PRODUCT ASSESSMENT REPORT OF A BIOCIDAL PRODUCT …

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Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal

products

PRODUCT ASSESSMENT REPORT OF A

BIOCIDAL PRODUCT FAMILY FOR SIMPLIFIED AUTHORISATION APPLICATION (submitted by the evaluating Competent Authority)

Public

Biocidal product family: Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray family

Product types: PT3 (Veterinary hygiene)

Lactic acid is included in the Annex I of Regulation (EU) No. 528/2012

Case Number in R4BP3: BC-LK040031-56

Evaluating Competent Authority: Latvia

Date: 20/August/2019

LV Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray family PT 3

2

CONTENTS

1 CONCLUSION .......................................................................................... 3

2 ASSESSMENT REPORT .............................................................................. 4

2.1 Summary of the product assessment ..........................................................4 2.1.2 Administrative information.....................................................................4

2.1.2 Product family composition and formulation ........................................... 10 2.1.3 Hazard and precautionary statements .................................................. 11 2.1.4 Authorised use ............................................................................... 11

2.1.5 General directions for use ................................................................. 12 2.1.6 Other information ........................................................................... 13 2.1.7 Packaging of the biocidal products ....................................................... 13 2.1.8 Documentation ............................................................................... 14

2.2 Assessment of the biocidal product family .................................................. 15

2.2.1 Intended use ................................................................................. 15 2.2.2 Physical, chemical and technical properties ............................................ 15 2.2.3 Physical, chemical and technical properties ............................................ 20 2.2.4 Methods for detection and identif ication ................................................ 21 2.2.5 Eff icacy against target organisms ........................................................ 22

2.2.7 Risk assessment for the environment ................................................... 30 2.2.8 Measures to protect man, animals and the environment............................ 31

References ………………………………………………………………………………………………………………………………32


3

1 CONCLUSION

The ready-to-use biocidal products within Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray family, formulated by Ecolab Europe GmbH, with active

substance Lactic acid (CAS No. 50-21-5, EC No. 200-018-0) at the concentration range 4.0-4.4% w/w are authorised for product type 3 (disinfectants for veterinary hygiene) as teat disinfectants for post-milking treatment.

Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray family is claimed with bactericidal and yeasticidal activity. The biocidal products are intended for professional users.

Following evaluation, Latvian CA considers that Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray family meets the conditions laid down in Article 25 of the Regulation (EU) No 528/2012: - the active substance Lactic acid (CAS No. 50-21-5, EC No. 200-018-0) in

the biocidal products appears in Annex I and satisfy the restriction specified in that Annex;

- the biocidal products do not contain any substances of concern; - the biocidal products do not contain nanomaterials; - the biocidal products are effective;

- the handling of the biocidal products and those intended use do not require personal protective equipment.

A person placing on the market or using the biocidal products included in

Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray family must comply with the conditions for placing on the market or use of the above mentioned biocidal product family set out in authorisation letter issued by Latvian Competent Authority and Summary of Products Characteristics.

In accordance with Article 17(4) of the Regulation (EU) 528/2012 the authorisation number is valid from 10th June 2019 until 10th June 2029.


4

2 ASSESSMENT REPORT

2.1 Summary of the product assessment

2.1.1 Administrative information

2.1.1.1 Identif ier of the product family

Identifier Country

Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray family

EU

2.1.1.1.1 Trade names of the products within the family

Trade name Other trade name FlexiGard Spray

EASYgold

MEPA Easy Spray D DESINTEC MH-LactiSpray

QUARESS-Din

Valiant Everyday Ultra

2.1.1.2 Authorisation holder

Name and address of the authorisation holder

Name Ecolab Deutschland GmbH

Address Ecolab Allee 1 40789 Monheim am Rhein Germany

Authorisation number for

biocidal product family EU-0019205-0000

Authorisation numbers of the biocidal products within family

FlexiGard Spray EU-0019205-0001

EASYgold EU-0019205-0002

MEPA Easy Spray D EU-0019205-0003

QUARESS-Din EU-0019205-0004

Valiant Everyday Ultra EU-0019205-0005

Date of the authorisation 10th June 2019 Expiry date of the

authorisation 10th June 2029

2.1.1.3 Manufacturer of the products of the family

Name of manufacturer Ecolab Europe GmbH

Address of manufacturer Richtistrasse 7, 8304 Wallisellen, Switzerland

Location of manufacturing sites

A.F.P. GmbH AFP GmbH, 21337, Lueneburg, Germany

ACIDEKA S.A. Edif icio Feria. Capuchinos de Basurto 6, 4a planta 48013

Bilbao, Bizkaia, Spain

ADIEGO HNOS

Adiego Ctra De Valencia, 50410 Cuarte de Huerva (Zaragoza), Spain

ALLIED PRODUCTS Allied Hygiene Unit 11, Belvedere Industrial Estate


5

Fishers Way, Belvedere Kent, DA17 6BS, United Kingdom

ARKEMA GmbH Morschheimer Srtrasse 19 D-67292, Krichheimbolanden,

Germany

AZELIS DENMARK

Lundtoftegårdsvej 95 2800 Kgs. Lyngby, Denmark

BELINKA-LJUBLJANA

Belinka Zasavska Cesta, 95 1001, Ljubljana, Slovenija

BENTUS LABORATORIES LTD.

105005, Moscow, Radio Street, 24 Bld.1, Russia

BIO PRODUCTIONS Ltd

72 Victoria Road, West Sussex, RH15 9LH, United Kingdom

BIOXAL SA Route des Varennes - Secteur A – BP 30072, 71103 Chalon sur Saône Cedex, France

BORES S.R.L. Bores Srl Via Pioppa, 179 44030 Pontegradella (FE), Italy

BRENNTAG ARDENNES Route de Tournes CD n 2 FR-08090 Cliron, France

BRENNTAG CEE – GUNTRAMSDORF Blending Bahnstr. 13 A, 2353 Guntramsdorf, Austria

BRENNTAG Duisburg Am Röhrenwerk 4647529 Duisburg, Germany

BRENNTAG Glauchau Boschstraße 08371 Glauchau, Germany

BRENNTAG Hamburg Hannoversche Str. 40, 21079 Hamburg, Germany

BRENNTAG Heilbronn Dieselstraße 574076 Heilbronn, Germany

BRENNTAG Kaiserslautern Merkurstr. 47 67663 Kaiserslautern, Germany

BRENNTAG Kleinkarlbach Humboldtring 15 45472 Muehlheim, Germany

BRENNTAG Lohfelden Am Fieseler Werk 934253 Lohfelden, Germany

BRENNTAG Nordic – HASLEV Høsten Teglværksvej 47, 4690 Haslev, Denmark

BRENNTAG Nordic – VEJLE Strandgade 35, Vejle, Denmark

BRENNTAG Normandy 12 Sente des Jumelles - BP 11 76710 Montville, France

BRENNTAG PL – Zgierz ul. Kwasowa 5 95-100 Zgierz, Poland

BRENNTAG Quimica Calle Gutemberg 22 Poligono Industrial El Lomo. 28906 Getafe, Madrid, Spain

BRENNTAG Schweizerhall Elsaesserstr. 231 CH-4056 Basel Schweiz, Switzerland

BUDICH INTERNATIONAL GmbH


6

Dieselstrasse 10 32120 Hiddenhause, Germany

CALDIC DEUTSCHLAND CHEMIE B.V Karlshof 10 D 40231 Duesseldorf, Germany

CARBON CHEMICALS GROUP LTD Ringaskiddy, County Cork, Ireland

COLEP BAD SCHMIEDEBERG Kemberger Str. 3 06905 Bad Schmiedeberg, Germany

LANA, S.A. Condado de Treviño, 46 P.I. Villalonquejar 09080 –

Burgos, Spain

COMERCIAL GODO

França, 13 08700 –Barcelona, Spain

COURTOIS SARL

Route de Pacy 27730 BUEIL, France

DAN-MOR Natural Products and Chemicals Ltd.

Akiva,30600, Israel

DENTECK BV Heliumstraat 8, 2718 SL Zoetermeer, The Netherlands

DETERGENTS BURGUERA S.L. Joan Ballester, 50 07630 – Campos (Illes Baleares), Spain

ECL BIEBESHEIM Justus-von-Liebig-Straße 11, 64584 Biebesheim am Rhein, Germany

ECL CELRA Celra C/ Tramuntana s/n Poligona Industrial Celra 17460 Girona, Spain

ECL CHALONS Avenue Du General Patton 51000 Chalons En Champagne, France

ECL CISTERNA

Via Ninf ina II Cisterna di Latina, 04012, Italy

ECL FAWLEY

Fawley Cadland Road, Hythe, Southampton, Hampshire SO45 3NP, United Kingdom

ECL LEEDS Lotherton Way Garforth Leeds LS25 2JY, United Kingdom

ECL MANDRA 25th km Old National Road Of Athens To Thiva, Mandra 19600, Greece

ECL MARIBOR Vajngerlova 4, SI-2001 Maribor, Slovenia

ECL MICROTEK BV Gesinkkampstraat 19, 7051 Hr, Varsseveld, The Netherlands

ECL MICROTEK MOSTA F20 Mosta Technopark, Mosta Mst 3000, Malta

ECL MULLINGAR Forrest Park Zone C Mullingar Industrial Estate Mullingar Co. Westmeath, Ireland

ECL NIEUWEGEIN


7

Brugwal 11 A, 3432 Nz Nieuwegein, The Netherlands

ECL ROVIGO ESOFORM Viale del Lavoro 10 45100 Rovigo, Italy

ECL ROZZANO Via A. Grandi, 20089 Rozzano MI, Italy

ECL TESJOKI NLC Tesjoki Kivikummuntie 1, Tesjoki, 07955, Finland

ECL TESSENDERLO Industriezone Ravenshout 4, 3980, Belgium

ECL WEAVERGATE NLC Weavergate Northwich, Cheshire West and Chester

CW8 4EE, United Kingdom

ECOLAB LTD BAGLAN/SWINDON

Plot 7a Baglan Energy Park, Port Talbot SA11 2HZ, Baglan, United Kingdom

FERDINAND EIMERMACHER GMBH &CO.KG Westring 24 48356 Nordwalde, Germany

F.E.L.T. BP 64 10 rue du Vertuquet 59531 Neuville En Ferrain, France

GALLOWS GREEN SERVICES LTD. Cod Beck Mill Industrial Estate Dalton Lane Thirsk North Yorkshire YO7 3HR, United Kingdom

GERDISA GERMAN RGUEZ DROGAS IND Gerdisa Pol Industrial Miralcampo parc.37 19200 Azuqueca de Henares Guadalajara, Spain

GIRASOL NATURAL PRODUCTS BV De Veldoven 12-14 3342 GR Hendrik-Ido-Ambacht, The

Netherland

HENKEL ENGELS

413116 Engels Prospekt Stroitel, Saratov, Russia

IMECO GmbH & Co. KG Boschstraße 5 D-63768, Hösbach, Germany

INNOVATE GmbH Am Hohen Stein 11 06618 Naumburg, Germany

INTERFILL LLC-TOSNO 187000, Moskovskoye shosse 1, Tosno - Leningradskaya oblast, Russia

JODEL - PRODUCTOS QUIMICOS Jodel Zona Industrial 2050 Aveiras de Cima, Portugal

KLEINMANN GmbH Am Trieb 13 72820 Sonnenbühl Sonnenbühl, Germany

KOMPAK NEDERLAND BV 433651 NL, Bavel, The Netherlands

LA ANTIGUA LAVANDERA, S.L. Apartado de Correos 58, 41500, Sevilla, Spain

LABORATOIRES ANIOS Pavé du moulin, 59260 Lille-Hellemmes, France

LABORATOIRES ANIOS 3330 Rue de Lille, 59262 Sainghin-en-Mélantois, France


8

LICHTENHELDT GmbH

Lichtenheldt Industriestrasse 7-9 23812 Wahlstedt, Germany

LONZA GmbH Morianstr.32 42103 Wuppertal, Germany

MULTIFILL BV Constructieweg 25-A 3641 SB Mijdrecht, The Netherlands

NOPA NORDISK PARFUMERIVARE Hvedevej 2-22 DK-8900 Randers, Denmark

PAL INTERNATIONAL LTD. Sandhurst Street, Leicester, United Kingdom

PLANOL GmbH Maybachstr. 17 63456 Hanau, Germany

PLUM A/S Frederik Plums Vej 2 DK 5610 Assens, Denmark

PRODUCTOS LA CORBERANA, S.L. 46612 - Corbera, (Valencia) Spain

THE PROTON GROUP LTD Ripley Drive, Normanton Industrial Estate, Wakefield, WF6 1QT, United Kingdom

QUIMICAS MORALES, S.L. Misiones 11, 05005 – Las Palmas De Gran Canaria, Spain

RNM PRODUCTOS QUIMICOS da Rua da Fabrica 123, 4765-080, Carreira Vila Nova de Famalicao, Portugal

ROQUETTE & BARENTZ Route De La Gorgue F-62136 Lestrem, France

RUTPEN LTD Membury Airfield Lambourn Berks RG16 7TJ, United Kingdom

SOLIMIX

Montseny 17-19 Pol. Ind. Sant Pere Molanta 08799 Olerdola Barcelona, Spain

STAUB & CO. D-86456 Gablingen, Industriestraße 3, Germany

STOCKMEIER CHEMIE EILENBURG GmbH & CO. KG Gustav-Adolf-Ring 5 04838 Eilenburg, Germany

SYNERLOGIC BV L.J. Costerstraat 5 6827 Arnhem, The Netherlands

UNIVAR Ltd Argyle House, Epsom Avenue, Wilmslow SK9 3RN, United Kingdom

UNIVAR SPA Via Caldera 21 20-153 Milano, Italy

VAN DAM BODEGRAVEN B.V Beneluxweg 6-8, 2410 AA Bodegraven, The Netherlands


9

2.1.1.4 Manufacturer of the active substance

Active substance Lactic acid

Name of manufacturer (1) PURAC BIOCHEM BV

Address of manufacturer Arkelsedijk 46, NL-4206 AC Gorinchem, The Netherlands


Arkelsedijk 46, NL-4206 AC Gorinchem, The Netherlands

Name of manufacturer (2) Jungbunzlauer S.A

Address of manufacturer Z. I. Portuaire BP 32, 67390, Marckolsheim, France


Z. I. Portuaire BP 32, 67390, Marckolsheim, France

LV Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray family PT3

10

2.1.2 Product family composition and formulation

2.1.2.1 Identity of the active substance

Main constituent ISO name Lactic acid

IUPAC or EC name 2-Hydroxypropanoic acid

EC number 200-018-0

CAS number 50-21-5

Index number in Annex VI of CLP

-

Minimum purity / content 80% w/w Structural formula

2.1.2.2 Candidate for substitution

Lactic acid does not meet the conditions laid down in Article 10 of Regulation (EU) No.

528/2012, and therefore is not considered as a candidate for substitution.

Lactic acid is listed in Annex I of the Regulation (EU) No 528/2012 under the Category 1 -

Substances authorised as food additives according to Regulation (EC) No 1333/2008.

2.1.2.3 Qualitative and quantitative information on the composition of the biocidal product

family

Common name

IUPAC name Function CAS number

EC number

Content (%), w/w

min max

Lactic acid

2-Hydroxypropanoic

acid

Active substance

50-21-5 200-018-0 4.0

4.4

The composition of the Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray family and composition of each biocidal product within family is described in the Section 3.2 of the Confidential Annex. Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray family does not

contain nanomaterials.

2.1.2.4 Information on technical equivalence

The active substance Lactic acid (CAS No. 50-21-5) is not included in the work programme for the systematic examination of all existing active substances contained in biocidal products referred in Regulation (EU) No 528/2012. The assessment of technical

equivalence of the active substance listed in Annex I of the Regulation (EU) No 528/2012 is not required.

11

2.1.2.5 Information on the substance(s) of concern

No substances of concern have been identif ied in the biocidal product family formulation.

The biocidal products within family do not contain endocrine disruptors.

2.1.2.6 Type of formulation

Ready-to-use water based liquids

2.1.3 Hazard and precautionary statements

Classification and labelling of the products of the family according to the Regulation (EC) 1272/2008

Taking into account the maximal concentration and classif ication of Lactic acid and co-

formulants the classification criteria are not fulf illed.

Classification Hazard category Not applicable

Hazard statement Not applicable

Labelling Signal words Not applicable

Hazard statements Not applicable Precautionary

statements

Not applicable

2.1.4 Authorised use

2.1.4.1 Use description

Table 1. Use 1 – Ready-to-use non-medical post-milking teat disinfection, spray

treatment

Product Type Product type 3 – Veterinary hygiene (Disinfectants)

Where relevant, an

exact description of the authorised use

Target organisms (including development stage)

Bacteria and yeasts

Field of use Indoor Post-milking disinfection of teats of milk producing animals

Application methods Manual and automated spraying

Application rates and frequency

The application rate apply a maximum of 15 ml product per milking event Frequency: 1-3 post-milking applications per day

Categories of users Professional

Pack sizes and packaging material

Container (Bottle, pouch/bag, Jerry can, bucket, drum, IBC) Plastic HDPE: 0.5-1000 L

12

2.1.4.2 Use-specific instructions for use

See Section 2.1.5

2.1.4.3 Use-specific risk mitigation measures

See Section 2.1.5

2.1.4.4 Where specific to the use, the particulars of likely direct or indirect effects, first

aid instructions and emergency measures to protect the environment

See Section 2.1.5

2.1.4.5 Where specific to the use, the instructions for safe disposal of the product and

its packaging

See Section 2.1.5

2.1.4.6 Where specific to the use, the conditions of storage and shelf-life of the product

under normal conditions of storage

See Section 2.1.5

2.1.5 General directions for use

2.1.5.1 Instructions for use

The product must be brought to temperature above 20°C before use. Fill the spray f lask with the indicated quantity of undiluted product or connect product to an automated spraying system. Make sure teats are visually clean before product application. The teat should be treated immediately after milking in such a way that the teats are fully covered with the product. Keep the cows standing or walking at least

5 minutes. The product can be used 1-3 times per day.

2.1.5.2 Risk mitigation measures

Not applicable

2.1.5.3 Particulars of likely direct or indirect effects, f irst aid instructions and

emergency measures to protect the environment

In case of eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. In case of skin contact: Wash with plenty of water.

If swallowed: Rinse mouth. Do not induce vomiting. If skin symptoms occurs: Get medical advice/attention. If inhaled: Get medical attention if symptoms occur.

2.1.5.4 Instructions for safe disposal of the product and its packaging

Dispose of contents/container to in accordance with national regulation.

13

2.1.5.5 Conditions of storage and shelf-life of the product under normal conditions of

storage

Keep out of reach of children. Keep container tightly closed. Store in original opaque container. Shelf-life: 2 years

2.1.6 Other information

N/A

2.1.7 Packaging of the biocidal products

Type of

packaging

Volume of

the packaging

Material

of the packaging

Type and

material of closure

User Compatibility of

the product with the

proposed

packaging materials

(Yes/No)

Container: Bottle,

pouch/bag, Jerry can, bucket,

drum, IBC

0.5–1000L HDPE Cap (HDPE) Professional Yes

14

2.1.8 Documentation

2.1.8.1 Data submitted in relation to product application

No new data has been submitted as part of this biocidal product family application. Please see Section 3.1 of Confidential Annex for a list of studies and statements used.

15

2.2 Assessment of the biocidal product family

2.2.1 Intended use

Product Type Product type 3 – Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Ready-to-use non-medical post-milking teat disinfectant for direct application to milkable animals.

Target organisms (including

development stage)

Bacteria and yeasts

Field of use Indoor

Application methods Manual and automated spraying Fill the spray f lask with the indicated quantity of undiluted

product or connect product to an automated spraying system. Make sure teats are visually clean before product application. The teat should be treated immediately after milking in such a way that the teats are fully covered with the product. Keep the cows standing or walking at least 5 minutes.

Application rates and frequency

The application rate: apply a maximum of 15 ml product per milking event Contact time: at least 5 minutes

Frequency: 1-3 post-milking applications per day

Categories of users Professional

Pack sizes and packaging material

Container (Bottle, pouch/bag, Jerry can, bucket, drum, IBC) Plastic HDPE: 0.5-1000 L

2.2.2 Physical, chemical and technical properties

Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray family is a family of water-based ready

for use formulations.

In the table below the data with regard to the physical and chemical properties of the representative’s products is included. The difference in the formulation of products is not signif icant. Therefore the data package is considered to sufficiently support the proposed

family structure.

The data for such parameters as physical state, colour, pH of undiluted products, relative

density, viscosity and surface tension is provided for each member of family.

The Applicant submitted accelerated storage stability test report for the biocidal product Easy Gold with Lactic acid concentration 4.0% w/w. To support no impact of dye on storage stability two samples were prepared: one with full composition, one without dye. The samples had been stored at 54°C during 2 weeks in glass bottles according to CIPAC

Method 46.3. Both samples were analyzed to determine the Lactic acid content and appearance. In order to prove shelf-life 2 years and to show that dye has no impact on

the stability, the values of both samples were compared to each other.

The data on a stability of the biocidal product FlexiGard Spray with Lactic acid concentration 4.0% w/w at low temperature is provided. The sample had been stored at 0°C during 1 week according to CIPAC Method 39.3. The sample was analyzed to

determine an appearance.

16

The results of the long term study at ambient temperature will be submitted to Latvian CA

once this study will be f inalised.

Property

Guideline

and

Method

Purity of the test

substance % (w/w) Results Reference

Physical state at 20 °C and

101.3 kPa

Visual All members of the family Liquid

Ecolab

protocol, 26.04.2019, M.

Schneider, B.

Berg

Colour at 20 °C and 101.3 kPa

Visual

FlexiGard Spray Clear, blue Ecolab

protocol,

26.04.2019, M. Schneider, B.

Berg

EASYgold Clear, yellow

MEPA Easy Spray D Clear, orange

QUARESS-Din Clear, purple

Valiant Everyday Ultra Clear, green

pH (neat

formulation)

Quality

Assurance

test method

006 "pH analysis”

according to

Ecolab Laboratory

Practices

Procedures. Relevant to

CIPAC 75.3

All members of the family 2.7-3.1

Ecolab

protocol,

26.040219, M. Schneider, B.

Berg

Relative density

Quality

Assurance

test method 024

"Specific

gravity” according to

Ecolab

Laboratory Practices

Procedures.

Relevant to EC method

A.3

All members of the family 1.02-1.06 g/ml

Ecolab protocol,

26.04.2019. M.

Schneider, B. Berg

Viscosity

Quality

Assurance

test method 084

"Brookfield

viscosity” according to

Ecolab

Laboratory Practices

Procedures.

at 30 rpm

All members of the family

3.0-5.0 mPa*s at 20°C

2.0-3.0 mPa*s at

40°C

Ecolab

protocol, 26.04.2019. M.

Schneider, B.

Berg

Surface tension

Ring

method at

20°C

All members of the family 26.0-29.0 mN/m

Ecolab protocol,

26.04.2019. M.

Schneider, B. Berg

Storage stability test –

Storage for 2 weeks at

EASYgold Sample with dye: Lactic acid content:

Berg, B and Schneider, M

17

Property

Guideline

and

Method

Purity of the test


accelerated

storage

54°C

(CIPAC MT46.3)

initial: 4.0%

After: 3.9% Clear, yellow liquid

after 2 weeks

Sample without

dye:

Lactic acid content: initial: 4.0%

After: 3.9%

Clear, colorless liquid after 2 weeks

Appearance of the tested samples did

not change after 2

weeks of storage at 54°C. Furthermore

the active

substance level of both samples did

not decrease more

than 10%. In addition no

difference could be

observed between sample with and

without dye.

It can be concluded that the product will

most likely comply

with a shelf life specification of 2

years

(2018); Gunz,

S and Lach, R (2018)

Report 17-

17496

Storage stability

test – long

term storage at ambient

temperature

According to statement from the Applicant, the study for biocidal product

FlexiGard Spray is expected to be finalized in May 2020 with a final report in July

2020. Latvian CA sets the post-authorisation condition to submit data till July 2020.

Storage stability

test – low temperature

stability test

for liquids

Storage for 7 days at 0°C

(CIPAC

MT39.3)

FlexiGard Spray

After storage for 1

weeks at 0°C no

precipitate and no phase separation

was observed. The

liquid remained dark blue and clear

transparent.

Dr. Nicolas Rodriguez

(2018), Study

No Mo6179

Effects on

content of the

active substance and

technical

characteristics of the biocidal

product - light

Opaque packaging,

therefore no influence of light on

the content of

active substance is expected.

Effects on

content of the


technical

The effect of

temperature on the

content of the active substance is

reported in the

18

Property

Guideline

and

Method

Purity of the test


characteristics

of the biocidal product –

temperature

and humidity

accelerated storage

reports (Storage for 2 weeks at 54°C).

The biocidal

products is a water-based formulations

and since the active

substance is unlimitedly soluble

in water and does

not react with water, humidity is

not expected.

Effects on

content of the


technical

characteristics of the biocidal

product -

reactivity towards

container

material

HDPE is resistant to active substance.

In additional this

parameter will be covered by long-

term storage

stability reports.

One from the

resources https://www.a

bsorbentsonlin

e.com/chemica

l-resistance-guide-for-high-

density-

polyethylene.htm

Wettability

Not applicable (the

biocidal products are a ready-to-use

liquid products).

Suspensibility,

spontaneity and

dispersion stability

Not applicable (the

biocidal products

are a ready-to-use liquid products).

Wet sieve

analysis and dry

sieve test

Not applicable (the biocidal products

are a ready-to-use

liquid products).

Emulsifiability,

re-emulsifiability

and emulsion

stability


are a ready-to-use

liquid products).

Disintegration time

Not applicable (the

biocidal products are a ready-to-use

liquid products).

Particle size

distribution, content of

dust/fines,

attrition, friability

All products of the

family are ready to

use liquids. Although the

products are used

in spray applications, the

products are not

sold in or together with spraying

equipment.

The risk assessment is not requested

https://www.absorbentsonline.com/chemical-resistance-guide-for-high-density-polyethylene.htm








19

Property

Guideline

and

Method

Purity of the test


under the simplified

procedure. The MMAD is not

relevant to

demonstrate efficacy.

Persistent

foaming


are a ready-to-use

liquid products and do not need to be

diluted).

Flowability/Pour

ability/Dustability

Not applicable (the

biocidal product is a

ready-to-use liquid product).

Burning rate —

smoke

generators

Not applicable (the biocidal product is a

ready-to-use liquid

product).

Burning

completeness — smoke

generators

Not applicable (the

biocidal product is a ready-to-use liquid

product).

Composition of

smoke —

smoke generators

Not applicable (the



Spraying

pattern —

aerosols

The products are not an aerosol and

are not sold in

spray packaging

Physical compatibility

Not applicable,

products not to be mixed with other

products

Chemical compatibility

Not applicable,

products not to be mixed with other

products

Degree of

dissolution and

dilution stability

Not applicable (the



Conclusion on the physical, chemical and technical properties of the product

The data provided by the Applicant was acceptable.

All products are ready to use colour liquids.

pH-measurements for all 5 products were performed. pH level between 2.7 and 3.1.

Values between these limits will not require any additional considerations.

The information on storage stability is considered representative for all products in the

family. According to accelerated storage the products are stable at ambient temperature

during 24 months.

20

2.2.3 Physical, chemical and technical properties

Property Guideline and

Method Results Reference

Explosives - Products do not contain substances

with chemicals groups associated

with explosive properties and is

therefore not considered explosive.

-

Flammable gases - Not applicable, products are a

liquids

-

Flammable aerosols - Not applicable, products are not an

aerosols

-

Oxidising gases - Not applicable, products are a

liquids

-

Gases under pressure - Not applicable, not under pressure -

Flammable liquids - Not applicable. Biocidal product

family only contains non-flammable

components.

-

Flammable solids - Not applicable, products are a

liquids

-

Self-reactive

substances and

mixtures

- Not applicable due to high water

content, as well as products

contain no self-reacting

substances.

-

Pyrophoric liquids - Not applicable due to high water

content, as well as products

contain no self-reacting

substances.

-

Pyrophoric solids - Not applicable due to high water,

as well as products contain

substances that do not ignite

spontaneously on coming into

contact with air at normal

temperatures.

-

Self-heating

substances and

mixtures

- Not applicable, no self-heating

compounds present.

-

Substances and

mixtures which in

contact with water

emit flammable gases

- Not applicable, products are a

stable aqueous solutions.

-

Oxidising liquids - No substances with oxidizing

properties in the products.

-

Oxidising solids - Not applicable, products are

liquids.

-

Organic peroxides - Not applicable, no compounds

present with bivalent O-O structure

present.

-

Corrosive to metals UN manual of

tests and

criteria Part III,

37.4 (test C.1)

Not classified as corrosive to metals.

A representative product EASYgold

was tested on metal corrosion

classification. The product shows a

Eschen B.,

Kruppa C. Henkel.

2019. Analysis

report 19-07238

21

Property Guideline and

Method Results Reference

EASYgold negative result for corrosion to

metal.

After 7 days of testing:

Aluminium: max 0.04%

Steel: max 2.72%

The weight loss is below the

threshold of 13.5%.

No localized corrosion is observed.

Auto-ignition

temperatures of

products (liquids and

gases)

- The products are known to be

stable at room temperature and do

not ignite spontaneously. The

product is not considered to be

auto-ignitable.

-

Relative self-ignition

temperature for solids

- Not applicable, products are a

liquids

-

Dust explosion hazard - Not applicable, products are a

liquids

-

Conclusion on the physical hazards and respective characteristics of the product

The biocidal products within Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray family are water-based ready-to-use liquids, are not f lammable and are not expected to have any explosive or oxidising properties. No classification and labelling for physical hazards is required.

2.2.4 Methods for detection and identification

This is no data requirement for an application in accordance with Article 25 of the

Regulation (EU) No 528/2012. However, as the method is also being used for storage

stability testing, the method has been validated.

Analytical methods for the analysis of the product as such including the active substance

An

aly

te

(ty

pe

of

an

aly

te

e.g

. a

ctiv

e

su

bsta

nce

)

An

aly

tic

al

me

th

od

Fo

rtif

ica

tio

n

ra

ng

e /

Nu

mb

er

of

me

asu

re

me

nts

Lin

ea

rit

y

Sp

ecif

icit

y

Re

co

ve

ry

ra

te

(%

)

Lim

it o

f q

ua

ntif

ica

tio

n

(LO

Q) o

r o

th

er

lim

its

Re

fere

nce

Range Mean RSD

EASYgold

4% w/w Lactic acid

HPLC-UV 70 – 130% >0.9999 Specific, interference from other

substances < 3% of total peak

99.8-100.8

100.3 0.51 Not required

Study No. Mo615

2, Rodriguez N., 2018

22

Conclusion on the methods for detection and identification of the product

The analytical method, based on HPLC-UV, for the determination of Lactic acid is found

to be valid.

2.2.5 Efficacy against target organisms

Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray family is developed based on Lactic

acid as an active substance which provides efficacy of the biocidal products.

The applied Standards for suspension tests (phase 2, step 1) are appropriate to support claims for evaluation of bactericidal and yeasticidal activity for Ecolab Annex I Lactic Acid

(CAS No. 50-21-5) spray family. Since no phase 2, step 2 test is available for PT3 Teat disinfection, a modified EN 1500 test with simulated conditions was used in the evaluation

process.

The following Standards were used:

• EN 1656 - Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in the

veterinary area. Test method and requirements (phase 2, step 1);

• EN 1657 - Chemical disinfectants and antiseptics. Quantitative suspension test for the

evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics

used in the veterinary area. Test method and requirements (phase 2, step 1);

• Modif ied EN 1500 – Chemical disinfectants and antiseptics – Hygienic handrub – Test

method and requirements (phase 2, step 2);

The efficacy studies on bactericidal and yeasticidal activity had been performed for biocidal

product with 4.0% w/w Lactic acid concentration. Two formulations of the biocidal product

EASYgold with dye and without dye were tested according to phase 2, step 1.

Eff icacy has been successfully demonstrated f or intended use. Full details of the test

conditions, test results and necessary statements are provided.

2.2.5.1 Function and field of use

The biocidal products within Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray family

are ready-to-use liquid solutions for the post-milking disinfection of teats of milkable

animals (cows, buffaloes, goats, sheep) that claim bactericidal and yeasticidal activity.

2.2.5.2 Effects on target organisms, including unacceptable suffering

The results of the efficacy studies are summarized in Section 3.3 of the Confidential Annex,

as well as, in the below following Table.

Phase 2, step 1 tests (EN 1656 and EN 1657) has been carried out to prove bactericidal

and yeasticidal efficacy of the product under test conditions defined for post-milking teat

disinfection.

To demonstrate the bactericidal activity quantitative suspension test according to the EN 1656 (dilution-neutralization method) against three reference strains: Staphylococcus aureus DSM 799, Streptococcus uberis DSM 20569 and Escherichia coli DSM 682, has been

performed.

23

Activity against bacteria has been evaluated at a 5 minutes contact time with product test concentrations of 94%1, 50% and 20% under dirty conditions (10 g/l skimmed milk) and temperature 30°C. The efficiency has been evaluated for both product formulations with

and without added dye.

All tested formulations concentrations demonstrate > 5.00 lg reduction for all tested bacterial species. Moreover, no difference in efficiency was observed in formulations with

or without the dye.

Therefore, the biocidal product with 4% w/w concentration of Lactic acid can be claimed

for a disinfectant with a bactericidal activity under the defined test conditions and exposure

of 5 minutes according to claimed Standard and intended use.

To demonstrate the yeasticidal activity a quantitative suspension test according to the EN 1657 (method dilution-neutralization) against yeast Candida albicans DSM 1386 has

been performed.

The activity against the yeast has been evaluated for the liquid at a 5 minutes contact time and product test concentrations of 94%1, 50% and 20% under dirty conditions (10

g/l skim milk) and temperature 30°C.

The results showed that the liquid demonstrates > 4.00 log reduction for the tested yeast species at the desired concentration ≥ 94% in samples with both added and not added

dye.

Therefore, the biocidal product with 4% w/w Lactic acid can be claimed as a disinfectant

with a yeasticidal activity under defined test conditions and exposure of 5 minutes

according to the claimed Standard and intended use.

Practical conditions

In the absence of a phase 2, step 2 test standard to test biocides as prophylactic teat treatment under practical conditions, the proposal has been made to use a modif ication of

a standard used for hygienic hand disinfectants (EN 1500). The test description, rationale regarding the change and suitability of the used reference and rationale for log reduction

is described in Section 3.3 of Confidential Annex.

The test has been performed under clean and dirty conditions. However, Applicant noted that there will be an automated pre-cleaning step by robot before application of the

product.

Simulation of practical conditions to establish whether the biocidal product has a bactericidal activity (basic requirement) for post-milking teat disinfection was performed

according to a modif ied EN 1500 (phase 2, step 2). Escherichia coli K12 DSM 11250 was tested under clean and dirty conditions (3 g/l bovine albumin and 10 g/l skimmed milk,

1 Although EN methodology normally prescribes the highest tested concentration to be 80%, however a dilution-

neutralisation method described in EN 13727 allows for a maximal concentration of 97% to be tested for ready

to use products. This modified method however caused issues with sedimentation of the interfering substance

(10 g/L skimmed milk). Therefore the concentration was adjusted to a point where these sedimentations wasn’t

observed anymore, being 94%.

Statement_on_the_t

esting_a_ready_to_use_product_at_94%_vs_97%.pdf

24

respectively) on > 18 healthy volunteers. The contact time was 5 minutes for tested and reference products. 1% PVP Iodine was used as a reference instead of propan-1-ol.

The results showed that under clean conditions (3 g/l bovine albumin) the tested product (EASYgold, 4% Lactic acid) was not inferior to 1% PVP Iodine. Mean log reduction for tested product and reference product is 2.32 and 2.63, respectively.

The results showed that under dirty conditions (10 g/l skimmed milk) the tested product (EASYgold, 4% Lactic acid) was not inferior to 1% PVP Iodine. Mean log reduction for tested product and reference product is 2.47 and 2.46, respectively.

For more details please look Section 3.3 of Confidential annex.

Therefore, the biocidal product with 4% w/w concentration of Lactic acid is a disinfectant with a bactericidal activity under the practical conditions according to claimed intended use.

2.2.5.3 Mode of action, including time delay

In solution, Lactic acid exists in a pH-dependent equilibrium between the undissociated and dissociated form. Only in its undissociated state, the acid is able to pass the cell

membrane. At a relatively low pH, the uncharged acid enters the cell. Inside the cell, the Lactic acid dissociates due to the higher pH. The molecules remain inside the cell, because the resulting ions cannot pass the membrane. The pH inside the cell is lowered and metabolic reactions are inhibited. Further effects are also reported. Decrease of the membrane permeability for amino acids, organic acids, phosphates resulting in uncoupling

of both substrate transport and oxidative phosphorylation from the electron transport

system. Furthermore, an inhibition of the glycolysis by the lactate ion is observed.

The results of the efficacy tests conclusively demonstrate that the biocidal product (liquid)

with the concentration of 4% w/w Lactic acid after a 5 minute contact time reached sufficient efficacy to reduce the target organisms (bacteria and yeast) above the minimal

threshold.

2.2.5.4 Efficacy data

Experimental data on the efficacy of the tested biocidal products against target

organisms for supporting of the family

Function Field

of use Test product

Test organisms

Test method Test system / concentrations applied /

exposure time

Test results: effects

Re

fere

nce

Bactericide

Teat

dis

infe

ction, post-

milkin

g EASYgold

(4% Lactic acid) With and

without dye

Staphylococcus aureus DSM 799 Streptococcus uberis DSM 20569

Escherichia coli DSM 682

EN 1656:2009; (phase 2, step 1) Test method: dilution-neutralization

/Quantitative suspension test

Tested product concentrations: 94%, 50%, 20% Contact time: 5 minutes

Dirty conditions with interfering substance: 10 g/l skimmed milk Test temperature

30°C

Tested product demonstrated the bactericidal activity at all concentrations in defined conditions (pass

R > 5 log)

U. Bäum

er,

Test

report

:

17-17283-1-1,

2018

25

Function Field of use

Test product

Test organisms

Test method Test system / concentrations applied / exposure time

Test results: effects

Re

fere

nce

Yeasticide

Teat

dis

infe

ction, post-

milkin

g EASYgold

(4% Lactic

acid) With and without dye

Candida albicans DSM 1386

EN 1657:2016; (phase 2,

step 1) Test method: dilution-neutralization/Quantitative suspension

test

Tested product concentrations: 94%, 50%, 20%

Contact time: 5 minutes Dirty conditions with interfering

substance: 10 g/l skimmed milk Test temperature 30°C

Tested product demonstrated the yeasticidal

activity at concentrations of ≥ 94% in defined conditions (pass R > 4 log)

U. Bäum

er,

Test

report

:

17-17283-2-1,

2018

Bactericide

Teat

dis

infe

ction, post-

milkin

g

EASYgold (4% Lactic acid)

With dye

Escherichia coli K12 DSM 11250

EN 1500:2013 (modified) (phase 2,

step 2); Volunteer test; Clean conditions

Tested product concentrations: 100% (undiluted)

Contact time: 5 minutes Clean conditions with interfering substance: 3 g/l

bovine albumin; 22 volunteers Reference substance: 1%

PVP-Iodine

The absolute difference between mean differences RP-PP

and PP-RP was 0.45 (Abs = [0.08 – 0.53] < 2, significance p > 0.025, thus, confirm). The data comply

with the inferiority margin of 0.6 (test: 0.47)

U. Bäum

er,

Test

report

18-07687-1,

2018

Bactericide

Teat

dis

infe

ction, post-

milkin

g

EASYgold (4%

Lactic acid) With dye

Escherichia coli K12 DSM

11250

EN 1500:2013

(modified) (phase 2, step 2); Volunteer test; Dirty

conditions

Tested product concentrations:

100% (undiluted) Contact time: 5 minutes

Dirty conditions with interfering substance: 10 g/l skimmed milk; 22 volunteers

Reference substance: 1% PVP-Iodine

The absolute difference

between mean differences RP-PP and PP-RP was 0.58 (Abs = [(-0.3)–0.28] < 2, significance p >

0.025, thus, confirm). The data comply with the inferiority margin of 0.6 (test: 0.24)

U. Bäum

er,

Test

report

18-13153-1,

2018

Conclusion on the efficacy of the product

Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray family meets the bactericidal and yeasticidal activity under the specif ied test requirements: temperature 30°C, contact time

5 minutes, dirty conditions (10g/L skimmed milk) according to appropriate EN Standard Method (EN 1656, EN 1657) for post-milking teat disinfection. Furthermore, as a phase 2, step 2 test is not available, a modif ied EN 1500 has been used to demonstrate efficacy against microbes attached to skin. The mean reduction factor for the reference product was not found to be signif icantly higher than those of the test product under the clean and dirty

conditions.

26

Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray family is a group of products with one active substance, similar use, but some differences in the dyes content. The efficacy studies on bactericidal and yeasticidal claim (phase 2, step 1) had been performed for biocidal

product with 4% w/w Lactic acid (minimal content within family). In addition, two formulations (without and with dye) of product were tested. According to the data there were no differences in eff icacy of the product with and without addition of dye into the formulation. Therefore, phase 2, step 2 performed for formulation with dye that is ready-to-use product for market. LV CA concludes that the tested product formulations cover all members within Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray family as all

formulations are considered identical with the exception of their colour .

It can be concluded that all products in this family are efficacious, when used in accordance

with the use instructions proposed in the SPC.

2.2.5.5 Occurrence of resistance and resistance management

The efficacy of the biocidal product family has provided due the content of the active

substance – Lactic acid. The resistance of target organisms to the biocidal product family actually could mean resistance to the Lactic acid. The possibility of the development of the resistance to Lactic acid was not evaluated. However, Latvian CA revising the scientific literature (Theron MM., 2010) concludes that no clear scientific evidence exists that target organisms have developed resistance against the organics acid, such as Lactic acid.

2.2.5.6 Known limitations

No limitations and no undesirable or unintended side-effects have been observed during

these studies.

2.2.5.7 Evaluation of the label claims

Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray family is intended to be used as post-

milking teat disinfectants.

The evaluation of efficacy demonstrates that the biocidal products within family meet

agreed criteria for reduction of bacteria and yeast population in presence of organic soiling.

The Latvian CA considers that the following label claim can be used on product label for professional users:

• Ready-to-use non-medical teat disinfectant for post-milking treatment:

bactericidal and yeasticidal activity at the contact time 5 minutes.

27

2.2.6 Risk assessment for human health

2.2.6.1 Assessment of effects on Human Health

No classification is proposed for human health, as the criteria for classification under Regulation (EC) 1272/2008 are not met.

Skin corrosion and irritation

Conclusion used in Risk Assessment – Skin corrosion and irritation

Value/conclusion Not corrosive or irritating to skin.

Justif ication for the

value/conclusion According to the CLP criteria and additivity approach, no

classif ication is warranted with respect to local effects on the skin

for the individual products of the BPF and thus the BPF itself.

The conclusion is made based on content of individual components

and generic concentration limits (GCLs) specif ied in CLP Annex I,

Table 3.2.3. The sum of the concentrations/GCL of individual

components does not exceed a concentration limit 1%.

Please refer to the Section Confidential Annex of the PAR for

detailed BPF composition and classif ication of individual

components.

Classif ication of the product according to CLP and DSD

No classif ication required.

Eye irritation

Summary table of animal studies on serious eye damage and eye irritation

Method, Guideline,

GLP status,

Reliability

Species, Strain,

Sex,

No/group

Test substance, Dose levels,

Duration of

exposure

Results

Remarks (e.g. major

deviations)

Reference

OECD

guidelines 405 (GLP)

Confidential

PAR

EASYgold Test results

presented in Section 3.4 of

the

Confidential PAR

- Confidential

PAR

Conclusion used in Risk Assessment – Eye irritation

Value/conclusion Not causing severe damage or eye irritation

Justif ication for the value/conclusion

According to the CLP criteria and additivity approach, classification is met with respect to local effects on the eyes for the individual products of the BPF and thus the BPF itself.

The conclusion is made based on content of individual components and generic concentration limits (GCLs) specif ied in CLP Annex I, Table 3.3.3. The sum of the concentrations/GCL of individual

components exceeds a concentration limit 1%.

However, Applicant submitted a study on eye irritation potential according to OECD Guideline No.405 with aim to support non-classif ication of representative product EasyGold.

According to test results and criteria of the CLP regulation (Annex I point 3.3.2.1) the product is not classif ied in Category 2.

28



Respiratory tract irritation

Conclusion used in the Risk Assessment – Respiratory tract irritation

Value/conclusion The products do not meet the classif ication criteria for skin or eye irritation and it can be predicted that it will not have the capacity

to cause respiratory tract irritation.

Justif ication for the

conclusion

There are currently no standard tests and no OECD TG available for respiratory irritation and there is no testing requirement for respiratory irritation under the Biocides Regulation.

For all products the exact composition is known. Please refer to the Confidential Annex to the PAR for detailed BPF composition and classif ication of individual components.

For active substance and each co-formulants valid data are available through Safety Data Sheets. As well, eCA is taken into account information from ECHA C&L inventory base (by majority of self-classifications) and REACH dossier. According to information from REACH dossier one substance is classified as STOT SE 3 H335. Based on content and CLP criteria (Section 3.8) no classif ication

criteria are fulfilled.

Classif ication of the product according to

CLP and DSD


Skin sensitization

Conclusion used in Risk Assessment – Skin sensitisation

Value/conclusion Not sensitising to skin.


Studies on skin sensitisation properties are not required.

According to Annex III of the Regulation (EU) 528/2012 “testing on the product/mixture does not need to be conducted if there are valid data available on each of the components in the mixture sufficient to allow classif ication of the mixture according to the rules laid down in Directive 1999/45/EC and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the

components are not expected.”

For all products the exact composition is known. Please refer to the Confidential Annex to the PAR for detailed BPF composition and classif ication of individual components. For active substance and each co-formulants valid data are available through Safety Data Sheets. As well, eCA is taken into account information from ECHA

C&L inventory base (by majority of self-classifications) and REACH dossier. Based on information family does not contain substances classif ied as Skin Sens. 1, H317.



29

Respiratory sensitization (ADS)

Conclusion used in Risk Assessment – Respiratory sensitisation

Value/conclusion Not respiratory sensitisers


Studies on respiratory sensitisation properties are not required.

According to Annex III of the Regulation (EU) 528/2012 “testing on the product/mixture does not need to be conducted if there are valid data available on each of the components in the mixture sufficient to allow classification of the mixture according to the rules

laid down in Directive 1999/45/EC and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected.” For all products the exact composition is known. Please refer to the Confidential Annex to the PAR for detailed BPF composition and

classif ication of individual components. For active substance and each co-formulants valid data are available through Safety Data Sheets. As well, eCA is taken into account information from ECHA C&L inventory base (by majority of self-classifications) and REACH dossier. Based on information family does not contain substances

classif ied as Resp. Sens. 1, H334



Acute toxicity

No studies are provided for Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray family.

Safety data sheets have been submitted for active substance and each co-formulant of Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray family. There are valid data available on each of the components sufficient to classify Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray family according to the rules laid down in CLP regulation and synergistic effects between any of the components are not expected.

a) Acute toxicity by oral route

One co-formulant is classif ied in Acute Tox. 4 (oral), H302. Based on calculation from the ATE value for co-formulant, ATEmix oral is greater than 2000 mg/kg. Therefore according to Table 3.1.1 of the CLP regulation, Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray

family is not classif ied as fatal, toxic or harmful if swallowed.

b) Acute toxicity by inhalation

One co-formulant is classified in Acute Tox. 2 (inhalation), H330 in neat form. According to SDS 35% aqueous formulation is classif ied Acute Tox. 4 (inhalation), H332.

For another co-formulant a several CLP notif ications identif ies that it may be harmful if inhaled (Acute Tox. 4, H332).

Based on calculation from the ATE values for co-formulants, ATEmix inhalation is greater than 5 mg/l. Therefore according to Table 3.1.1 of the CLP regulation, Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray family is not classified for acute toxicity via inhalation.

c) Acute toxicity by dermal route

Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray family does not contain a component classif ied for acute toxicity via dermal route. Therefore, Ecolab Annex I Lactic Acid (CAS

30

No. 50-21-5) spray family not classif ied as fatal, toxic or harmful by contact with skin according to CLP regulation.

Assessment for endocrine disrupting properties

The Commission Delegated Regulation (EU) 2017/2100 specifying the scientific criteria for the determination of endocrine-disrupting properties (ED criteria) under Regulation (EU) No 528/2012 (BPR) establishes that the ED criteria become applicable by 7 June 2018 for biocides.

The Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray family contains Lactic acid as the active substance and co-formulants. The products within family were not tested for potential endocrine disruption properties.

For Lactic acid no ED assessment is required because active substance is included in Annex I of the BPR.

A screening phase for all co-formulants was performed by the Applicant. No warning regarding potential ED properties has been identif ied.

2.2.6.2 Exposure assessment

Lactic acid is listed in Annex I of the Regulation (EU) No 528/2012. There are no substances of concern present. Therefore the detailed exposure assessment is not relevant

under the simplif ied authorisation procedure according to Regulation (EU) 528/2012. Latvian CA accepts that the personal protective equipment are not required for the use of the Ecolab Annex I Lactic Acid (CAS No. 50-21-5) spray family.

2.2.6.3 Risk characterisation for human health

Taking into account the information on wide use of Lactic acid in food and cosmetic areas, no presence of substance of concerns, as well as, results on no classif ication of family,

Latvian CA considers that authorisation of Ecolab Annex I Lactic Acid (CAS No. 50-21-5)

spray family is acceptable from a human health perspective.

2.2.7 Risk assessment for the environment

2.2.7.1 Effects assessment on the environment

There are valid data available on active substance and each co-formulant. Ecolab Annex I

Lactic acid (CAS No. 50-21-5) spray family is not classif ied for environmental hazards.

Based on the data provided by the Applicant, there is no concern regarding the ED

properties of the co-formulants used in the Ecolab Annex I Lactic Acid (CAS No. 50-21-5)

spray family.

2.2.7.2 Exposure assessment

Lactic acid is listed in Annex I of the Regulation (EU) No 528/2012. There are no

substances of concern present. Therefore the detailed exposure assessment is not relevant

under the simplif ied authorisation procedure according to Regulation (EU) 528/2012.

31

2.2.7.3. Risk characterisation for the environment

Taking into account the information on wide use of Lactic acid in food and cosmetic areas, no presence of substance of concerns, as well as, results on no classif ication of family, Latvian CA considers that authorisation of Ecolab Annex I Lactic Acid (CAS No. 50-21-5)

spray family is acceptable from an environmental perspective.

2.2.8 Measures to protect man, animals and the environment

For the protection of man, animals and the environment label must contain the following indications in addition to the elements already listed in Article 69 of Regulation (EU) 528/2012:

1. The instruction for use must contain the following indications on

application: The product must be brought to temperature above 20°C before use. Fill the spray flask

with the indicated quantity of undiluted product or connect product to an automated spraying system. Make sure teats are visually clean before product application. The teat should be treated immediately after milking in such a way that the teats are fully covered with the product. Keep the cows standing or walking at least 5 minutes. The product can be used 1-3 times per day.

2. Label claim:

Ready-to-use non-medical teat disinfectant for post-milking treatment: bactericidal and yeasticidal activity at the contact time 5 minutes.

3. Information on first aid instruction:

In case of eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

In case of skin contact: Wash with plenty of water. If swallowed: Rinse mouth. Do not induce vomiting. If skin symptoms occurs: Get medical advice/attention. If inhaled: Get medical attention if symptoms occur.

4. Waste management measures:

Dispose of contents/container to in accordance with national regulation.

5. Storage conditions and stability:

Keep out of reach of children. Keep container tightly closed. Store in original opaque container. Shelf-life: 2 years

2.2.9. Requirements for further information:

The authorisation holder shall complete, within the stated timeframe, the actions set out

in the table below:

32

Description Due date Long term storage tests at ambient

temperature for representative product in commercial packaging.

30th June 2020

33

Reference

1. Theron MM, J.F. Rykers Lues, 2010. Organics Acid and Food preservation, CRC

Press.

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