides | | Non-Active substance | 110615-47-9 | | 3,52 % (w/w) 1\. META SPC 8 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 8 identifier Identifier | Meta SPC: 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 PT04: Food and feed area ---|--- 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 (%) ---|---|---|---|---|--- L-(+)-lactic acid | | active substance | 79-33-4 | 201-196-2 | 0,627 - 1,566 % (w/w) 2.2. Type(s) of formulation of the meta SPC 8 Formulation type(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 4.1. Use description Table 1 Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in domestic, institutional and industrial areas) Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Scientific name: Viruses Common name: Enveloped viruses Development stage: no data Field(s) of use | indoor use outdoor use | — | In domestic, institutional and industrial 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: - 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 See general instructions for use 4.1.2. Use-specific risk mitigation measures See general instructions for use 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general instructions for use 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general instructions for use 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general instructions for use 4.2. Use description Table 2 Food and feed area disinfectants (disinfectant for all washable hard surfaces in domestic, institutional and industrial areas) Product type | PT04: Food and feed area ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Field(s) of use | indoor use outdoor use | — | In 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: - 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 See general instructions for use 4.2.2. Use-specific risk mitigation measures See general instructions for use 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general instructions for use 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general instructions for use 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general instructions for use 5\. GENERAL DIRECTIONS FOR USE OF THE META SPC 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 % (w/w) 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 % (w/w) 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 % (w/w) 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 % (w/w) 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 % (w/w) 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 % (w/w) 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 % (w/w) 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 % (w/w) 1\. META SPC 9 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 9 identifier Identifier | Meta SPC: 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 PT04: Food and feed area ---|--- 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 (%) ---|---|---|---|---|--- L-(+)-lactic acid | | active substance | 79-33-4 | 201-196-2 | 0,627 - 0,627 % (w/w) 2.2. Type(s) of formulation of the meta SPC 9 Formulation type(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 4.1. Use description Table 1 Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in domestic, institutional and industrial areas) Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Scientific name: Viruses Common name: Enveloped viruses Development stage: no data Field(s) of use | indoor use outdoor use | — | In domestic, institutional and industrial area. ---|--- Application method(s) | Method: Spraying, spreading, wiping, foam application, brush treatment, dip treatment, immersion, mopping Detailed description: | — | without mechanical action ---|--- Application rate(s) and frequency | Application rate: - - 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 See general instructions for use 4.1.2. Use-specific risk mitigation measures See general instructions for use 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general instructions for use 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general instructions for use 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general instructions for use 4.2. Use description Table 2 Food and feed area disinfectants (disinfectant for all washable hard surfaces in domestic, institutional and industrial areas) Product type | PT04: Food and feed area ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Field(s) of use | indoor use outdoor use | — | In 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: - - 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 See general instructions for use 4.2.2. Use-specific risk mitigation measures See general instructions for use 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general instructions for use 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general instructions for use 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general instructions for use 5\. GENERAL DIRECTIONS FOR USE OF THE META SPC 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 % (w/w) 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 % (w/w) 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 % (w/w) * * * ELI: http://data.europa.eu/eli/reg_impl/2025/285/oj ISSN 1977-0677 (electronic edition) * * *