# L_2018238EN.01003301.xml

| 21.9.2018 | EN | Official Journal of the European Union | L 238/33 |
| --- | --- | --- | --- |

21.9.2018

EN

Official Journal of the European Union

L 238/33

---

COMMISSION IMPLEMENTING REGULATION (EU) 2018/1261

of 20 September 2018

granting a Union authorisation for the biocidal product family Hypred's iodine based products

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5) thereof,

Whereas:

| (1) | On 16 July 2015, Hypred SAS submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named Hypred's iodine based products (‘the product family’) of product-type 3, as defined in Annex V to that Regulation. The Netherlands agreed that their competent authority referred to in Article 43(1) of Regulation (EU) No 528/2012 evaluate this application. The application was recorded under the case number BC-LC018584-49 in the Register for Biocidal Products (‘the Register’). |
| --- | --- |

(1)

On 16 July 2015, Hypred SAS submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named Hypred's iodine based products (‘the product family’) of product-type 3, as defined in Annex V to that Regulation. The Netherlands agreed that their competent authority referred to in Article 43(1) of Regulation (EU) No 528/2012 evaluate this application. The application was recorded under the case number BC-LC018584-49 in the Register for Biocidal Products (‘the Register’).

| (2) | The biocidal product family contains iodine as active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012. Taking into account the intrinsic properties of the active substance, once the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100 (2) will become applicable, the Commission will consider the need to review the approval of iodine, including polyvinylpyrrolidone iodine, in accordance with Article 15 of Regulation (EU) No 528/2012. Depending on the outcome of that review, the Commission will then consider whether the Union authorisations for products containing the active substance have to be reviewed in accordance with Article 48 of Regulation (EU) No 528/2012. |
| --- | --- |

(2)

The biocidal product family contains iodine as active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012. Taking into account the intrinsic properties of the active substance, once the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100 (2) will become applicable, the Commission will consider the need to review the approval of iodine, including polyvinylpyrrolidone iodine, in accordance with Article 15 of Regulation (EU) No 528/2012. Depending on the outcome of that review, the Commission will then consider whether the Union authorisations for products containing the active substance have to be reviewed in accordance with Article 48 of Regulation (EU) No 528/2012.

| (3) | On 6 June 2017 the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, the assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’). |
| --- | --- |

(3)

On 6 June 2017 the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, the assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

| (4) | On 12 January 2018, the Agency submitted to the Commission an opinion (3), including the draft summary of the biocidal product characteristics (hereinafter ‘SPC’) and the final product assessment report on the product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. The opinion concluded that the product family falls within the definition of ‘biocidal product family’ laid down in Article 3(1)(s) of Regulation (EU) No 528/2012, that it was found eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, the product family meets the conditions laid down in Article 19(1) and (6) of that Regulation. |
| --- | --- |

(4)

On 12 January 2018, the Agency submitted to the Commission an opinion (3), including the draft summary of the biocidal product characteristics (hereinafter ‘SPC’) and the final product assessment report on the product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. The opinion concluded that the product family falls within the definition of ‘biocidal product family’ laid down in Article 3(1)(s) of Regulation (EU) No 528/2012, that it was found eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, the product family meets the conditions laid down in Article 19(1) and (6) of that Regulation.

| (5) | On 26 February 2018, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. |
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(5)

On 26 February 2018, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

| (6) | The Commission concurs with the opinion of the Agency and considers therefore appropriate to grant a Union authorisation for the biocidal product family, and to record the SPC and the product assessment report on the product family in the Register in accordance with Article 71(6) of Regulation (EU) No 528/2012. |
| --- | --- |

(6)

The Commission concurs with the opinion of the Agency and considers therefore appropriate to grant a Union authorisation for the biocidal product family, and to record the SPC and the product assessment report on the product family in the Register in accordance with Article 71(6) of Regulation (EU) No 528/2012.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation is granted to Hypred SAS for the biocidal product family Hypred's iodine based products with authorisation number EU-0018397-0000.

The Union authorisation is valid from 11 October 2018 until 30 September 2028.

The Union authorisation is subject to compliance with the SPC set out in the Annex.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 20 September 2018.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  
  OJ L 167, 27.6.2012, p. 1.

1

(2)  Commission delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p. 1).

2

(3)  ECHA opinion of 12 December 2017 on the Union authorisation of Hypred's iodine based products (ECHA/BPC/178/2017).

3

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ANNEX

Summary of product characteristics for a biocidal product family

HYPRED's iodine based products

Product type 3 — Veterinary hygiene (Disinfectants)

Authorisation number: EU-0018397-0000

R4BP asset number: EU-0018397-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

| Name | HYPRED's iodine based products |
| --- | --- |
| | |

Name

HYPRED's iodine based products

1.2.   Product type(s)

| Product type(s) | PT03 - Veterinary hygiene (Disinfectants) |
| --- | --- |
| | |

Product type(s)

PT03 - Veterinary hygiene (Disinfectants)

1.3.   Authorisation holder

| Name and address of the authorisation holder | Name | Hypred SAS |
| --- | --- | --- |
| Address | 55, Boulevard Jules Verger - BP10180 35803 DINARD Cedex France |
| Authorisation number | EU-0018397-0000 |
| R4BP asset number | EU-0018397-0000 |
| Date of the authorisation | 11 October 2018 |
| Expiry date of the authorisation | 30 September 2028 |

Name and address of the authorisation holder

Name

Hypred SAS

Address

55, Boulevard Jules Verger - BP10180 35803 DINARD Cedex France

Authorisation number

EU-0018397-0000

R4BP asset number

EU-0018397-0000

Date of the authorisation

11 October 2018

Expiry date of the authorisation

30 September 2028

1.4.   Manufacturer(s) of the biocidal products

| Name of manufacturer | HYPRED SAS |
| --- | --- |
| Address of manufacturer | 55, Boulevard Jules Verger - BP10180 35803 DINARD France |
| Location of manufacturing sites | HYPRED SAS - 55, Boulevard Jules Verger - BP10180 35803 DINARD France
  HYPRED POLSKA SP. Z O.O. NIEPRUSZEWO, KASZTANOWA 4 64320 Buk Poland
  HYPRED IBERICA S.L Pol. Ind. Arazuri-Orcoyen C/C no 32 31160 Orcoyen – NAVARRA Spain
  HYPRED GmbH Marie-Curie-Straße 23 53332 Bornheim – Sechtem Germany
  HYPRED Italia s.r.l. Strada Montodine-Gombito Loc. Cà Nova 26010 Ripalta Arpina CR Italy |

Name of manufacturer

HYPRED SAS

Address of manufacturer

55, Boulevard Jules Verger - BP10180 35803 DINARD France

Location of manufacturing sites

HYPRED SAS - 55, Boulevard Jules Verger - BP10180 35803 DINARD France

HYPRED POLSKA SP. Z O.O. NIEPRUSZEWO, KASZTANOWA 4 64320 Buk Poland

HYPRED IBERICA S.L Pol. Ind. Arazuri-Orcoyen C/C no 32 31160 Orcoyen – NAVARRA Spain

HYPRED GmbH Marie-Curie-Straße 23 53332 Bornheim – Sechtem Germany

HYPRED Italia s.r.l. Strada Montodine-Gombito Loc. Cà Nova 26010 Ripalta Arpina CR Italy

1.5.   Manufacturer(s) of the active substance(s)

| Active substance | Iodine |
| --- | --- |
| Name of manufacturer | COSAYACH: SCM Cía. Cosayach Minera Negreiros, Rut. N°96.625.710-5 |
| Address of manufacturer | Terrenos de Elena S/N Terrenos de Elena S/N Huara, Región de Tarapacá Chile |
| Location of manufacturing sites | Mined at: S.C.M. Cía. Minera Negreiros, S.C.M. Cosayach Soledad.
  Refined at: S.C.M. Cía. Minera Negreiros. Pozo Almonte Chile |

Active substance

Iodine

Name of manufacturer

COSAYACH: SCM Cía. Cosayach Minera Negreiros, Rut. N°96.625.710-5

Address of manufacturer

Terrenos de Elena S/N Terrenos de Elena S/N Huara, Región de Tarapacá Chile

Location of manufacturing sites

Mined at: S.C.M. Cía. Minera Negreiros, S.C.M. Cosayach Soledad.

Refined at: S.C.M. Cía. Minera Negreiros. Pozo Almonte Chile

| Active substance | Iodine |
| --- | --- |
| Name of manufacturer | ACF MINERA SA |
| Address of manufacturer | San Martín 499 Iquique Chile |
| Location of manufacturing sites | Faena Lagunas KM. 1.722 Ruta A-5, Pozo Almonte Chile |

Active substance

Iodine

Name of manufacturer

ACF MINERA SA

Address of manufacturer

San Martín 499 Iquique Chile

Location of manufacturing sites

Faena Lagunas KM. 1.722 Ruta A-5, Pozo Almonte Chile

| Active substance | Iodine |
| --- | --- |
| Name of manufacturer | SOCIEDAD QUIMICA y MINERA SA |
| Address of manufacturer | Los Militares 4290 SANTIAGO DE CHILE Chile |
| Location of manufacturing sites | Pedro de Valdivia (PV) Route B 180 Antofagasta Chile
  Nueva Victoria (NV) Route 5 North, Km 1925 Pozo Almonte Chile |

Active substance

Iodine

Name of manufacturer

SOCIEDAD QUIMICA y MINERA SA

Address of manufacturer

Los Militares 4290 SANTIAGO DE CHILE Chile

Location of manufacturing sites

Pedro de Valdivia (PV) Route B 180 Antofagasta Chile

Nueva Victoria (NV) Route 5 North, Km 1925 Pozo Almonte Chile

2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the family

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,25 | 2,5 |
| Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) | Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy | Non active substance | 68439-50-9 | | 2,697 | 24,199 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

Active substance

7553-56-2

231-442-4

0,25

2,5

Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy

Non active substance

68439-50-9

2,697

24,199

2.2.   Type(s) of formulation

| Formulation(s) | AL - Any other liquid
  SL - Soluble concentrate |
| --- | --- |
| | |

Formulation(s)

AL - Any other liquid

SL - Soluble concentrate

PART II

SECOND INFORMATION LEVEL - META SPC(S)

META SPC 1

1.   META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier

| Identifier | meta SPC 1: Dipping products - ready to use |
| --- | --- |

Identifier

meta SPC 1: Dipping products - ready to use

1.2.   Suffix to the authorisation number

| Number | 1-1 |
| --- | --- |

Number

1-1

1.3.   Product type(s)

| Product type(s) | PT03 - Veterinary hygiene (Disinfectants) |
| --- | --- |
| | |

Product type(s)

PT03 - Veterinary hygiene (Disinfectants)

2.   META SPC 1 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 1

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,25 | 0,49 |
| Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) | Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy | Non active substance | 68439-50-9 | | 2,697 | 4,993 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

Active substance

7553-56-2

231-442-4

0,25

0,49

Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy

Non active substance

68439-50-9

2,697

4,993

2.2.   Type(s) of formulation of the meta SPC 1

| Formulation | AL - Any other liquid |
| --- | --- |
| | |

Formulation

AL - Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

| Hazard statements | Causes serious eye irritation.
  Harmful to aquatic life with long lasting effects. |
| --- | --- |
| Precautionary statements | Keep out of reach of children.
  Wash hands thoroughly after handling.
  Wear protective gloves.
  Wear protective clothing.
  Wear eye protection.
  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
  If eye irritation persists: Get medical advice/attention. |

Hazard statements

Causes serious eye irritation.

Harmful to aquatic life with long lasting effects.

Precautionary statements

Keep out of reach of children.

Wash hands thoroughly after handling.

Wear protective gloves.

Wear protective clothing.

Wear eye protection.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

If eye irritation persists: Get medical advice/attention.

4.   AUTHORISED USE(S) OF THE META SPC 1

4.1.   Use description

Table 1. Use # 1 – Manual or automated dipping after milking

| Product Type | PT03 - Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria
  Yeasts
  Algae |
| Field(s) of use | Indoor
  Disinfection of teats of milk producing animals by dipping after milking |
| Application method(s) | Dipping -
  Manual or automated disinfection of teats by dipping after milking.
  Dipping cup or automated dipping machine. |
| Application rate(s) and frequency | — | cows and buffaloes (3 to 10 ml: 5 ml recommended) |

Product Type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Bacteria

Yeasts

Algae

Field(s) of use

Indoor

Disinfection of teats of milk producing animals by dipping after milking

Application method(s)

Dipping -

Manual or automated disinfection of teats by dipping after milking.

Dipping cup or automated dipping machine.

Application rate(s) and frequency

—

cows and buffaloes (3 to 10 ml: 5 ml recommended)

| — | sheep (1,5 to 5 ml: 1,5 ml recommended) |
| --- | --- |

—

sheep (1,5 to 5 ml: 1,5 ml recommended)

| — | goats (2,5 to 6 ml: 2,5 ml recommended) |
| --- | --- |

—

goats (2,5 to 6 ml: 2,5 ml recommended)

Frequency: 2 to 3 times per day

Category(ies) of users

Professional

Pack sizes and packaging material

HDPE JERRYCAN 5, 10, 22 L

HDPE DRUM 60, 120, 220 L

HDPE CONTAINER 1 000  L

4.1.1.   Use-specific instructions for use

See general directions for use of meta SPC 1

4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 1

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 1

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

None: See general directions for use of meta SPC 1

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 1

5.   GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1

5.1.   Instructions for use

Always read the label or leaflet before use and follow all the instructions provided.

The product must be brought to a temperature above 20 °C before use.

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the dipping cup manually or automatically with the ready to use product.

Apply by dipping manually or automatically on animal's teats on the full length of the teat after milking.

| — | cows and buffaloes (3 to 10 ml: 5 ml recommended) |
| --- | --- |

—

cows and buffaloes (3 to 10 ml: 5 ml recommended)

| — | sheep (1,5 to 5 ml: 1,5 ml recommended) |
| --- | --- |

—

sheep (1,5 to 5 ml: 1,5 ml recommended)

| — | goats (2,5 to 6 ml: 2,5 ml recommended) |
| --- | --- |

—

goats (2,5 to 6 ml: 2,5 ml recommended)

Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).

At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

Where necessary, repeat the application after each milking.

Clean the application equipment regularly with warm water.

5.2.   Risk mitigation measures

Wear eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

FIRST AID INSTRUCTIONS

| — | In the event of inhalation: Bring to fresh air. |
| --- | --- |

—

In the event of inhalation: Bring to fresh air.

| — | In the event of contact with the skin: Wash with water. |
| --- | --- |

—

In the event of contact with the skin: Wash with water.

| — | In the event of contact with the eyes:
  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
  If eye irritation persists: Get medical advice/attention. |
| --- | --- |

—

In the event of contact with the eyes:

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

If eye irritation persists: Get medical advice/attention.

| — | In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice. |
| --- | --- |

—

In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

Refer to the safety data sheet available for professional user: it contains an emergency phone number.

Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

5.4.   Instructions for safe disposal of the product and its packaging

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

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

Shelf life: 2 years in HDPE

Do not store at a temperature higher than 30 °C.

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | Dip-io 2500
  JOD DIP
  IODERM PSP
  DERMINO FR
  Iododip
  IODEX EXTRA
  Iodystrong
  DERMIODE
  INO IODE EPAIS
  INO STAR +
  IODACTIV 2500
  IODIUM BX2500
  Usual Iod Post
  ASiRAL Dip Coat
  IODOCAN EXTRA
  UDDER PLUS
  PRIMADIODE
  CERTIODE EPAIS
  IODIPACK GEL
  HELIO IODE EPAIS
  VAGEL
  GELAPIS ACTIV
  IOSAPIS GEL
  ZENCARE FLASH
  REPROGEL
  DERMADINE +
  KRONI Jod Dipp 2500
  WÜBBELMANN JOD DIP
  Iodine Cleaner&Sanitizer
  MUNGIFILM
  ZEP FS FILMIODINE NIPPLE NP |
| --- | --- |
| Authorisation number | EU-0018397-0001 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,25 |
| Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) | Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy | Non active substance | 68439-50-9 | | 2,697 |

Trade name(s)

Dip-io 2500

JOD DIP

IODERM PSP

DERMINO FR

Iododip

IODEX EXTRA

Iodystrong

DERMIODE

INO IODE EPAIS

INO STAR +

IODACTIV 2500

IODIUM BX2500

Usual Iod Post

ASiRAL Dip Coat

IODOCAN EXTRA

UDDER PLUS

PRIMADIODE

CERTIODE EPAIS

IODIPACK GEL

HELIO IODE EPAIS

VAGEL

GELAPIS ACTIV

IOSAPIS GEL

ZENCARE FLASH

REPROGEL

DERMADINE +

KRONI Jod Dipp 2500

WÜBBELMANN JOD DIP

Iodine Cleaner&Sanitizer

MUNGIFILM

ZEP FS FILMIODINE NIPPLE NP

Authorisation number

EU-0018397-0001 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

Active substance

7553-56-2

231-442-4

0,25

Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy

Non active substance

68439-50-9

2,697

7.2.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | Dip-io YB MAX
  INO Io Dip MAX
  JOD DIP YB MAX
  IodoDip YB MAX
  Iodium Dip YB MAX
  JodyDip YB MAX
  Delta IoDip YB MAX |
| --- | --- |
| Authorisation number | EU-0018397-0002 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,49 |
| Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) | Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy | Non active substance | 68439-50-9 | | 4,993 |

Trade name(s)

Dip-io YB MAX

INO Io Dip MAX

JOD DIP YB MAX

IodoDip YB MAX

Iodium Dip YB MAX

JodyDip YB MAX

Delta IoDip YB MAX

Authorisation number

EU-0018397-0002 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

Active substance

7553-56-2

231-442-4

0,49

Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy

Non active substance

68439-50-9

4,993

META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

| Identifier | meta SPC 2: Dipping, foaming, spraying products - Ready to use |
| --- | --- |

Identifier

meta SPC 2: Dipping, foaming, spraying products - Ready to use

1.2.   Suffix to the authorisation number

| Number | 1-2 |
| --- | --- |

Number

1-2

1.3.   Product type(s)

| Product type(s) | PT03 - Veterinary hygiene (Disinfectants) |
| --- | --- |
| | |

Product type(s)

PT03 - Veterinary hygiene (Disinfectants)

2.   META SPC 2 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 2

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,25 | 0,49 |
| Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) | Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy | Non active substance | 68439-50-9 | | 2,697 | 4,69 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

Active substance

7553-56-2

231-442-4

0,25

0,49

Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy

Non active substance

68439-50-9

2,697

4,69

2.2.   Type(s) of formulation of the meta SPC 2

| Formulation | AL - Any other liquid |
| --- | --- |
| | |

Formulation

AL - Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

| Hazard statements | Causes serious eye irritation.
  Harmful to aquatic life with long lasting effects. |
| --- | --- |
| Precautionary statements | Keep out of reach of children.
  Wash hands thoroughly after handling.
  Wear protective gloves.
  Wear protective clothing.
  Wear eye protection.
  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
  If eye irritation persists: Get medical advice/attention. |

Hazard statements

Causes serious eye irritation.

Harmful to aquatic life with long lasting effects.

Precautionary statements

Keep out of reach of children.

Wash hands thoroughly after handling.

Wear protective gloves.

Wear protective clothing.

Wear eye protection.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

If eye irritation persists: Get medical advice/attention.

4.   AUTHORISED USE(S) OF THE META SPC 2

4.1.   Use description

Table 2. Use # 1 – Manual or automated dipping, foaming or spraying before milking

| Product Type | PT03 - Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria
  Yeasts |
| Field(s) of use | Indoor
  Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking |
| Application method(s) | Dipping, foaming or spraying before milking -
  Manual or automated disinfection of teats by dipping, foaming or spraying before milking
  Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine |
| Application rate(s) and frequency | — | cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) |

Product Type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking

Application method(s)

Dipping, foaming or spraying before milking -

Manual or automated disinfection of teats by dipping, foaming or spraying before milking

Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine

Application rate(s) and frequency

—

cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended)

| — | sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) |
| --- | --- |

—

sheep (1,5 to 5 ml: 1,5 to 3 ml recommended)

| — | goats (2,5 to 6 ml: 2,5 to 4 ml recommended) |
| --- | --- |

—

goats (2,5 to 6 ml: 2,5 to 4 ml recommended)

Frequency: 2 to 3 times per day

Category(ies) of users

Professional

Pack sizes and packaging material

HDPE JERRYCAN 5, 10, 22 L

HDPE DRUM 60, 120, 220 L

HDPE CONTAINER 1 000 L

4.1.1.   Use-specific instructions for use

Eliminate all visible dirt before applying the product.

Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat before milking.

Let the product act at least one minute.

Use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general instructions for use of meta SPC 2.

4.1.2.   Use-specific risk mitigation measures

For manual dipping/foaming application: Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/eye protection.

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 2

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 2

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 2

4.2.   Use description

Table 3. Use # 2 – Manual or automated dipping, foaming or spraying after milking

| Product Type | PT03 - Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria
  Yeasts
  Algae |
| Field(s) of use | Indoor
  Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking |
| Application method(s) | Dipping, foaming, spraying after milking -
  Manual or automated disinfection of teats by dipping, foaming or spraying after milking
  Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine |
| Application rate(s) and frequency | — | cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) |

Product Type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Bacteria

Yeasts

Algae

Field(s) of use

Indoor

Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking

Application method(s)

Dipping, foaming, spraying after milking -

Manual or automated disinfection of teats by dipping, foaming or spraying after milking

Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine

Application rate(s) and frequency

—

cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended)

| — | sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) |
| --- | --- |

—

sheep (1,5 to 5 ml: 1,5 to 3 ml recommended)

| — | goats (2,5 to 6 ml: 2,5 to 4 ml recommended) |
| --- | --- |

—

goats (2,5 to 6 ml: 2,5 to 4 ml recommended)

Frequency: 2 to 3 times per day

Category(ies) of users

Professional

Pack sizes and packaging material

HDPE JERRYCAN 5, 10, 22 L

HDPE DRUM 60, 120, 220 L

HDPE CONTAINER 1 000 L

4.2.1.   Use-specific instructions for use

Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat after milking.

Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).

At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general instructions for use of meta SPC 2.

4.2.2.   Use-specific risk mitigation measures

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 2

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 2

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 2

5.   GENERAL DIRECTIONS FOR USE (2) OF THE META SPC 2

5.1.   Instructions for use

See use-specific instructions for each use.

Always read the label or leaflet before use and follow all the instructions provided.

The product must be brought to a temperature above 20 °C before use.

The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping/foaming cup/sprayer manually or automatically with the ready to use product.

Where necessary repeat the application at each milking

Clean the application equipment regularly with warm water.

5.2.   Risk mitigation measures

See use-specific risk mitigation measures for each use.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

FIRST AID INSTRUCTIONS

| — | In the event of inhalation: Bring to fresh air. |
| --- | --- |

—

In the event of inhalation: Bring to fresh air.

| — | In the event of contact with the skin: Wash with water. |
| --- | --- |

—

In the event of contact with the skin: Wash with water.

| — | In the event of contact with the eyes:
  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
  If eye irritation persists: Get medical advice/attention. |
| --- | --- |

—

In the event of contact with the eyes:

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

If eye irritation persists: Get medical advice/attention.

| — | In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice. |
| --- | --- |

—

In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

Refer to the safety data sheet available for professional user: it contains an emergency phone number.

Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

5.4.   Instructions for safe disposal of the product and its packaging

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

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

Shelf life: 2 years in HDPE

Do not store at a temperature higher than 30 °C.

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | Liq-io 2500
  JOD SPRAY
  IODINE 3000 RTU
  IODEX 2500
  Usual Iod Liquid
  Iodoliquid
  Iodospray
  DESINTEAT
  IODYSPRAY
  RBT 2500
  IODY'FLASH
  INO IODE SPRAY
  IODYPRO 2500
  IODYPRO BL2500
  Robot Liq-io 25
  ADF iDip+
  ASiRAL Dip Spray J
  IODIPACK
  HELIO IODE LIQUIDE
  POLY-IODE
  CERTIODE LIQUIDE
  IOSAPIS FLUID
  GELAPIS ROBOT
  ZENCARE SPRAY
  HELIO IODE SPRAY +
  IODIP +
  KRONI Jod Spray 2500
  WÜBBELMANN JOD LIQUID |
| --- | --- |
| Authorisation number | EU-0018397-0003 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,25 |
| Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) | Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy | Non active substance | 68439-50-9 | | 2,697 |

Trade name(s)

Liq-io 2500

JOD SPRAY

IODINE 3000 RTU

IODEX 2500

Usual Iod Liquid

Iodoliquid

Iodospray

DESINTEAT

IODYSPRAY

RBT 2500

IODY'FLASH

INO IODE SPRAY

IODYPRO 2500

IODYPRO BL2500

Robot Liq-io 25

ADF iDip+

ASiRAL Dip Spray J

IODIPACK

HELIO IODE LIQUIDE

POLY-IODE

CERTIODE LIQUIDE

IOSAPIS FLUID

GELAPIS ROBOT

ZENCARE SPRAY

HELIO IODE SPRAY +

IODIP +

KRONI Jod Spray 2500

WÜBBELMANN JOD LIQUID

Authorisation number

EU-0018397-0003 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

Active substance

7553-56-2

231-442-4

0,25

Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy

Non active substance

68439-50-9

2,697

7.2.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | Liq-io YB MAX
  INO Io Liquid Max
  Iodoliquid YB MAX
  Iodospray YB MAX
  Desinteat YB MAX
  Iodium Spray YB MAX
  JodySpray YB MAX
  Delta IoSpray YB MAX |
| --- | --- |
| Authorisation number | EU-0018397-0004 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,49 |
| Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) | Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy | Non active substance | 68439-50-9 | | 4,69 |

Trade name(s)

Liq-io YB MAX

INO Io Liquid Max

Iodoliquid YB MAX

Iodospray YB MAX

Desinteat YB MAX

Iodium Spray YB MAX

JodySpray YB MAX

Delta IoSpray YB MAX

Authorisation number

EU-0018397-0004 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

Active substance

7553-56-2

231-442-4

0,49

Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy

Non active substance

68439-50-9

4,69

META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier

| Identifier | meta SPC 3: Dipping, foaming, spraying concentrated products |
| --- | --- |

Identifier

meta SPC 3: Dipping, foaming, spraying concentrated products

1.2.   Suffix to the authorisation number

| Number | 1-3 |
| --- | --- |

Number

1-3

1.3.   Product type(s)

| Product type(s) | PT03 - Veterinary hygiene (Disinfectants) |
| --- | --- |
| | |

Product type(s)

PT03 - Veterinary hygiene (Disinfectants)

2.   META SPC 3 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 3

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 2,5 | 2,5 |
| Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) | Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy | Non active substance | 68439-50-9 | | 24,199 | 24,199 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

Active substance

7553-56-2

231-442-4

2,5

2,5

Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy

Non active substance

68439-50-9

24,199

24,199

2.2.   Type(s) of formulation of the meta SPC 3

| Formulation | SL - Soluble concentrate |
| --- | --- |
| | |

Formulation

SL - Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

| Hazard statements | Causes serious eye damage.
  May cause damage to organs (thyroid) through prolonged or repeated exposure oral.
  Toxic to aquatic life with long lasting effects.
  May be corrosive to metals. |
| --- | --- |
| Precautionary statements | Keep out of reach of children.
  Do not breathe mist.
  Do not breathe vapours.
  Do not breathe spray.
  Wash hands thoroughly after handling.
  Wear protective gloves.
  Wear protective clothing.
  Wear eye protection.
  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
  Immediately call a poison center/doctor.
  Get medical advice/attention if you feel unwell.
  Dispose of contents to in accordance with local/regional/national/international regulations. Dispose of container to in accordance with local/regional/national/international regulations.
  Keep only in original container.
  Absorb spillage to prevent material damage. |

Hazard statements

Causes serious eye damage.

May cause damage to organs (thyroid) through prolonged or repeated exposure oral.

Toxic to aquatic life with long lasting effects.

May be corrosive to metals.

Precautionary statements

Keep out of reach of children.

Do not breathe mist.

Do not breathe vapours.

Do not breathe spray.

Wash hands thoroughly after handling.

Wear protective gloves.

Wear protective clothing.

Wear eye protection.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a poison center/doctor.

Get medical advice/attention if you feel unwell.

Dispose of contents to in accordance with local/regional/national/international regulations. Dispose of container to in accordance with local/regional/national/international regulations.

Keep only in original container.

Absorb spillage to prevent material damage.

4.   AUTHORISED USE(S) OF THE META SPC 3

4.1.   Use description

Table 4. Use # 1 – Manual or automated dipping, foaming or spraying before milking

| Product Type | PT03 - Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria
  Yeasts |
| Field(s) of use | Indoor
  Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking |
| Application method(s) | Dipping, foaming, spraying -
  Manual or automated disinfection of teats by dipping, foaming or spraying before milking.
  Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine |
| Application rate(s) and frequency | A dilution at 10 % (v/v) should be prepared
  Application rate for the diluted product:






  — | cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) |

Product Type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking

Application method(s)

Dipping, foaming, spraying -

Manual or automated disinfection of teats by dipping, foaming or spraying before milking.

Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine

Application rate(s) and frequency

A dilution at 10 % (v/v) should be prepared

Application rate for the diluted product:

—

cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended)

| — | sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) |
| --- | --- |

—

sheep (1,5 to 5 ml: 1,5 to 3 ml recommended)

| — | goats (2,5 to 6 ml: 2,5 to 4 ml recommended) |
| --- | --- |

—

goats (2,5 to 6 ml: 2,5 to 4 ml recommended)

Frequency: 2 to 3 times per day

Category(ies) of users

Professional

Pack sizes and packaging material

HDPE JERRYCAN 5, 10, 22 L

HDPE DRUM 60, 120, 220 L

HDPE CONTAINER 1 000 L

4.1.1.   Use-specific instructions for use

Prepare a dilution at 10 % (v/v: 10 ml product, add water up to 100 ml) for bactericidal and yeasticidal activity.

Fill the dipping/foaming cup/sprayer manually or automatically with the prepared dilution.

Eliminate all visible dirt before applying the product.

Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat before milking.

Let the product act at least one minute.

Use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general directions for use of meta SPC 3.

4.1.2.   Use-specific risk mitigation measures

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 3

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 3

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 3

4.2.   Use description

Table 5. Use # 2 – Manual or automated dipping, foaming or spraying after milking

| Product Type | PT03 - Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria
  Yeasts
  Algae
  Viruses |
| Field(s) of use | Indoor
  Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking |
| Application method(s) | Dipping, foaming, spraying -
  Manual or automated disinfection of teats by dipping, foaming or spraying after milking.
  Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine |
| Application rate(s) and frequency | For disinfection of bacteria, yeasts and algae a dilution at 10 % (v/v: 10 ml product, add water up to 100 ml) should be prepared.
  For disinfection of viruses a dilution at 20 % (v/v: 20 ml product, add water up to 100 ml) should be prepared
  Application rate for the diluted product:






  — | cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) |

Product Type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Bacteria

Yeasts

Algae

Viruses

Field(s) of use

Indoor

Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking

Application method(s)

Dipping, foaming, spraying -

Manual or automated disinfection of teats by dipping, foaming or spraying after milking.

Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine

Application rate(s) and frequency

For disinfection of bacteria, yeasts and algae a dilution at 10 % (v/v: 10 ml product, add water up to 100 ml) should be prepared.

For disinfection of viruses a dilution at 20 % (v/v: 20 ml product, add water up to 100 ml) should be prepared

Application rate for the diluted product:

—

cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended)

| — | sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) |
| --- | --- |

—

sheep (1,5 to 5 ml: 1,5 to 3 ml recommended)

| — | goats (2,5 to 6 ml: 2,5 to 4 ml recommended) |
| --- | --- |

—

goats (2,5 to 6 ml: 2,5 to 4 ml recommended)

Frequency: 2 to 3 times per day

Category(ies) of users

Professional

Pack sizes and packaging material

HDPE JERRYCAN 5, 10, 22 L

HDPE DRUM 60, 120, 220 L

HDPE CONTAINER 1 000 L

4.2.1.   Use-specific instructions for use

Prepare a dilution at 10 % (v/v: 10 ml product, add water up to 100 ml) for bactericidal, yeasticidal and algaecidal activity or 20 % (v/v: 20 ml product, add water up to 100 ml) in case virucidal activity is also needed.

Fill the dipping/foaming cup/sprayer manually or automatically with the prepared dilution.

Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat after milking.

Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).

At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general directions for use of meta SPC 3.

4.2.2.   Use-specific risk mitigation measures

For manual spraying applications wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 3

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 3

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 3

5.   GENERAL DIRECTIONS FOR USE (3) OF THE META SPC 3

5.1.   Instructions for use

See use-specific instructions for each use.

Always read the label or leaflet before use and follow all the instructions provided.

The product must be brought to a temperature above 20 °C before use.

The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping/foaming cup/sprayer manually or automatically with the prepared dilution.

Where necessary, repeat the application at each milking

Clean the application equipment regularly with warm water.

5.2.   Risk mitigation measures

See use-specific risk mitigation measures for each use.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

In case of faintness, get medical advice/attention. Show this safety data sheet to the doctor.

FIRST AID INSTRUCTIONS

| — | In the event of inhalation: Bring to fresh air. |
| --- | --- |

—

In the event of inhalation: Bring to fresh air.

| — | In the event of contact with the skin: Wash with water. |
| --- | --- |

—

In the event of contact with the skin: Wash with water.

| — | In the event of contact with the eyes: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open.
  Remove contact lenses if present and easy to do. Continue rinsing.
  Immediately call a POISON CENTER or doctor/physician. |
| --- | --- |

—

In the event of contact with the eyes: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open.

Remove contact lenses if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER or doctor/physician.

| — | In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice. |
| --- | --- |

—

In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

Refer to the safety data sheet available for professional user: it contains an emergency phone number.

Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

5.4.   Instructions for safe disposal of the product and its packaging

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

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

Shelf life: 2 years in HDPE

Do not store at a temperature higher than 30 °C.

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | Liq-io concentrate
  INO Jod Konzentrat
  Usual Iod Concent
  Iodoconcentrat
  D 10 IODINE
  D 5 IODINE
  Liq-io C
  INO IODE C
  D 4 IODINE
  ADF iDip+ concentrate
  Mammizan Concentré |
| --- | --- |
| Authorisation number | EU-0018397-0005 1-3 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 2,5 |
| Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) | Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy | Non active substance | 68439-50-9 | | 24,199 |

Trade name(s)

Liq-io concentrate

INO Jod Konzentrat

Usual Iod Concent

Iodoconcentrat

D 10 IODINE

D 5 IODINE

Liq-io C

INO IODE C

D 4 IODINE

ADF iDip+ concentrate

Mammizan Concentré

Authorisation number

EU-0018397-0005 1-3

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

Active substance

7553-56-2

231-442-4

2,5

Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy

Non active substance

68439-50-9

24,199

META SPC 4

1.   META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier

| Identifier | meta SPC 4: Dipping products reaching virucidal activity – Ready to use |
| --- | --- |

Identifier

meta SPC 4: Dipping products reaching virucidal activity – Ready to use

1.2.   Suffix to the authorisation number

| Number | 1-4 |
| --- | --- |

Number

1-4

1.3.   Product type(s)

| Product type(s) | PT03 - Veterinary hygiene (Disinfectants) |
| --- | --- |
| | |

Product type(s)

PT03 - Veterinary hygiene (Disinfectants)

2.   META SPC 4 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 4

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,5 | 0,5 |
| Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) | Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy | Non active substance | 68439-50-9 | | 4,993 | 4,993 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

Active substance

7553-56-2

231-442-4

0,5

0,5

Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy

Non active substance

68439-50-9

4,993

4,993

2.2.   Type(s) of formulation of the meta SPC 4

| Formulation | AL - Any other liquid |
| --- | --- |
| | |

Formulation

AL - Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

| Hazard statements | Causes serious eye irritation.
  Harmful to aquatic life with long lasting effects. |
| --- | --- |
| Precautionary statements | Keep out of reach of children.
  Wash hands thoroughly after handling.
  Wear protective gloves.
  Wear protective clothing.
  Wear eye protection.
  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
  If eye irritation persists: Get medical advice/attention. |

Hazard statements

Causes serious eye irritation.

Harmful to aquatic life with long lasting effects.

Precautionary statements

Keep out of reach of children.

Wash hands thoroughly after handling.

Wear protective gloves.

Wear protective clothing.

Wear eye protection.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

If eye irritation persists: Get medical advice/attention.

4.   AUTHORISED USE(S) OF THE META SPC 4

4.1.   Use description

Table 6. Use # 1 – Manual or automated dipping after milking

| Product Type | PT03 - Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria
  Yeasts
  Algae
  Viruses |
| Field(s) of use | Indoor
  Disinfection of teats of milk producing animals by dipping after milking |
| Application method(s) | Dipping -
  Manual or automated disinfection of teats by dipping after milking.
  Dipping cup or automated dipping machine. |
| Application rate(s) and frequency | — | cows and buffaloes (3 to 10 ml: 5 ml recommended) |

Product Type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Bacteria

Yeasts

Algae

Viruses

Field(s) of use

Indoor

Disinfection of teats of milk producing animals by dipping after milking

Application method(s)

Dipping -

Manual or automated disinfection of teats by dipping after milking.

Dipping cup or automated dipping machine.

Application rate(s) and frequency

—

cows and buffaloes (3 to 10 ml: 5 ml recommended)

| — | sheep (1,5 to 5 ml: 1,5 ml recommended) |
| --- | --- |

—

sheep (1,5 to 5 ml: 1,5 ml recommended)

| — | goats (2,5 to 6 ml: 2,5 ml recommended) |
| --- | --- |

—

goats (2,5 to 6 ml: 2,5 ml recommended)

Frequency: 2 to 3 times per day

Category(ies) of users

Professional

Pack sizes and packaging material

HDPE JERRYCAN 5, 10, 22 L

HDPE DRUM 60, 120, 220 L

HDPE CONTAINER 1 000 L

4.1.1.   Use-specific instructions for use

See general directions for use of meta SPC 4

4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 4

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 4

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 4

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 4

5.   GENERAL DIRECTIONS FOR USE (4) OF THE META SPC 4

5.1.   Instructions for use

Always read the label or leaflet before use and follow all the instructions provided.

The product must be brought to a temperature above 20 °C before use.

The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping cup manually or automatically with the ready to use product.

Apply by dipping manually or automatically on animal's teats on the full length of the teat after milking.

| — | cows and buffaloes (3 to 10 ml: 5 ml recommended) |
| --- | --- |

—

cows and buffaloes (3 to 10 ml: 5 ml recommended)

| — | sheep (1,5 to 5 ml: 1,5 ml recommended) |
| --- | --- |

—

sheep (1,5 to 5 ml: 1,5 ml recommended)

| — | goats (2,5 to 6 ml: 2,5 ml recommended) |
| --- | --- |

—

goats (2,5 to 6 ml: 2,5 ml recommended)

Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).

At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

Where necessary, repeat the application after each milking.

Clean the application equipment regularly with warm water.

5.2.   Risk mitigation measures

Wear eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

FIRST AID INSTRUCTIONS

| — | In the event of inhalation: Bring to fresh air. |
| --- | --- |

—

In the event of inhalation: Bring to fresh air.

| — | In the event of contact with the skin: Wash with water. |
| --- | --- |

—

In the event of contact with the skin: Wash with water.

| — | In the event of contact with the eyes:
  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
  If eye irritation persists: Get medical advice/attention. |
| --- | --- |

—

In the event of contact with the eyes:

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

If eye irritation persists: Get medical advice/attention.

| — | In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice. |
| --- | --- |

—

In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

Refer to the safety data sheet available for professional user: it contains an emergency phone number.

Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

5.4.   Instructions for safe disposal of the product and its packaging

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

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

Shelf life: 2 years in HDPE

Do not store at a temperature higher than 30 °C.

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | Dip-io 5000
  IODIUM TX
  INO JOD 50 DIP
  Usual Iod Post +
  IODIUM PRO DIP
  IODERM PSP +
  IODEX EXTRA +
  Iododip +
  IODYSTRONG PLUS
  INO TREMP
  INO STAR
  IODACTIV 5000
  DERMINO
  IODERM 5000
  IODIUM BX5000
  HOEVE-PLUS DIP
  TREMPASEPT IODE
  DERMADINE
  MAMMO-DERM
  KRONI Jod Dipp 5000 |
| --- | --- |
| Authorisation number | EU-0018397-0006 1-4 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,5 |
| Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) | Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy | Non active substance | 68439-50-9 | | 4,993 |

Trade name(s)

Dip-io 5000

IODIUM TX

INO JOD 50 DIP

Usual Iod Post +

IODIUM PRO DIP

IODERM PSP +

IODEX EXTRA +

Iododip +

IODYSTRONG PLUS

INO TREMP

INO STAR

IODACTIV 5000

DERMINO

IODERM 5000

IODIUM BX5000

HOEVE-PLUS DIP

TREMPASEPT IODE

DERMADINE

MAMMO-DERM

KRONI Jod Dipp 5000

Authorisation number

EU-0018397-0006 1-4

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

Active substance

7553-56-2

231-442-4

0,5

Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy

Non active substance

68439-50-9

4,993

META SPC 5

1.   META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 5 identifier

| Identifier | meta SPC 5: Dipping, foaming, spraying products 5 500  ppm – Ready to use |
| --- | --- |

Identifier

meta SPC 5: Dipping, foaming, spraying products 5 500  ppm – Ready to use

1.2.   Suffix to the authorisation number

| Number | 1-5 |
| --- | --- |

Number

1-5

1.3.   Product type(s)

| Product type(s) | PT03 - Veterinary hygiene (Disinfectants) |
| --- | --- |
| | |

Product type(s)

PT03 - Veterinary hygiene (Disinfectants)

2.   META SPC 5 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 5

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,55 | 0,55 |
| Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) | Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy | Non active substance | 68439-50-9 | | 4,69 | 4,69 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

Active substance

7553-56-2

231-442-4

0,55

0,55

Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy

Non active substance

68439-50-9

4,69

4,69

2.2.   Type(s) of formulation of the meta SPC 5

| Formulation | AL - Any other liquid |
| --- | --- |
| | |

Formulation

AL - Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

| Hazard statements | Causes serious eye irritation.
  Harmful to aquatic life with long lasting effects. |
| --- | --- |
| Precautionary statements | Keep out of reach of children.
  Wash hands thoroughly after handling.
  Wear protective gloves.
  Wear protective clothing.
  Wear eye protection.
  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
  If eye irritation persists: Get medical advice/attention. |

Hazard statements

Causes serious eye irritation.

Harmful to aquatic life with long lasting effects.

Precautionary statements

Keep out of reach of children.

Wash hands thoroughly after handling.

Wear protective gloves.

Wear protective clothing.

Wear eye protection.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

If eye irritation persists: Get medical advice/attention.

4.   AUTHORISED USE(S) OF THE META SPC 5

4.1.   Use description

Table 7. Use # 1 – Manual or automated dipping, foaming or spraying before milking

| Product Type | PT03 - Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria
  Yeasts |
| Field(s) of use | Indoor
  Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking |
| Application method(s) | Dipping, foaming, spraying -
  Manual or automated disinfection of teats by dipping, foaming or spraying before milking
  Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine |
| Application rate(s) and frequency | — | cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) |

Product Type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking

Application method(s)

Dipping, foaming, spraying -

Manual or automated disinfection of teats by dipping, foaming or spraying before milking

Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine

Application rate(s) and frequency

—

cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended)

| — | sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) |
| --- | --- |

—

sheep (1,5 to 5 ml: 1,5 to 3 ml recommended)

| — | goats (2,5 to 6 ml: 2,5 to 4 ml recommended) |
| --- | --- |

—

goats (2,5 to 6 ml: 2,5 to 4 ml recommended)

Frequency: 2 to 3 times per day

Category(ies) of users

Professional

Pack sizes and packaging material

HDPE JERRYCAN 5, 10, 22 L

HDPE DRUM 60, 120, 220 L

HDPE CONTAINER 1 000 L

4.1.1.   Use-specific instructions for use

Fill the dipping/foaming cup/sprayer manually or automatically with the ready to use product.

Eliminate all visible dirt before applying the product.

Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat before milking.

Let the product act at least one minute.

Use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general instructions for use of meta SPC5.

4.1.2.   Use-specific risk mitigation measures

For manual dipping/foaming application: Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/eye protection.

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 5

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 5

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 5

4.2.   Use description

Table 8. Use # 2 – Manual or automated dipping, foaming or spraying after milking

| Product Type | PT03 - Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria
  Yeasts
  Algae
  Viruses |
| Field(s) of use | Indoor
  Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking |
| Application method(s) | Dipping, foaming, spraying -
  Manual or automated disinfection of teats by dipping, foaming or spraying after milking.
  Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine. |
| Application rate(s) and frequency | — | cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) |

Product Type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Bacteria

Yeasts

Algae

Viruses

Field(s) of use

Indoor

Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking

Application method(s)

Dipping, foaming, spraying -

Manual or automated disinfection of teats by dipping, foaming or spraying after milking.

Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine.

Application rate(s) and frequency

—

cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended)

| — | sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) |
| --- | --- |

—

sheep (1,5 to 5 ml: 1,5 to 3 ml recommended)

| — | goats (2,5 to 6 ml: 2,5 to 4 ml recommended) |
| --- | --- |

—

goats (2,5 to 6 ml: 2,5 to 4 ml recommended)

Frequency: 2 to 3 times per day

Category(ies) of users

Professional

Pack sizes and packaging material

HDPE JERRYCAN 5, 10, 22 L

HDPE DRUM 60, 120, 220 L

HDPE CONTAINER 1 000 L

4.2.1.   Use-specific instructions for use

Fill the dipping/foaming cup/sprayer manually or automatically with the ready to use product.

Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat after milking.

Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).

At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general instructions for use of meta SPC 5.

4.2.2.   Use-specific risk mitigation measures

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 5

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 5

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 5

5.   GENERAL DIRECTIONS FOR USE (5) OF THE META SPC 5

5.1.   Instructions for use

See use-specific instructions for each use.

Always read the label or leaflet before use and follow all the instructions provided.

The product must be brought to a temperature above 20 °C before use.

The use of a dosing pump for filling the product into the application equipment is recommended.

Where necessary repeat the application at each milking.

Clean the application equipment regularly with warm water.

5.2.   Risk mitigation measures

See use-specific risk mitigation measures for each use.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

FIRST AID INSTRUCTIONS

| — | In the event of inhalation: Bring to fresh air. |
| --- | --- |

—

In the event of inhalation: Bring to fresh air.

| — | In the event of contact with the skin: Wash with water. |
| --- | --- |

—

In the event of contact with the skin: Wash with water.

| — | In the event of contact with the eyes:
  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
  If eye irritation persists: Get medical advice/attention. |
| --- | --- |

—

In the event of contact with the eyes:

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

If eye irritation persists: Get medical advice/attention.

| — | In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice. |
| --- | --- |

—

In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

Refer to the safety data sheet available for professional user: it contains an emergency phone number.

Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

5.4.   Instructions for safe disposal of the product and its packaging

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

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

Shelf life: 2 years in HDPE

Do not store at a temperature higher than 30 °C.

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | Liq-io 5500
  IODYPRO
  INO JOD 50 Liquid
  Usual Iod Liquid +
  IODIUM PRO SPRAY
  IODEX
  Iodoliquid +
  Iodospray Plus
  DESINTEAT PLUS
  ROBOSPRAY IODE
  INOTRAYON
  IODYPRO 5500
  Robot Liq-io 55
  IODYPRO BL5500
  ADF iDip+ 5500
  HOEVE-JODIUM SPRAY
  GRUPAIODE
  IODOCAN
  JOFO
  JODI PLUS
  K-AGRO PRODIP ID
  IODIP
  HELIO IODE SPRAY
  MAMMO-JOD
  KRONI Jod Spray 5500
  MUNGI-IOD
  LELY QUARESS-Iodine |
| --- | --- |
| Authorisation number | EU-0018397-0007 1-5 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,55 |
| Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) | Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy | Non active substance | 68439-50-9 | | 4,69 |

Trade name(s)

Liq-io 5500

IODYPRO

INO JOD 50 Liquid

Usual Iod Liquid +

IODIUM PRO SPRAY

IODEX

Iodoliquid +

Iodospray Plus

DESINTEAT PLUS

ROBOSPRAY IODE

INOTRAYON

IODYPRO 5500

Robot Liq-io 55

IODYPRO BL5500

ADF iDip+ 5500

HOEVE-JODIUM SPRAY

GRUPAIODE

IODOCAN

JOFO

JODI PLUS

K-AGRO PRODIP ID

IODIP

HELIO IODE SPRAY

MAMMO-JOD

KRONI Jod Spray 5500

MUNGI-IOD

LELY QUARESS-Iodine

Authorisation number

EU-0018397-0007 1-5

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

Active substance

7553-56-2

231-442-4

0,55

Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy

Non active substance

68439-50-9

4,69

---

(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC1.

(2)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC2.

(3)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC3.

(4)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC4.

(5)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC5.

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