HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

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1 Toelatingsnummer N HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN 1 TOELATING Gelet op de aanvraag d.d. 9 september 2012 ( TB) van REYMERINK B.V. Stichtse Kade 47 A 1244 HW ANKEVEEN tot verkrijging van een toelating als bedoeld in artikel 49, eerste lid, Wet gewasbeschermingsmiddelen en biociden voor de biocide, op basis van de werkzame stof(fen) ethanol, Alcohol dentior 70% gelet op artikel 121, eerste lid, jo. artikel 44, eerste lid, Wet gewasbeschermingsmiddelen en biociden, BESLUIT HET COLLEGE als volgt: 1.1 Toelating 1. Het middel Alcohol dentior 70% is toegelaten voor de in bijlage I genoemde toepassingen onder nummer N met ingang van datum dezes. Voor de gronden van dit besluit wordt verwezen naar bijlage II bij dit besluit. 2. De toelating geldt tot 1 mei Samenstelling, vorm en verpakking De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als waarvoor de toelating is verleend. 1.3 Gebruik Het middel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage I onder A bij dit besluit is voorgeschreven. Alcohol dentior 70% N 1

2 1.4 Classificatie en etikettering Gelet op artikel 50, eerste lid, sub d, Wet gewasbeschermingsmiddelen en biociden, 1. De aanduidingen, welke ingevolge artikelen en van de Wet milieubeheer en artikelen 14, 15a, 15b, 15c en 15d van de Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten op de verpakking moeten worden vermeld, worden hierbij vastgesteld als volgt: aard van het preparaat: Andere vloeistoffen voor directe toepassing werkzame stof: gehalte: ethanol 70 % letterlijk en zonder enige aanvulling: andere zeer giftige, giftige, bijtende of schadelijke stof(fen): - gevaarsymbool: F aanduiding: Licht ontvlambaar Waarschuwingszinnen: R11 -Licht ontvlambaar. Veiligheidsaanbevelingen: S16 S35 -Verwijderd houden van ontstekingsbronnen. Niet roken. -Deze stof en de verpakking op veilige wijze afvoeren. Specifieke vermeldingen: - Alcohol dentior 70% N 2

3 2. Behalve de onder 1. bedoelde en de overige bij de Wet Milieugevaarlijke Stoffen en Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten voorgeschreven aanduidingen en vermeldingen moeten op de verpakking voorkomen: a. letterlijk en zonder enige aanvulling: het wettelijk gebruiksvoorschrift De tekst van het wettelijk gebruiksvoorschrift is opgenomen in Bijlage I, onder A. b. hetzij letterlijk, hetzij naar zakelijke inhoud: de gebruiksaanwijzing De tekst van de gebruiksaanwijzing is opgenomen in Bijlage I, onder B. De tekst mag worden aangevuld met technische aanwijzingen voor een goede bestrijding mits deze niet met die tekst in strijd zijn. c. De vervaldatum (2 jaar na de productiedatum) dient op het etiket te worden vermeld. 2 DETAILS VAN DE AANVRAAG Het betreft een aanvraag tot verkrijging van een toelating van het middel Alcohol dentior 70% (14081 N), een middel op basis van de werkzame stof(fen) ethanol. De aanvrager heeft een adequaat aanvraagdossier ingediend. Het Ctgb is in de beoordeling uitgegaan van de wetenschappelijk gezien beste eindpunten. Bij gebruik volgens het Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is het middel Alcohol dentior 70% op basis van de werkzame stof(fen) ethanol voldoende werkzaam en heeft het geen schadelijke uitwerking op de gezondheid van de mens en het milieu (artikel 49, Wet gewasbeschermingsmiddelen en biociden). Alcohol dentior 70% N 3

4 Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 119, eerste lid, Wet gewasbeschermingsmiddelen en biociden en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College voor de toelating van gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 217, 6700 AE WAGENINGEN. Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld. Wageningen, 10 mei 2013 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN, ir. J.F. de Leeuw voorzitter Alcohol dentior 70% N 4

5 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE I bij het besluit d.d. 10 mei 2013 tot toelating van het middel Alcohol dentior 70%, toelatingnummer N A. WETTELIJK GEBRUIKSVOORSCHRIFT Toegestaan is uitsluitend het gebruik als middel ter bestrijding van bacteriën (exclusief mycobacteriën en bacteriesporen), gisten en schimmels: - op harde oppervlakken in de gezondheidszorg, in pedicurepraktijken, in tattoopraktijken, in schoonheidssalons en in nagelstudio s, met uitzondering van oppervlakken die in contact kunnen komen met eet- en drinkwaren en grondstoffen hiervoor. De dosering en inwerktijd zoals aangegeven in de gebruiksaanwijzing moeten worden aangehouden. Het middel is uitsluitend bestemd voor professioneel gebruik. B. GEBRUIKSAANWIJZING Het middel is een gebruiksklare vloeistof die onverdund gebruikt moet worden. Desinfectie van harde oppervlakken Het middel alleen toepassen op kleine oppervlakken (maximaal 0,5 m 2 ). Te behandelen oppervlakken eerst reinigen. Een daarbij gebruikt reinigingsmiddel afspoelen met schoon water. Overtollig water verwijderen. Breng het middel met een doekje of prop watten aan op het te behandelen oppervlak (verbruik ml per 0,5 m 2 ) en laat minimaal 5 minuten inwerken. Bij het desinfecteren zo veel vloeistof gebruiken dat de oppervlakken gedurende de gehele inwerktijd nat blijven. Hierna met behulp van een celstof doekje het oppervlak droogwrijven. Minimale inwerktijd: 5 minuten Alcohol dentior 70% N 5

6 BIJLAGE II bij het besluit d.d. 10 mei 2013 tot toelating van het middel Alcohol dentior 70%, toelatingnummer N RISKMANAGEMENT Contents Page 1. Introduction Identity Physical and chemical properties Efficacy Human toxicology Environment Conclusion Classification and labelling pag. 1 van 10

7 1. Introduction This assessment concerns the biocidal product Alcohol dentior 70%, based on the active substance ethanol. This application has been submitted as a comparative application of Alcohol podior 70% ( TBO; 14061N) which has been submitted under the differentiated enforcement policy of biocides. The assessment includes the following product: Product Applicant PT Application number Alcohol dentior 70% Reymerink BV PT01 PT TB The active substance ethanol has been notified for product types 1, 2, and 4. Ethanol has not been placed on annex 1 of Directive 98/8/EC yet. 2. Identity Identity of the active substance ethanol General Active substance (ISO Common Name) Ethanol (non-iso) Name in Dutch Ethanol Identity Chemical name (IUPAC) Chemical name (CA) Ethanol Ethanol CAS No EC No Other substance No. - Molecular formula C 2 H 6 O Molecular mass Structural formula CH 3 -CH 2 -OH The active substance is not yet included in annex I of Directive 98/8/EC. A CAR of the active substance is not yet available. Physical and chemical properties of the active substance ethanol relevant to the risk assessment Appearance Colourless clear liquid Surface tension mn/m Vapour pressure (Pa) 5726 Pa at 19.6 C Henry s law constant (Pa m 3 mol -1 ) Solubility in water (g/l or mg/l) Partition coefficient (log P OW ) 0.31 Dissociation constant UV/VIS absorption (max.) (if absorption > 5903 Pa at 25 C 0.57 Pa x m 3 /mol 1000 g/l at 25 C (ethanol is indefinitely miscible with water No dissociation within an environmentally relevant ph range. No UV maximum >290 nm pag. 2 van 10

8 290 nm state ε at wavelength) Hazard identification for classification and labelling Flammability Flashpoint: Highly flammable Flammability: N/A Auto-flammability: 363 C Oxidising properties Not oxidising Explosive properties Not explosive Analytical methods for the technical active substance Adequate analytical methodology is available to determine the content of active substance and significant and/or relevant impurities in the technical active substance. Conclusions active substance The identity, physical and chemical properties and analytical methods of the active substance are sufficiently described. 3. Physical and chemical properties 3.1 Identity of the biocidal product Name Alcohol dentior 70% Content active substance Ethanol: 70%v/v Formulation type AL Packaging 100mL glass 1L, 5L HDPE 3.2 Physical and chemical properties of the biocidal product Appearance Colourless, transparent liquid Explosive properties Not explosive Oxidising properties Not oxidising Auto-flammability Not self-igniting Flashpoint or Flammability 21 o C ph 1% solution ~ 7 Relative density 0.87 g/ml Storage stability/ Shelf life 2 years Physical and chemical compatibility Not applicable Viscosity Not applicable Surface tension Not applicable 3.3 Analytical methods for detection and identification Analytical methods for analysis of the biocidal product Preparation (principle of method) Densitometry, GC-FID Residue analytical methods Adequate residue analytical methodology is available to monitor residues of the biocide taking into account all possible exposure scenarios and the toxicity of the active substance. 3.4 Conclusions biocidal product The identity, the physical and chemical properties and the analytical methods of the biocidal product are sufficiently described. pag. 3 van 10

9 4. Efficacy 4.1 Function Alcohol dentior 70% is a disinfectant (PT01 and PT02) based on ethanol 70% v/v. 4.2 Field of use envisaged The proposed field of use of Alcohol dentior 70% is the control of bacteria (excluding mycobacteria and bacterial spores), yeasts and fungi on: human skin; surfaces; instruments in the health care, pedicure practices, tattoo-shops, beauty saloons and nailstudios. These uses are included in PT01 and PT02. The product is intended for professional use only. 4.3 Effects on target organisms and efficacy On request of the applicant for Alcohol dentior 70% a comparative evaluation is made with Alcohol podior 70% ( TBO). The proposed field of use, the concentration of the active substance ethanol and the use concentrations are identical for both products. The only difference between Alcohol dentior 70% and Alcohol podior 70% is how the active substance ethanol is denaturated; Alcohol dentior 70% is denaturated with IPA and Alcohol podior 70% is denaturated with bitrex. The applicant has provided a justification stating that efficacy testing was performed with Alcohol podior 70% which contains ethanol, bitrex and water. Since no disinfective properties were ever demonstrated for bitrex, it is concluded that the disinfective properties of Alcohol Podior 70% can be solely attributed to the ethanol and not to the other constituents of the product. In the product Alcohol dentior 70%, bitrex is replaced by 2-propanol. Since 2-Propanol is known to have disinfective properties at 30% v/v and above and the 2-propanol contents of Alcohol dentior 70% is less than the concentration at which the substance obtains disinfective properties, it is concluded that it is likely that Alcohol dentior 70% is at least as effective as the tested product Alcohol podior 70%. Considering that the authorisation is done under article 121 of the WGB this justification is acceptable. The available information was sufficient to evaluate the efficacy, considering that the authorisation is done under article 121 of the WGB. Several references / studies testing efficacy were provided, some were considered to be suitable and acceptable. PT01 For the intended use of skin-/hand disinfection several references/tests have been provided according to acknowledged standards. Sufficient efficacy was demonstrated in quantitative suspension tests (phase 2, step1) with the required standard organisms for bacteria and yeasts at low level soiling conditions of 0.3 g/l bovine albumin and a contact time of 30 seconds. In addition a handrub test (phase 2, step 2) according to EN 1500 is provided with the required standard bacteria organism Escherichia coli. The test was carried out with a contact time that exceeded 30 seconds. This is not acceptable as the maximum acceptable contact time for hand disinfection is 30 seconds. Therefore, not sufficient bactericidal efficacy in the handrub test has been demonstrated. As this is a mandatory requirement, PT01 skin-/hand disinfection will be removed from the claim. PT02 Bacteria and yeasts Tests following EN standards have been done with the required standard organisms for the intended use and the required test temperature. The tests demonstrated efficacy pag. 4 van 10

10 against bacteria and yeasts at the use concentration (100%, undiluted), a contact time of 30 seconds, and low level soiling conditions of 0.3 g/l bovine albumin. Fungi Fungicidal efficacy was demonstrated in quantitative suspension tests according to EN with the required standard organism at the use concentration (100%, undiluted), low level soiling conditions of 0.3 g/l bovine albumin and a contact time of 30 seconds. Viruses No acceptable studies / references are provided with the required virus standard organisms. Therefore, the use for instrument disinfection has to be removed from the claim, as virucidal efficacy is mandatory for this intended use Evaluation of the WG/GA The applicant has provided a Dutch WG/GA. This has been adapted to our standards. Mycobacteria and bacterial spores will be excluded from the bacterial claim, because these are not claimed organisms and no data on mycobactericidal or sporicidal efficacy have been provided. The use on surfaces that come into contact with food and drink or raw materials thereof will be excluded, as this product is claimed for PT02 only. The use on human skin (i.e. hand disinfection) has been removed from the claim as not sufficient data on bactericidal efficacy are provided with the required contact time of maximum 30 seconds; The use for instrument disinfection has been removed from the claim as virucidal efficacy is mandatory for this intended use and not sufficient data are provided to substantiate virucidal efficacy Mode of action The following information is provided: Denaturation of proteins and disruption of cytoplasmic membrane by dissolving lipid. 4.4 Resistance The following information is provided: Resistances are not reported. As ethanol is not specific for just one cellular target but interferes with membrane integrity and denatures proteins, the development of true resistances is not to be expected. Considering that the authorisation is done under article 121 of the WGB this is acceptable. 4.5 Conclusions Based on the data submitted and considering that the evaluation is done under article 121 of the WGB, it can be concluded that Alcohol dentior 70% when used in accordance with the proposed label (WG/GA) is effective in controlling bacteria (excluding mycobacteria and bacterial spores), yeasts and fungi on: hard surfaces in the health care, pedicure practices, tattoo-shops, beauty saloons and nailstudios, excluding surfaces that come into contact with food and drink and the raw materials thereof. The use for hand disinfection has been removed from the claim as not sufficient bactericidal efficacy was demonstrated in a handrub test, and disinfection of instruments has been removed from the claim as not sufficient virucidal efficacy has been demonstrated. 5. Human toxicology Product application An application has been submitted for the authorisation of the biocidal product Alcohol dentior 70%, for the disinfection of hands and other skin surfaces (PT1), and for the control of bacteria, yeasts and fungi in private and public area (PT2) containing 70% v/v ethanol. pag. 5 van 10

11 Toxicity of the formulated product No studies on acute toxicity, irritation or sensitisation with the formulated product have been submitted. The classification and labelling of the formulation has been prepared based on the calculation method described in Annex II of Directive 1999/45/EC. Risk characterisation for human health Alcohol dentior 70% is intended to be used for the disinfection of hands and other skin surfaces and for the disinfection of hard surfaces and the disinfection of instruments by professionals. In this risk assessment Alcohol dentior 70% is compared to the reference product Alcohol podior 70% (14061N). The concentration ethanol, the intended uses and use concentrations are identical for both products. The only difference between Alcohol dentior 70% and Alcohol podior 70% is how the active substance ethanol is denaturated, which has no impact on the risk assessment for human health. Based on the risk assessment for Alcohol podior 70% (14061N), no adverse health effects are expected for the unprotected professional user after dermal and respiratory exposure to ethanol as a result of the application of Alcohol podior 70%. Considering that the concentration ethanol, the intended uses uses and use concentrations are identical for both products, exposure to ethanol will be the same for the professional user and therefore the conclusions for Alcohol podior 70% can also be applied to the risk assessment for the professional user of Alcohol dentior 70%. Based on the risk assessment for Alcohol podior 70%, no adverse health effects are expected for the general public by indirect exposure. Considering that the intended uses and use concentrations are identical for Alcohol podior 70% and Alcohol dentior 70%, this conclusion can also be applied to the risk assessment for Alcohol dentior 70%. Conclusions for the aspect human health Based on the comparable risk assessment, it was concluded that no adverse health effects are expected for the unprotected professional user, including the general public, after dermal and respiratory exposure to ethanol as a result of the application of Alcohol dentior 70%, when used in accordance to the WG/GA. Classification and labelling of the formulation concerning health Proposal for the classification and labelling of the formulation concerning health Based on the profile of the substance, the provided toxicology of the preparation, the characteristics of the co-formulants, the method of application and the risk assessment for the operator, as mentioned above, the following labelling of the preparation is proposed: 6. Environment 6.1 Introduction Authorisation is requested for the biocidal product Alcohol dentior 70%. The product concern disinfectant for closed skin surfaces, hard surfaces and equipment by dipping (PT1: human hygiene biocidal products, PT2: private area and public health are disinfectants and other biocidal products). The risk assessment is done in accordance with Chapter 10 of the RGB [transition period for guideline 98/8/EC] for products based on active substances which have not been placed on Annex I of Directive 98/8/EC.The a.s. in the product Alcohol dentior 70% is ethanol. Ethanol is considered a High Production Volume Chemical in the definition of the Ctgb. The notifier indicated that it is possible to make a comparative assessment to assess the environmental fate and the ecotoxicological risk of the products, comparing the use of Alcohol dentior 70% with reference product Alcohol podior 70% ( TBO).The pag. 6 van 10

12 products are used as a disinfectant for closed skin surfaces, hard surfaces and equipment by dipping (PT1: human hygiene biocidal products, PT2: private area and public health are disinfectants and other biocidal products). The comparative assessment procedure prescribes that a simplified regime is accepted for the environmental aspect if the requested authorisation of Alcohol dentior 70% has a similar risk. It must be determined whether no additional risk for the environment is expected for Alcohol dentior 70% in comparison with the already authorised product Alcohol podior 70%. As part of the simplified procedure comparativeness of the referred and the requested application are tested for the following aspects: 1. The type and scale of the use; 2. Use concentrations; 3. Emission to air, STP, surface water and soil for the application phase, the inservice phase and the waste phase of the product; 4. Risk assessment (section 7.3); 5 Risk mitigating methods (section 7.4). 6.2 Evaluation The intended use of Alcohol dentior 70% and the reference product Alcohol podior 70% is described in table E.1. The evaluation is based on a comparison of the practical use and emission routes of the requested applications to their reference products. Table E.1. Overview of intended use Requested applications Reference products Alcohol dentior 70% Alcohol podior 70% Product description Disinfectant for closed skin surfaces, hard Idem surfaces and equipment by dipping Organisms to be Bacteria (including spores), yeasts and fungi Idem controlled Active substance(s) Ethanol Idem (a.s) Denaturant 2-propanol bitrex (denatonium benzoate) concentration a.s. in 70% Idem product Dosage Skin: ml/m 2 Idem Hard surfaces: ml/m 2 Equipment: sufficient product to immerse equipment Indoor/outdoor Indoor Idem Objects to be protected Skin of patients/customers during treatment Hard surfaces Idem Professional / non-professional Equipment Professional pag. 7 van 10 Idem 1. The type and scale of the use Comparison of the type and scale of use is performed qualitatively only. From the intended use can be concluded that the intended use of Alcohol dentior 70% and the reference product Alcohol podior 70% is identical, indicating a similar risk. 2. Use concentrations The use concentration of the active substance in the reference products is equal to the concentration of the active substance in Alcohol dentior 70%. Considering this, the environmental risk of Alcohol podior 70% and Alcohol dentior 70% is expected to be similar.

13 3. Emission to air, STP, surface water and soil for the application phase, the inservice phase and the waste phase of the product Releases into the environment can take place at any stage of the life cycle of a product. It is expected that ethanol applied on closed skin or hard surfaces evaporates completely and these surface are thus not rinsed with water and subsequently emitted to the sewer. Emission to air is possible as ethanol is very volatile (vapour pressure 5726 Pa at 19.6 C) and this route is assessed in a qualitative way for the reference product Alcohol podior 70%. Direct emission to soil is considered negligible..in the Netherlands, surplus sludge of public STPs is not applied for fertilization and soil improvement of agricultural soil. Exposure of soil and groundwater via STP surplus sludge application is not considered relevant. The content of the tub with undiluted product in which materials or equipment are dipped for cleaning needs to be removed as chemical waste. Compared to emissions from the application phase, service life and waste phase of the product, emissions from a.i. production and product formulation are considered less relevant. The foreseeable routes of entry into the environment during the application phase, service life and waste phase are summarised in Table E.2. Table E.2 Foreseeable routes of entry into the environment on the basis of the use envisaged Main scenario Environmental compartments and groups of organisms exposed STP Freshwater 1 Saltwater 1 Soil 2, Air Birds and mammals 1. disinfection of closed skin surfaces and hard surfaces 2. disinfection of equipment by dipping (Q) (Q) - ++ Compartment directly exposed, + Compartment indirectly exposed, (+) Compartment potentially exposed (but unlikely significant concern due to a.s. hazard data and scale of exposure), - Compartment not exposed, (Q) Qualitative assessment, depending on application, 1 Including sediment, 2 Including groundwater, and soil invertebrates and arthropods, 3 In the Netherlands, surplus sludge of public STPs is not applied for fertilization and soil improvement of agricultural soil. Therefore, exposure of soil and groundwater via STP surplus sludge application is not part of the risk assessment. 6.3 Risk characterisation for the environment The current risk assessment for the product Alcohol dentior 70% ( TB) is based on the risk assessment of products performed within the differentiated enforcement policy. In the differentiated enforcement policy the PT4 application of ethanol for cleaning of pipelines in the food industry (CIP) is considered worst-case for emissions to the STP and surface water. Although Alcohol dentior 70% and the reference products Alcohol podior 70% ( TBO) are PT1 and PT2 applications with no or less emission to the environment compared to this PT4 application, the PT4 application is still used as basis for the comparative risk assessment of Alcohol dentior 70%. In the risk assessment of Alcohol Podior 70%, it was concluded that application of all ethanol products in the differentiated enforcement policy (including the reference product), when used in accordance with the proposed labels (WG/GA), comply with the environmental standards and will not cause unacceptable effects on the environment. Since the release pathways are the same (indoor use) for the requested application and the reference product, it can be concluded that Alcohol dentior 70% when used in 3 pag. 8 van 10

14 accordance with the proposed label (WG/GA), complies with the environmental standards and will not cause unacceptable effects on the environment. In Table E.3 an overview is presented of the qualitative risk assessment on basis of a comparison of the authorised applications and the potential risk of the requested application. For each aspect the risk is assessed. Table E.3 overview of risks per environmental aspect Environmental Item Similar or Reasoning aspect lower risk? Aquatic organisms Direct / indirect exposure Yes No direct emission to surface water Indirect emission to surface water is similar Dosage Yes Frequency Yes Emission to STP Dosage (kg a.s. / STP) Yes Persistence NA No emission to soil Soil organisms Direct / indirect NA No emission to soil (soil micro-organisms exposure earthworms, plants) Dosage NA Frequency NA Non target arthropods Direct / indirect NA No emission to soil and bees exposure Leaching to Dosage NA No emission to soil groundwater Frequency NA Fraction applied NA to soil Birds, mammals Direct / indirect NA exposure Direct emission to the STP Indirect emission is similar Birds and mammals are not exposed directly or indirectly Dosage NA Frequency NA Air Emission Yes Direct emission to air N.A. = not applicable 6.4 Evaluation of precautionary and risk mitigation measures in the WGGA The applicant did not include any risk mitigation measures for the environment in the draft WG/GA and PGB-PUB. Additional risk mitigation measures are not required for the proposed use as disinfectant for hands and other skin surfaces considering that risks to the environment are acceptable for these intended uses. The proposed use of Alcohol dentior 70% as disinfectant for materials or equipment by dipping is acceptable for the environment but only in case a restriction is included in the WG/GA stating that left over product needs to be removed as chemical waste: [resten die het middel bevatten, moeten worden verwijderd als chemisch afval] 6.5 Conclusion Based on a comparable risk assessment, it can be concluded that the product Alcohol dentior 70%, when used in accordance with the proposed Legal Instructions for Use (WG/GA), comply with the environmental standards and will not cause unacceptable effects on the environment. pag. 9 van 10

15 7. Conclusion The use on human skin (i.e. hand disinfection) has been removed from the claim as not sufficient data on bactericidal efficacy are provided with the required contact time of maximum 30 seconds; The use for instrument disinfection has been removed from the claim as virucidal efficacy is mandatory for this use and not sufficient data are provided to substantiate virucidal efficacy. As a result of the assessment safe use and efficacy is demonstrated for the use as disinfectants to control bacteria (excluding mycobacteria and bacterial spores), yeasts and fungi on hard surfaces in the health care, pedicure practices, tattoo-shops, beauty saloons and nail studios, excluding surfaces that come into contact with food and drink and the raw materials thereof, when used as described on the Legal Conditions for Use and the Directions for Use (WG/GA). The authorised uses as mentioned on the WGGA fall within product type Classification and labelling Proposed for classification and labelling for the formulation Based on 1999/45/EC: Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances) *: - Symbol: F Indication of danger: R phrases R11 Highly flammable Highly flammable S phrases S16 Keep away from sources of ignition - No smoking. Special provisions: DPD-phrases S35 Child-resistant fastening obligatory? - - Tactile warning of danger obligatory? * according to 1999/45/EC, article 10, point 2.3 This material and its container must be disposed of in a safe way. Not applicable Not applicable Remarks: S35 is required since the formulation is to be used professionally. S2 is only needed for nonprofessional use. S7 is only required for solid materials or products, and is therefore not included in the Ctgb proposal The active substance does not need to be included in this table, as it is mandatory to show the identity of every active substance and its concentration on the label (according to BPD 98/8/EC, art 20, 3a). pag. 10 van 10