# L_2020410EN.01007001.xml

| 7.12.2020 | EN | Official Journal of the European Union | L 410/70 |
| --- | --- | --- | --- |

7.12.2020

EN

Official Journal of the European Union

L 410/70

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/1995

of 4 December 2020

amending Implementing Regulation (EU) No 2018/1261 as regards administrative changes of the information related to the Union authorisation of 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 50(2) thereof,

Whereas:

| (1) | On 20 September 2018, a Union authorisation with authorisation number EU-0018397-0000 was granted by Commission Implementing Regulation (EU) 2018/1261 (2) to HYPRED SAS for the making available on the market and use of the biocidal product family ‘Hypred’s iodine based products‘. |
| --- | --- |

(1)

On 20 September 2018, a Union authorisation with authorisation number EU-0018397-0000 was granted by Commission Implementing Regulation (EU) 2018/1261 (2) to HYPRED SAS for the making available on the market and use of the biocidal product family ‘Hypred’s iodine based products‘.

| (2) | On 04 April 2019, HYPRED SAS submitted a notification to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013 (3), in respect of administrative changes to the Union authorisation of the biocidal product family ‘Hypred’s iodine based products’ as described in Title 1, Sections 1 and 2 of the Annex to that Regulation. |
| --- | --- |

(2)

On 04 April 2019, HYPRED SAS submitted a notification to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013 (3), in respect of administrative changes to the Union authorisation of the biocidal product family ‘Hypred’s iodine based products’ as described in Title 1, Sections 1 and 2 of the Annex to that Regulation.

| (3) | HYPRED SAS proposed the following changes to the summary of the product characteristics for the biocidal product family ‘Hypred’s iodine based products’, as set out in the Annex to Implementing Regulation (EU) 2018/1261: (a) the addition of names for the biocidal product family in Section 7.1 of the third information level: individual products in the meta SPCs 1, 2, 3 and 5; (b) the change of the name of the authorisation holder in Section 1.3; (c) the addition of two manufacturers for the active substance and their respective manufacturing sites in Section 1.5; (d) the change of administrative details of the manufacturer in Section 1.4; (e) changes of administrative details of the location of existing manufacturing sites, and addition of location of new manufacturing sites in Section 1.4. The notification was recorded under case number BC-KC049719-36 in the Register for Biocidal Products. |
| --- | --- |

(3)

HYPRED SAS proposed the following changes to the summary of the product characteristics for the biocidal product family ‘Hypred’s iodine based products’, as set out in the Annex to Implementing Regulation (EU) 2018/1261: (a) the addition of names for the biocidal product family in Section 7.1 of the third information level: individual products in the meta SPCs 1, 2, 3 and 5; (b) the change of the name of the authorisation holder in Section 1.3; (c) the addition of two manufacturers for the active substance and their respective manufacturing sites in Section 1.5; (d) the change of administrative details of the manufacturer in Section 1.4; (e) changes of administrative details of the location of existing manufacturing sites, and addition of location of new manufacturing sites in Section 1.4. The notification was recorded under case number BC-KC049719-36 in the Register for Biocidal Products.

| (4) | On 19 June 2019, the Agency submitted to the Commission an opinion on the proposed changes, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013. The opinion concludes that the amendments to the existing authorisation sought by the authorisation holder falls under the category of change set out in Article 50(3)(a) of Regulation (EU) No 528/2012, and that after the implementation of the changes the conditions of Article 19 to that Regulation are still met. |
| --- | --- |

(4)

On 19 June 2019, the Agency submitted to the Commission an opinion on the proposed changes, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013. The opinion concludes that the amendments to the existing authorisation sought by the authorisation holder falls under the category of change set out in Article 50(3)(a) of Regulation (EU) No 528/2012, and that after the implementation of the changes the conditions of Article 19 to that Regulation are still met.

| (5) | On 28 June 2019, the Agency transmitted to the Commission the revised summary of the biocidal product characteristics in all the official languages of the Union in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013. |
| --- | --- |

(5)

On 28 June 2019, the Agency transmitted to the Commission the revised summary of the biocidal product characteristics in all the official languages of the Union in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.

| (6) | The Commission concurs with the opinion of the Agency and considers it therefore appropriate to amend the Union authorisation of the biocidal product family ‘Hypred’s iodine based products’. |
| --- | --- |

(6)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to amend the Union authorisation of the biocidal product family ‘Hypred’s iodine based products’.

| (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

Implementing Regulation (EU) 2018/1261 is amended as follows:

| (1) | in Article 1, ‘HYPRED SAS’ is replaced by ‘HYPRED SAS – KERSIA Group’; |
| --- | --- |

(1)

in Article 1, ‘HYPRED SAS’ is replaced by ‘HYPRED SAS – KERSIA Group’;

| (2) | the Annex is replaced by the Annex to this Regulation. |
| --- | --- |

(2)

the Annex is replaced by the Annex to this Regulation.

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, 4 December 2020.

For the Commission

The President

Ursula VON DER LEYEN

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

1

(2)  Commission Implementing Regulation (EU) 2018/1261 of 20 September 2018 granting a Union authorisation for the biocidal product family Hypred’s iodine based products (OJ L 238, 21.9.2018, p. 33).

2

(3)  Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4).

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 – KERSIA Group |
| --- | --- | --- |
| 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 – KERSIA Group

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 – KERSIA Group |
| --- | --- |
| Address of manufacturer | 55, Boulevard Jules Verger - BP10180 35803 DINARD France |
| Location of manufacturing sites | HYPRED SAS – KERSIA Group - 55, Boulevard Jules Verger - BP10180 35803 DINARD France
  KERSIA POLSKA Sp.z.o.o. - NIEPRUSZEWO, KASZTANOWA 4 64320 Buk Poland
  KERSIA IBERICA SL - Pol. Miguel Eguía C/Zarapuz s/n
  31200 ESTELLA (NAVARRA) Spain
  KERSIA DEUTSCHLAND GmbH Marie-Curie-Straße 23 53332 Bornheim – Sechtem Germany
  HYPRED Italia s.r.l. – KERSIA Group Strada Montodine-Gombito Loc. Cà Nova 26010 Ripalta Arpina CR Italy
  AG France S.A.S – KERSIA Group - Zone Industrielle Le Roineau, 72500 VAAS, FRANCE
  KERSIA DEUTSCHLAND GmbH - OBERBRÜHLSTRAßE 16-18, 87700 MEMMINGEN, GERMANY
  KERSIA AUSTRIA GmbH - PFONGAUERSTRAßE 17, 5202 NEUMARKT AM WALLERSEE, AUSTRIA
  Kilco Holdings Ltd – KERSIA Group - Broomhouses 2 Industrial Estate, Old Glasgow Road, LOCKERBIE - DG11 2SD, UNITED KINGDOM
  Kilco (International) Ltd – KERSIA Group - 1A Trench Road Mallusk, Newtownabbey, CO ANTRIM BT36 4TY, IRELAND
  Medentech Ltd – KERSIA Group - Clonard Road, WEXFORD, Y35Y7WY, IRELAND |

Name of manufacturer

HYPRED SAS – KERSIA Group

Address of manufacturer

55, Boulevard Jules Verger - BP10180 35803 DINARD France

Location of manufacturing sites

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

KERSIA POLSKA Sp.z.o.o. - NIEPRUSZEWO, KASZTANOWA 4 64320 Buk Poland

KERSIA IBERICA SL - Pol. Miguel Eguía C/Zarapuz s/n

31200 ESTELLA (NAVARRA) Spain

KERSIA DEUTSCHLAND GmbH Marie-Curie-Straße 23 53332 Bornheim – Sechtem Germany

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

AG France S.A.S – KERSIA Group - Zone Industrielle Le Roineau, 72500 VAAS, FRANCE

KERSIA DEUTSCHLAND GmbH - OBERBRÜHLSTRAßE 16-18, 87700 MEMMINGEN, GERMANY

KERSIA AUSTRIA GmbH - PFONGAUERSTRAßE 17, 5202 NEUMARKT AM WALLERSEE, AUSTRIA

Kilco Holdings Ltd – KERSIA Group - Broomhouses 2 Industrial Estate, Old Glasgow Road, LOCKERBIE - DG11 2SD, UNITED KINGDOM

Kilco (International) Ltd – KERSIA Group - 1A Trench Road Mallusk, Newtownabbey, CO ANTRIM BT36 4TY, IRELAND

Medentech Ltd – KERSIA Group - Clonard Road, WEXFORD, Y35Y7WY, IRELAND

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

| Active substance | Iodine |
| --- | --- |
| Name of manufacturer | ISE Chemicals Corporation |
| Address of manufacturer | 3-1, Kyobashi 1-Chome, Chuo-ku, Tokyo Japan |
| Location of manufacturing sites | Shirasato Plant (3695 Kitaimaizumi, Oamishirasato City, Chiba, Japan) |

Active substance

Iodine

Name of manufacturer

ISE Chemicals Corporation

Address of manufacturer

3-1, Kyobashi 1-Chome, Chuo-ku, Tokyo Japan

Location of manufacturing sites

Shirasato Plant (3695 Kitaimaizumi, Oamishirasato City, Chiba, Japan)

| Active substance | Iodine |
| --- | --- |
| Name of manufacturer | Nihon Tennen Gas Development Co., Ltd |
| Address of manufacturer | 661 Mobara 297-8550 Mobara City, Chiba Japan |
| Location of manufacturing sites | Chiba Plant, 2508 Minami Hinata, 299-4205 Shirako-Machi, Chosei-Gun, Chiba Japan |

Active substance

Iodine

Name of manufacturer

Nihon Tennen Gas Development Co., Ltd

Address of manufacturer

661 Mobara 297-8550 Mobara City, Chiba Japan

Location of manufacturing sites

Chiba Plant, 2508 Minami Hinata, 299-4205 Shirako-Machi, Chosei-Gun, Chiba Japan

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 10ml : 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 10ml : 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 1000L

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 10ml : 5 ml recommended) |
| --- | --- |

—

cows and buffaloes (3 to 10ml : 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 : |
| --- | --- |

—

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
  IODOFILM
  EMPRASAN UDDER SHIELD
  ANGLIA FARMERS IO-FILM
  BARRICADE
  STANTON IODOFILM
  WYNNSAN IOFILM TEAT DIP |
| --- | --- |
| 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

IODOFILM

EMPRASAN UDDER SHIELD

ANGLIA FARMERS IO-FILM

BARRICADE

STANTON IODOFILM

WYNNSAN IOFILM TEAT DIP

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 10ml : 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 10ml : 5 to 8 ml recommended)

| — | sheep (1.5 to 5 ml : 1.5 to 3ml recommended) |
| --- | --- |

—

sheep (1.5 to 5 ml : 1.5 to 3ml 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 1000L

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 10ml : 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 10ml : 5 to 8 ml recommended)

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

—

sheep (1,5 to 5 ml : 1,5 to 3ml 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 1000L

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 : |
| --- | --- |

—

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
  PRECEPT
  ANGLIA FARMERS PRECLENZ
  H&M PREDIP
  FULLWOOD PRECLEANSE
  M WILLIAMS PRECEPT
  STANTON PREDIP RTU
  WYNNSAN IODINE PREDIP RTU
  PREMIER GOLD PRE-DIP
  HODGES & MOSS PREDIP
  LANODIP PREPOST
  DAIRYSAN MULTICARE
  EMPRASAN ADVANCE
  UDDERWASH IODINE
  ANGLIA FARMERS PREPOST-IO
  PREMIER GOLD PRE/POST
  FULLWOOD PRE/POST IODINE
  HODGES & MOSS ADVANCE
  WYNNSAN IODINE PREPOST |
| --- | --- |
| 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

PRECEPT

ANGLIA FARMERS PRECLENZ

H&M PREDIP

FULLWOOD PRECLEANSE

M WILLIAMS PRECEPT

STANTON PREDIP RTU

WYNNSAN IODINE PREDIP RTU

PREMIER GOLD PRE-DIP

HODGES & MOSS PREDIP

LANODIP PREPOST

DAIRYSAN MULTICARE

EMPRASAN ADVANCE

UDDERWASH IODINE

ANGLIA FARMERS PREPOST-IO

PREMIER GOLD PRE/POST

FULLWOOD PRE/POST IODINE

HODGES & MOSS ADVANCE

WYNNSAN IODINE PREPOST

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 10ml : 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 10ml : 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 1000L

4.1.1.   Use-specific instructions for use

Prepare a dilution at 10% (v/v: 10 ml product, add water up to 100ml) 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 100ml) should be prepared.
  For disinfection of viruses a dilution at 20% (v/v: 20 ml product, add water up to 100ml) should be prepared
  Application rate for the diluted product:






  — | cows and buffaloes (3 to 10ml : 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 100ml) should be prepared.

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

Application rate for the diluted product:

—

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

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

—

sheep (1,5 to 5 ml : 1,5 to 3ml 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 1000L

4.2.1.   Use-specific instructions for use

Prepare a dilution at 10% (v/v: 10 ml product, add water up to 100ml) for bactericidal, yeasticidal and algaecidal activity or 20% (v/v: 20 ml product, add water up to 100ml) 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. |
| --- | --- |

—

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
  WYNNSAN IODINE CONCENTRATE
  EMPRASAN OPTIMA
  ANGLIA FARMERS CONC
  PROLAC SENTINEL CONC
  PREMIER GOLD CONCENTRATE
  FULLWOOD IODINE CONC
  H&M OPTIMA
  SENTINAL CONC
  HARRY TRAVIS SUPER CONC TEAT DIP
  LANODIP CONC
  E/SAN SOVEREIGN
  PROLAC SENTINEL CONC |
| --- | --- |
| 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

WYNNSAN IODINE CONCENTRATE

EMPRASAN OPTIMA

ANGLIA FARMERS CONC

PROLAC SENTINEL CONC

PREMIER GOLD CONCENTRATE

FULLWOOD IODINE CONC

H&M OPTIMA

SENTINAL CONC

HARRY TRAVIS SUPER CONC TEAT DIP

LANODIP CONC

E/SAN SOVEREIGN

PROLAC SENTINEL CONC

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 10ml : 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 10ml : 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 1000L

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 10ml : 5 ml recommended) |
| --- | --- |

—

cows and buffaloes (3 to 10ml : 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 : |
| --- | --- |

—

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 5500 ppm – Ready to use |
| --- | --- |

Identifier

meta SPC 5 : Dipping, foaming, spraying products 5500 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 10ml : 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 10ml : 5 to 8 ml recommended)

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

—

sheep (1,5 to 5 ml : 1,5 to 3ml 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 1000L

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 10ml : 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 10ml : 5 to 8 ml recommended)

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

—

sheep (1,5 to 5 ml : 1,5 to 3ml 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 1000L

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 : |
| --- | --- |

—

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
  GOLD GLYCODIP
  EMPRASAN EXTRA CARE
  H&M RTU IODINE
  ANGLIA FARMERS SUPPLEDIP-IO
  PROLAC RTU IODINE TEAT DIP
  PREMIER GOLD POST DIP
  FULLWOOD IODINE EXTRA
  H&M EXTRACARE
  M WILLIAMS TEAT DIP
  PLATINUM
  WDH GOLD DIP RTU
  WYNNSAN IODINE HE RTU |
| --- | --- |
| 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

GOLD GLYCODIP

EMPRASAN EXTRA CARE

H&M RTU IODINE

ANGLIA FARMERS SUPPLEDIP-IO

PROLAC RTU IODINE TEAT DIP

PREMIER GOLD POST DIP

FULLWOOD IODINE EXTRA

H&M EXTRACARE

M WILLIAMS TEAT DIP

PLATINUM

WDH GOLD DIP RTU

WYNNSAN IODINE HE RTU

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

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(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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