HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

Toelatingsnummer 14408 N

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN 1 TOELATING Gelet op de aanvraag d.d. 21 december 2012 (20130001 TB) van BODE CHEMIE GmbH MELANCHTHONSTRASSE 27 22525 HAMBURG DUITSLAND

tot verkrijging van een toelating als bedoeld in artikel 49, eerste lid, Wet gewasbeschermingsmiddelen en biociden voor de biocide, op basis van de werkzame stof ethanol, Sterillium Gel pure gelet op artikel 121, eerste lid, jo. artikel 44, eerste lid, Wet gewasbeschermingsmiddelen en biociden,

BESLUIT HET COLLEGE als volgt: 1.1 Toelating 1. Het middel Sterillium Gel pure is toegelaten voor de in bijlage I genoemde toepassingen onder nummer 14408 N met ingang van datum dezes. Voor de gronden van dit besluit wordt verwezen naar bijlage II bij dit besluit. 2. De toelating geldt tot 1 april 2024. 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.

Sterillium Gel pure 14408 N

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1.4 Classificatie en etikettering Gelet op artikel 50 Wet gewasbeschermingsmiddelen en biociden worden voorschriften gegeven. Dit leidt tot de volgende voorschriften: De aanduidingen, welke moeten worden vermeld, worden hierbij vastgesteld als volgt: aard van het preparaat: Andere vloeistoffen voor directe toepassing werkzame stof: ethanol

gehalte: 85,0 %

de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel: PICTOGRAM(MEN) pictogram: GHS02-ontvlambaar SIGNAALWOORD Gevaar Gevarenaanduidingen H225

Licht ontvlambare vloeistof en damp.

Voorzorgsmaatregelen P210

Verwijderd houden van warmte/vonken/open vuur/hete oppervlakken. — Niet roken. P233 In goed gesloten verpakking bewaren. P301 + P310 NA INSLIKKEN: Onmiddellijk een ANTIGIFCENTRUM of een arts raadplegen. P305 + P351 + P338 BIJ CONTACT MET DE OGEN: voorzichtig afspoelen met water gedurende een aantal minuten; contactlenzen verwijderen, indien mogelijk. Blijven spoelen. P337 + P313 Bij aanhoudende oogirritatie: een arts raadplegen. P501 Inhoud/verpakking afvoeren naar inzamelpunt voor gevaarlijk of bijzonder afval.

Behalve de 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.


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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.

2 DETAILS VAN DE AANVRAAG Het betreft een aanvraag tot verkrijging van een toelating van het middel Sterillium Gel pure (14408 N), een middel op basis van de werkzame stof ethanol. Het middel wordt aangevraagd als middel voor: • hygiënische handdesinfectie, ter bestrijding van bacteriën (excl. bacteriënsporen), mycobacteriën, gisten en schimmels; • chirurgische handdesinfectie, ter bestrijding van bacteriën (excl. bacteriënsporen), mycobacteriën, gisten, schimmels en virussen voor gebruik in ziekenhuizen en overige instellingen voor gezondheidszorg en laboratoria. 2.2 Informatie met betrekking tot de stof Er zijn in Nederland reeds andere middelen op basis van de werkzame stof ethanol toegelaten. Ethanol staat nog niet op de Unielijst van werkzame stoffen volgens de biocidenverordening EU 528/2012. 2.3 Karakterisering van het middel Sterillium Gel Pure is een middel op basis van de werkzame stof ethanol. Ethanol vertoont een non-specifiek werkingsmechanisme. Het tast de buitenmembraan aan waardoor er verstoring van de membraanfluiditeit en lekkage optreedt, en het dringt het cytoplasma binnen en verstoort de structuur van celmoleculen en plasma-eiwitten. Dit leidt tot verlies van celactiviteit en uiteindelijke celdood. 2.4 Voorgeschiedenis De aanvraag is op 20 december 2012 ontvangen; op 16 januari 2013 zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 21 januari 2013 is de aanvraag in behandeling genomen. Op 14 januari 2014 zijn aanvullende vragen gesteld. Deze zijn op 28 januari 2014 ontvangen. 2.5 Eindconclusie Bij gebruik volgens het Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is het middel Sterillium Gel pure op basis van de werkzame stof ethanol voldoende werkzaam en heeft het geen schadelijke uitwerking op de gezondheid van de mens en het milieu.


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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, 7 maart 2014 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN,

ir. J.F. de Leeuw voorzitter


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HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE I bij het besluit d.d. 7 maart 2014 tot toelating van het middel Sterillium Gel pure, toelatingnummer 14408 N A. WETTELIJK GEBRUIKSVOORSCHRIFT

Toegestaan is uitsluitend het gebruik als middel voor: • hygiënische handdesinfectie, ter bestrijding van bacteriën (excl. bacteriënsporen), mycobacteriën, gisten en schimmels; • chirurgische handdesinfectie, ter bestrijding van bacteriën (excl. bacteriënsporen), mycobacteriën, gisten, schimmels en virussen voor gebruik in ziekenhuizen en overige instellingen voor gezondheidszorg en laboratoria. De gebruiksaanwijzing zoals opgenomen onder B. moet worden aangehouden. Het middel is uitsluitend bestemd voor professioneel gebruik. B. GEBRUIKSAANWIJZING Het middel onverdund op schone en droge handen opbrengen d.m.v. handpompje of dispenser. Hygiënische handdesinfectie De droge handen gedurende 30 seconden inwrijven met 3 ml Sterillium Gel pure. Ook de vingertoppen, duimen, gebieden tussen de vingers en polsen moeten grondig met het middel worden ingewreven. Zorg dat de handen gedurende de gehele inwerktijd vochtig blijven. Daarna niet afspoelen. Dosering: 3 ml Bij gebruik handpompjes: 2x pompen, bij gebruik dispensers: instellen op 1,5 ml per slag, 2 slagen voor 3 ml Minimale inwerktijd: 30 seconden Chirurgische handdesinfectie Sterillium Gel pure op de droge handen en onderarmen opbrengen en inwrijven, zodat alle huid bedekt wordt. Zorg dat de handen en onderarmen gedurende de gehele inwerktijd van 1,5 minuut vochtig blijven (gebruik ca. 2 keer 3 ml). Daarna niet afspoelen. Dosering: tenminste 2 x 3 ml. Bij gebruik handpompjes 4x pompen, dispensers instellen op 1,5 ml per slag, 4 slagen voor 6 ml. Minimale inwerktijd: 1,5 minuut NB: - contact met de ogen vermijden.


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HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE II bij het besluit d.d. 7 maart 2014 tot toelating van het middel Sterillium Gel pure, toelatingnummer 14408 N RISKMANAGEMENT

Contents Page H.1. Introduction ................................................................................................................. 3 H.2. Identity ........................................................................................................................ 3 H.3. Physical and chemical properties ................................................................................ 4 H.4. Analytical methods for detection and identification ...................................................... 5 H.5. Efficacy ....................................................................................................................... 5 H.6. Human toxicology ....................................................................................................... 9 H.7. Environment ............................................................................................................. 10 H.8. Conclusion ................................................................................................................ 13 H.9. Classification and labelling ........................................................................................ 14 H.10. References ........................................................................................................... 14


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H.1.

Introduction

H.1.1 Applicant BODE CHEMIE GmbH H.1.2 Ethanol

Active substance

H.1.3 Product Sterillium Gel Pure H.1.4 Function Hygienic and surgical hand disinfection (PT01) H.1.5 Background to the application Application for authorisation of a new biocidal product H.1.6 Intended uses The product is intended to be used for hygienic and surgical hand disinfection (PT01) H.1.7

Packaging details

Product in HDPE (50 ml, 100 ml, 475 ml, and 1 L) H.2.

Identity

H.2.1 Identity of the active substance Common name Ethanol Name in Dutch Ethanol Chemical name Ethanol CAS no 64-17-5 EC no 200-578-6 The active substance ethanol is considered a bulk chemical. Therefore, limited data is required because the properties of ethanol are well documented. The applicant is allowed to use the IUCLID database of this active substance. Ethanol used is denatured with methylethylketone (MEK). The minimum purity, of the ethanol formulated, is 99%. H.2.2 Identity of the biocidal poduct Name Sterillium Gel Pure AL Formulation type Content active substance Ethanol: 85% w/w Packaging information: Material Professional use HDPE

Size / content 50 ml, 100 ml, 475 ml, 1 L

Other information PP screw cap

H.2.3 Overall conclusions identity The identity of the active substances and the biocidal product is sufficiently described.


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Data requirements None.

H.3.

Physical and chemical properties

H.3.1 Physical and chemical properties of the active substance Regarding the physical and chemical properties of ethanol, please refer to the published IUCLID dossier. H.3.2 Physical and chemical properties of the biocidal product Appearance Transparent, colourless and slightly viscous liquid, alcoholic smelling Explosive properties Not explosive Oxidative properties Not oxidising Autoflammability Not auto flammable 17°C Flashpoint pH 1% solution 8-9 (neat) Particle size distribution Not applicable Surface tension Not applicable Viscosity Not applicable Relative density 0.82 Storage stability/Shelf life/Packaging A shelf life study in HDPE (100 ml, 475 ml and 975 ml) was carried out at 25°C during 60 months. Checked parameters: appearance, refraction index, density, pH, 2-butanon content, ethanol content, viscosity, weight loss, appearance packaging, microbiologic purity The 100 ml bottle was initially slightly convex, later convex. The 475 ml bottle was initially slightly concave, later slightly convex. The 975 ml bottle was initially slightly concave, later slightly convex. The changes in the packaging did not negatively affect the quality of the product.

Technical properties Physical and chemical compatibility

Based on test results a shelf life of 60 months can be assigned. Not applicable Not applicable

The shelf life of the product is 5 years in HDPE. H.3.3 Overall conclusions physical and chemical properties The physical and chemical properties of the active substances and the biocidal product are sufficiently described by the available information. Data requirements None.


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H.4.

Analytical methods for detection and identification

H.4.1 Analytical methods for the technical active substance Ethanol is a bulk chemical. No detailed information on analytical methodology for determination of the purity of the active substance is required. H.4.2 Analytical methods for analysis of the biocidal product Preparation (principle of method) GC-FID The product contains a polymer which may result in issues using a GC-FID method for the determination of ethanol in Sterillium Gel Pure. A statement was provided by the applicant that dilution with methanol during sample preparation will solve this problem. Although this will allow the material to be brought onto the column, polymers are not expected to evaporate, possibly resulting in damage to the column. Evidence that the method used does not negatively influence the column’ performance was set as a data requirement. The applicant has sufficiently shown that the presence of a small amount of polymer does not negatively influence the performance of the GC-FID column. H.4.3 Residue analytical methods Ethanol is a bulk chemical. No detailed information on analytical methodology for residue analysis of the active substance is required. As ethanol is a common chemical, sufficient data is publicly available to determine ethanol in environmentally relevant matrices. H.4.4 Overall conclusions methods of analysis The submitted analytical methods meet the requirements. Data requirements H.5. Efficacy H.5.1 Function Sterillium Gel pure is a disinfectant based on ethanol 85% w/w. H.5.2 Field of use envisaged The proposed field of use of Sterillium Gel pure is the control of bacteria (excluding bacterial spores), mycobacteria, yeasts, fungi and viruses for hygienic and surgical hand disinfection in health care institutions (including hospitals) and laboratories. These uses are included in PT01. The product is intended for professional use. H.5.3 Efficacy data submitted and evaluation of data 24 Studies were provided of which 12 studies were considered to be relevant and these were used in this assessment. These are summarised in Table 1. Some of the studies assessed were performed with another formulation of Sterillium Gel. The applicant confirms that there was no indication that the antimicrobial activity or in vivo efficacy of this formulation is different to Sterillium Gel pure. This explanation is acceptable.


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Table 1. Summary of studies assessed Test (version) Phase, step prEN 13727 (2009) 2, 1

Test organism

Test parameters

Staphylococcus aureus Enterococcus hirae Pseudomonas aeruginosa Escherichia coli

EN 1500 (1997) 2,2 Hyg. hand disinf.

Escherichia coli NCTC 10538

Concentration (%): 20; 50 and 80% v/v Interfering substances: 0.3 g/L BSA (clean) and 3 g/L BSA + 3 ml sheep erythr. (= dirty for medical) Contact time: 15 sec; 30 sec; 60 sec; 5 min Test temperature: 20°C Product, undiluted: 3 ml / 30 sec Ref: Propan-2-ol 60% v/v: 2x3 ml / 60 sec

Results*

All species, log R>5: 80 %; Dirty conditions 15 sec; 20°C

Product: logR = 4,97 Reference: logR = 4,79 Test passed

EN 1500 (1997) 2,2 Hyg. hand disinf.


n =15 Test with and without prior use of 1 ml care product Baktolan lotion (contact time 2 min, further waiting time to disinfection 3 min)

Product with Baktolan lotion logR = 5,31

without Baktolan lotion: Product, undiluted: 3 ml / 30 sec logR = 5,15 Ref: Propan-2-ol 60% v/v: 2x3 ml / 60 sec

Reference: logR = 4,96

n =15 EN 1500 (1997) 2,2 Hyg. hand disinf.


Test with and without prior use of 1 ml care product Baktolan balm (contact time 2 min, further waiting time to disinfection 3 min) Product, undiluted: 3 ml / 30 sec Ref: Propan-2-ol 60% v/v: 2x3 ml / 60 sec

Product with Baktolan balm logR = 5,05 without Baktolan balm: logR = 5,15 Reference: logR = 4,96 Test passed

EN 12791 (2005) 2,2 Surgical handdisinf.

Normal skin flora

n =15 Product, undiluted 2x3 ml / 2 x 45 sec (= 1.5 min) Ref. Propan-1-ol, 60%: 9 ml/3 min. n = 20

Product: logR = 1.94 immediate log R = 1.86 after 3 h Reference: logR = 2.13 logR = 1.68 P is less than R


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Test Test organism (version) Phase, step

prEN 13624 (2010) 2, 1

Candida albicans

EN 14348 (2005) 2, 1

Mycobacterium terrae

EN 14348 (2005) 2, 1

Mycobacterium terrae Mycobacterium avium

prEN 13624 (2010) 2, 1

Aspergillus brasiliensis (formerly niger)

prEN 14476 (2011) 2, 1

Adenovirus type 5

prEN 14476 (2011) 2, 2

Poliovirus


Test parameters

Concentration (%): 20; 80; 97% Interfering substances: 0.3 g/L BSA (clean); 3.0 g/L BSA + 3.0 ml sheep erythr (dirty, medical) Contact time: 15 sec; 30 sec; 60 sec Test temperature: 20°C Concentration (%): 20: 50 and 80% Interfering substances: 0.3 g/L BSA (clean) 3 g/L BSA + 3 ml sheep erythr (dirty) Contact time: 15 sec and 30 sec Test temperature: 20°C Concentration (%): 20: 50 and 80% Interfering substances: 0.3 g/L BSA (clean) 3 g/L BSA + 3 ml sheep erythr. (dirty) Contact time: 15 sec, 30 sec and 60 sec Test temperature: 20°C Concentration (%): 20; 80 and 97% Interfering substances: 0.3 g/L BSA (clean) 3 g/L BSA + 3 ml sheep erythr. (dirty) Contact time: 15 sec; 30 sec; 60 sec; 2 min; 3 min; 5 min Test temperature: 20°C Concentration (%): 10%, undiluted (80% and 97%) Interfering substances: 0.3 g/L BSA (clean) Contact time: 30, 60, 90 and 120 sec Test temperature: 20°C Concentration (%): 10%, undiluted (80% and 97%) Interfering substances: 0.3 g/L BSA (clean) Contact time:

Results*

After statistical testing (p=0.1): no significant difference Test passed log R>4: 80 % v/v; Dirty conditions 15 sec; 20°C

log R>4: 80 %; Dirty 15 sec; 20°C

log R>4: 80 %; Dirty 15 sec; 20°C

log R>4: 97 %; Dirty 30 sec; 20°C

log R>4: 80% (undiluted) Clean 60 sec; 20°C

log R>4: 97% Clean 30 sec; 20°C

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Test Test organism (version) Phase, step

prEN 14476 (2011) 2, 2

Murine Noro virus

Test parameters

30, 60 and 120 sec Test temperature: 20°C Concentration (%): 10%, 80% (undiluted) and 97% Interfering substances: 0.3 g/L BSA (clean) Contact time: 15, 30 and 60 sec Test temperature: 20°C

Results*

log R>4: 80% (undiluted) Clean 15 sec; 20°C

The available information was sufficient to evaluate the efficacy of Sterillium Gel pure for control of bacteria (excluding bacterial spores), mycobacteria, yeasts, fungi and viruses, considering that the evaluation is done under article 121 of the WGB. Bacteria, mycobacteria, yeast, fungi Both the quantitative suspension tests and the simulated use tests show that the criteria for lg reduction for hygienic and surgical handdisinfection for the key species of the claimed target organisms were met, when used in accordance with the instructions described on the WG/GA. All phase 2, step 1 tests were carried out (and passed) with low and high level soiling conditions for the medical area. Viruses Sufficient virucidal efficacy was demonstrated against the standard virus organisms at a contact time of 60 seconds. This is in accordance with the intended use of surgical hand disinfection where a contact time of minimum 90 seconds is claimed and acceptable. However, for hygienic hand disinfection the claimed (and realistic) contact time is 30 seconds. Therefore, the claim of virucidal efficacy for hygienic handdisinfection is not acceptable. Humaneness: effect on target vertebrates Because no vertebrates are controlled, this point is not relevant. Evaluation of the label (WG/GA) The applicant has provided a WG/GA in Dutch. This has been adapted to our standards. • the use against viruses for hygienic hand disinfection has been removed as sufficient virucidal efficacy has not been demonstrated at a contact time of 30 seconds. H.5.4 Mode of action Ethanol exhibits an unspecific mechanism of effect. It affects the outer cell membrane causing alteration of membrane fluidity and leakage, enters the cytoplasm and destroys the inner structure of the cell molecules and of the cytoplasm’s proteins. This process (referred to as denaturation) and the enzymes’ coagulation leads to a loss of cellular activity resulting in the cell’s death. Ethanol rapidly inactivates the target microorganisms without time delay due to the unspecific mode of action (topical disinfectant). The time required for sufficient inactivation is strongly depending on the formulation, concentrations of ethanol contained in the applied biocidal product, the type of target organisms and on the specific use conditions. H.5.5 Limitations on efficacy including resistance General limitations No limitations are mentioned.


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Resistance Resistances are not reported. As ethanol is not specific for just one cellular target but interferes with membrane integrity and denatures proteins, the development of true resistances is not to be expected. H.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 Sterillium Gel pure, when used in accordance with the proposed label (WG/GA), is effective in controlling • bacteria (excluding bacterial spores), mycobacteria, yeasts and fungi for hygienic hand disinfection by handrub • bacteria (excluding bacterial spores), mycobacteria, yeasts, fungi and viruses for surgical hand disinfection in the public health area (including hospitals) and laboratories. The use against viruses for hygienic hand disinfection has been removed as sufficient efficacy was not demonstrated at the required contact time of 30 seconds.

H.6.

Human toxicology

6.1

Product application

An application has been submitted for the authorisation of the biocidal product Sterillium Gel Pure, a ready-to-use liquid for both hygienic disinfection and surgical disinfection of hands and forearms for professional users (PT1). The product contains 85% ethanol as active substance. 6.2

Toxicity of the formulated product

No studies with the formulation have been submitted and the classification and labelling of the formulation has been prepared based on the calculation method described in Annex I of Regulation 1272/2008/EC. 6.3

Risk characterisation for human health

Sterillium Gel Pure is intended to be used for hygienic disinfection and surgical disinfection of hands and forearms for professional users. In this risk assessment Sterillium Gel Pure is compared to the reference product Sterillium Med (13451 N). The active substance concentration of both products are only marginally different (85% vs 84.15%) and the intended uses are identical, therefore a comparative assessment can be performed. Based on the risk assessment for Sterillium Med, no adverse health effects are expected for the unprotected professional user after dermal and respiratory exposure to ethanol as a result of the application of Sterillium Med. Furthermore, in the risk assessment of Sterillium Med it was concluded that secondary or indirect exposure to the bystander by touching freshly disinfected hands (skin) is not probable. Subsequently, no adverse health effects are expected for the general public after indirect exposure to ethanol by the use of Sterillium Med. Considering the identical intended uses and similar concentration, exposure to ethanol will be the same for the professional users and the general public after the application of Sterillium Gel pure and therefore the conclusions for Sterillium Med can also be applied to the risk assessment for Sterillium Gel pure.


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6.4

Overall conclusions for the aspect human health

Based on the comparable risk assessment, it was concluded that no adverse health effects are expected for unprotected professional user, including the general public, after dermal and respiratory exposure to ethanol as a result of the application of Sterillium Gel pure, when used in accordance to the WG/GA. H.7.

Environment

7.1 Introduction Authorisation is requested for the product Sterillium Gel Pure. The product concerns a human hygiene biocidal product (PT1). The active substance in the product, ethanol, is not included in Annex I of directive 98/8/EC and no reviewed list of endpoints is available in the EU. The Board considers that ethanol is a bulk chemical (C157.4; May 2005) therefore accepts publicly available data from IUCLID. The data in the IUCLID sheet is however the same data submitted under the biocidal directive. Bode Chemie GmbH is part of the ethanol task force which submitted data for the IUCLID sheet and for the biocidal directive. The risk assessment is performed in accordance with Chapter 10 of the RGB [Transition period for directive 98/08/EC] for products based on active substances which have not been placed on Annex I of directive 98/8/EC. The notifier indicated that it is possible to make a comparative assessment to assess the environmental fate and the eco-toxicological risk of the product Sterillium Gel Pure, comparing the use with reference product Sterillium med (13451 N). The latter product is used as a disinfectant of hands / forearms for professional and non-professional users and for surgical disinfection of hands/forearms for professional users. The comparative assessment procedure prescribes that a simplified regime is accepted for the environmental aspect if the requested authorisation of Sterillium Gel Pure has a similar risk. It must be determined whether no additional risk for the environment is expected for Sterillium Gel Pure in comparison with the already authorised product Sterillium med. As part of the simplified procedure comparativeness of the referred and the requested application are tested for the following aspects: 1. The type and scale of the use; 2. Use concentrations; 3. Emission to air, STP, surface water and soil for the application phase, the in-service phase and the waste phase of the product; 4. Risk assessment (section 7.3); 5 Risk mitigating methods (section 7.4). 7.2 Evaluation The intended use of Sterillium Gel Pure and the reference product Sterillium med is described in table E.1. The evaluation is based on a comparison of the practical use and emission routes of both products.


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Table E.1. Overview of intended use Requested application Sterillium Gel Pure Product Disinfection of hands / forearms description for professional users Surgical disinfection of hands/forearms for professional users. Organisms to be bacteria (incl. mycobacteria), controlled fungi (moulds and yeasts) and viruses (enveloped and nonenveloped viruses).

Reference product Sterillium med Disinfection of hands / forearms for professional users Surgical disinfection of hands/forearms for professional users. bacteria, fungi (moulds and yeasts) and viruses

Ethanol

Ethanol

85%

85%

Ready to use Indoor

Ready to use Indoor

Purpose of the product

Hygienic hand disinfection

Hygienic hand disinfection

Professional / non-professional

for professional users in health care areas

for professional users in health care areas

Active substance(s) (a.s) concentration a.s. in product Dosage Indoor/outdoor

1. The type and scale of the use Comparison of the type and scale of use is performed qualitatively only. From the intended use can be derived that the professional use of Sterillium Gel Pure is similar as compared with the professional use of Sterillium med against target organisms like pathogenic bacteria, fungi (moulds and yeasts) and viruses. There is some difference in target species considered efficacious, but this does not influence the type nor scale of use. 2. Use concentrations Use concentration of the active substance in the reference product is the same as the concentration of the active substance in Sterillium Gel Pure (85%). Considering this, the environmental risk of Sterillium Gel Pure and Sterillium med is expected to be similar. 3. Emission to air, STP, surface water and soil for the application phase, the in-service phase and the waste phase of the product; Various phases in the life cycle of a product may cause emissions and environmental exposure. Emissions from active substance production and product formulation are considered less relevant compared to emissions from the application phase, in service and waste phase of the product. Application phase and in-service phase The application phase consists of adding the product to hands and forearms of the nurses and patients. The in-service phase is the period that the product expresses its disinfection properties. The applicant indicates that for hygienic hand disinfection at least 3 ml are rubbed into the dry hands for 30 seconds. A nurse may use this product up to 36 times a day. For Sterillium Gel pure 14408 N

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surgical disinfection, at least 12 ml are rubbed into dry hands for 1.5-2 minutes, which might occur up to 5 times a day. The waste phase is the phase when the product is removed. There is no release to the STP after the prescribed contact time as the intended use states that the ethanol should completely be evaporated into the air. The latter two phases are considered relevant for the environmental risk assessment. This is similar for both Sterillium Gel Pure and Sterillium med. Waste phase For Sterillium Gel Pure and Sterillium med which are applied indoors, releases to the environment occur in the waste phase to air, due to evaporation and ventilation of the product. Emission to the STP and secondary compartments surface water/sediment via STP effluent is considered negligible. Emission to soil is considered negligible. The foreseeable routes of entry into the environment during the application phase, service life and waste phase are listed in Table E.2. Table E.2.

Foreseeable routes of entry into the environment on the basis of the use envisaged Environmental compartments and groups of organisms exposed STP Freshwater* Saltwater* Soil** Air Birds and mammals + -

No

Use scenario

1

Disinfection of hands / forearms Compartment exposed (air) Compartment not exposed Including sediment Including groundwater, bees and non-target arthropods

+ * **

7.3 Risk characterisation for the environment In the risk assessment of the reference product Sterillium med (authorised on 04-05-2011) it was concluded that potential releases to the environment are considered not substantial. Application of the reference product, when used in accordance with the proposed label (WG/GA), complies with the environmental standards and will not cause unacceptable effects on the environment. Since the release pathways are the same (indoor use) and the emission to the receiving compartments is considered not substantial for both the requested application and the reference product, it can be concluded that Sterillium Gel Pure, when used in accordance with the proposed label (WG/GA), complies with the environmental standards and will not cause unacceptable effects on the environment. In Table E.3 an overview is presented of the qualitative risk assessment on basis of a comparison of the authorised applications and the potential risk of the requested applications. For each aspect the risk is assessed.


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Table E.3 overview of risks per environmental aspect Environmental Item Similar or Reasoning aspect lower risk? Aquatic organisms Direct / indirect Yes No direct emission to surface water exposure Indirect emission to surface water is similar Dosage Yes ‘’ ‘’ Frequency Yes ‘’ ‘’ Emission to STP Dosage (kg a.s. / Yes Emission is similar STP) Persistence NA No emission to soil Direct / indirect NA No emission to soil Soil organisms (soil micro-organisms exposure earthworms, plants) Dosage NA ‘’ ‘’ Frequency NA ‘’ ‘’ Non target arthropods Direct / indirect NA No emission to soil and bees exposure Leaching to Dosage NA No emission to soil groundwater Frequency NA ‘’ ‘’ Fraction applied NA ‘’ ‘’ to soil Birds, mammals Direct / indirect NA Birds and mammals are not exposure exposed directly or indirectly

Air N.A. = not applicable

Dosage Frequency Emission

NA NA Yes

‘’ ‘’ ‘’ ‘’ Direct emission to air

7.4 Evaluation of precautionary and risk mitigation measures in the WGGA No risk mitigation measures are required. 7.5 Overall conclusion Based on a comparable risk assessment, it can be concluded that the product Sterillium Gel Pure, when used in accordance with the proposed Legal Instructions for Use (WG/GA), complies with the environmental standards and will not cause unacceptable effects on the environment. 7.6 References USEPA IUCLID EU

USEPA RED document on aliphatic alcohols (1995) EPA 738-R-95-013 IUCLID data sheet of ethanol EU summary dossier of ethanol (RMS DE)

H.8. Conclusion The applicant has proven that Sterillium Gel Pure, 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).


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H.9.

Classification and labelling

Proposal for the classification and labelling of the formulation Based on the profile of the substance, the provided toxicology of the preparation, the characteristics of the co-formulants, the method of application and the risk assessment for the operator, as mentioned above, the following labeling of the preparation is proposed: For professional use: The identity of all substances in the mixture that contribute to the classification of the mixture: Pictogram GHS02 Signal word DANGER Hazard H225 Highly flammable liquid and vapour. statements Precautionary P210 Keep away from heat/sparks/open flames/hot surfaces. No Statements smoking. P233 Keep container tightly closed. P301 + P310 IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician. P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P337 + P313 If eye irritation persists: Get medical advice/attention. P501 Dispose of contents/container to hazardous or special waste collection point. Supplemental Hazard information Child-resistant fastening obligatory? Not applicable Tactile warning of danger obligatory? Not applicable

Explanation: Pictogram: H-statements: P-statements:

P102 as proposed by applicant is not assigned as the product is only for professional use. Other: * according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)

H.10. References No references are available.


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HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

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