HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

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1 14304 N HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN 1 BESLUIT Op 18 augustus 2017 is van Ecolab B.V. Iepenhoeve 7a 3438 MR NIEUWEGEIN een uitbreiding toelating biocide ontvangen voor het middel Asepto FL-D op basis van de werkzame stof actief chloor gevormd uit natriumhypochloriet. HET COLLEGE BESLUIT tot uitbreiding van bovenstaand middel. Alle bijlagen vormen een onlosmakelijk onderdeel van dit besluit. Voor nadere gegevens over deze toelating wordt verwezen naar de bijlagen: - Bijlage I voor details van de aanvraag en toelating; - Bijlage II voor de etikettering; - Bijlage III voor wettelijk gebruik; - Bijlage IV voor de onderbouwing. 1.1 Samenstelling, vorm en verpakking De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als waarvoor de toelating is verleend. 1.2 Gebruik Het middel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage III bij dit besluit is voorgeschreven. 1.3 Classificatie en etikettering Mede gelet op de onder wettelijke grondslag vermelde wetsartikelen, dienen alle volgende aanduidingen en vermeldingen op de verpakking te worden vermeld: De aanduidingen, letterlijk en zonder enige aanvulling, zoals vermeld onder verpakkingsinformatie in bijlage I. Asepto FL-D, UB 1

2 14304 N Het toelatingsnummer. De etikettering zoals opgenomen in bijlage II bij dit besluit, deze moet volgens de voorschriften op de verpakking worden vermeld. Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in bijlage III, onder A. De gebruiksaanwijzing, hetzij letterlijk, hetzij naar zakelijke inhoud, zoals opgenomen in bijlage III, onder B. De tekst mag worden aangevuld met technische aanwijzingen voor een goede bestrijding mits deze niet met die tekst in strijd zijn. Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen. 2 WETTELIJKE GRONDSLAG Besluit art 93 van Verordening EU/528/2012 jo art 130a, vierde lid van de Wet gewasbeschermingsmiddelen en biociden (Wgb) jo art 4, tweede lid Wgb (oud) jo art 121 Wgb (oud) jo art 44 Wgb (oud) Classificatie en etikettering artikel 89, tweede lid, Verordening 528/2012, jo. artikel 130a, vierde lid, WBB, jo. artikel 50 WGB oud Gebruikt toetsingskader RGB (Hoofdstuk 10) 3 BEOORDELINGEN 3.1 Fysische en chemische eigenschappen De aard en de hoeveelheid van de werkzame stoffen en de in humaan-toxicologisch en ecotoxicologisch opzicht belangrijke onzuiverheden in de werkzame stof en de hulpstoffen zijn bepaald. De identiteit van het middel is vastgesteld. De fysische en chemische eigenschappen van het middel zijn vastgesteld en voor juist gebruik en adequate opslag van het middel aanvaardbaar geacht. 3.2 Analysemethoden De geleverde analysemethoden voldoen aan de vereisten om de residuen te kunnen bepalen die vanuit humaan-toxicologisch en ecotoxicologisch oogpunt van belang zijn, volgend uit geoorloofd gebruik. 3.3 Risico voor de mens Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor de mens verwacht. 3.4 Risico voor het milieu Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor het milieu verwacht. 3.5 Werkzaamheid Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften verwacht dat het werkzaam is. 4 Wijziging van de toelating De toelating wordt op de volgende punten gewijzigd: - de toepassing door middel van dompelen van (onderdelen van) melkwinningsappartuur vervalt; - de gebruiksinstructie wijzigt voor gebruik in melkwinningsapparatuur van 1% met een inwerktijd van 15 minuten naar 0,7% met een inwerktijd van uten; - de houdbaarheid wijzigt van 9 naar 11 maanden. Asepto FL-D, UB 2

3 14304 N Bezwaarmogelijkheid Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 4 van Bijlage 2 bij de Algemene wet bestuursrecht 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 8030, 6710 AA, EDE. Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld. Ede, 2 november 2018 Het College voor de toelating van gewasbeschermingsmiddelen en biociden, voor deze: de voorzitter, Ir. J.F. de Leeuw Asepto FL-D, UB 3

4 14304 N HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING 1 Aanvraaginformatie Aanvraagnummer: UB Type aanvraag: uitbreiding toelating biocide Middelnaam: Asepto FL-D Verzenddatum aanvraag: 16 augustus 2017 Formele registratiedatum: * 9 november 2017 Datum in behandeling name: 29 juni 2018 * Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan. 2 Stofinformatie Werkzame stof Natriumhypochloriet Gehalte 63 g/l (ALS ACTIEF CHLOOR) De werkzame stof actief chloor gevormd uit natriumhypochloriet is opgenomen in het reviewprogramma voor het gevraagde PT04 en zal per 1 januari 2019 worden geplaatst op de Unielijst van Goedgekeurde Werkzame stoffen volgens Verordening 528/ Toelatingsinformatie Toelatingsnummer: N Expiratiedatum: 1 januari 2024 Afgeleide of parallel: Wijziging Middel Biocide, gewasbeschermingsmiddel of Biocide toevoegingsstof: Gebruikers: Professioneel 4 Verpakkingsinformatie Aard van het preparaat: Met water mengbaar concentraat Uiterste gebruiksdatum: 11 maanden na productiedatum Asepto FL-D, UB 1

5 14304 N HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE II Etikettering van het middel Asepto FL-D Professioneel gebruik de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel: Pictogram Signaalwoord Gevarenaanduidingen Voorzorgsmaatregelen Aanvullende etiketelementen GHS05 GHS09 Gevaar H290 Kan bijtend zijn voor metalen. H314 Veroorzaakt ernstige brandwonden en oogletsel. H410 Zeer giftig voor in het water levende organismen, met langdurige gevolgen. P280 Beschermende handschoenen/beschermende kleding/oogbescherming/gelaatsbescherming dragen. P303 + P361 + P353 + P310 BIJ CONTACT MET DE HUID (of het haar): verontreinigde kleding onmiddellijk uittrekken. Huid met water afspoelen/afdouchen. Onmiddellijk een ANTIGIFCENTRUM/arts/... raadplegen. P305 + P351 + P338 + P310 BIJ CONTACT MET DE OGEN: voorzichtig afspoelen met water gedurende een aantal minuten; contactlenzen verwijderen, indien mogelijk. Blijven spoelen. Onmiddellijk een ANTIGIFCENTRUM/arts/... raadplegen. EUH031 Vormt giftig gas in contact met zuren. Asepto FL-D, UB 1

6 14304 N HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE III WG/GA van het middel Asepto FL-D A. WETTELIJK GEBRUIKSVOORSCHRIFT Toegestaan is uitsluitend het gebruik als middel ter bestrijding van bacteriën (excl. bacteriesporen en mycobacteriën), gisten en schimmels in melkwinningsapparatuur op de boerderij; in leidingen en opslagtanks in de voeding- en drankenindustrie. De gebruiksaanwijzing zoals opgenomen onder B. moet worden aangehouden. Het middel is uitsluitend bestemd voor professioneel gebruik. B. GEBRUIKSAANWIJZING Algemeen Het middel is bestemd voor 1) gecombineerde reiniging en desinfectie van melkwinningsapparatuur (melkleidingen, melkkoeltanks, melkmachines) op de boerderij door middel van Cleaning-In-Place (CIP), alsmede 2) desinfectie van leidingen en opslagtanks in de voeding- en drankenindustrie door middel van Cleaning-In-Place (CIP), waarbij losse onderdelen handmatig kunnen worden gereinigd en gedesinfecteerd door middel van dompelen. Gebruiksinstructies: Reiniging en desinfectie in melkwinningsapparatuur op de boerderij d.m.v. CIP. De temperatuur van de vloeistof dient voor de recirculatie minimaal C te bedragen. Naspoelen met schoon, koud leidingwater. Dosering en minimale inwerktijd: - voor bestrijding van bacteriën en gisten: 0,7% oplossing (7 ml per liter water) gedurende 10 minuten; - voor bestrijding van schimmels: 3% oplossing (30 ml per liter water) gedurende 15 minuten. Reiniging en desinfectie in leidingen, opslagtanks en losse onderdelen (aftapkranen of koppelstukken) in de voeding- en drankenindustrie d.m.v. CIP en dompelen. Leidingen, opslagtanks en losse onderdelen eerst grondig reinigen. Het daarbij gebruikt reinigingsmiddel goed afspoelen met schoon water. Overtollig water verwijderen. Naspoelen met schoon, koud leidingwater. Dosering en minimale inwerktijd: - voor bestrijding van bacteriën en gisten: 1% oplossing (10 ml per liter water) gedurende 15 minuten; - voor bestrijding van schimmels: 3% oplossing (30 ml per liter water) gedurende 15 minuten. Attentie Asepto FL-D, UB 1

7 14304 N Melkwinningsapparatuur dient éénmaal per week in plaats van met Asepto FL-D met een daarvoor geschikt zuur te worden behandeld. Daarna goed naspoelen met schoon leidingwater. Het middel niet toepassen in melkwinningsapparatuur die werkt met temperaturen boven 80 C. Asepto FL-D, UB 2

8 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE IV RISKMANAGEMENT Contents 1 Introduction Identity Physical and chemical properties Analytical methods for detection and identification Efficacy Human toxicology Environment Conclusion Classification and labelling References Asepto FL-D, UB 3

9 1 Introduction 1.1 Applicant Ecolab B.V. Iepenhoeve 7a 3438 MR NIEUWEGEIN 1.2 Active substance Active chlorine generated from sodium hypochlorite 1.3 Product Asepto FL-D 1.4 Function Asepto FL-D is a disinfectant (PT04). 1.5 Background to the application This concerns an application for extension of an existing authorisation. 1.6 Intended uses Asepto FL-D is currently authorised (14304 N) for the control of bacteria (excluding mycobacteria and bacterial spores), yeasts, and fungi by Cleaning in Place (CIP) and dipping in milking systems at farms, and in pipes and vessels in the food and beverage industry. These uses are included in PT04. The product is intended for professional use. The current application concerns: - removal of application by dipping in milking systems; - adapted dosing instructions for the control of bacteria and yeast in milking systems: from a uniform use concentration of 1% and a contact time of 15 minutes to a differentiated dose instruction for fresh product (age product 0-4 months) and aged product (age product 4-7 months) of resp. 0.5% and 0.7%, and a contact time of utes (regardless the age of the product). Dose instructions for fungi remain unaffected, as well as the use in food and beverage industry. The product is meant for cleaning in place disinfection (CIP) where a dilution is circulated during the prescribed contact times, and for dipping of small parts. 1.7 Packaging details 1L L in HDPE (not changed). 2 Identity The identity of Asepto FL-D has not been changed, and therefore this assessment was not performed. 3 Physical and chemical properties The physical and chemical properties of Asepto FL-D have not been changed, and therefore a full assessment was not performed. An extension for the shelf life was requested with the application. The shelf life of the product is prolonged from 9 to 11 months in HDPE. Asepto FL-D, UB 4

10 4 Analytical methods for detection and identification The analytical methods for detection and identification of Asepto FL-D have not been changed, and therefore this assessment was not performed. 5 Efficacy 5.1 Function Asepto FL-D is a disinfectant based on sodium hypochlorite (63 g active chlorine/l). 5.2 Field of use envisaged Asepto FL-D is currently authorised (14304 N) for the control of bacteria (excluding mycobacteria and bacterial spores), yeasts, and fungi by Cleaning in Place (CIP) and dipping in milking systems at farms, and in pipes and vessels in the food and beverage industry. These uses are included in PT04. The product is intended for professional use. The current application concerns: - removal of application by dipping in milking systems; - adapted dosing instructions for the control of bacteria and yeast in milking systems: from a uniform use concentration of 1% and a contact time of 15 minutes to a differentiated dose instruction for fresh product (age product 0-4 months) and aged product (age product 4-7 months) of resp. 0.5% and 0.7%, and a contact time of utes (regardless the age of the product). Dose instructions for fungi remain unaffected, as well as the use in food and beverage industry. The product is meant for cleaning in place disinfection (CIP) where a dilution is circulated during the prescribed contact times, and for dipping of small parts. 5.3 Effects on target organisms and efficacy Efficacy data submitted and evaluation of data Nine studies were provided and used in this assessment. These are summarised in Table 1. Table 2. Summary of studies assessed Test (version) Phase, step Test organism Test parameters Results* Bacteria (excluding mycobacteria and bacterial spores) EN 1276 (2009) 2, 1 Staphylococcus aureus Enterococcus hirae Pseudomonas aeruginosa Escherichia coli Concentration (%): 0, after 0 months of storage log R>5.16: 0.4 %; ; Asepto FL-D, UB 5

11 Test (version) Phase, step EN 1276 (2009) 2, 1 Test organism Test parameters Results* Staphylococcus aureus Enterococcus hirae Pseudomonas aeruginosa Escherichia coli Concentration (%): after 4 months of storage log R>5.32: 0.6 %; ; EN 1276 Staphylococcus aureus Concentration (%): EN 1276 Staphylococcus aureus Concentration (%): EN 1276 Staphylococcus aureus Concentration (%): EN 1276 Staphylococcus aureus Concentration (%): EN 1276 Staphylococcus aureus Concentration (%): after 6 months of storage log R>5.21: 0.6 %; ; after 8 months of storage log R>5.27: 0.6 %; ; after 9 months of storage log R>5.16: 0.7 %; ; after 10 months of storage log R>5.27: 0.7 %; ; after 11 months of storage log R>5.52: 0.7 %; ; Asepto FL-D, UB 6

12 Test (version) Phase, step EN 1650 (2008) 2, 1 EN 1650 (2008) 2, 1 Test organism Test parameters Results* Yeasts Candida albicans Concentration (%): Candida albicans Concentration (%): log R>4.11: 0.4 %; ; after 4 months of storage log R>4.40: 0.5 %; ; EN 1650 Candida albicans Concentration (%): EN 1650 Candida albicans Concentration (%): EN 1650 Candida albicans Concentration (%): EN 1650 Candida albicans Concentration (%): after 6 months of storage log R>4.21: 0.6 %; ; after 8 months of storage log R>4.2: 0.6 %; ; after 9 months of storage log R>4.38: 0.6 %; ; after 10 months of storage log R>4.50: 0.6 %; ; Asepto FL-D, UB 7

13 Test (version) Phase, step EN 1650 Candida albicans Concentration (%): Test organism Test parameters Results* * For phase 2, step 1 studies the most challenging test conditions resulting in the required lg reduction are given after 11 months of storage log R>4.48: 0.7 %; ; The available information was sufficient to evaluate the efficacy of the proposed adaptions of the dosing instructions for Asepto FL-D for control of bacteria and yeast, considering evaluation is done under article 121 of the WGB. The provided quantitative suspension tests (phase 2, step 1) with product that was stored for four months demonstrated bactericidal and yeasticidal efficacy at a use concentration of 0.6% and a contact time of utes. Therefore, the claimed use concentration of 0.5% with product aged 0 to 4 months is not acceptable. To demonstrate bactericidal efficacy with a product shelf life of 4 to 11 months, tests with one bacteria species, Staphylococcus aureus, were submitted. This is acceptable as the tests with shelf life up to 4 months demonstrated that S. aureus is the least sensitive of the standard bacteria species tested and therefore most challenging. Bactericidal and yeasticidal efficacy was demonstrated with product after 11 months of storage at a use concentration of 0.7% and a contact time of utes. The submitted tests confirm that the dose must be increased when the product is stored for more than four months. However, it is the Ctgb s opinion that the proposed product age-dependent differentiated dosing instructions cannot be accepted as such instructions are sensitive to errors. In addition, longer storage (4 to 7 months compared to 0 to 4 months) only requires a small increase of the dose (0.6% to 0.7%), which does not compensate for possible misuse and inefficacy due to underdosing Evaluation of the label (WG/GA) The applicant has provided a WG/GA in Dutch. This has been adapted to our standards. - the application by dipping in milking systems is removed on request of the applicant; - the use concentration of 0.5% at a contact time of utes for control of bacteria and yeast in milking systems has been removed as not sufficient efficacy was demonstrated. 5.4 Mode of action The chlorination and the oxidation reaction of hypochlorous acid are unspecific. Hypochlorous acid reacts by chlorination of nitrogen with amino acids. This results in: a destructive permeability change in bacterial walls and leakage of cell contents inactivation of enzymes essential to cell metabolism destruction of virus capsids At low concentrations in water (0.1 to 1 mg/l) hypochlorite is able to inhibit bacterial growth. In this case the proteins of the membrane are partly destroyed and the bacteria are not able to multiply. 5.5 Limitations on efficacy including resistance General limitations The following limitations are mentioned: - not to be used in combination with acids - not to be used in milking equipment that use process water temperatures of more than 80 C Asepto FL-D, UB 8

14 5.5.2 Resistance Although different species vary in their sensitivity to hypochlorite, development of acquired resistance is not expected. Hypochlorite is regarded by experts as one of the biocides where acquired resistance is least likely to develop. Firstly it is a reactive biocide which attacks and inactivates microbial cells in many different ways, reacting with and decomposes a wide range of molecules in the cell wall and cell interior and degrading or destroying the cell completely. Secondly, being reactive, hypochlorite is also rapidly decomposed on contact with organic matter during use such that organisms are not exposed to active residual. For the same reasons cross-resistance is not to be expected, nor has it been observed. Despite use for almost a century in purifying drinking water, where very low (sub ppm) concentrations are continuously maintained, the development of acquired resistance has not been observed Resistance management strategies No management strategy is necessary. 5.6 Overall conclusions of efficacy Based on the data submitted and considering that the evaluation is done under article 121 of the WGB, it can be concluded that Asepto FL-D, when used in accordance with the proposed label (WG/GA): - is effective in controlling bacteria (excluding mycobacteria and bacterial spores) and yeasts in milking systems at farms at a reduced use concentration of 0.7% and utes by CIP. - is not effective in controlling bacteria (excluding mycobacteria and bacterial spores) and yeasts in milking systems at farms at a reduced use concentration of 0.5% and utes by CIP. 6 Human toxicology The proposed extension for use involves an application in farms and milking facilities and the food and beverage industry for which the risk assessment can be extrapolated from the current authorisation based on the method of application and dosage. Therefore, the proposed changes remains within the existing risk envelope for the section human health. 7 Environment 7.1 Introduction Asepto FL-D containing sodium hypochlorite as the active substance is currently authorised (14304 N) as disinfectant for the control bacteria (excluding spores), yeast and fungi in milking systems at farms and in the food and beverage industry (PT04). The authorized uses are described in table E.1. The current request for authorisation concerns an adjustment in the dosage of the product as indicated in table E.1. The adjustment is indicated in bold. Table E.1. Intended uses No. Product / area of use envisaged PT04: Food and feed area disinfectants 1 CIP (Cleaning in Place) cleaning and disinfectant for milking equipment 2 CIP cleaning and disinfectant for the food and beverage industry Use concentration active substance (mg/l) 0.026%-0.158% as active chlorine Dosage product 0.5%-0.7% w/w (bacteria and yeast) or 3% w/w (fungi) Asepto FL-D, UB 9

15 7.2 Product related studies The exposure assessment is based on data for the active substance. There are no fate or ecotoxicity data available for the product. 7.3 Environmental exposure assessment Chemistry and/or metabolism Sodium hypochlorite is gaseous chlorine (Cl 2) in a solution of sodium hydroxide (NaOH). Chlorine will be present as a gas, hydrochloric acid (HOCl), or hypochlorite (OCl - ), depending on the ph. The biocidal principle of sodium hypochlorite is based on hydrochloric acid, which is a strong oxidiser. Above ph 11 the biocidal aim of sodium hypochlorite is strongly decreased as chlorine is only present as hypochlorite. In strongly diluted solutions hydrochloride acid decomposes into chlorine and oxygen, a chemical reaction that is accelerated by light and the presence of metals. Free available chlorine can be built in organic matter forming chlorinated organic micro pollutants Distribution in the environment Various phases in the life cycle of a product may cause emissions and environmental exposure. Significant release to the environment will therefore occur during the application of products holding the biocide. Table E.3 summarises the receiving environmental compartments that have been identified as potentially exposed during the use of the product. Compartments indicated with a Q will be qualitatively assessed only. Emissions from active substance production and product formulation are not part of the risk assessment. The routes of entry into the environment are explained in more detail in the next sections. Table E.3. Main scenario Foreseeable routes of entry into the environment on the basis of the intended use. Environmental compartments exposed STP 1 Freshwater 2 Saltwater 2 Soil 3 Air Disinfection of surfaces that come in contact with food, feed, and liquors, including their ingredients ++ (Q) + (Q) (Q) ++ Compartment directly exposed, + Compartment indirectly exposed, - Compartment not exposed, 1 Sewage Treatment Plant, 2 Including sediment, 3 Including groundwater. Residues of the product are discharged to the sewer along with the rinse water and enter the aquatic environment via the sewage treatment plant (STP). Application of sewage sludge as a soil fertiliser is highly unlikely in The Netherlands as its chemical composition does not fulfil the environmental standards regarding organic pollutants and heavy metals. In order to avoid unnecessary contamination of the receiving soils, sewage sludge is treated as hazardous waste instead. Emission to air is likely during application and the active substance may evaporate from waste water during sewage treatment. 7.4 Risk characterisation for the environment Aquatic compartment (incl. sediment) and STP Water and sediment organisms and micro-organisms in the STP Hypochlorite is a very reactive compound. During and after use of the product the concentration strongly decreases when hypochlorite reacts through a chain of reactions, thereby forming chlorine. Residues will react with organic matter present in the pipeline system that discharges to the STP. The wastewater discharged to the sewer system will contain very low or no hypochlorite, hypochloric acid or free chlorine because of the degradation processes that occur in the sewer system. The Asepto FL-D, UB 10

16 remaining fraction of residues will be removed in the STP. Therefore, no unacceptable risks for micro-organisms in the STP and organisms in the aquatic compartment are expected. Conclusively, the proposed applications when used in compliance with the legal directions for use (WG/GA) meet the standards for aquatic organisms, sediment organisms and micro-organisms in the STP Monitoring data (surface water) Dutch water boards have a well-established programme for monitoring pesticide contamination of surface waters for which the results are publicly available on-line (www. bestrijdingsmiddelenatlas.nl). Here, monitoring data are processed in a graphic format aiming to provide an insight into measured pesticide contamination of Dutch surface waters against environmental standards. The Pesticide Atlas was used to evaluate measured concentrations of pesticides in Dutch surface water, but no data are available regarding the presence of sodium hypochlorite or active chlorine in Dutch surface water Surface water intended for the abstraction of drinking water Biocidal products with the active substance sodium hypochlorite (and active chlorine) have been on the market for more than three years. The existing active substance is not included in the list of substances of concern due to its presence in surface water at drinking water abstraction points as established by VEWIN/Ctgb (2015). In addition, the active substance is not included in the recommended list of biocides to be monitored for drinking water from surface water (RIVM, 2010). Considering this the Ctgb concludes that there are in this case insufficient indications for concern about the consequences of this product for surface water from which drinking water is produced, when used in compliance with the directions for use. Thus the standards for surface water destined for the production of drinking water are met Terrestrial compartment Soil organisms For the intended use of the product, emission of the active substance to soil is not expected. Direct exposure is negligible for bees as the product is used indoors. The exposure of non-target arthropods and soil organisms (including bees) to the active substance is therefore deemed negligible. Hence, the risk for soil organisms and non- target arthropods (including bees) is considered acceptable for the intended use Groundwater Assessment of the drinking water criterion defines that the concentration of the active substance and the relevant metabolites in groundwater for the preparation of drinking water needs to be <0.1 µg/l. Considering the application of the product, emission routes to the environment, and the biochemical profile of the active substance, environmental concentrations in soil and soil pore water are expected to be low. Leaching and concentrations in shallow groundwater will be negligible. Therefore, the risk for groundwater is considered acceptable Persistence in soil Sodium hypochlorite is chemically instable and a highly reactive oxidant. Hence, sodium hypochlorite is not considered as persistent and the standards for persistence are met Non compartment specific effects relevant to the food chain Bioconcentration The risk for bioconcentration in aquatic organisms is considered low for the active substance, as the log K ow is < 3 (= -0.87). Bioconcentration and biomagnification is not expected (conform the Asepto FL-D, UB 11

17 biomagnification trigger value proposed for K ow in the Guidance on biocide legislation, Part B, volume IV) and the risk for bioconcentration for the proposed use is therefore considered acceptable Primary and secondary poisoning of birds and mammals The concentration of sodium hypochlorite in waste water will be negligible after discharge to surface water because of the degradation processes that occur in the sewer system and the STP. Therefore, the direct exposure of birds and mammals to the product is not expected and primary poisoning of birds and mammals is not considered relevant. Indirect exposure through the consumption of aquatic or soil organisms is also not considered relevant. As direct and indirect exposure of birds and mammals to the active substance or contaminated aquatic and terrestrial organisms is expected to be negligible, the risk for the primary and secondary poisoning is considered acceptable Atmosphere Criteria for the examination of environmental risks to air are not specified in the form of a numerical standard. The assessment of potential impacts on air quality is aimed to minimize the risk for stratospheric ozone depletion. There are no indications that sodium hypochlorite (and active chlorine) contribute to depletion of the ozone layer as the compounds are not listed as controlled substance Annex I of Regulation (EC) No 1005/2009 of the European Parliament. In addition, although the volatilization of chlorine gas depends on the ph, volatilization is expected to be very low. The calculated half-life is 2750 hours and long distance transport seems likely. However, it is not expected that this will result in unacceptable risks as the active substance is quickly oxidised once entering the sewer system and not volatile resulting in a negligible emission from the STP during sewage treatment. The environmental risk to air are therefore considered acceptable for the substance. 7.5 Measures to protect the environment (risk mitigation measures) 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, considering that risks to the environment are acceptable for the intended use. 7.6 Overall conclusion for the aspect Environment An authorisation of a biocide in The Netherlands is only possible when the risks related to the product application are acceptable. When used in accordance with the legal Instructions for Use (WG/GA), Asepto FL-D complies with the environmental standards and will not cause unacceptable effects to the environment. No risk mitigation measures are necessary. 7.7 Data requirements There are no additional data required. 8 Conclusion The applicant has proven that Asepto FL-D under the proposed Legal Conditions for Use and the Directions for Use (WG/GA), is sufficiently effective and that no unacceptable risk is expected to human health, the person who uses the product and the environment. 9 Classification and labelling Classification and labelling have not been changed. 10 References Bakker, J. Biociden in oppervlaktewater voor drinkwaterproductie, National Institute of Public Health and the Environment, RIVM report , 2010, Bilthoven, The Netherlands. Asepto FL-D, UB 12

18 Database with monitoring data from pesticides in surface water obtained from regional water boards. Emission Scenario Document for Product Type 4: Disinfectants used in food and feed areas, JRC Scientific and Technical Reports, Report nr. EUR EN, Publications Office of the European Union, Luxembourg, 2011 Lijst met probleemstoffen voor de bereiding van drinkwater uit oppervlaktewater, VEWIN, Regulation (EC) No 1005/2009 of the European Parliament and the Council of 16 September 2009 on substances that deplete the ozone layer. Guidance on the Biocidal Product Regulation. Volume IV: Environment - Part B+C: Assessment and Evaluation. European Chemicals Agency, Report no. ECHA-17-G-23-EN, Helsinki, Finland, Asepto FL-D, UB 13