﷡﷡﷡﷡﷡

Toelatingsnummer 13279 N

Intra Hydrocare

13279 N

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

1 UITBREIDING TOELATING

Gelet op de aanvraag d.d. 24 februari 2010 (20100199 UB) van

Intracare B.V.

Voltaweg 4

5466 AZ VEGHEL

tot uitbreiding van de gebruiksdoeleinden van de toelating voor de biocide, op basis van de werkzame stof waterstofperoxide

Intra Hydrocare

gelet op artikel 121, eerste lid, jo. artikel 44, eerste lid, Wet gewasbeschermingsmiddelen en biociden,

BESLUIT HET COLLEGE als volgt:

1.1 Uitbreiding

1. Het gebruiksgebied van het middel Intra Hydrocare wordt met ingang van datum dezes uitgebreid met de toepassing bestrijding van bacteriën (exclusief bacteriesporen), gisten en schimmels in leidingsystemen door middel van vullen:

a. welke in contact kunnen komen met eet- en drinkwaren en de grondstoffen hiervoor, echter met uitzondering van melkwinningsapparatuur op de boerderij, leidingsystemen in keukens in ziekenhuizen en overige instellingen voor gezondheidszorg en drinkwatersystemen.

b. leidingsystemen in industrie, echter met uitzondering van drinkwatersystemen.

c. waterinstallaties in de veterinaire sector (water voor consumptie door vee, proceswater, waterwinning-, opslag- en distributiesystemen), echter met uitzondering van drinkwatersystemen.

Voor de gronden waarop dit besluit berust wordt verwezen naar bijlage II bij dit besluit.

2. De toelating geldt tot 1 januari 2020.

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 onder A 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:	gehalte:
waterstofperoxide	590 g/l

letterlijk en zonder enige aanvulling:

andere zeer giftige, giftige, bijtende of schadelijke stof(fen):

gevaarsymbool:	aanduiding:
Xn	Schadelijk
N	Milieugevaarlijk

Waarschuwingszinnen:

R22 -Schadelijk bij opname door de mond.

R37/38 -Irriterend voor ademhalingswegen en de huid.

R41 -Gevaar voor ernstig oogletsel.

R51/53 -Vergiftig voor in het water levende organismen; kan in het aquatisch milieu op lange termijn schadelijke effecten veroorzaken.

Veiligheidsaanbevelingen:

S23d -Spuitnevel niet inademen.

S26 -Bij aanraking met de ogen onmiddellijk met overvloedig water afspoelen en deskundig medisch advies inwinnen.

S36/37/39d-NL-Draag geschikte beschermende kleding, handschoenen en een beschermingsmiddel voor de ogen bij het verdunnen.

S46 -In geval van inslikken onmiddellijk een arts raadplegen en verpakking of etiket tonen

S49 -Uitsluitend in de oorspronkelijke verpakking bewaren.

S61 -Voorkom lozing in het milieu. Vraag om speciale instructies / veiligheidsgegevenskaart.

Specifieke vermeldingen:

1) 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:

§ letterlijk en zonder enige aanvulling:
het wettelijk gebruiksvoorschrift
De tekst van het wettelijk gebruiksvoorschrift is opgenomen in Bijlage I, onder A.

§ 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

2.1 Aanvraag

Het betreft een aanvraag tot uitbreiding van het gebruiksgebied van het middel Intra Hydrocare (13279 N), een middel op basis van de werkzame stof waterstofperoxide. Het middel is bij besluit van 8 januari 2010 reeds toegelaten als middel ter bestrijding van niet sporenvormende bacteriën, gisten en schimmels op:

1. Oppervlakken en materialen, welke in contact kunnen komen met eet- en drinkwaren en de grondstoffen hiervoor, echter met uitzondering van melkwinningsapparatuur op de boerderij en keukens in ziekenhuizen en overige instellingen voor gezondheidszorg.

2. Oppervlakken en materialen, in ruimten bestemd voor het verblijf van mensen, echter met uitzondering van ziekenhuizen en overige instellingen voor gezondheidszorg.

3. Oppervlakken en materialen, in ruimten bestemd voor dieren en bijbehorende ruimten.

4. Het uitwendige en inwendige oppervlak van installaties die in contact komen met water voor veterinair gebruik (proceswater, water winning-, opslag- en distributiesystemen, waterinstallaties).

Het middel is bij dit besluit toegelaten tot 1 januari 2020. Met onderliggende aanvraag wordt toelating gevraagd als middel ter bestrijding van bacteriën (exclusief bacteriesporen), gisten en schimmels in leidingsystemen door middel van vullen:

1. welke in contact kunnen komen met eet- en drinkwaren en de grondstoffen hiervoor, echter met uitzondering van melkwinningsapparatuur op de boerderij, leidingsystemen in keukens in ziekenhuizen en overige instellingen voor gezondheidszorg en drinkwatersystemen.

2. leidingsystemen in industrie, echter met uitzondering van drinkwatersystemen.

3. waterinstallaties in de veterinaire sector (water voor consumptie door vee, proceswater, waterwinning-, opslag- en distributiesystemen), echter met uitzondering van drinkwatersystemen.

2.2 Informatie met betrekking tot de stof

Er zijn in Nederland reeds andere middelen op basis van de werkzame stof waterstofperoxide toegelaten.

De werkzame stof waterstofperoxide is genotificeerd voor productsoort 1,2,3,4,5,6,11,12 en wordt door Finland beoordeeld. Er is geen concept van de Europese beoordeling beschikbaar.

Er is nog geen besluit genomen tot plaatsing van de werkzame stof op bijlage 1 of 1A van de biociderichtlijn 98/8/EG

2.3 Karakterisering van het middel

Het betreft een desinfectiemiddel op basis van de oxidant waterstofperoxide.

2.4 Voorgeschiedenis

De aanvraag is op 26 februari 2010 ontvangen; op 1 april 2010 zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 26 augustus 2010 is de aanvraag in behandeling genomen.

2.5 Eindconclusie

Bij gebruik volgens het gewijzigde Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is de uitbreiding voor de gevraagde doeleinden van het middel Intra Hydrocare op basis van de werkzame stof waterstofperoxide voldoende werkzaam en heeft het geen schadelijke uitwerking op de gezondheid van de mens en het milieu (artikel 28, eerste lid, Wet gewasbeschermingsmiddelen en biociden).

Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 119, eerste lid, Wet gewasbeschermingsmiddelen en biociden en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College voor de toelating van gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 217, 6700 AE WAGENINGEN. Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld.

Wageningen, 8 oktober 2010

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN,

dr. D. K. J. Tommel

voorzitter

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

BIJLAGE II bij het besluit d.d. 8 oktober 2010 tot uitbreiding van de toelating van het middel Intra Hydrocare, toelatingnummer 13279 N

RISKMANAGEMENT

Contents Page

H.1. Introduction. 2

H.2. Identity. 2

H.3. Physical and chemical properties. 2

H.4. Analytical methods for detection and identification. 3

H.5. Efficacy. 3

H.6. Human toxicology. 7

H.7. Environment 9

H.8. Conclusion. 11

H.9. Classification and labelling. 12

H.10. References. 12

H.1. Introduction

H.1.1 Applicant

Intracare B.V.

H.1.2 Active substance

Hydrogen peroxide

H.1.3 Product

Intra Hydrocare

H.1.4 Function

Intra Hydrocare is a disinfectant based on hydrogen peroxide (590 g/l, 49.5% w/w).

H.1.5 Background to the application

This is an application for the extension of the field of use of the biocide Intra Hydrocare

H.1.6 Intended uses

The proposed extension of the field of use of Intra Hydrocare is the control of bacteria (excluding spore-forming bacteria), yeasts and fungi:

In pipe systems by means of filling

1. which can be in contact with food and drinks and raw material with the exception of milking equipment on farms and pipe systems in kitchens in hospitals and other institutes for health care and drinking water systems

2. in industry with the exception of drinking water systems

3. which can be in contact with water for veterinary purposes (water supply for the consumption by cattle, process water, storage and distribution systems) with the exception of drinking water systems

These uses are included in PT2, PT3 and PT4.

H.1.7 Packaging details

The product is marketed in 10 L HDPE cans.

H.2. Identity

Since the composition of Intra Hydrocare does not change, the assessment concerning identity was not performed.

H.3. Physical and chemical properties

Since the composition of Intra Hydrocare does not change, the assessment concerning physical and chemical properties was not performed.

Upon request by the applicant the classification of the product was reassessed. It was determined that in the previous assessment the rules O and R8 were wrongly assigned to the product and will be removed. As a result of this the rules S17 and S35 can also be removed from the product classification.

H.3.4 Classification and labeling of the biocidal product concerning physical and chemical properties

H.3.4.1 Proposal for the classification of the active substance

Symbol:	O	Indication of danger: oxidising
R-phrases	8	Contact with combustible material may cause fire.

H.3.4.2 Proposal for the classification of the biocidal product

Professional use:

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):

Symbol:	-	-	-
R phrases	-	-
S phrases	S49	Keep only in the original container
Special provisions: DPD-phrases	-	-

Explanation:
Hazard symbol:	-
Risk phrases:	-
Safety phrases:	-
Other:	-

H.4. Analytical methods for detection and identification

Since the composition of Intra Hydrocare does not change, the assessment concerning analytical methods for detection and identification was not performed.

H.5. Efficacy

H.5.1 Function

Intra Hydrocare is a disinfectant based on hydrogen peroxide (590 mg/ml, 49.5% w/w).

H.5.2 Field of use envisaged

The proposed extension of the field of use of Intra Hydrocare is the control of bacteria (excluding spore-forming bacteria), yeasts and fungi:

In pipe systems by means of filling

2. in industry with the exception of drinking water systems

These uses are included in PT2, PT3 and PT4.

H.5.3 Effects on target organisms and efficacy

H.5.3.1 Efficacy data

H.5.3.1.1. Data requirements

To demonstrate the efficacy of Intra Hydrocare for pipe work disinfection the following organisms should be tested:

organism	Private or Medical sector Pt 2	Veterinary sector Pt 3	Food sector Pt 4
Bacteria	-Staphylococcus aureus ATCC 6538; - Enterococcus faecium DVG 8582 or Enterococcus hirae ATCC 10541 - Pseudomonas aeruginosa ATCC 15442; - Proteus mirabilis ATCC 14153 or Escherichia coli K12 NCTC 10538 (=DSM11250)	- Staphylococcus aureus ATCC 6538; - Salmonella typhimurum ATCC 13311; or Escherichia coli K12 NCTC 10538 (=DSM11250) - Pseudomonas aeruginosa ATCC 15442; - Enterococcus faecalis NCTC 8213 or Enterococcus hirae ATCC 10541	See medical sector
Yeast	Candica albicans ATCC 10231.	Candida albicans ATCC 10231.	- Saccharomyses cerevisiae ATCC 9763; for milking equipment: - Candida albicans ATCC 10231
Fungi	conidiospores of Aspergillus fumigatus Fres. or A. niger ATCC 16404 or ATCC 64958	See medical sector	See medical sector

Norms and criteria for phase 2, step 1 tests:

Disinfectants	Bacteria Log reduction (time)	Yeasts log reduction (time)	Fungi log reduction (time)
Pt 2. public and medical sector	5 (5 min)	5 (5 min)	4 (5 min)
Pt 3 veterinary sector (animal sector);	4 (5 min)	4 (5 min)	3 (5 min)
Pt 4 Food industry/ institutional (institutes etc)	5 (5 min)	4 (5 min)	4 (5 min)

In the cleaning of surfaces a contact time of 5 minutes has been set because active substances in disinfectants are only efficient as long as the product is not evaporated and the treated surface is still wet. However, when treatment takes place in pipe work contact time can be much longer as in this case no evaporation of the product takes place.

For disinfection of drinking water systems a field trial is required in which efficacy against Legionella is proven. Such a test has not been provided. Thus drinking water systems should be exempted on the WG/GA. However, water systems of the veterinary sector functioning as water supply for the consumption by cattle may be mentioned on the WG/GA.

H.5.3.1.2. Data submitted

The applicant provided suspensions tests similar to EN 1276 for the standard bacteria and EN 1650 and EN1657 for yeast and fungi.

Bacteria:

The two bacterial species Salmonella typhimurium ATCC 13311 and Enterococcus faecalis NCTC 8213 have not been tested. This is acceptable as for the earlier authorization procedure of this product an EN 1656 test including these species has been provided, in which sufficient efficacy against those two species has been demonstrated. For the present authorization procedure Escherichia coli ATCC 10536 has been tested as surrogate for Salmonella typhimurium ATCC 13311. Enterococcus hirae ATCC 10541 has been tested as surrogate for Enterococcus faecalis NCTC 8213.

All provided tests are conducted with organic load for both “clean” surfaces (with interfering substance 0,3 g/l bovine albumin) and “dirty” surfaces (with interfering substance 3 g/l bovine albumin), at room temperature (20^oC). For the standard tests designed for PT 3 (veterinary area) the organic loads are higher: interfering substance 3 g/l bovine albumin for “low level soiling” and interfering substance 10 g/l bovine albumin and 10 g/l yeast extract for “high level soiling”. Soiling means in this case contamination with feces (bacteria). Thus for PT 3 only “low level soiling” has been tested. This is acceptable as for the veterinary sector use is claimed for external and internal surfaces that come into contact with water for the veterinary use, which can be considered low level soiling.

Yeasts and Fungi:

All required strains have been tested. In EN 1650 Candida albicans ATCC 10231 and Aspergillus niger ATCC 16404 have been tested under both “clean” and “dirty” conditions. In EN 1657 Saccharomyces cerevisiae ATCC 9763 and Aspergillus niger ATCC 16404 have been tested with organic load for both “low level soiling” and “high level soiling”. All tests are done at room temperature (20^oC).

Overview of test results:

Test	Test organism	Contact time (minutes)	Concentration of the product tested (%)	Log Reduction clean conditions	Log Reduction dirty conditions
Bacteria
EN 1276	Enterococcus hirae ATCC 10541	30 45 60 75 90 105 120 135 150	3% in all tests		< 2,7 < 2,7 3,3 6,2 > 7,2 > 7,2 > 7,2 > 7,2 > 7,2 > 7,2
EN 1276	Enterococcus hirae ATCC 10541	75	3%	>6.7	>6.7
EN 1276	Escherichia coli ATCC 10536	75	3%	>6.5	>6.5
EN 1276	Staphylococcus aureus ATCC 6538	75 90	3% in all tests	3,0 5,6	1,9 5,5
EN 1276	Pseudomonas aeruginosa ATCC 15442	75	3%	>6.5	>6.5
Yeasts
EN 1657	Saccharomyces cerevisiae ATCC 9763	180 240 300	3% in all tests	1,9 3,0 >5,9	1,0 0,9 >5,9
EN 1650	Candida albicans ATCC 10231	120 180 300	3% in all tests	2,1 >5,3 >5,3	1,1 4,1 >5,3
Fungi
EN1650 & EN1656	Aspergillus niger ATCC 16404	90 120	3% in all tests	4,1 4,8	4,4 4,8

H.5.3.2 Humaneness: effect on target vertebrates

Because no vertebrates are controlled, this point is not relevant.

H.5.3.3 Evaluation of data

The available information was sufficient to evaluate the efficacy of Intra Hydrocare for pipe system disinfection considering the evaluation is done under article 121 of the WGB. The tests show that Intra Hydrocare complies with the criteria for log reduction for bacteria, yeasts and fungi with the contact times stated in the WG/GA.

When the claimed dose rate of 3% is tested, a log 5 reduction or higher for bacteria is found within 90 minutes. For the yeasts Saccharomyces cerevisiae and Candida albicans a log 5 reduction or higher is found with a dose rate of 3% in combination with a contact time of 300 minutes. The efficacy against fungi is demonstrated with a dose rate of 3% and a contact time of 90 minutes.

No data on Legionella are provided therefore use in drinking water installations should be excluded.

H.5.3.4 Evaluation of the WG/GA

No data on Legionella are provided therefore use in drinking water installations should be excluded. The term ‘drinkwater’ in Dutch is used for drinking water for humans.

H.5.4 Mode of action

Hydrogen peroxide

The disinfection mechanism of hydrogen peroxide is based on the release of free oxygen radicals. Free oxygen radicals decompose pollutions, and only water remains. Free radicals have both oxidising and disinfecting abilities. Hydrogen peroxide eliminates proteins through oxidation. The efficiency of hydrogen peroxide depends on several factors, such as pH, catalysers, temperature, peroxide concentration and reaction time.

H.5.5 Limitations on efficacy including resistance

H.5.5.1 General limitations

According to the applicant the product should not be used in combination with other cleaning or disinfectant agents. Therefore, this should be mentioned in the WG/GA.

H.5.5.2 Resistance

No data was submitted on the possible occurrence of resistance of target organisms to hydrogen peroxide, only a statement saying there is no resistance reported.

The mechanism of action of hydrogen peroxide is that of a general oxidiser. Oxidisers will react with essential macromolecules that make up microbial life, including the oxidation of various proteins, carbohydrates, lipids and nuclear acids. Due to this activity, oxidizers will have dramatic effects on the structure and function of micro-organisms. This is such a general reaction to so many different molecules that it is very unlikely that an organism will develop a resistance mechanism for that.

H.5.5.3 Resistance management strategies

No management strategy was submitted.

H.5.6 Overall conclusions

The available information was sufficient to evaluate the efficacy of Intra-Hydrocare, considering that the authorisation is done under article 121 of the WGB. Based on the data submitted it can be concluded that Intra Hydrocare, when used in accordance with the proposed label, may be expected to be effective in controlling bacteria (excluding spore-forming bacteria), yeasts and fungi

· In pipe systems which can be in contact with food and drinks and raw material with the exception of milking equipment on farms and pipe systems in kitchens in hospitals and other institutes for health care and drinking water systems.

· In pipe systems in industry with the exception of drinking water systems.

· In pipe systems which can be in contact with water for veterinary purposes (water supply for the consumption by cattle, process water, storage and distribution systems) with the exception of drinking water systems.

H.6. Human toxicology

6.1 Product application

An application has been submitted for the extension of the authorisation of the biocidal product Intra Hydrocare, for the control of bacteria, yeasts and fungi in private and public area (PT2), in veterinary hygiene (PT3), and in food and feed area (PT4) containing 49.5% hydrogen peroxide.

Intra Hydrocare is already authorized for the same PT groups (PT2, 3 and 4) for the use on surfaces, this application considers the use of Intra Hydrocare in piping systems.

6.2 Toxicity of the formulated product

The toxicity of the formulated product does not change.

6.3 Risk characterisation for human health

Intra Hydrocare is already authorized to be used for the disinfection of surfaces. The dosage is 25% Intra Hydrocare (generates a 12.4% hydrogen peroxide solution) with at least 5 minutes contact time. For disinfection of piping systems (this application), the dosage is 3% Intra Hydrocare (generates a 1.5% hydrogen peroxide solution) with 90 (bacteria) or 300 (yeasts) minutes contact time. As the piping systems are closed systems and a lower dosing is used, the exposure of the operator is lower compared to the surface disinfection. Furthermore, after use of Intra Hydrocare, both surfaces and piping systems have to be rinsed with clean tap water until no hydrogen peroxide can be measured (using test strips). Therefore, secondary exposure of the general public to hydrogen peroxide residues is considered to be negligible.

Based on the risk assessment for Intra Hydrocare (13279N), no adverse health

effects are expected for the protected (gloves, suitable protective clothing and eye/face protection) professional user after dermal and respiratory exposure, including the general public, to hydrogen peroxide as a result of the application of Intra Hydrocare. The personal protective equipment is prescribed considering the skin and eye irritation properties of the active substance. As the exposure of the professional operator when used for piping systems is lower compared to the already authorized surface disinfection and secondary exposure of the general public is considered negligible, this conclusion also applies for using Intra Hydrocare in piping systems.

6.4 Overall conclusions

Based on the comparable risk assessment, it was concluded that no adverse health effects are expected for the professional user, including the general public, after dermal and respiratory exposure to hydrogen peroxide as a result of the application of Intra Hydrocare, when used in accordance to the WG/GA.

6.5 Classification and labelling of the formulation concerning health

6.5.1 Proposal for the classification of the active substance

Symbol:

Indication of danger: Corrosive

Risk phrases	R20/R22	Harmful by inhalation and if swallowed.
	R35	Causes severe burns

6.5.2 Proposal for the classification and labelling of the formulation concerning health

The current classification can be maintained.

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):
-
Symbol:	Xn	Indication of danger:	Harmful
R phrases	R22	Irritating to eyes.
	R37/38	Irritating to respiratory system and skin.
	R41	Risk of serious damage to eyes.
S phrases	S23d	Do not breathe spray.
	S26	In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
	S36/37/39d	Wear suitable protective clothing, gloves and face protection.
	S46	If swallowed, seek medical advice immediately and show this container or label.
Special provisions: DPD-phrases	-	-
Plant protection products phrase: DPD-phrase	-	-
Child-resistant fastening obligatory?			n.a.
Tactile warning of danger obligatory?			n.a.

Explanation:
Hazard symbol:	-
Risk phrases:	-
Safety phrases:	S1/2 is not assigned to formulations intended for professional use only. S28 and S45 are not obligatory in combination with the assigned R-phrase(s).
Other:	-

H.7. Environment

7.1 Legislative framework

Authorisation is requested for an extension of the application of the biocidal product Intra Hydrocare. Intra Hydrocare is applied as a PT2 (Private area and public health area disinfectants), PT3 (Veterinary hygiene biocidal products) and PT 4 (Food and feed area disinfectants) disinfection product. The proposed field of use of Intra Hydrocare is the control of bacteria (excluding spore-forming bacteria and legionella), yeasts and fungi.

The risk assessment is done in accordance with Chapter 10 of the RGB [transition period for guideline 98/8/EC] for products based on active substances which have not yet been placed on Annex I of Directive 98/8/EC.The active substance in the product Intra Hydrocare is hydrogen peroxide.

Hydrogen peroxide is a bulk chemical not placed on Annex I yet. The product is used all year round indoors by professionals only.

Intra Hydrocare is currently authorised (13279 N) for the cleaning of surfaces with a dosage of 25% v/v of the product. An expansion of the authorised applications is requested for the use of a dosage of 3% v/v of the product in piping systems. An overview of the uses is listed in Table M.0.

Table M.0 Overview of intended uses (in bold information on the requested additional application is stated)

No.	Application	Application product	Dosage active substance
1.	on surfaces in accommodations for people, with the exception of hospitals and other institutes for health care (PT2) in piping systems	Dilute 2,5 liter Intra Hydrocare with 10 liter tapwater. The dosage is 25% v/v product	25% = 147, 5 g/l 3% = 17.7 g/l
2.	on surfaces in accommodations for animals, annexes and vehicles for transport of animals (PT3) in piping systems	Dilute 2,5 liter Intra Hydrocare with 10 liter tapwater. The dosage is 25% v/v product	25% = 147, 5 g/l 3% = 17.7 g/l
3.	on surfaces which can be in contact with food and drinks with the exception of milking equipment on farms and kitchens in hospitals and other institutes for health care (PT4) in piping systems	Dilute 2,5 liter Intra Hydrocare with 10 liter tapwater. The dosage is 25% v/v product	25% = 147, 5 g/l 3% = 17.7 g/l

The TBE-procedure prescribes that a simplified regime is accepted for the environmental aspect if the requested applications of Intra Hydrocare have a similar risk. It must be determined whether no additional risk for the environment is expected for the requested applications in comparison with the already authorised applications of the product Intra Hydrocare. As part of the simplified procedure comparability of the existing and the requested application is assessed 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 (issued in a several paragraphs); (section 7.4)

7.2 Evaluation

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 risk of the use of the requested applications in comparison with the authorised applications is comparable.

2. Use concentrations

The use concentration of the active substance in the expanded application in piping systems is more than 8 times lower than the concentration of the active substance in the authorised applications. Considering this, the environmental risk of the requested and the authorised applications is expected to be comparable.

3. Emission to air, STP, surface water and soil for the application phase, the in-service phase and the waste phase of the product;

Releases into the environment can take place at any stage of the life cycle of a product.

The application phase consists of adding the product to surfaces, materials, equipment or piping systems with release to the STP after the prescribed contact time. The in-service phase is the period that the product expresses its disinfection properties. The waste phase is the phase when the product is removed to the sewer and may enter surface water via the STP.

For the proposed use as a PT2 (Private area and public health area disinfectants), PT3 (Veterinary hygiene biocidal products) and PT 4 (Food and feed area disinfectants) disinfection product, the relevant emission route for environmental exposure is discharge via the STP to surface water (waste phase).

The organic load in the sewer will rapidly and completely transform hydrogen peroxide to harmless substances such as oxidation products, H₂O and O₂. Product residues will not reach the STP, as the active substance will be removed in the sewer.

7.3 Risk characterisation for the environment

In the risk assessment of the authorised applications for the product Intra Hydrocare

it was concluded that potential releases to the environment are considered not substantial.

Since the release pathways are the same (indoor use) and the emission to the receiving compartments is considered not substantial for both the requested applications and the authorised applications, it can be concluded that Intra Hydrocare, when used in accordance with the proposed label (WG/GA), complies with the environmental standards and will not cause unacceptable effects on the environment.

7.4 Evaluation of precaution and risk mitigation measures in the WGGA

No measures to protect the environment (risk mitigation measures) are required.

7.5 Overall conclusion

Based on a comparable risk assessment, it can be concluded that the product Intra Hydrocare, 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 Classification and Labelling

Proposal for the classification and labeling of the active substance hydrogen peroxide (symbols and R phrases)

Symbol:

Indication of danger: -

R phrases

Proposal for the classification and labelling of the formulation concerning the environment

Based on the profile of the substance, the provided toxicology of the preparation and the characteristics of the co-formulants, the following labeling of the preparation is proposed:

Symbol:	N	Indication of danger:	Dangerous for the environment.
R phrases	R51/53	Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

S phrases	S61	Avoid release to the environment. Refer to special instructions/safety data sheets.
Special provisions (DPD-phrases) :	-	-

Explanation:
Hazard symbol:	Classification based on silver nitrate, present as co-formulant (stabilizer). Based on LC50 of 0.011 mg NaNO3 /L for algae and the triggers laid down in 2006/08/EC the product is classified with N, R51/53
Risk phrases:	Classification based on silver nitrate, present as co-formulant (stabilizer). Based on LC50 of 0.011 mg NaNO3 /L for algea and the triggers laid down in 2006/08/EC the product is classified with N, R51/53
Safety phrases:	S1/2 is not assigned to formulations intended for professional use only. S28 and S45 are not obligatory in combination with the assigned R-phrase(s). S61 is assigned to biocidal products for professional use with R51/53
Other:	-

H.8. Conclusion

The applicant has proven that Intra Hydrocare, 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

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):

Symbol:	Xn	Indication of danger:	Harmful
	N	Indication of danger:	Dangerous for the environment.
R phrases	R22	Irritating to eyes.
	R37/38	Irritating to respiratory system and skin.
	R41	Risk of serious damage to eyes.
	R51/53	Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
S phrases	S23d	Do not breathe spray.
	S26	In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
	S36/37/39d	Wear suitable protective clothing, gloves and face protection.
	S46	If swallowed, seek medical advice immediately and show this container or label.
	S49	Keep only in the original container.
	S61	Avoid release to the environment. Refer to special instructions/safety data sheets.

Explanation:
Hazard symbol:	Classification based on silver nitrate, present as co-formulant (stabilizer). Based on LC50 of 0.011 mg NaNO3 /L for algae and the triggers laid down in 2006/08/EC the product is classified with N, R51/53
Risk phrases:	Classification based on silver nitrate, present as co-formulant (stabilizer). Based on LC50 of 0.011 mg NaNO3 /L for algea and the triggers laid down in 2006/08/EC the product is classified with N, R51/53
Safety phrases:	S61 is assigned to biocidal products for professional use with R51/53
Other:	-

H.10. References

No references are available.