Toelatingsnummer 12134 N
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN 1 UITBREIDING TOELATING Gelet op de aanvraag d.d. 8 juli 2013 (20131033 UB) van Certis Safariweg 55 3605 MA MAARSSEN tot uitbreiding van de gebruiksdoeleinden van de toelating als bedoeld in artikel 49, eerste lid, Wet gewasbeschermingsmiddelen en biociden voor de biocide, op basis van de werkzame stof(fen) perazijnzuur en waterstofperoxide Jet 5 gelet op artikel 44, eerste lid, Wet gewasbeschermingsmiddelen en biociden,
BESLUIT HET COLLEGE als volgt: 1.1 Uitbreiding 1. Het gebruiksgebied van het middel Jet 5 wordt met ingang van datum dezes uitgebreid met de toepassing als middel ter bestrijding van: a. bacteriën (exclusief bacterie sporen) en gisten in kassen, warenhuizen en bewaarplaatsen; b. bacteriën (exclusief bacterie sporen) en gisten op betonvloeren, teelttafels, bevloeiingsmatten, druppelsystemen, plantcontainers, stekbakjes, plantenkwekerkisten, antiworteldoek en handgereedschap ten behoeve van de teelt van land- en tuinbouwgewassen; c. bacteriën (exclusief bacterie sporen) en gisten op apparatuur gebruikt bij het rooien, transporteren en verwerken van aardappelen; d. bacteriën (exclusief bacterie sporen) en gisten op oppervlakken en materialen ten behoeve van de teelt van eetbare paddenstoelen, echter met dien verstande, dat gebruik niet is toegestaan in teeltruimten tijdens de teelt, noch in ruimten waarin eetbare paddenstoelen zijn opgeslagen. . Voor de gronden waarop dit besluit berust wordt verwezen naar bijlage II bij dit besluit. Jet 5 12134 N
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2. Het middel wordt toegelaten tot het tijdstip waarop de lidstaten maatregelen genomen hebben om de nationale toelating in overeenstemming te brengen met het besluit over de werkzame stof van de Europese Commissie. 1.2 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 bij dit besluit is voorgeschreven. 1.4 Classificatie en etikettering Gelet op artikel 50, eerste lid, sub d, Wet gewasbeschermingsmiddelen en biociden, 1. De aanduidingen, welke ingevolge artikelen 9.2.3.1 en 9.2.3.2 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: Met water mengbaar concentraat werkzame stof: perazijnzuur waterstofperoxide
gehalte: 55 g/l 220 g/l
letterlijk en zonder enige aanvulling: andere zeer giftige, giftige, bijtende of schadelijke stof(fen): gevaarsymbool: C O
aanduiding: Bijtend Oxiderend
Waarschuwingszinnen: R07 R20/21/22 R34
-Kan brand veroorzaken. -Schadelijk bij inademing, opname door de mond en aanraking met de huid. -Veroorzaakt brandwonden.
Veiligheidsaanbevelingen:
Jet 5 12134 N
S03/07 S14
-Gesloten verpakking op een koele plaats bewaren. -Verwijderd houden van (stoffen waarmee contact vermeden dient te worden aan te geven door fabrikant).
S23d
-Spuitnevel niet inademen. 2
S26/28-NL S35 S36/37/39b S42b S45
-Bij aanraking met de ogen of de huid onmiddellijk met overvloedig water afspoelen en deskundig medisch advies inwinnen. -Deze stof en de verpakking op veilige wijze afvoeren. -Draag geschikte beschermende kleding, handschoenen en een beschermingsmiddel voor het gezicht. -Tijdens de bespuiting een geschikte ademhalingsbescherming dragen. -Bij een ongeval of indien men zich onwel voelt onmiddellijk een arts raadplegen (indien mogelijk hem dit etiket tonen).
Specifieke vermeldingen: 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. bij het toelatingsnummer een cirkel met daarin de aanduiding W.3. De nieuwe etikettering dient bij de eerstvolgende aanmaak op de verpakking te worden aangebracht. Oude verpakkingen mogen worden opgemaakt.
2 DETAILS VAN DE AANVRAAG 2.1 Aanvraag Het betreft een aanvraag tot uitbreiding van het gebruiksgebied van het middel Jet 5 (12134 N), een middel op basis van de werkzame stoffen perazijnzuur en waterstofperoxide. Het middel is bij besluit van 18 augustus 2000 reeds toegelaten als als middel ter bestrijding van groene aanslag; Het middel is bij dit besluit toegelaten tot het tijdstip waarop de lidstaten maatregelen genomen hebben om de nationale toelating in overeenstemming te brengen met het besluit over de werkzame stof van de Europese Commissie. Met onderliggende aanvraag wordt toelating als middel ter bestrijding van: a. bacteriën (exclusief bacterie sporen) en gisten in kassen, warenhuizen en bewaarplaatsen; b. bacteriën (exclusief bacterie sporen) en gisten op betonvloeren, teelttafels, bevloeiingsmatten, druppelsystemen, plantcontainers, stekbakjes, plantenkwekerkisten, antiworteldoek en handgereedschap ten behoeve van de teelt van land- en tuinbouwgewassen; c. bacteriën (exclusief bacterie sporen) en gisten op apparatuur gebruikt bij het rooien, transporteren en verwerken van aardappelen; Jet 5 12134 N
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d. bacteriën (exclusief bacterie sporen) en gisten op oppervlakken en materialen ten behoeve van de teelt van eetbare paddenstoelen, echter met dien verstande, dat gebruik niet is toegestaan in teeltruimten tijdens de teelt, noch in ruimten waarin eetbare paddenstoelen zijn opgeslagen. . 2.2 Informatie met betrekking tot de stof Er zijn in Nederland reeds andere middelen op basis van de werkzame stoffen perazijnzuur en waterstofperoxide toegelaten. De werkzame stoffen zijn nog niet geplaatst op de Unielijst van goedgekeurde werkzame stoffen van de EU verordening 528/2012 2.3 Karakterisering van het middel Lerasept Forte is een middel op basis van perazijnzuur en waterstofperoxide. De werkzame combinatie leidt tot de vorming van hydroxyl radicalen die leidt tot (1) denaturatie van celeiwitten en verstoring van intracellulair transport, (2) inactivatie van enzymen die essentieel zijn voor celmetabolisme en (3) disruptie van de celmembraan en verstoring van de permeabiliteit. 2.4 Voorgeschiedenis De aanvraag is op 9 juli 2013 ontvangen; op 19 juli 2013 zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 11 februari 2014 is de aanvraag in behandeling genomen. 2.5 Eindconclusie Bij gebruik volgens het Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is het middel Jet 5 op basis van de werkzame stoffen perazijnzuur en waterstofperoxide voldoende werkzaam en heeft het geen schadelijke uitwerking op de gezondheid van de mens en het milieu. 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 217, 6700 AE WAGENINGEN. Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld. Wageningen, 9 mei 2014 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN,
ir. J.F. de Leeuw voorzitter
Jet 5 12134 N
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HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE I bij het besluit d.d. 9 mei 2014 tot uitbreiding van de toelating van het middel Jet 5, toelatingnummer 12134 N A. WETTELIJK GEBRUIKSVOORSCHRIFT Toegestaan is uitsluitend het gebruik als middel ter bestrijding van: a. groene aanslag; b. bacteriën (exclusief bacterie sporen) en gisten in kassen, warenhuizen en bewaarplaatsen; c. bacteriën (exclusief bacterie sporen) en gisten op betonvloeren, teelttafels, bevloeiingsmatten, druppelsystemen, plantcontainers, stekbakjes, plantenkwekerkisten, antiworteldoek en handgereedschap ten behoeve van de teelt van land- en tuinbouwgewassen; d. bacteriën (exclusief bacterie sporen) en gisten op apparatuur gebruikt bij het rooien, transporteren en verwerken van aardappelen; e. bacteriën (exclusief bacterie sporen) en gisten op oppervlakken en materialen ten behoeve van de teelt van eetbare paddenstoelen, echter met dien verstande, dat gebruik niet is toegestaan in teeltruimten tijdens de teelt, noch in ruimten waarin eetbare paddenstoelen zijn opgeslagen. Om bodem- en in het waterlevende organismen te beschermen dienen resten die het middel bevatten uitsluitend te worden afgevoerd naar het riool met aansluiting op de RWZ. In geen geval mag dit middel worden geloosd op een Individuele Behandeling Afvalwater (IBA). De gebruiksaanwijzing zoals aangegeven onder B. moet worden aangehouden. Dit middel is uitsluitend bestemd voor professioneel gebruik. B. GEBRUIKSAANWIJZING Algemeen Jet 5 is een middel op basis van een krachtige oxidator. Voorkom tijdens het gebruik opspatten en nevelvorming. Metalen zoals koper, brons, aluminium en zink kunnen bij toepassing verkleuren. Spuitoplossing niet aanmaken in metalen vaten. Bestrijding van groene aanslag Indien mogelijk vuil van tevoren verwijderen. De te behandelen oppervlakten goed bevochtigen met de klaargemaakte oplossing van het middel. Voor bevochtiging van poreuze materialen (baksteen, trottoirtegels en dergelijke.) is meer vloeistof nodig dan voor gladde en harde materialen (glas en dergelijke). Na enkele dagen kan men desgewenst dode algen verwijderen door af te spuiten of te schrobben. Afhankelijk van de dikte van de groene aanslag kan herhaling noodzakelijk zijn. Toepassing en dosering: Spuiten met een concentratie van 1% (100 ml middel aanvullen tot 10 liter water).
Jet 5 12134 N
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Desinfectie Algemeen Te ontsmetten oppervlakken en materialen eerst goed reinigen, bijvoorbeeld met een hogedrukspuit. Overtollige vloeistof verwijderen. Bij het ontsmetten rijkelijk vloeistof gebruiken, zodat de oppervlakken gedurende de inwerktijd nat blijven. Niet naspoelen. Draag geschikte adembescherming bij het spuiten van dit middel. Tijdens het spuiten mogen geen onbevoegde mensen aanwezig zijn in de ruimtes. Desinfectie toepassingen In kassen, warenhuizen en bewaarplaatsen toepassen door middel van spuiten of borstelen. Op betonvloeren, teelttafels, bevloeiingsmatten, druppelsystemen (uitwendig), plantcontainers, stekbakjes, plantenkwekerkisten, antiworteldoek en handgereedschap ten behoeve van de teelt van land- en tuinbouwgewassen toepassen door middel van spuiten of borstelen of dompelen. . Op apparatuur gebruikt bij het rooien, transporteren en verwerken van aardappelen toepassen door middel van spuiten of borstelen. Ten behoeve van de teelt van eetbare paddenstoelen (champignons, oesterzwam en shiitake) toepassen door middel van spuiten of borstelen. Het is bestemd voor de ontsmetting van muren, vloeren, stellingen, netten, werkgangen, nevenruimten, gereedschappen en hulpmiddelen ten behoeve van de teelt, lege teeltruimten en lege koel- en opslagruimten. Dosering: 2% (200 ml middel aanvullen tot 10 liter water) bij een inwerktijd van 5 minuten of 1,5% (150 ml middel aanvullen tot 10 liter water) bij een inwerktijd van 30 minuten De oppervlakken moeten gedurende de gehele inwerktijd nat blijven.
Jet 5 12134 N
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HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE II bij het besluit d.d. 9 mei 2014 tot uitbreiding van de toelating van het middel Jet 5, toelatingnummer 12134 N RISKMANAGEMENT
Contents Page H.1. Introduction................................................................................................................ 4 H.2. Identity ........................................................................................................................ 4 H.3. Physical and chemical properties ............................................................................ 4 H.4. Analytical methods for detection and identification ............................................... 4 H.5. Efficacy ....................................................................................................................... 4 H.6. Human toxicology...................................................................................................... 7 H.7. Environment ............................................................................................................... 7 H.8. Conclusion ............................................................................................................... 23 H.9. Classification and labelling ..................................................................................... 23 H.10. References .............................................................................................................. 23
Jet 5 12134 N
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H.1.
Introduction
H.1.1 Applicant Certis Europe B.V. H.1.2 Active substance Hydrogen peroxide and peracetic acid H.1.3 Jet 5
Product
H.1.4 Function Jet 5 is a disinfectant that is already authorised (12134 N) as a product to control algae on surfaces. Additional authorisation is requested for the control of bacteria and yeast (PT2 and PT4) H.1.5 Background to the application Application to modify the field of use of an authorised biocide H.1.6 Intended uses Additional authorisation is requested for the control of bacteria and yeast : 1. in greenhouses and storage rooms; 2. on concrete floors, on cultivation tables, in irrigation systems, on plant containers, on root canvas, and on tools applied in the agricultural and horticultural industry; 3. on equipment for potato lifting, transportation, and processing; 4. on surfaces and tools applied for the culture of edible mushrooms.
H.2.
Identity
Since the product has not been changed, this assessment has not been performed.
H.3.
Physical and chemical properties
Since the physical and chemical properties have not been changed, this assessment has not been performed.
H.4.
Analytical methods for detection and identification
Since the analytical methods for detection and identification have not been changed, this assessment has not been performed.
H.5.
Efficacy
Function Jet 5 is a disinfectant based on hydrogen peroxide (220 g/L) and peracetic acid (55 g/L). Field of use envisaged Jet 5 is already authorised (12134 N) as a product to control algae on surfaces. Jet 5 12134 N
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Additional authorisation is requested for the control of bacteria and yeast : 1. in greenhouses and storage rooms; 2. on concrete floors, on cultivation tables, in irrigation systems, on plant containers, on root canvas, and on tools applied in the agricultural and horticultural industry; 3. on equipment for potato lifting, transportation, and processing; 4. on surfaces and tools applied for the culture of edible mushrooms. Only these new uses will be evaluated now. These intended uses are included in PT02 and 04. The product is intended for professional use only. Effects on target organisms and efficacy Efficacy data submitted and evaluation of data For the current authorisation five studies have been submitted. The relevant studies are summarised in Table 1. Some of the studies assessed were performed with a product with a different name. The applicant has declared that the formulation of this product is identical to the formulation of Jet 5. Table 1. Summary of studies assessed Test (version) Phase, step EN 1656 (2000) phase 2, step 1
EN 14349 (2004) phase 2, step 2
Test organism
Test parameters
Staphylococcus aureus Pseudomonas aeruginosa Proteus vulgaris Enterococcus hirae
Concentration (%): 0.1; 0.6; 1.5; 2.0; 4.0 and 8.0% Interfering substances: mixture of 1% bovine albumin and 1% yeast extract Contact time: 5 and 30 min Test temperature: 10°C
Staphylococcus aureus Pseudomonas aeruginosa Proteus vulgaris Enterococcus hirae
Concentration (%): 0.1; 0.6; 1.5; 2.0; 4.0 and 8.0% Interfering substances: mixture of bovine albumin and yeast extract (1%, dirty conditions) Contact time: 5 and 30 min Test temperature: 10°C
Results*
log R>5: 1.5 %; Dirty 5 min; 10°C log R>5: 0.6 %; Dirty 30 min; 10°C log R>4: 4.0 %; Dirty 5 min; 10°C
log R>4: 2.0 %; Dirty 30 min; 10°C Concentration (%): log R>4: 0.1; 0.6; 1.5; 2.0; 4.0 and 8.0% 2.0 %; Interfering substances: Clean bovine albumin solution (0.3%), clean 5 min; coditions 10°C Contact time: log R>4: 5 and 30 min Test temperature: 1.5 %; 10°C Clean 30 min; 10°C
Jet 5 12134 N
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Test Test organism (version) Phase, step Candida albicans ATCC EN1657 10231 (2005) phase 2, step 1
Test parameters
Concentration (%): 0.6; 1.5; 2.0; 4.0 and 8.0% Interfering substances: mixture of 1% bovine albumin and 1% yeast extract (dirty conditions) Contact time: 5 Test temperature: 10°C
Results*
log R>4.55: 0.6 %; Dirty 5 min; 10°C
The available information was sufficient to evaluate the efficacy of Jet 5 for control of bacteria and yeasts, considering evaluation is done under article 121 of the WGB. All test are done at 10°C which is a relevant temperature for some of the uses and the worst case situation. The suspension tests show that Jet 5 complies with the criteria for lg reduction for the key species of the target organisms, at a concentration of 1.5% with a contact time of 5 minutes and at a concentration of 1% with a contact time of 30 minutes under dirty conditions. The surface test shows efficacy under clean conditions at an even higher concentration: 2% at 5 min. contact time or 1.5% at 30 min. contact time. This is not in accordance with the instructions described on the WG/GA, which state a concentration of 1% with a contact time of 5 minutes under clean conditions. Therefore, the instructions described on the WG/GA have to be revised as follows: - a concentration of 2% with a contact time of 5 minutes - a concentration of 1.5% with a contact time of 30 minutes. It can be concluded that Jet 5, when used in accordance with these label instruction, will be effective in controlling bacteria and yeasts. Evaluation of the label (WG/GA) The applicant has provided a WG/GA in Dutch. This has been adapted to our standards. The use instructions have been revised according to the efficacious use concentration and contact time. Efficacy against bacterial spores was not demonstrated, therefore bacterial spores will be excluded on the WG/GA. Mode of action Hydrogen peroxide and peracetic acid are strong oxidisers. The antimicrobial action of hydrogen peroxide stems from its ability to form powerful oxidants such as the hydroxyl radical and singlet oxygen. These reactive oxygen species cause irreversible damage to a host of cell components such as enzymes, membrane constituents and DNA. The destruction of the microbial cell by peracetic acid can be grouped into three mechanisms: o denaturation of cell proteins and interruption of cell transport o inactivation of enzymes essential to cell metabolism, and o disruption of cell membranes and their permeability. Limitations on efficacy including resistance Resistance The mode of action of the active substances is that of non-specific general oxidisers. Oxidisers will react with essential macromolecules that make up microbial life, including the oxidation of various proteins, carbohydrates, lipids and nuclear acids. This is such a general reaction to so many different molecules that it is very unlikely that an organism will develop a simple resistance mechanism for that. Therefore no resistance management strategy is necessary.
Jet 5 12134 N
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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 Jet 5, when used in accordance with the proposed label (WG/GA), is effective in controlling bacteria (excluding bacterial spores) and yeasts 1. in greenhouses and storage rooms; 2. on concrete floors, on cultivation tables, in irrigation systems, on plant containers, on root canvas, and on tools applied in the agricultural and horticultural industry; 3. on equipment for potato lifting, transportation, and processing; 4. on surfaces and tools applied for the culture of edible mushrooms.
H.6.
Human toxicology
Hydrogen peroxide A first draft CA-report for hydrogen peroxide is available for PT1-6 on which comments have been provided by the Netherlands; however, it has not yet been discussed at the EU level. However, hydrogen peroxide is also a bulk chemical for which an IUCLID dossier is available. The List of Endpoints is based on the IUCLID dossier. List of endpoints Information with regard to the absorption of hydrogen peroxide after oral or dermal exposure is limited. It is assumed that hydrogen peroxide decomposes fast by normal cellular detoxification pathways. Hydrogen peroxide has an LD50 oral of 1600 mg/kg bw (at 9.6% hydrogen peroxide) to ca. 800 mg/kg (at 60% hydrogen peroxide). Dermal LD50 values were > 2000 mg/kg bw in several species. Acute inhalation exposure of rats and mice leads to severe damage of the lungs (congestion and emphysema). Hydrogen peroxide is irritating to rabbit skin (at concentrations ≥ 35%) and eye (at concentrations > 5%). At concentrations above 50% hydrogen peroxide is corrosive. The concentrations of hydrogen peroxide ≥ 8% cause serious damage to eyes. Hydrogen peroxide is not classified for skin sensitisation. The lowest NOAELs found in repeated dose toxicity studies in rats and mice were 0.5% (rat/mouse, drinking water), 50 mg/kg bw/d (rat, oral gavage) and 1 mg/m3 (rat, inhalation). Hydrogen peroxide causes DNA damage and mutations in bacteria. It causes DNA damage, gene mutations, sister chromatid exchanges and chromosome aberrations in mammalian cells in vitro. It induced no recessive lethal effects in Drosophila melanogaster. Micronucleus tests in mice are negative, as well as a bone marrow chromosome tests aberration in rats. All recent evaluations have concluded that hydrogen peroxide is of no concern with regard to a possible carcinogenicity in humans. Since hydrogen peroxide did not lead to effects in a limited one-generation study, causes mostly local effects and decomposes fast after absorption, it is not expected that developmental effects will occur. Local effects and determination of local Acceptable Exposure Level (AELlocal) The effects of hydrogen peroxide found in mammalians are particularly caused by the reactivity of hydrogen peroxide and are therefore to a large extent restricted to damage of the skin or mucosa (stomach, intestine) or lungs and eyes. The possibly systemic effects are considered secondary to the primary local irritating effects. Based on the available information no reliable systemic NOAEL can be derived for hydrogen peroxide. Since after oral or dermal exposure to hydrogen peroxide the most critical effect is Jet 5 12134 N
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local irritation of mucous membranes, in the risk evaluation a AELlocal of 3%, or 30 g/L is used. For inhalation exposure SCOEL (2010, second consultation) recommends a STEL (15 min) of 0.5 ppm (equal to 0.655 mg/m3) and an 8-hour TWA of 0.2 ppm (equal to 0.262 mg/m3). For all applications it should be noted that concentrations of 3% hydrogen peroxide are worldwide free available. However, it should be also noted that according to the guideline for cosmetic products the maximal content of hydrogen peroxide in tooth bleaching products is 0.1% hydrogen peroxide. This lower concentration is specifically related to the expected oral exposure by using these tooth products. Data requirements active substance No additional data requirements are identified. Peracetic acid Peracetic acid is produced by reacting hydrogen peroxide with acetic acid in aqueous solution. In this process, peracetic acid is not obtained as a pure substance but in the form of aqueous equilibrium solutions containing peracetic acid, acetic acid, hydrogen peroxide and water. The peracetic acid content in equilibrium solutions ranges between 0.4% and 17% (w/w). The equilibrium solution is the biocidal product which is placed on the market. List of Endpoints The provided List of Endpoints is based on the first draft CAR of peracetic acid. As this draft CAR has not yet been discussed at the TM, the List of Endpoints should be regarded as provisional. Absorption, distribution, metabolism and excretion in mammals Rate and extent of oral absorption:
Not determined
Rate and extent of dermal absorption:
Not determined; 100% as a default
Rate and extent of inhalation absorption:
Not determined; 100% as a default 20 % of radio-activity tissue-bound with highest levels found in liver, gastro-intestinal tract and exposed skin No evidence for bioaccumulation - approx. 30 – 60 % of the applied dose recovered as CO2 after 72 hours with the majority formed after 24 hours; an initial lag phase of approx. 1 hour evident - about 17 % of given radioactivity excreted via the urine after 72 hours; majority of urinary excretion occurred after 24 hours - about 4 - 5 % of given radioactivity excreted via the faeces and 17 % via urine after 72 hours; majority of faecal excretion occurred after 24 hours
Distribution:
Potential for accumulation: Rate and extent of excretion:
Toxicologically significant metabolite(s)
None
Acute toxicity Rat LD50 oral
1020 mg/kg; (Acute Tox. 4 *, H302; Xn, R22)
Rat LD50 dermal
1147 mg/kg; (Acute Tox. 4 *, H312; Xn, R21)
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Rat LC50 inhalation Skin irritation Eye irritation Skin sensitization (test method used and result)
1 mg/L ≤ LC50 ≤ 5 mg/L; (Acute Tox.4 *, H332; Xn, R20) Corrosive; (Skin Corr. 1A, H314; C, R35) Corrosive (severe damage to the eyes) ; (Skin Corr. 1A H314; Xi, R41) Non-sensitising (GPMT)
Repeated dose toxicity Species/ target / critical effect Lowest relevant oral NOAEL / LOAEL
Lowest relevant dermal NOAEL / LOAEL Lowest relevant inhalation NOAEL / LOAEL
Genotoxicity
Rat (oral): local irritation in stomach/gastrointestinal-tract, no systemic effects 90-days gavage study in rats NOAEL 15 mg/kg bw/day corresponding to 0.055% peracetic acid Not established No study required for this endpoint for animal welfare reasons and owing to the intrinsic properties of peracetic acid (primary local irritation/corrosion at the site of first contact and absence of systemic effects/systemic availability) In vitro: Positive results in in vitro cytogenetic assay (chromosome aberrations) in human lymphocytes. Negative results in Ames test, gene mutation assay in mammalian cells, negative/equivocal in vitro chromosome aberration assay with Chinese hamster lung fibroblasts In vivo: Equivocal in three micronucleus tests and in vivo UDS. The biological meaning of any result from the in vivo studies is questionable in view of uncertainty of the availability of the test substance in the target organ. Weight of evidence indicates no concern of mutagenic / genotoxic potential
Carcinogenicity Species/type of tumour
lowest dose with tumours
Jet 5 12134 N
No study required for this endpoint for animal welfare reasons and owing to the intrinsic properties of peracetic acid (primary local irritation/corrosion at the site of first contact and absence of systemic effects/systemic availability). No concern of mutagenic / genotoxic potential. Site of contact carcinogenicity not tested. Not applicable
9
Reproductive toxicity Species/ Reproduction target / critical effect
No indication of reproductive toxicity in 90-days oral and continuous breeding studies. In the absence of both teratogenic effect and findings on reproductive organs in repeated dose toxicity studies, no study is required for this particular endpoint for animal welfare reasons and owing to the intrinsic properties of peracetic acid (primary local irritation/corrosion at the site of first contact and absence of systemic effects/systemic availability)
Lowest relevant reproductive NOAEL / LOAEL
Not applicable.
Species/Developmental target / critical effect
Rat: maternal effects: reductions in body weight, body weight gain developmental effects: impairment of ossification (bones missing or poor/hypertrophic ossification)
Lowest relevant developmental NOAEL / LOAEL
Maternal: 12.5 mg peracetic acid/kg bw/d Developmental: 12.5 mg peracetic/kg bw/d
Neurotoxicity / Delayed neurotoxicity Species/ target/critical effect
No indicative signs from acute and repeated dose studies; no structural alerts
Lowest relevant developmental NOAEL / LOAEL.
n.a.
Other toxicological studies Neurotoxicity Toxic effects on livestock and pets
Jet 5 12134 N
No indicative signs from acute and repeated dose studies; no structural alerts Not required since the mode of action of peracetic acid is known, i.e. the primary toxicological effect (local irritation/corrosion) which is not specific to any particular mammalian species or organ/tissue but is limited to the site of first contact. Peracetic acid is not systemically available in the body beyond the site of first contact due to rapid breakdown to the physiological metabolites hydrogen peroxide, water, oxygen and acetic acid The toxicity of peracetic acid has been investigated and it has been shown not to be mutagenic or teratogenic. In the summary report of the Committee for Veterinary Medicinal Products (CVMP) on Peracetic acid (EMEA/MRL/060/96-FINAL, Doc. No. 983001), peracetic acid is admitted for use in livestock animals and that there is no need to 10
Studies related to the exposure of the a.s. to humans
Food and feeding stuffs
Other tests related to exposure of the a.s. to human considered to be necessary
Tests to assess toxic effects from metabolites of treated plants
Mechanistic studies
Jet 5 12134 N
establish an MRL for peracetic acid. Not required since the mode of action of peracetic acid is known, i.e. the primary toxicological effect (local irritation/corrosion) which is not specific to any particular mammalian species or organ/tissue but is limited to the site of first contact. Peracetic acid is not systemically available in the body beyond the site of first contact due to rapid breakdown to the physiological metabolites hydrogen peroxide, water, oxygen and acetic acid. These degradation products will form in any species and no other pathways of degradation occur. No degradation pathways other than those known from animal studies are expected to occur. Thus, peracetic acid will not be transformed to further substances which were not observed and assessed in the available mammalian toxicity studies. Peracetic acid is not intended to be used in or on food or feeding stuff. In uses, however, where residues on food stuff packaging material cannot be excluded, no safety concern for does exist since peracetic acid is rapidly degraded to the physiological metabolites hydrogen peroxide, oxygen and acetic acid. Based on the evaluation of and the conclusions made by the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food, possible residues of peracetic acid on food and feeding stuff are not considered to be associated with a safety concern. Thus, there is no requirement for submission of information as laid down in the Technical Guidance Document on Data Requirements. No other tests related to the exposure of the active substance to humans for the purpose of performing reliable human health risk assessments studies necessary. The proposed biocidal products are sufficiently covered by the aforementioned tests. There are no endpoints of concern which would require further testing. Peracetic acid is not used in products for action against plants. Therefore, no tests to assess toxic effects of metabolites from treated plants are required. Based upon the known mode of action of peracetic acid, no mechanistic studies are required. The toxicity of peracetic acid is due to 11
Further human health related studies
its locally irritating properties, i.e. decomposition to hydrogen peroxide, oxygen and acetic acid. After contact with organs and tissues, hydrogen peroxide will undergo decomposition into water and oxygen. The primary toxicological effect (local irritation) is not specific to any particular mammalian species or organ/tissue but is limited to the site of first contact. Peracetic acid is not systemically available in the body beyond the site of first contact due to rapid breakdown to the physiological metabolites hydrogen peroxide, water, oxygen and acetic acid. Acetic acid is introduced in the C2-pool or further metabolised via physiological pathways to carbon dioxide and water. All occurring metabolites are rapidly eliminated and do not bioaccumulate. In view of the known mode of action and considering results of available mammalian toxicity studies, no further human healthrelated studies are required.
Medical data Medical surveillance data on manufacturing plant personnel
Jet 5 12134 N
No data available
12
Direct observations, e.g. clinical cases, poisoning incidents
Health records, both form industry and any other sources
Jet 5 12134 N
1: The cytotoxic and irritating potential of peracetic acid in humans used as a disinfectant for hand washing procedures applied by surgeons was investigated. Three of 15 surgeons developed immediately erythema and 6 of 15 surgeons developed dermatosis of the hands after 7 days following daily soaping, brushing and disinfection of skin with Peracetic acid at a concentration of 0.5 %. Peracetic acid applied as Wofasteril caused dermal irritation reactions in a third of health care workers. 2: Several recommendations were made to allow a safe handling with concentrated Peracetic acid solutions: - wearing protective gloves and protective glasses for diluting concentrated peracetic acid - dilutions should be made in a ventilated room - for spray application of dilutions for disinfection purposes a respirator should be used. 3: Effects of diluted peracetic acid solutions used as an aerosol (0.8 % peracetic acid) as a disinfectant for human skin (0.08 or 0.2 % peracetic acid) and for the treatment of a recurrent, pruritic epidermitis (0.1 % peracetic acid): - irritation of the respiratory tract, lachrimation, salivation, increased nasal discharge and partly temporal loss of olfactory senses (0.8 % peracetic acid) - slight skin desquamation after 1 or 2 days without hypersensitivity (0.2 % peracetic acid) - daily skin disinfection for 3 years using solutions of 0.2 % peracetic acid mixed with alcohol did not cause any adverse effects - temporarily reduced skin roughness after 1 day. The hands appeared slippery when wet, smooth and wellmanicured (0.2 % peracetic acid) - treatment of a recurrent, pruritic epidermitis using a 0.1 % peracetic acid successful - Concentrations of 0.2 % peracetic acid can be considered as non to only slightly irritating to skin. 4: After a Patch test with dilutions of 1:33 (1500 mg/L peracetic acid), 1:20 (2500 mg/L peracetic acid) and 1:15 (3500 mg/L according to publication, correct value should be 3300 mg/L) it was concluded that up to 2500 mg/L peracetic acid (corresponding to an about 0.25 % solution) is non-irritant. At 3300 mg/L peracetic acid (corresponding to an about 0.33 % solution) is a mild irritant. The Persteril dilution containing 0.2 % peracetic acid was well tolerated by the 20 volunteers. The concentration of 0.2 % peracetic acid is sufficient for eradication of pyogenic staphylococci and 97 % reduction of 13
Epidemiological studies on the general population
residual flora on the hand within 3 minutes. Peracetic acid does not have a residual effect. Solutions of peracetic acid with concentrations of 0.2 % do not damage the skin. No data available
Diagnosis of poisoning including specific signs of poisoning and clinical tests
Not available.
Sensitization/allergenicity observations
The cases of two subjects who developed cough wheezing and shortness of breath after being exposed to peracetic acid-hydrogen peroxide (peracetic acid-HP) vapours are investigated. The main symptoms observed were rhinorrhoea, conjunctivitis, continuous cough, breathlessness and chest tightness appeared after several hours of exposure to peracetic acid-HP vapours and improved after removal from exposure. It was concluded that symptoms in these subjects were generated by an irritant mechanism and occupational prolonged exposure to vapours of peracetic acid-HP mixtures caused symptoms which were the consequence of a sustained irritation process rather than a real asthmatic reaction. Basic aid: decontamination and symptomatic treatment is warranted. No specific antidote is known. Eyes: In case of contact with eyes rinse thoroughly with water. Contact a physician immediately. Skin: Remove contaminated clothes. Wash affected body areas carefully with plenty of water and soap. Ingestion: Rinse out mouth and give plenty of water to drink. Do not induce vomiting. Inhalation: Ensure supply of fresh air. Contact a physician as necessary. Depending on severity of effects
Specific treatment in case of an accident or poisoning: first aid measures and medial treatment
Prognosis following poisoning Summary ADI (acceptable daily intake, external long-term reference dose)
AELacute/medium/long-term
AEClocal dermal short/medium-term
Jet 5 12134 N
Value n.a.; peracetic acid is not systemically available n.a.; peracetic acid is not systemically available 0.2%
Study
Safety factor
Human volunteer study
None
14
AEClocal dermal long-term
0.1%
AECinhalation
0.23 mg/m3 (0.075 ppm)
ARfD
n.a.; peracetic acid is not systemically available
Rabbit one year study RD10 0.6 ppm in Sensory irritation study in mice (Gagnaire et al. 2002, Doc. No. 592-048; Doc IIIA, A6.1.3/04)
2 8
Drinking water limit Reference value for dermal absorption
100 % as default
Local effects Peracetic acid is a corrosive substance and produces local effects after acute and repeated exposure. Peracetic acid quickly decomposes at the site of contact and does not become systemically available, therefore the risk assessment will be based on local effects. Data requirements active substance No additional data requirements are identified. 6.1
Human exposure assessment active substance
6.1.1 General aspects Jet 5 is a liquid formulation (relative density 1.1) containing 220 g/L hydrogen peroxide and 55 g/L peracetic acid as active substances. Currently the formulation is authorized for the use against green algae (authorization number 12134N). The extension of the authorization is requested for the use against bacteria and yeasts in greenhouses, warehouses and storage facilities; against bacteria and yeasts on concrete floors, cultivation tables, irrigation mats, drop systems, plant containers, sprig boxes, gardener chests, anti-root towels and tools in the cultivation of agricultural and garden plants; against bacteria and yeasts on the equipment used in the grubbing up, transporting and processing of potatoes; and against bacteria and yeasts on surfaces and materials in the cultivation of edible mushrooms (with the use in cultivation rooms during the cultivation period and in storage rooms where mushrooms are currently stored being prohibited). The formulation will be applied by coarse spraying, brushing or dipping. The maximal dose level is 2% (200 mL formulation diluted in 10 L water) for the contact time of 5 minutes and 1.5% (150 mL formulation diluted in 10 L water) for the contact time of 30 minutes. The formulation Jet 5 is intended for professional use only. 6.1.2
Identification of main paths of professional exposure towards active substance from its use in biocidal product The professional user can be dermally and respiratory exposed to hydrogen peroxide and peracetic acid during the preparation of the in-use dilution of the formulation and the subsequent application via coarse spraying or brushing. Respiratory exposure is considered
Jet 5 12134 N
15
possible in view of high vapour pressure of active substances (hydrogen peroxide: 214 Pa at 20 ºC, peracetic acid: 1410 Pa at 20 ºC). As Jet 5 is intended for professional use only, oral exposure is considered negligible. 6.1.3
Identification of main paths of non-professional exposure towards active substance from its use in biocidal product The formulation Jet 5 is intended for professional use only. 6.1.4 Indirect exposure as a result of use of the active substance in biocidal product Both hydrogen peroxide and peracetic acid are expected to react quickly with organic matter on the surface and decompose. Secondary respiratory exposure of bystanders during the application of Jet 5 cannot be excluded due to high volatility of hydrogen peroxide and peracetic acid. However, this exposure is expected to be lower than the exposure of professional users during the application of the formulation. 6.2
Human health effects assessment product
6.2.1 Toxicity of the formulated product No studies with the formulation have been submitted, and classification and labelling has been prepared based on the calculation rules according to Regulation 1272/2012/EC. 6.2.2 Data requirements formulated product No additional data requirements are identified. 6.3
Risk characterisation for human health
6.3.1 Professional users Professional users may be potentially dermally and respiratory exposed to active substances hydrogen peroxide and peracetic acid during mixing and loading of Jet 5 and during the disinfection by coarse spraying, brushing or dipping. During the mixing and loading professional users may be exposed to the undiluted formulation, corresponding to 5.0% peracetic acid and 20% hydrogen peroxide. During the actual disinfection process professional users may be exposed to the 2% formulation as the highest in-use dilution, corresponding to 0.1% peracetic acid and 0.4% hydrogen peroxide. Both hydrogen peroxide and peracetic acid cause primarily local effects by exposure; therefore risk assessment will be based on local effects. As professional users will be exposed repeatedly to the formulation, the resulting exposure will be compared with the long-term AEClocal dermal for peracetic acid and 8-hour TWA for hydrogen peroxide. Mixing and loading During mixing and loading, the concentrations of hydrogen peroxide and peracetic acid in undiluted formulation are above the AEClocal dermal of 3% for hydrogen peroxide and 0.1% for peracetic acid. Therefore the use of personal protective equipment (gloves, coverall) is prescribed for professional users during mixing and loading operations. To estimate potential respiratory exposure to hydrogen peroxide and peracetic acid during mixing and loading of undiluted Jet 5 Mixing and Loading Model 7 (corrected) for manual pouring of liquids is used according to HEEG Opinion 2008 (endorsed at TM I 2008). This model gives an indicative respiratory exposure of 0.94 mg biocidal product/m3, which corresponds to 0.047 mg/m3 peracetic acid and 0.188 mg/m3 hydrogen peroxide. These concentrations are below the 8-hour TWA of 0.262 mg/m3 for hydrogen peroxide and the Jet 5 12134 N
16
AEClocal inhalation of 0.23 mg/m3 for peracetic acid. The resulting risk indices are (0.188/0.262 =) 0.72 and (0.047/0.23 =) 0.20 for hydrogen peroxide and peracetic acid, respectively. Based on this no adverse effects are expected for protected (gloves, coverall) professional users from exposure to hydrogen peroxide and peracetic acid during mixing and loading operations with undiluted Jet 5. Application by coarse spraying, brushing and dipping During the application of the in-use dilution of Jet 5 by coarse spraying, brushing or dipping the in-use concentration of hydrogen peroxide (0.4%) is below the AEClocal dermal of 3%. Therefore no concern for adverse local dermal effects from exposure to hydrogen peroxide during application of Jet 5 by coarse spraying, brushing or dipping exists for unprotected professional user. However, the concentration of peracetic acid (0.1%) is equal to the AEClocal dermal long-term of 0.1%. Based on this adverse local dermal effects due to the exposure to peracetic acid during the application of the in-use dilution of Jet 5 by coarse spraying, brushing or dipping cannot be excluded. Therefore the use of personal protective equipment (gloves, coverall) is prescribed for professional users during the application of 2% solution of Jet 5 by coarse spraying, brushing or dipping. To estimate potential respiratory exposure to hydrogen peroxide and peracetic acid during the application of the in-use dilution of Jet 5 by coarse spraying, Spraying Model 1 (User Guidance v.1, 2002, p.31) is used. This model gives an indicative respiratory exposure of 104 mg biocidal product/m3. The in-use concentrations of hydrogen peroxide and peracetic acid are 0.4% and 0.1%, respectively. Therefore the resulting concentrations of hydrogen peroxide and peracetic acid in air are 0.416 mg/m3 and 0.104 mg/m3, respectively. For hydrogen peroxide, the estimated concentration is above the 8-hour TWA of 0.262 mg/m3; the resulting risk index is (0.416/0.262 = )1.59. Therefore the use of respiratory protective equipment is prescribed for professional user. As hydrogen peroxide causes only local effects by respiratory exposure, the use of respiratory protective equipment is considered to be sufficient to prevent these effects from occurring and to ensure a sufficient level of protection for professional users. The following sentence will be added to the WG/GA: “Wear suitable respiratory protective equipment during the application of Jet 5 by coarse spraying”. For peracetic acid, the resulting risk index is (0.104/0.23 = ) 0.45. Therefore no adverse local respiratory effects are expected for unprotected professional users during the application of the 2% in-use dilution of Jet 5 by coarse spraying. To estimate potential respiratory exposure to hydrogen peroxide and peracetic acid during the application of the 2% in-use dilution of Jet 5 by brushing, Surface Disinfection Model 1 (User Guidance v.1, 2002, p. 28) is considered to be the most appropriate. This model gives the indicative respiratory exposure of 22.9 mg biocidal product/m3, corresponding to 0.092 mg/m3 hydrogen peroxide and 0.023 mg/m3 peracetic acid. These concentrations are below the 8-hour TWA of 0.262 mg/m3 for hydrogen peroxide and the AEClocal inhalation of 0.23 mg/m3 for peracetic acid. The resulting risk indices are (0.092/0.262 =) 0.35 and (0.023/0.23 =) 0.10. Therefore no adverse local respiratory effects are expected for unprotected professional users during the application of 2% in-use dilution of Jet 5 by brushing. To estimate potential respiratory exposure to hydrogen peroxide and peracetic acid during the disinfection by dipping using the 2% in-use dilution of Jet 5, Dipping Model 4 (User Guidance v.1, 2002, p.27) was used in the first draft CAR of peracetic acid. The indicative inhalation exposure given by this model is 0.2 mg biocidal product/m3, which in case of the in-use dilution of Jet 5 corresponds to 0.0008 mg/m3 hydrogen peroxide and 0.0002 mg/m3 peracetic acid. These concentrations are significantly below the 8-hour TWA of 0.262 mg/m3 for hydrogen peroxide and the AEClocal inhalation of 0.23 mg/m3 for peracetic acid. The resulting risk indices are (0.0008/0.262 = ) < 0.01 and (0.0002/0.23 =) < 0.01. Therefore no adverse local respiratory Jet 5 12134 N
17
effects are expected for unprotected professional users during the disinfection by dipping using the 2% in-use dilution of Jet 5. In summary, based on the risk assessment, no adverse effects from dermal and respiratory exposure to hydrogen peroxide and peracetic acid are expected to protected (gloves, coverall) professional users during the mixing and loading operations with undiluted Jet 5. Based on the risk assessment, no adverse effects from dermal and respiratory exposure to hydrogen peroxide and peracetic acid are expected for protected (gloves, coverall, respiratory protective equipment) professional users due to the application of the 2% in-use dilution of Jet 5 by coarse spraying. Based on the risk assessment, no adverse effects from dermal and respiratory exposure to hydrogen peroxide and peracetic acid are expected for protected (gloves, coverall) professional users due to the application of the 2% in-use dilution of Jet 5 by brushing or dipping. 6.3.2 Indirect exposure as a result of use Both hydrogen peroxide and peracetic acid are expected to react quickly with organic matter on the surface and decompose. Secondary respiratory exposure of bystanders during the application of Jet 5 cannot be excluded due to high volatility of hydrogen peroxide and peracetic acid. However, this exposure is expected to be lower than the exposure of professional users during the application of the formulation. As no concern for the respiratory exposure of unprotected professional users exists during the application of Jet 5 by brushing or dipping, also no concern for bystander exposure exists. However, for the application by coarse spraying, the use of respiratory protective equipment is prescribed for professional users in order to prevent possible adverse local effects from respiratory exposure. As no respiratory protective equipment can be prescribed for bystanders, the following sentence should be added to the WG/GA: “During the disinfection by spraying no unauthorized people may be present in the facilities”. Combined exposure The formulation Jet 5 contains a mixture of two active substances, hydrogen peroxide and peracetic acid. The combined toxicological effect of these two active substances has not been investigated with regard to repeated dose toxicity. Possibly, the combined exposure to these active substances may lead to a different toxicological profile than the profiles based on the individual substances. However, both hydrogen peroxide and peracetic acid cause primarily local effects by exposure. Local effects are considered to be additive in nature. For dermal effects, the use of protective gloves and coverall is prescribed for professional users. For respiratory effects, for all types of application (with the exception of coarse spraying, for which the use of respiratory protective equipment is prescribed) the sum of the resulting risk indices is calculated to be below 1, as shown below: Mixing and loading: 0.72 + 0.20 = 0.92 Application by brushing: 0.35 + 0.10 = 0.45 Application by dipping: < 0.01 + < 0.01 = < 0.01 Based on this no concern for adverse effects by combined exposure to hydrogen peroxide and peracetic acid exists due to the application of Jet 5. 6.3.3 Substance of Concern The formulation Jet 5 contains 13% of a co-formulant which can be considered as a substance of concern. For this co-formulant, referred to as SoC Human Toxicology 1, a risk assessment is performed. For the risk assessment of SoC Human Toxicology 1, the same models as for the assessment of the active substance have been used. The risk assessment resulted in the following risk indices: Jet 5 12134 N
18
Mixing and loading: <0.01. Application by coarse spraying, brushing and dipping: 0.01, 0.01 and <0.01. Based on this assessment, no adverse effects from exposure to SoC Human Toxicology 1 is expected for unprotected professional user as a result of mixing and loading and the application of Jet 5 by coarse spraying, brushing and dipping. 6.4
Overall conclusions for the aspect human health
Based on this risk assessment, it was concluded that no adverse health effects are expected for the protected (gloves, suitable protective clothing, respiratory protective equipment) professional user after dermal and respiratory exposure to hydrogen peroxide and peracetic acid as a result of the application of Jet 5, when used in accordance to the WG/GA. The following sentences will be added to the WG/GA to minimize the professional user and bystander exposure: “Wear suitable respiratory protective equipment during the application of Jet 5 by coarse spraying” and “During the disinfection by spraying no unauthorized people may be present in the facilities”. Furthermore, when used according to the WG/GA, no adverse health effects are expected for the general public by indirect exposure to hydrogen peroxide and peracetic acid as a result of the application of Jet 5.
H.7.
Environment
7.1 Introduction An expansion of the authorisation is requested for the product Jet 5, which contains hydrogen peroxide (H2O2, 22% w/w) and peracetic acid (C2H4O3, 5.5% w/w) as active substances. In the current authorisation (12134 N), the product is permitted to be applied as a green algae remover in a use dosage of 1%. The requested expansion concerns the application of the product as a disinfectant (PT02 and PT04) for several uses (see table E1) in a dosage of 2%. The comparison and assessment will be performed qualitatively. The product is used by professionals only. The intended use, dosage of the product, and concentration in the diluted solution are summarised in Table E.1. The product does not contain any Substances of Concern for the environmental compartment. Table E.1 Intended uses of Jet 5 Product / area of use envisaged
Dosage product
Use concentration active substance (g/L) hydrogen peroxide
peracetic acid
PT02 and PT04 Disinfection in greenhouses, warehouses and storage facilities.
200 ml in 10L
4.4
1.1
Disinfection of concrete floors, cultivation tables, irrigation mats, drip systems (external), plant containers, nursery containers, nurseryman boxes, anti-root fabric and hand tools for the cultivation of agricultural and horticultural crops
200 ml in 10L
4.4
1.1
Jet 5 12134 N
19
Product / area of use envisaged
Dosage product
Use concentration active substance (g/L) hydrogen peroxide
peracetic acid
Disinfection of equipment used at harvest, transport and processing of potatoes
200 ml in 10L
4.4
1.1
Disinfection of walls, floors, shelving, nets, work corridors, ancillary areas, tools and equipment for the cultivation, empty cultivation spaces and empty cooling and storage spaces used in the cultivation of edible mushrooms
200 ml in 10L
4.4
1.1
7.3. Environmental exposure assessment product 7.3.1 Chemistry and/or metabolism In the product, and in the subsequent dilution, peracetic acid is in chemical equilibrium with hydrogen peroxide and acetic acid. Both hydrogen peroxide and peracetic acid are strong oxidising agents that react strongly with organic substances, resulting in water, free oxygen and acetic acid. Acetic acid is a natural occurring substance found in the environment, food, and organisms. The compound is readily biodegradable resulting in only carbon dioxide and water. Moreover, acetic acid disappears from soils within 2 days due to biodegradation and incorporation into humic or fulvic acids. Possible pH effects on the environment were not considered, because the receiving compartments are expected to have sufficient buffering. 7.3.2 Distribution in the environment Releases into the environment can take place at any stage of the life cycle of a product. The major routes of entry into the environment during application are listed in Table E.2. The relevant exposure routes are discussed below. Table E.2
PT PT02 PT04
PT02 PT04
PT02 PT04
PT02 PT04
Foreseeable routes of entry into the environment on the basis of the use envisaged
Use scenario Disinfection in greenhouses, warehouses and storage facilities. Disinfection of concrete floors, cultivation tables, irrigation mats, drip systems (external), plant containers, nursery containers, nurseryman boxes, anti-root fabric and hand tools for the cultivation of agricultural and horticultural crops Disinfection of equipment used at harvest, transport and processing of potatoes Disinfection of walls, floors, shelving, nets, work corridors, ancillary areas, tools and equipment for the cultivation, empty cultivation spaces and empty cooling and storage spaces used in the cultivation of edible mushrooms
Jet 5 12134 N
Environmental compartments and groups of organisms exposed STP Freshwater* Saltwater* Soil** Air ++
(+)
-
++
-
++
(+)
-
++
-
++
(+)
-
++
-
++
(+)
-
++
-
20
++ + -
Compartment directly exposed Compartment indirectly exposed Compartment not exposed
* **
Including sediment Including groundwater, non-target arthropods and bees. 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.
After disinfection, waste water holding residues of the product are predominantly discharged to the sewer and via the sewage treatment plant (STP) eventually end up in surface water. Direct release to the soil compartment is possible due to spillage or leaching after application near a porous floor/surface. 7.4 Risk characterisation for the environment 7.4.1 Water and sediment organisms and micro-organisms in the STP Considering the active substances’ mode of action, negligible amounts will reach the STP as the active substances are being consumed during disinfection. Once released to the sewer the remaining amounts of hydrogen peroxide and peracetic acid rapidly decrease due to oxidation with the excess organic matter present in the sewer pipeline system. Oxidation continues once the product arrived in the STP as half-lives reported for both compounds are less than 2 minutes. The concentrations in the STP’s effluent are expected to be negligible. In view of this, a low risk for aquatic organisms, sediment organisms, and micro-organisms in the STP, surface water, and sediments is expected. Direct exposure of the product to the surface water should be avoided, due to the acute effects of the active substances on aquatic organisms in the direct proximity of the release. Additionally, release of the product or it’s dilution to an private on-site waste water treatments (In Dutch: Individuele Behandeling Afvalwater (IBA) may result in malfunction of the waste water treatment system, as high loads of hydrogen peroxide and peracetic acid may kill the microbial population instantly because of the system’s limited volume (3-6 m³). Degradation in the IBA’s sewer is not expected as it is short and not fully loaded with organic material. 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 microorganisms in the STP. 7.4.2 Monitoring data (surface water) The Pesticide Atlas on internet (www.pesticidesatlas.nl) is checked to evaluate measured concentrations of pesticides in Dutch surface water. There are however, no data available in the Pesticide Atlas regarding the presence of the substances hydrogen peroxide and peracetic acid in surface water. 7.4.3 Surface water intended for the abstraction of drinking water Biocidal products with the active substances hydrogen peroxide and peracetic acid have been on the market for more than three years. The existing active substances are 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. In addition, none of the active substances are included on 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 for all products.
Jet 5 12134 N
21
7.4.4 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 hydrogen peroxide and peracetic acid contribute to the depletion of the ozone layer, as the compounds are not listed as ‘controlled substance’ listed in Annex I of Regulation (EC) No 1005/2009 of the European Parliament. Moreover, AOPwin calculates a half life in air for hydrogen peroxide of 16 hours and for peractic acid of 32 hours (OH timeframe 24 hrs/day, 0.5×106 OH radicals/cm3). These calculated half lives are below the trigger of < 2 days, which is used as cut off value to identify chemicals that could be of potential concern for long range transport through the atmosphere. Considering this, the environmental risk to air is deemed acceptable. 7.4.5 Terrestrial compartment Soil organisms and non target arthropods (including bees) No half lifes are available for the degradation of peracetic acid and hydrogen peroxide in soil. Considering that the active substances quickly (minutes) react with the organic material in the soil possible exposure to the soil compartment will therefore not result in a risk to soil organisms. The exposure of bees is considered negligible as bees are not considered to forage where the product is applied. Moreover, both compounds can not accumulate in plants and exposure of bees via pollen is considered negligible. Therefore, risk for soil organisms, non target arthropods and bees are considered negligible and the standards for the terrestrial environment are met when the products is applied in accordance to the WG/GA. 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. An exceeding of the drinking water criterion is not expected considering the the biochemical profile (quick degradation once release to the environment) of the compounds. Leaching to shallow groundwater will be negligible and therefore the standards for groundwater are met. Persistence in soil Hydrogen peroxide and peracetic acid are chemically instable and highly reactive oxidants. Hence, the active substances are not persistent and the standards for persistence (DT50 <180 days) are met. 7.4.6 Non compartment specific effects relevant to the food chain Bioconcentration Logarithmic octanol-water partition coefficients (log Kow) are -1.5 for hydrogen peroxide and 0.52 for peracetic acid. As the log Kow for both substances are < 3, the risk for bioconcentration in aquatic organisms is considered low. Bioconcentration and secondary poisoning are not likely to occur with strongly oxidative compounds. The risk for bioconcentration in the proposed use is therefore considered not relevant. The standards for bioaccumulation are met. Primary and secondary poisoning of birds and mammals For the proposed use of the active substances direct or indirect exposure of birds and mammals to the active substance or contaminated aquatic and terrestrial organisms is considered negligible as the active substances have a low potential to bioaccumulate. The risk for the primary and secondary poisoning is considered acceptable and the proposed applications meets the standards for birds and mammals.
Jet 5 12134 N
22
7.5 Measures to protect the environment (risk mitigation measures) The aquatic risk assessment concludes that there is no risk when the remaining product is discharged to the sewer, or alternatively to a slurry pit. Risks for micro-organisms in on-site STPs (IBA’s in Dutch) and subsequent malfunction of the water treatment are expected when high amounts of the active substances enter the system. Therefore, a precautionary measure will be added to the WG/GA (see next section) 7.6 Overall conclusion for the aspect environment Based on the available data, it can be concluded that the product Jet 5 complies with the environmental standards and will not cause unacceptable effects on the environment when used in accordance with the proposed label (WG/GA) on the condition that waste water is disposed to the sewer connected to the STP or the manure storage. Therefore, the following precautionary measure will be added to the WG/GA: Possible residues containing the product must be discharged to the slurry pit or to a municipal STP. It is not allowed to discharge this product to an on-site wastewater treatment system. Om bodem- en in het waterlevende organismen te beschermen dienen resten die het middel bevatten uitsluitend te worden afgevoerd naar het riool met aansluiting op de RWZI of de mestopslag. In geen geval mag dit middel worden geloosd op een Individuele Behandeling Afvalwater (IBA). . 7.7 Data requirements There are no additional data required. 7.8 References 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 Competent Authority Report on peracetic acid (PT1-6), December 2012 European Union Risk Assessment Report. Hydrogen peroxide. 2nd Priority list, volume 38. European Commission Joint Research Centre, EUR 20844 EN, Luxembourg, 2003 IUCLID dataset. Peracetic acid. February 19th, 2000. http://esis.jrc.ec.europa.eu/doc/existing-chemicals/IUCLID/data_sheets/79210.pdf Lijst met probleemstoffen voor de bereiding van drinkwater uit oppervlaktewater, VEWIN, 2013, http://www.vewin.nl/probleemstoffen RIVM, 2010: Biociden in oppervlaktewater voor drinkwaterproductie., National institute for public health and the environment, RIVM-report 601712007/2010, Bilthoven, The Netherlands
H.8. Conclusion The applicant has proven that Jet 5, 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 (Art. 121 jo art. 49 first paragraph Dutch 2007 Plant Protection Products and Biocides Act).
H.9. Classification and labelling Since the product has not been changed, labelling was not adjusted.
Jet 5 12134 N
23
