# L_2020268EN.01000101.xml

| 14.8.2020 | EN | Official Journal of the European Union | L 268/1 |
| --- | --- | --- | --- |

14.8.2020

EN

Official Journal of the European Union

L 268/1

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/1187

of 7 August 2020

granting a Union authorisation for the biocidal product family ‘Iodine based products – CID LINES NV’

(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 the first subparagraph of Article 44(5) thereof,

Whereas:

| (1) | On 13 August 2015, CID LINES NV submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Iodine based products – CID LINES NV’ of product-types 3 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-BY019142-30 in the Register for Biocidal Products. |
| --- | --- |

(1)

On 13 August 2015, CID LINES NV submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Iodine based products – CID LINES NV’ of product-types 3 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-BY019142-30 in the Register for Biocidal Products.

| (2) | ‘Iodine based products – CID LINES NV’ contains iodine including polyvinylpyrrolidone iodine, as the 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, and the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100 (2), the Commission is carrying out a review of 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 consider whether the Union authorisations for products containing the active substance have to be cancelled or amended in accordance with Article 48 of Regulation (EU) No 528/2012. |
| --- | --- |

(2)

‘Iodine based products – CID LINES NV’ contains iodine including polyvinylpyrrolidone iodine, as the 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, and the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100 (2), the Commission is carrying out a review of 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 consider whether the Union authorisations for products containing the active substance have to be cancelled or amended in accordance with Article 48 of Regulation (EU) No 528/2012.

| (3) | On 28 May 2019, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’). |
| --- | --- |

(3)

On 28 May 2019, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

| (4) | On 17 January 2020, the Agency submitted to the Commission an opinion (3), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘Iodine based products – CID LINES NV’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. |
| --- | --- |

(4)

On 17 January 2020, the Agency submitted to the Commission an opinion (3), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘Iodine based products – CID LINES NV’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.

| (5) | The opinion concludes that ‘Iodine based products – CID LINES NV’ is a biocidal product family within the meaning of Article 3(1)(s) of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation. |
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(5)

The opinion concludes that ‘Iodine based products – CID LINES NV’ is a biocidal product family within the meaning of Article 3(1)(s) of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.

| (6) | On 4 February 2020 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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(6)

On 4 February 2020 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.

| (7) | The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Iodine based products – CID LINES NV’. |
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(7)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Iodine based products – CID LINES NV’.

| (8) | According to the opinion of the Agency, as regards the non-active substances sodium iodide and sodium iodate contained in ‘Iodine based products – CID LINES NV’, it was not possible to conclude whether they meet the scientific criteria for the determination of endocrine-disrupting properties set out in Delegated Regulation (EU) 2017/2100 within the period for the evaluation of the application. Further examination of sodium iodide and sodium iodate should therefore take place. If it is concluded that sodium iodide or sodium iodate or both are considered as having endocrine-disrupting properties, the Commission will consider whether to cancel or amend the Union authorisation for ‘Iodine based products – CID LINES NV’ in accordance with Article 48 of Regulation (EU) No 528/2012. |
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(8)

According to the opinion of the Agency, as regards the non-active substances sodium iodide and sodium iodate contained in ‘Iodine based products – CID LINES NV’, it was not possible to conclude whether they meet the scientific criteria for the determination of endocrine-disrupting properties set out in Delegated Regulation (EU) 2017/2100 within the period for the evaluation of the application. Further examination of sodium iodide and sodium iodate should therefore take place. If it is concluded that sodium iodide or sodium iodate or both are considered as having endocrine-disrupting properties, the Commission will consider whether to cancel or amend the Union authorisation for ‘Iodine based products – CID LINES NV’ in accordance with Article 48 of Regulation (EU) No 528/2012.

| (9) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
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(9)

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 with authorisation number EU-0022265-0000 is granted to CID LINES NV for the making available on the market and use of the biocidal product family ‘Iodine based products – CID LINES NV’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 3 September 2020 until 31 August 2030.

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, 7 August 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 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 11 December 2019 on the Union authorisation of ‘Iodine based products – CID LINES NV’ (ECHA/BPC/237/2019).

3

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ANNEX

Summary of product characteristics for a biocidal product family

Iodine based products – CID LINES NV

Product type 3 – Veterinary hygiene (Disinfectants)

Product type 4 – Food and feed area (Disinfectants)

Authorisation number: EU-0022265-0000

R4BP asset number: EU-0022265-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

| Name | Iodine based products – CID LINES NV |
| --- | --- |

Name

Iodine based products – CID LINES NV

1.2.   Product type(s)

| Product type(s) | PT03 – Veterinary hygiene (Disinfectants)
  PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT03 – Veterinary hygiene (Disinfectants)

PT04 – Food and feed area (Disinfectants)

1.3.   Authorisation holder

| Name and address of the authorisation holder | Name | CID LINES NV |
| --- | --- | --- |
| Address | Waterpoortstraat 2, 8900, Ieper, Belgium |
| Authorisation number | EU-0022265-0000 |
| R4BP asset number | EU-0022265-0000 |
| Date of the authorisation | 3 September 2020 |
| Expiry date of the authorisation | 31 August 2030 |

Name and address of the authorisation holder

Name

CID LINES NV

Address

Waterpoortstraat 2, 8900, Ieper, Belgium

Authorisation number

EU-0022265-0000

R4BP asset number

EU-0022265-0000

Date of the authorisation

3 September 2020

Expiry date of the authorisation

31 August 2030

1.4.   Manufacturer(s) of the biocidal products

| Name of manufacturer | CID LINES NV |
| --- | --- |
| Address of manufacturer | Waterpoortstraat 2, 8900 Ieper Belgium |
| Location of manufacturing sites | Waterpoortstraat 2, 8900 Ieper Belgium |

Name of manufacturer

CID LINES NV

Address of manufacturer

Waterpoortstraat 2, 8900 Ieper Belgium

Location of manufacturing sites

Waterpoortstraat 2, 8900 Ieper Belgium

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

| Active substance | Iodine |
| --- | --- |
| Name of manufacturer | SQM S.A. |
| Address of manufacturer | Los Militares, Piso 4, 4290 Santiago Chile |
| Location of manufacturing sites | Nueva Victoria plant, 00 Pedro de Valdivia Chile |

Active substance

Iodine

Name of manufacturer

SQM S.A.

Address of manufacturer

Los Militares, Piso 4, 4290 Santiago Chile

Location of manufacturing sites

Nueva Victoria plant, 00 Pedro de Valdivia Chile

| Active substance | Iodine |
| --- | --- |
| Name of manufacturer | Cosayach Nitratos S.A. |
| Address of manufacturer | Amunategui 178, 00 Santiago Chile |
| Location of manufacturing sites | Cala Cala, 00 Pozo Almonte Chile |

Active substance

Iodine

Name of manufacturer

Cosayach Nitratos S.A.

Address of manufacturer

Amunategui 178, 00 Santiago Chile

Location of manufacturing sites

Cala Cala, 00 Pozo Almonte Chile

| Active substance | Iodine |
| --- | --- |
| Name of manufacturer | ACF Minera S.A. |
| Address of manufacturer | San Martin No 499, 00 Iquique Chile |
| Location of manufacturing sites | Lagunas mine, 00 Pozo Almonte Chile |

Active substance

Iodine

Name of manufacturer

ACF Minera S.A.

Address of manufacturer

San Martin No 499, 00 Iquique Chile

Location of manufacturing sites

Lagunas mine, 00 Pozo Almonte Chile

| Active substance | Iodine |
| --- | --- |
| Name of manufacturer | ISE Chemicals Corporation |
| Address of manufacturer | 3-1, Kyobashi 1-Chome, 104-0031 Tokyo Japan |
| Location of manufacturing sites | 3695 Kitaimaizumi, 299-3201 Oamishirasato city Japan |

Active substance

Iodine

Name of manufacturer

ISE Chemicals Corporation

Address of manufacturer

3-1, Kyobashi 1-Chome, 104-0031 Tokyo Japan

Location of manufacturing sites

3695 Kitaimaizumi, 299-3201 Oamishirasato city Japan

| Active substance | Polyvinylpyrrolidone iodine |
| --- | --- |
| Name of manufacturer | ISP Chemicals LLC, Afiliate of Ashland Inc |
| Address of manufacturer | 455 N. main st (HWY 95), KY 42029 Calvert City United States |
| Location of manufacturing sites | 455 N. main st (HWY 95), KY 42029 Calvert City United States |

Active substance

Polyvinylpyrrolidone iodine

Name of manufacturer

ISP Chemicals LLC, Afiliate of Ashland Inc

Address of manufacturer

455 N. main st (HWY 95), KY 42029 Calvert City United States

Location of manufacturing sites

455 N. main st (HWY 95), KY 42029 Calvert City United States

| Active substance | Polyvinylpyrrolidone iodine |
| --- | --- |
| Name of manufacturer | Pantheon FZE (DMCC branch) |
| Address of manufacturer | 403, Reef Tower, Jumeira Lake Tower Shaikh Zayed Road, 00 Dubai United Arab Emirates |
| Location of manufacturing sites | Cala Cala, 00 Pozo Almonte Chile |

Active substance

Polyvinylpyrrolidone iodine

Name of manufacturer

Pantheon FZE (DMCC branch)

Address of manufacturer

403, Reef Tower, Jumeira Lake Tower Shaikh Zayed Road, 00 Dubai United Arab Emirates

Location of manufacturing sites

Cala Cala, 00 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 | 0,0 | 3,0 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 0,0 | 10,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 0,0 | 21,0 |
| Phosphoric acid | Phosphoric acid | Non-active Substance | 7664-38-2 | 231-633-2 | 0,0 | 30,0 |
| Alcohol C9-11 + 6 EO | Alcohol C9-11 + 6 EO | Non-active Substance | 68439-46-3 | | 0,0 | 12,5 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

Active Substance

7553-56-2

231-442-4

0,0

3,0

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

0,0

10,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

0,0

21,0

Phosphoric acid

Phosphoric acid

Non-active Substance

7664-38-2

231-633-2

0,0

30,0

Alcohol C9-11 + 6 EO

Alcohol C9-11 + 6 EO

Non-active Substance

68439-46-3

0,0

12,5

2.2.   Type(s) of formulation

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

Formulation(s)

SL – Soluble concentrate

AL – Any other liquid

PART II

SECOND INFORMATION LEVEL – META SPC(S)

META SPC 1

1.   META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier

| Identifier | metaSPC 1: PT3 Concentrated teat disinfectants Iodine |
| --- | --- |

Identifier

metaSPC 1: PT3 Concentrated teat disinfectants Iodine

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 | 1,5 | 1,5 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 0,0 | 0,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 12,05 | 12,05 |
| Phosphoric acid | Phosphoric acid | Non-active Substance | 7664-38-2 | 231-633-2 | 0,0 | 0,0 |
| Alcohol C9-11 + 6 EO | Alcohol C9-11 + 6 EO | Non-active Substance | 68439-46-3 | | 0,0 | 0,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

Active Substance

7553-56-2

231-442-4

1,5

1,5

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

0,0

0,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

12,05

12,05

Phosphoric acid

Phosphoric acid

Non-active Substance

7664-38-2

231-633-2

0,0

0,0

Alcohol C9-11 + 6 EO

Alcohol C9-11 + 6 EO

Non-active Substance

68439-46-3

0,0

0,0

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

| Formulation(s) | SL – Soluble concentrate |
| --- | --- |

Formulation(s)

SL – Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

| Hazard statements | Causes serious eye damage.
  Harmful to aquatic life with long lasting effects.
  May cause damage to organs (thyroid) through prolonged or repeated exposure (oral). |
| --- | --- |
| Precautionary statements | Wear eye protection.
  Wear protective clothing.
  Wear protective gloves.
  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
  Immediately call a doctor or a poison center.
  Avoid release to the environment.
  Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
  Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. |

Hazard statements

Causes serious eye damage.

Harmful to aquatic life with long lasting effects.

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

Precautionary statements

Wear eye protection.

Wear protective clothing.

Wear protective gloves.

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

Immediately call a doctor or a poison center.

Avoid release to the environment.

Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

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

4.1.   Use description

Table 1. Use # 1 – PT3– Concentrated Teat disinfectant, post-milking, Iodine

| Product type | PT03 – Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria
   
   
  Yeasts
   
   
  Viruses |
| Field(s) of use | Indoor
  Post-milking teat disinfection of milk producing animals |
| Application method(s) | Manual or automatic spraying on teats |
| Application rate(s) and frequency | Dilute the product to a final concentration of 0,3 % (w/w) available iodine.
  Apply 2 times per day with manual sprayer and 3 times per day with a robot. |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
  HDPE (High Density Polyethylene) |

Product type

PT03 – Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Bacteria

Yeasts

Viruses

Field(s) of use

Indoor

Post-milking teat disinfection of milk producing animals

Application method(s)

Manual or automatic spraying on teats

Application rate(s) and frequency

Dilute the product to a final concentration of 0,3 % (w/w) available iodine.

Apply 2 times per day with manual sprayer and 3 times per day with a robot.

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L

HDPE (High Density Polyethylene)

4.1.1.   Use-specific instructions for use

See general directions for use.

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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.

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

See general directions for use.

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.

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

5.1.   Instructions for use

The product must be diluted before use with clean potable water to allow a final concentration of iodine of 0,3 % (200 ml product, add water up to 1 L).

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

Assume 5 mL diluted product per cow per treatment. The use of a dosing pump for filling the product into the application equipment is recommended. Use gloves and eye protection during the dilution step. The diluted product can be kept and used during 1 week but do not prepare more fluid than necessary.

Apply the diluted product on the teats with a manual sprayer or with an automatic sprayer.

The product should be used directly after milking 2 times per day by using a manual sprayer and 3 times per day when using a robot (automatic sprayer).

Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Do not mix with other chemicals.

5.2.   Risk mitigation measures

| — | For mixing and loading of the product: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) and eye/face protection. |
| --- | --- |

—

For mixing and loading of the product: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) and eye/face protection.

| — | For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information). |
| --- | --- |

—

For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).

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

—

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

| — | Keep out of reach of children. |
| --- | --- |

—

Keep out of reach of children.

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

After eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Obtain emergency medical attention if pain, blinking, tears or redness persist.

If medical advice is needed, have product container or label at hand.

After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice.

Have product container or label at hand.

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.

| — | |
| --- | --- |

—

| — | |
| --- | --- |

—

| — | |
| --- | --- |

—

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

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

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) | Kenodin SD 400
  IodoSD 400
  Velvet Concentrate
  Wynnsan Iodine 3 – 1 conc
  Iodin Teat Spray 400 | |
| --- | --- | --- |
| Authorisation number | EU-0022265-0001 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 1,5 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 0,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 12,05 |

Trade name(s)

Kenodin SD 400

IodoSD 400

Velvet Concentrate

Wynnsan Iodine 3 – 1 conc

Iodin Teat Spray 400

Authorisation number

EU-0022265-0001 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

Active Substance

7553-56-2

231-442-4

1,5

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

0,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

12,05

META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

| Identifier | metaSPC 2: PT3 – Ready to Use (RTU) Teat disinfectants Iodine |
| --- | --- |

Identifier

metaSPC 2: PT3 – Ready to Use (RTU) Teat disinfectants Iodine

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 | 0,3 | 0,3 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 0,0 | 0,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 2,1 | 2,9 |
| Phosphoric acid | Phosphoric acid | Non-active Substance | 7664-38-2 | 231-633-2 | 0,0 | 0,0 |
| Alcohol C9-11 + 6 EO | Alcohol C9-11 + 6 EO | Non-active Substance | 68439-46-3 | | 0,0 | 0,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

Active Substance

7553-56-2

231-442-4

0,3

0,3

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

0,0

0,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

2,1

2,9

Phosphoric acid

Phosphoric acid

Non-active Substance

7664-38-2

231-633-2

0,0

0,0

Alcohol C9-11 + 6 EO

Alcohol C9-11 + 6 EO

Non-active Substance

68439-46-3

0,0

0,0

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

| Formulation(s) | AL – Any other liquid |
| --- | --- |

Formulation(s)

AL – Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

| Hazard statements | Harmful to aquatic life with long lasting effects. |
| --- | --- |
| Precautionary statements | Avoid release to the environment.
  Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
  Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. |

Hazard statements

Harmful to aquatic life with long lasting effects.

Precautionary statements

Avoid release to the environment.

Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

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

4.1.   Use description

Table 2. Use # 1 – PT3– RTU Teat disinfectant, post-milking, Iodine

| Product type | PT03 – Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria
   
   
  Yeasts
   
   
  Viruses |
| Field(s) of use | Indoor
  Post-milking teat disinfection of milk producing animals |
| Application method(s) | By dipping or spraying on teats |
| Application rate(s) and frequency | The product is ready to use.
  Apply 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
  HDPE |

Product type

PT03 – Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Bacteria

Yeasts

Viruses

Field(s) of use

Indoor

Post-milking teat disinfection of milk producing animals

Application method(s)

By dipping or spraying on teats

Application rate(s) and frequency

The product is ready to use.

Apply 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L

HDPE

4.1.1.   Use-specific instructions for use

See general directions for use.

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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.

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

See general directions for use.

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.

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

5.1.   Instructions for use

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

Apply the product by dipping or by spraying:

| — | By dipping: Apply the product with a dip cup. Wash the dip cup with water after use. |
| --- | --- |

—

By dipping: Apply the product with a dip cup. Wash the dip cup with water after use.

| — | By spraying: Apply the product with a manual sprayer or with an automatic sprayer. |
| --- | --- |

—

By spraying: Apply the product with a manual sprayer or with an automatic sprayer.

Do not prepare more fluid than necessary; assume 5 mL solution per cow per treatment. The use of a dosing pump for filling the product into the application equipment is recommended.

The product should be used immediately after each milking: 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot. Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Do not mix with other chemicals.

5.2.   Risk mitigation measures

| — | For manual dipping application: No special protection equipment is recommended under normal conditions of use. |
| --- | --- |

—

For manual dipping application: No special protection equipment is recommended under normal conditions of use.

| — | For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information. |
| --- | --- |

—

For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information.

| — | If 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. |
| --- | --- |

—

If 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.

| — | Keep out of reach of children. |
| --- | --- |

—

Keep out of reach of children.

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

After eye contact: Rinse immediately with water.

After ingestion: Rinse mouth. Spit.

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.

| — | |
| --- | --- |

—

| — | |
| --- | --- |

—

| — | |
| --- | --- |

—

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

Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

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) | IodoDip 3000
  Bio Tec Jodip 3000
  Recoïode
  Stalosan Io Dip
  Stalosan Super Dip
  Velvet High Visco
  Bühning Joddip 3000
  Kenodin
  Wynnsan trikill RTU
  Wynnsan Iodine RTU teat dip
  Wynnsan Iodine dip RTU
  Iocid
  Iodip+
  Wynngold Iodine Dip
  Pezerk iv plus
  Iod protect 3000 Film
  Seivit® Iode 3000
  Kenostart
  GAHERYOD
  Kenodin 3000
  Iodin Teat Dip 3000
  Iod 3000 dip
  Iodoschutz dip
  Ioschutz dip
  Iodocoop dip
  Iodotech dip
  Iodactiv’ dip
  Iododip
  MIROX Dip Jod
  HCP Iodine Dip
  Agib Jodium Dip
  Jod 3000
  Iod dip
  Iode 3000
  Iodoschutz
  Coopjod
  Coopiode
  Coopiode épais
  Semex jod
  Iodotech
  Iododip green
  Iodip bio
  Iododip bio
  Iodactive épais
  Iodactiv
  Iodoactiv’
  Bayley’s Premier Iodine Teat Dip
  Pearce Premier Iodine Teat Dip
  Diamond 1:3 Concentrate Iodine Post Dip Spray
  JODOCARE
  KENOSTART DYP
  STREPTOFIT
  Iodall Film | |
| --- | --- | --- |
| Authorisation number | EU-0022265-0002 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,3 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 0,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 2,17 |

Trade name(s)

IodoDip 3000

Bio Tec Jodip 3000

Recoïode

Stalosan Io Dip

Stalosan Super Dip

Velvet High Visco

Bühning Joddip 3000

Kenodin

Wynnsan trikill RTU

Wynnsan Iodine RTU teat dip

Wynnsan Iodine dip RTU

Iocid

Iodip+

Wynngold Iodine Dip

Pezerk iv plus

Iod protect 3000 Film

Seivit® Iode 3000

Kenostart

GAHERYOD

Kenodin 3000

Iodin Teat Dip 3000

Iod 3000 dip

Iodoschutz dip

Ioschutz dip

Iodocoop dip

Iodotech dip

Iodactiv’ dip

Iododip

MIROX Dip Jod

HCP Iodine Dip

Agib Jodium Dip

Jod 3000

Iod dip

Iode 3000

Iodoschutz

Coopjod

Coopiode

Coopiode épais

Semex jod

Iodotech

Iododip green

Iodip bio

Iododip bio

Iodactive épais

Iodactiv

Iodoactiv’

Bayley’s Premier Iodine Teat Dip

Pearce Premier Iodine Teat Dip

Diamond 1:3 Concentrate Iodine Post Dip Spray

JODOCARE

KENOSTART DYP

STREPTOFIT

Iodall Film

Authorisation number

EU-0022265-0002 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

Active Substance

7553-56-2

231-442-4

0,3

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

0,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

2,17

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

| Trade name(s) | Kenodin Film
  IodoFilm
  Wynnsan Iofilm teat dip
  Kenodin Film Extra
  Wynngold Film
  Wynnsan trikill film teat dip
  Kenodin Film Soft
  Iocid Film
  TOP Film
  Seivit® Iode Gel
  IOD protect 3000 Film
  Iodin Film Teat Dip 3000
  Iodin Barrier Teat Dip 3000
  Iodin Film Teat Dip
  Iodin Barrier Teat Dip
  Iod 3000 film
  Iodoschutz film
  Ioschutz film
  Iodocoop film
  Iodotech film
  Iodactiv’ film
  Iodofilm
  HCP Iodine Film
  Iod 3000 film
  Coopjod film
  Coopiode film
  Iodocoop film
  Semex jod film
  Iodofilm
  Iodofilm bio
  Iofilm bio
  Iodactive film
  Iodactiv film
  Iodactiv’ film
  SCUDO 3000 | |
| --- | --- | --- |
| Authorisation number | EU-0022265-0003 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,3 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 0,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 2,9 |

Trade name(s)

Kenodin Film

IodoFilm

Wynnsan Iofilm teat dip

Kenodin Film Extra

Wynngold Film

Wynnsan trikill film teat dip

Kenodin Film Soft

Iocid Film

TOP Film

Seivit® Iode Gel

IOD protect 3000 Film

Iodin Film Teat Dip 3000

Iodin Barrier Teat Dip 3000

Iodin Film Teat Dip

Iodin Barrier Teat Dip

Iod 3000 film

Iodoschutz film

Ioschutz film

Iodocoop film

Iodotech film

Iodactiv’ film

Iodofilm

HCP Iodine Film

Iod 3000 film

Coopjod film

Coopiode film

Iodocoop film

Semex jod film

Iodofilm

Iodofilm bio

Iofilm bio

Iodactive film

Iodactiv film

Iodactiv’ film

SCUDO 3000

Authorisation number

EU-0022265-0003 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

Active Substance

7553-56-2

231-442-4

0,3

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

0,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

2,9

META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier

| Identifier | metaSPC 3: PT3-RTU Udder disinfectants Iodine |
| --- | --- |

Identifier

metaSPC 3: PT3-RTU Udder disinfectants Iodine

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 | 0,3 | 0,99 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 0,0 | 0,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 2,17 | 2,95 |
| Phosphoric acid | Phosphoric acid | Non-active Substance | 7664-38-2 | 231-633-2 | 0,0 | 0,0 |
| Alcohol C9-11 + 6 EO | Alcohol C9-11 + 6 EO | Non-active Substance | 68439-46-3 | | 0,0 | 0,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

Active Substance

7553-56-2

231-442-4

0,3

0,99

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

0,0

0,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

2,17

2,95

Phosphoric acid

Phosphoric acid

Non-active Substance

7664-38-2

231-633-2

0,0

0,0

Alcohol C9-11 + 6 EO

Alcohol C9-11 + 6 EO

Non-active Substance

68439-46-3

0,0

0,0

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

| Formulation(s) | AL – Any other liquid |
| --- | --- |

Formulation(s)

AL – Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

| Hazard statements | Harmful to aquatic life with long lasting effects. |
| --- | --- |
| Precautionary statements | Avoid release to the environment.
  Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
  Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. |

Hazard statements

Harmful to aquatic life with long lasting effects.

Precautionary statements

Avoid release to the environment.

Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

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

4.1.   Use description

Table 3. Use # 1 – PT3- RTU Udder disinfectant, Iodine

| 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
  Skin disinfection only for use on intact skin of:






  — | the udder of dairy and beef cattle before calving |

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

Skin disinfection only for use on intact skin of:

—

the udder of dairy and beef cattle before calving

| — | the udder of sows before farrowing |
| --- | --- |

—

the udder of sows before farrowing

Application method(s)

Spraying

Application rate(s) and frequency

The product is ready to use.

Apply to:

| — | the udder of dairy and beef cattle: 1 spray on each teat (equivalent to 4,8 mL per application) |
| --- | --- |

—

the udder of dairy and beef cattle: 1 spray on each teat (equivalent to 4,8 mL per application)

| — | the udder of sows: 15 to 20 mL per animal |
| --- | --- |

—

the udder of sows: 15 to 20 mL per animal

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L

HDPE

4.1.1.   Use-specific instructions for use

See general directions for use.

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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.

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

See general directions for use.

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.

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

5.1.   Instructions for use

For disinfection of the skin:

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.

Apply by spraying on the animals’ intact skin for a topical disinfection:

| — | on the udder of dairy and beef cattle before calving: 1 spray on each teat (equivalent to 4,8 mL per application). Disinfection takes place once, one day before calving and once, one day after calving. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing at least 5 minutes). |
| --- | --- |

—

on the udder of dairy and beef cattle before calving: 1 spray on each teat (equivalent to 4,8 mL per application). Disinfection takes place once, one day before calving and once, one day after calving. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing at least 5 minutes).

| — | on the udder of sows before farrowing: Assume 15 to 20 mL per animal, once one day before farrowing and once every day during 4 days after farrowing. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes). |
| --- | --- |

—

on the udder of sows before farrowing: Assume 15 to 20 mL per animal, once one day before farrowing and once every day during 4 days after farrowing. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Only for use on intact skin.

Do not mix with other chemicals.

5.2.   Risk mitigation measures

For manual spraying application on cows and sows: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).

In case a combination of post-milking disinfection of cows and skin disinfection of cows is necessary, an iodine based product shall not be used by the same person to perform both disinfections.

Keep out of reach of children.

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

After eye contact: Rinse immediately with water.

After ingestion: Rinse mouth. Spit

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.

| — | |
| --- | --- |

—

| — | |
| --- | --- |

—

| — | |
| --- | --- |

—

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

Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

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) | Animal Skin Disinfectant
  Dermades 3000
  Iodin Skin Disinfectant | |
| --- | --- | --- |
| Authorisation number | EU-0022265-0004 1-3 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,3 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 0,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 2,17 |

Trade name(s)

Animal Skin Disinfectant

Dermades 3000

Iodin Skin Disinfectant

Authorisation number

EU-0022265-0004 1-3

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

Active Substance

7553-56-2

231-442-4

0,3

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

0,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

2,17

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

| Trade name(s) | Dermades
  Animal skin disinfectant 1 %
  Dermades Strong
  Iodin Skin Disinfectant Strong | |
| --- | --- | --- |
| Authorisation number | EU-0022265-0005 1-3 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,99 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 0,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 2,95 |

Trade name(s)

Dermades

Animal skin disinfectant 1 %

Dermades Strong

Iodin Skin Disinfectant Strong

Authorisation number

EU-0022265-0005 1-3

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

Active Substance

7553-56-2

231-442-4

0,99

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

0,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

2,95

META SPC 4

1.   META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier

| Identifier | metaSPC 4: PT3 – RTU Udder and Teat disinfectants Iodine |
| --- | --- |

Identifier

metaSPC 4: PT3 – RTU Udder and Teat disinfectants Iodine

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 | 0,3 | 0,3 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 0,0 | 0,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 2,17 | 2,17 |
| Phosphoric acid | Phosphoric acid | Non-active Substance | 7664-38-2 | 231-633-2 | 0,0 | 0,0 |
| Alcohol C9-11 + 6 EO | Alcohol C9-11 + 6 EO | Non-active Substance | 68439-46-3 | | 0,0 | 0,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

Active Substance

7553-56-2

231-442-4

0,3

0,3

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

0,0

0,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

2,17

2,17

Phosphoric acid

Phosphoric acid

Non-active Substance

7664-38-2

231-633-2

0,0

0,0

Alcohol C9-11 + 6 EO

Alcohol C9-11 + 6 EO

Non-active Substance

68439-46-3

0,0

0,0

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

| Formulation(s) | AL – Any other liquid |
| --- | --- |

Formulation(s)

AL – Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

| Hazard statements | Harmful to aquatic life with long lasting effects. |
| --- | --- |
| Precautionary statements | Avoid release to the environment.
  Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
  Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. |

Hazard statements

Harmful to aquatic life with long lasting effects.

Precautionary statements

Avoid release to the environment.

Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

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

4.1.   Use description

Table 4. Use # 1 – PT3– RTU Teat disinfectant, Post-milking, Iodine

| Product type | PT03 – Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria
   
   
  Yeasts
   
   
  Viruses |
| Field(s) of use | Indoor
  Ready to use teat disinfectant to be used post milking on milk producing animals. |
| Application method(s) | Dipping or spraying |
| Application rate(s) and frequency | The product is ready to use.
  Apply 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot. |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
  HDPE |

Product type

PT03 – Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Bacteria

Yeasts

Viruses

Field(s) of use

Indoor

Ready to use teat disinfectant to be used post milking on milk producing animals.

Application method(s)

Dipping or spraying

Application rate(s) and frequency

The product is ready to use.

Apply 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot.

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L

HDPE

4.1.1.   Use-specific instructions for use

For disinfection of the teats:

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

| — | By dipping: Apply the product on the teats with a dip cup. Wash the dip cup with water after use. |
| --- | --- |

—

By dipping: Apply the product on the teats with a dip cup. Wash the dip cup with water after use.

| — | By spraying: Apply the product on the teats with a manual sprayer or with an automatic sprayer. |
| --- | --- |

—

By spraying: Apply the product on the teats with a manual sprayer or with an automatic sprayer.

Do not prepare more fluid than necessary. Assume 5 mL solution per cow per treatment. The use of a dosing pump for filling the product into the application equipment is recommended.

The product should be used directly after milking by using a dipping cup or a manual or automatic sprayer. Ensure that the teat is completely covered to three quarters of its length.

The product is applied after milking: 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot.

Let the product dry on the teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Do not mix with other chemicals.

4.1.2.   Use-specific risk mitigation measures

| — | For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information). |
| --- | --- |

—

For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).

| — | For manual dipping application: no Personal Protection Equipment (PPE) is necessary for safe use. |
| --- | --- |

—

For manual dipping application: no Personal Protection Equipment (PPE) is necessary for safe use.

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

—

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

| — | Keep out of reach of children. |
| --- | --- |

—

Keep out of reach of children.

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.

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

See general directions for use.

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.

4.2.   Use description

Table 5. Use # 2 – PT3- RTU Udder disinfectant, Iodine

| Product type | PT03 – Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Yeasts
   
   
  Bacteria |
| Field(s) of use | Indoor
  Ready to use skin disinfectant, only for use on intact skin of:






  — | the udder of dairy and beef cattle before calving |

Product type

PT03 – Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Yeasts

Bacteria

Field(s) of use

Indoor

Ready to use skin disinfectant, only for use on intact skin of:

—

the udder of dairy and beef cattle before calving

| — | the udder of sows before farrowing |
| --- | --- |

—

the udder of sows before farrowing

Application method(s)

Application on animal skin: by spraying

Application rate(s) and frequency

The product is ready to use.

Apply to:

| — | the udder of dairy and beef cattle: 1 spray on each teat (equivalent to 4,8 mL per application) |
| --- | --- |

—

the udder of dairy and beef cattle: 1 spray on each teat (equivalent to 4,8 mL per application)

| — | the udder of sows: 15 to 20 mL per animal |
| --- | --- |

—

the udder of sows: 15 to 20 mL per animal

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L

HDPE

4.2.1.   Use-specific instructions for use

For disinfection of the skin:

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.

Apply by spraying on the animals’ intact skin for a topical disinfection:

| — | on the udder of dairy and beef cattle before calving: 1 spray on each teat (equivalent to 4,8 mL per application). Disinfection takes place once, one day before calving and once, one day after calving. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes). |
| --- | --- |

—

on the udder of dairy and beef cattle before calving: 1 spray on each teat (equivalent to 4,8 mL per application). Disinfection takes place once, one day before calving and once, one day after calving. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

| — | on the udder of sows before farrowing: Assume 15 to 20 mL per animal, once one day before farrowing and once every day during 4 days after farrowing. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes). |
| --- | --- |

—

on the udder of sows before farrowing: Assume 15 to 20 mL per animal, once one day before farrowing and once every day during 4 days after farrowing. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Let the product dry on skin.

Only for use on intact skin.

Do not mix with other chemicals.

4.2.2.   Use-specific risk mitigation measures

| — | For manual spraying application on cows and sows: no PPE is necessary for safe use. |
| --- | --- |

—

For manual spraying application on cows and sows: no PPE is necessary for safe use.

| — | Keep out of reach of children. |
| --- | --- |

—

Keep out of reach of children.

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.

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

See general directions for use.

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.

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

5.1.   Instructions for use

See use-specific instructions for use.

5.2.   Risk mitigation measures

See use-specific risk mitigation measures

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

After eye contact: Rinse immediately with water.

After ingestion: Rinse mouth. Spit.

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.

| — | |
| --- | --- |

—

| — | |
| --- | --- |

—

| — | |
| --- | --- |

—

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

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

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) | Kenodin SD
  IodoSD 3000
  Bio Tec Jodspray 3000
  Q Farm Iodine Des
  ANRO – Euterpflege Dip
  Stalosan Io Spray
  Stalosan Super Spray
  IDip+
  Bühning Jodspray 3000
  Velvet RTU
  Wynnsan trikill spray
  Wynnsan Iodine spray RTU
  Wynngold Iodine Dip and spray
  Pezerk IL
  Iod protect 3000 Sprüh
  Seivit® Iode Spray
  IOD protect 3000 Sprüh
  Kenodin SprayFilm
  Iodo SP
  Kenostart SD
  GAHERYOD SPRAY
  Iodin Teat & Skin 3000
  Iod 3000 sprüh
  Iodoschutz sprüh
  Ioschutz sprüh
  Iodocoop sprüh
  Iodotech sprüh
  Iodactiv’ sprüh
  Iodosprüh
  MIROX Spray Jod
  HCP Iodine SD
  Agib Jodium Spray
  Jod 3000 spray
  Iod sprüh
  Coopjod
  Coopiode spray
  Iodocoop spray
  Semex jod spray
  Iododip spray
  Iododip spray green
  Iodospray Bio
  Iospray bio
  Iodactive spray
  Iodactiv spray
  Iodactiv’ spray
  Ark Iodine S+D
  Agrihealth Iodine SD
  AGRO LOGIC JODOCARE SPRAY
  IODACTIVE | |
| --- | --- | --- |
| Authorisation number | EU-0022265-0006 1-4 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,3 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 0,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 2,17 |

Trade name(s)

Kenodin SD

IodoSD 3000

Bio Tec Jodspray 3000

Q Farm Iodine Des

ANRO – Euterpflege Dip

Stalosan Io Spray

Stalosan Super Spray

IDip+

Bühning Jodspray 3000

Velvet RTU

Wynnsan trikill spray

Wynnsan Iodine spray RTU

Wynngold Iodine Dip and spray

Pezerk IL

Iod protect 3000 Sprüh

Seivit® Iode Spray

IOD protect 3000 Sprüh

Kenodin SprayFilm

Iodo SP

Kenostart SD

GAHERYOD SPRAY

Iodin Teat & Skin 3000

Iod 3000 sprüh

Iodoschutz sprüh

Ioschutz sprüh

Iodocoop sprüh

Iodotech sprüh

Iodactiv’ sprüh

Iodosprüh

MIROX Spray Jod

HCP Iodine SD

Agib Jodium Spray

Jod 3000 spray

Iod sprüh

Coopjod

Coopiode spray

Iodocoop spray

Semex jod spray

Iododip spray

Iododip spray green

Iodospray Bio

Iospray bio

Iodactive spray

Iodactiv spray

Iodactiv’ spray

Ark Iodine S+D

Agrihealth Iodine SD

AGRO LOGIC JODOCARE SPRAY

IODACTIVE

Authorisation number

EU-0022265-0006 1-4

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

Active Substance

7553-56-2

231-442-4

0,3

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

0,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

2,17

META SPC 5

1.   META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 5 identifier

| Identifier | metaSPC 5: PT3 – RTU Teat disinfectants PVP-Iodine |
| --- | --- |

Identifier

metaSPC 5: PT3 – RTU Teat disinfectants PVP-Iodine

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 | 0,0 | 0,0 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 3,0 | 3,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 1,5 | 2,9 |
| Phosphoric acid | Phosphoric acid | Non-active Substance | 7664-38-2 | 231-633-2 | 0,0 | 0,0 |
| Alcohol C9-11 + 6 EO | Alcohol C9-11 + 6 EO | Non-active Substance | 68439-46-3 | | 0,0 | 0,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

Active Substance

7553-56-2

231-442-4

0,0

0,0

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

3,0

3,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

1,5

2,9

Phosphoric acid

Phosphoric acid

Non-active Substance

7664-38-2

231-633-2

0,0

0,0

Alcohol C9-11 + 6 EO

Alcohol C9-11 + 6 EO

Non-active Substance

68439-46-3

0,0

0,0

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

| Formulation(s) | AL – Any other liquid |
| --- | --- |

Formulation(s)

AL – Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

| Hazard statements | Harmful to aquatic life with long lasting effects. |
| --- | --- |
| Precautionary statements | Avoid release to the environment.
  Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
  Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. |

Hazard statements

Harmful to aquatic life with long lasting effects.

Precautionary statements

Avoid release to the environment.

Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

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

4.1.   Use description

Table 6. Use # 1 – PT3 – RTU Teat disinfectant, post milking, PVP-Iodine

| Product type | PT03 – Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria
   
   
  Yeasts
   
   
  Viruses |
| Field(s) of use | Indoor
  Post-milking disinfection on teats of milk producing animals |
| Application method(s) | Dipping or spraying |
| Application rate(s) and frequency | The product is ready to use.
  Apply 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot. |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
  HDPE |

Product type

PT03 – Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Bacteria

Yeasts

Viruses

Field(s) of use

Indoor

Post-milking disinfection on teats of milk producing animals

Application method(s)

Dipping or spraying

Application rate(s) and frequency

The product is ready to use.

Apply 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot.

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L

HDPE

4.1.1.   Use-specific instructions for use

See general directions for use.

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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.

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

See general directions for use.

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.

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

5.1.   Instructions for use

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.

Apply the product by dipping or by spraying:

| — | By dipping: Apply the product with a dip cup. Wash the dip cup with water after use. |
| --- | --- |

—

By dipping: Apply the product with a dip cup. Wash the dip cup with water after use.

| — | By spraying: Apply the product with a manual sprayer or with an automatic sprayer. |
| --- | --- |

—

By spraying: Apply the product with a manual sprayer or with an automatic sprayer.

Do not prepare more fluid than necessary. Assume 5 mL solution per cow per treatment.

The product should be used immediately after each milking, two times per day for manual spraying and 3 times per day for manual dipping and spraying with robot. Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Do not mix with other chemicals.

5.2.   Risk mitigation measures

| — | For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information. |
| --- | --- |

—

For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information.

| — | For manual dipping application: no PPE is necessary for safe use. |
| --- | --- |

—

For manual dipping application: no PPE is necessary for safe use.

| — | If 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. |
| --- | --- |

—

If 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.

| — | Keep out of reach of children. |
| --- | --- |

—

Keep out of reach of children.

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

After eye contact: Rinse immediately with water.

After ingestion: Rinse mouth. Spit.

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.

| — | |
| --- | --- |

—

| — | |
| --- | --- |

—

| — | |
| --- | --- |

—

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

Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 18 months.

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) | Iodo PVP
  Iodin Teat Dip 3000 PVP | |
| --- | --- | --- |
| Authorisation number | EU-0022265-0007 1-5 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,0 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 3,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 2,5 |

Trade name(s)

Iodo PVP

Iodin Teat Dip 3000 PVP

Authorisation number

EU-0022265-0007 1-5

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

Active Substance

7553-56-2

231-442-4

0,0

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

3,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

2,5

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

| Trade name(s) | Iodo SD PVP
  Iodin Teat Spray & Dip 3000 PVP | |
| --- | --- | --- |
| Authorisation number | EU-0022265-0008 1-5 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,0 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 3,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 2,5 |

Trade name(s)

Iodo SD PVP

Iodin Teat Spray & Dip 3000 PVP

Authorisation number

EU-0022265-0008 1-5

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

Active Substance

7553-56-2

231-442-4

0,0

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

3,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

2,5

META SPC 6

1.   META SPC 6 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 6 identifier

| Identifier | metaSPC 6: PT3- RTU Udder disinfectants PVP-Iodine |
| --- | --- |

Identifier

metaSPC 6: PT3- RTU Udder disinfectants PVP-Iodine

1.2.   Suffix to the authorisation number

| Number | 1-6 |
| --- | --- |

Number

1-6

1.3.   Product type(s)

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

Product type(s)

PT03 – Veterinary hygiene (Disinfectants)

2.   META SPC 6 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 6

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,0 | 0,0 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 10,0 | 10,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 2,0 | 2,0 |
| Phosphoric acid | Phosphoric acid | Non-active Substance | 7664-38-2 | 231-633-2 | 0,0 | 0,0 |
| Alcohol C9-11 + 6 EO | Alcohol C9-11 + 6 EO | Non-active Substance | 68439-46-3 | | 0,0 | 0,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

Active Substance

7553-56-2

231-442-4

0,0

0,0

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

10,0

10,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

2,0

2,0

Phosphoric acid

Phosphoric acid

Non-active Substance

7664-38-2

231-633-2

0,0

0,0

Alcohol C9-11 + 6 EO

Alcohol C9-11 + 6 EO

Non-active Substance

68439-46-3

0,0

0,0

2.2.   Type(s) of formulation of the meta SPC 6

| Formulation(s) | AL – Any other liquid |
| --- | --- |

Formulation(s)

AL – Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6

| Hazard statements | Harmful to aquatic life with long lasting effects.
  May cause damage to organs (thyroid) through prolonged or repeated exposure (oral). |
| --- | --- |
| Precautionary statements | Avoid release to the environment.
  Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
  Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
  Do not breathe spray. |

Hazard statements

Harmful to aquatic life with long lasting effects.

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

Precautionary statements

Avoid release to the environment.

Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

Do not breathe spray.

4.   AUTHORISED USE(S) OF THE META SPC 6

4.1.   Use description

Table 7. Use # 1 – PT3- RTU Udder disinfectant PVP-Iodine

| 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
  Ready to use skin disinfectant, only for use on intact skin of:






  — | the udder of dairy and beef cattle: before calving |

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

Ready to use skin disinfectant, only for use on intact skin of:

—

the udder of dairy and beef cattle: before calving

| — | the udder of sows: before farrowing |
| --- | --- |

—

the udder of sows: before farrowing

Application method(s)

Spraying

Application rate(s) and frequency

The product is ready to use.

Apply to:

| — | The udder of dairy and beef cattle: 1 spray on each teat (equivalent to 4,8 mL per application) |
| --- | --- |

—

The udder of dairy and beef cattle: 1 spray on each teat (equivalent to 4,8 mL per application)

| — | The udder of sows: 15 to 20 mL per animal |
| --- | --- |

—

The udder of sows: 15 to 20 mL per animal

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L

HDPE

4.1.1.   Use-specific instructions for use

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.

| — | Dairy and beef cattle: Apply the product by spraying on the udder before calving (1 spray/teat equivalent to 4,8 mL per application). Disinfection takes place once, one day before calving and once, one day after calving. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes). |
| --- | --- |

—

Dairy and beef cattle: Apply the product by spraying on the udder before calving (1 spray/teat equivalent to 4,8 mL per application). Disinfection takes place once, one day before calving and once, one day after calving. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

| — | Sows, on the udder before farrowing: Assume 15 to 20 mL per animal. Disinfection takes place once, one day before farrowing and once every day during 4 days after farrowing. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes). |
| --- | --- |

—

Sows, on the udder before farrowing: Assume 15 to 20 mL per animal. Disinfection takes place once, one day before farrowing and once every day during 4 days after farrowing. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Only for use on intact skin.

Do not mix with other chemicals.

4.1.2.   Use-specific risk mitigation measures

| — | For manual spraying application on cows and sows: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information). |
| --- | --- |

—

For manual spraying application on cows and sows: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).

| — | In case a combination of post-milking disinfection of cows and skin disinfection of cows is necessary, an iodine based product shall not be used by the same person to perform both disinfections. |
| --- | --- |

—

In case a combination of post-milking disinfection of cows and skin disinfection of cows is necessary, an iodine based product shall not be used by the same person to perform both disinfections.

| — | Keep out of reach of children. |
| --- | --- |

—

Keep out of reach of children.

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.

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

See general directions for use.

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.

5.   GENERAL DIRECTIONS FOR USE (6)
  OF THE META SPC 6

5.1.   Instructions for use

See use-specific instructions for use.

5.2.   Risk mitigation measures

See use-specific risk mitigation measures.

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

After eye contact: Rinse immediately with water.

After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice.

Have product container or label at hand.

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.

| — | |
| --- | --- |

—

| — | |
| --- | --- |

—

| — | |
| --- | --- |

—

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

Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6

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

| Trade name(s) | Dermades PVP
  Wynngold 10 % Iodine Solution
  Iodin Skin Disinfectant PVP | |
| --- | --- | --- |
| Authorisation number | EU-0022265-0009 1-6 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,0 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 10,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 2,0 |

Trade name(s)

Dermades PVP

Wynngold 10 % Iodine Solution

Iodin Skin Disinfectant PVP

Authorisation number

EU-0022265-0009 1-6

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

Active Substance

7553-56-2

231-442-4

0,0

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

10,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

2,0

META SPC 7

1.   META SPC 7 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 7 identifier

| Identifier | metaSPC 7: PT3 and PT4 – Concentrated Surface disinfectants Iodine |
| --- | --- |

Identifier

metaSPC 7: PT3 and PT4 – Concentrated Surface disinfectants Iodine

1.2.   Suffix to the authorisation number

| Number | 1-7 |
| --- | --- |

Number

1-7

1.3.   Product type(s)

| Product type(s) | PT03 – Veterinary hygiene (Disinfectants)
  PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT03 – Veterinary hygiene (Disinfectants)

PT04 – Food and feed area (Disinfectants)

2.   META SPC 7 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 7

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 1,8 | 2,49 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 0,0 | 0,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 3,15 | 9,45 |
| Phosphoric acid | Phosphoric acid | Non-active Substance | 7664-38-2 | 231-633-2 | 0,0 | 0,0 |
| Alcohol C9-11 + 6 EO | Alcohol C9-11 + 6 EO | Non-active Substance | 68439-46-3 | | 2,5 | 12,5 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

Active Substance

7553-56-2

231-442-4

1,8

2,49

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

0,0

0,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

3,15

9,45

Phosphoric acid

Phosphoric acid

Non-active Substance

7664-38-2

231-633-2

0,0

0,0

Alcohol C9-11 + 6 EO

Alcohol C9-11 + 6 EO

Non-active Substance

68439-46-3

2,5

12,5

2.2.   Type(s) of formulation of the meta SPC 7

| Formulation(s) | SL – Soluble concentrate |
| --- | --- |

Formulation(s)

SL – Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7

| Hazard statements | Causes serious eye damage.
  May cause damage to organs (thyroid) through prolonged or repeated exposure (oral).
  May be corrosive to metals.
  Toxic to aquatic life with long lasting effects. |
| --- | --- |
| Precautionary statements | Wear protective gloves.
  Wear protective clothing.
  Wear eye protection.
  Wear face 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 doctor or a POISON CENTER.
  Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
  Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
  Collect spillage.
  Avoid release to the environment. |

Hazard statements

Causes serious eye damage.

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

May be corrosive to metals.

Toxic to aquatic life with long lasting effects.

Precautionary statements

Wear protective gloves.

Wear protective clothing.

Wear eye protection.

Wear face 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 doctor or a POISON CENTER.

Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

Collect spillage.

Avoid release to the environment.

4.   AUTHORISED USE(S) OF THE META SPC 7

4.1.   Use description

Table 8. Use # 1 – PT 4 – Concentrated Surface disinfectant in kitchens and in food industry, Iodine

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria
   
   
  Yeasts |
| Field(s) of use | Indoor
  Non-porous surface disinfection in professional kitchens and in food industry |
| Application method(s) | By spraying with a manual or an automatic sprayer |
| Application rate(s) and frequency | Assume 0,04 L solution for every square meter that has to be disinfected. Bactericidal and yeasticidal activity: 0,015 % iodine
  Frequency is once per day. |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
  HDPE |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Non-porous surface disinfection in professional kitchens and in food industry

Application method(s)

By spraying with a manual or an automatic sprayer

Application rate(s) and frequency

Assume 0,04 L solution for every square meter that has to be disinfected. Bactericidal and yeasticidal activity: 0,015 % iodine

Frequency is once per day.

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L

HDPE

4.1.1.   Use-specific instructions for use

Use in professional kitchens (PT4) and in food industry (PT4):

The product must be diluted with water before use (according to the table below).

Clean the surfaces thoroughly with a detergent before disinfection. Rinse with clean water and remove surplus water.

The product is used in professional kitchens (surface disinfection): Frequency is once per day.

The product is used in food industry (surface disinfection): Frequency is once per day.

Use at room temperature.

Apply the product by spraying with a manual or an automatic sprayer. Make sure to wet the surface completely. Allow to take effect for at least 15 minutes and rinse the surfaces afterwards with clean water.

| Example for a product containing 1 % iodine (*1) | Dilution of the product | Contact time |
| --- | --- | --- |
| Bactericidal and yeasticidal activity | 1,5 % (15 ml product, add water up to 1 L) | 15 min |

Example for a product containing 1 % iodine (*1)

Dilution of the product

Contact time

Bactericidal and yeasticidal activity

1,5 % (15 ml product, add water up to 1 L)

15 min

Do not mix with other chemicals.

Do not prepare more fluid than necessary.

4.1.2.   Use-specific risk mitigation measures

| — | During pouring and pumping of the concentrated product: Wear chemical resistant gloves (material to be specified by the authorisation holder within the product information) and eye/face protection. |
| --- | --- |

—

During pouring and pumping of the concentrated product: Wear chemical resistant gloves (material to be specified by the authorisation holder within the product information) and eye/face protection.

| — | During spraying of the product: Wear chemical resistant gloves and protective coverall (at least type X, EN XXXXX) (glove and coverall material to be specified by the authorisation holder within the product information). |
| --- | --- |

—

During spraying of the product: Wear chemical resistant gloves and protective coverall (at least type X, EN XXXXX) (glove and coverall material to be specified by the authorisation holder within the product information).

| — | Keep out of reach of children. |
| --- | --- |

—

Keep out of reach of children.

| — | The general public and animals should be kept away from treated areas until surfaces are dry. |
| --- | --- |

—

The general public and animals should be kept away from treated areas until surfaces are dry.

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.

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

See general directions for use.

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.

4.2.   Use description

Table 9. Use # 2 – PT3 – Concentrated Surface disinfectant for veterinary use, Iodine

| Product type | PT03 – Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria
   
   
  Yeasts
   
   
  Viruses |
| Field(s) of use | Indoor
  Non-porous surface disinfection in veterinary field |
| Application method(s) | By spraying with a manual or an automatic sprayer |
| Application rate(s) and frequency | Assume 0,04 L solution for every square meter that has to be disinfected. Bactericidal and yeasticidal activity: 0,025 % in-use iodine Virucidal activity: 0,035 % in-use iodine |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
  HDPE |

Product type

PT03 – Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Bacteria

Yeasts

Viruses

Field(s) of use

Indoor

Non-porous surface disinfection in veterinary field

Application method(s)

By spraying with a manual or an automatic sprayer

Application rate(s) and frequency

Assume 0,04 L solution for every square meter that has to be disinfected. Bactericidal and yeasticidal activity: 0,025 % in-use iodine Virucidal activity: 0,035 % in-use iodine

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L

HDPE

4.2.1.   Use-specific instructions for use

Use in veterinary field (PT3), surface disinfection:

The product should be diluted with water before use (according to table below).

Clean the surfaces thoroughly with a detergent before disinfection. Rinse with clean water and remove surplus water.

The product is used to disinfect animal housings of pigs, cows and poultry.

Apply the product by spraying with a manual or an automatic sprayer. Make sure to wet the surface completely. Allow to take effect for at least 30 minutes. Animal housing must be empty of animals during application and animals can re-enter 24h after the end of the application.

| Example for a product containing 2,49 % iodine (*2) | Dilution of the product | Contact time |
| --- | --- | --- |
| Bactericidal and yeasticidal activity | 1 % (10ml product, add water up to 1 L) | 30 min |
| Virucidal activity | 1,4 % (14ml product, add water up to 1 L) | 30 min |

Example for a product containing 2,49 % iodine (*2)

Dilution of the product

Contact time

Bactericidal and yeasticidal activity

1 % (10ml product, add water up to 1 L)

30 min

Virucidal activity

1,4 % (14ml product, add water up to 1 L)

30 min

Do not mix with other chemicals.

Do not prepare more fluid than necessary.

4.2.2.   Use-specific risk mitigation measures

| — | During pouring and pumping of the concentrated product: Wear chemical resistant gloves, coated coverall (material to be specified by the authorisation holder within the product information) and eye/face protection. |
| --- | --- |

—

During pouring and pumping of the concentrated product: Wear chemical resistant gloves, coated coverall (material to be specified by the authorisation holder within the product information) and eye/face protection.

| — | During spraying of the product: Wear chemical resistant gloves and protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product (glove and coverall material to be specified by the authorisation holder within the product information). |
| --- | --- |

—

During spraying of the product: Wear chemical resistant gloves and protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product (glove and coverall material to be specified by the authorisation holder within the product information).

| — | Only use one kind of Iodine-containing product per day. |
| --- | --- |

—

Only use one kind of Iodine-containing product per day.

| — | Due to potential concern for human health the same professional user shall not carry out animal house disinfection more than 3 times per month and shll not use Iodine products for other purposes during that period. |
| --- | --- |

—

Due to potential concern for human health the same professional user shall not carry out animal house disinfection more than 3 times per month and shll not use Iodine products for other purposes during that period.

| — | Due to potential concern for animal health, disinfection of stables should not be carried out more than once per year or once per lifetime for calves and pigs. Feeding troughs must be covered during application. |
| --- | --- |

—

Due to potential concern for animal health, disinfection of stables should not be carried out more than once per year or once per lifetime for calves and pigs. Feeding troughs must be covered during application.

| — | Keep out of reach of children. |
| --- | --- |

—

Keep out of reach of children.

| — | The general public and animals should be kept away from treated areas until surfaces are dry. |
| --- | --- |

—

The general public and animals should be kept away from treated areas until surfaces are dry.

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.

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

See general directions for use.

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.

5.   GENERAL DIRECTIONS FOR USE (7)
  OF THE META SPC 7

5.1.   Instructions for use

See use-specific instructions for use.

5.2.   Risk mitigation measures

See use-specific risk mitigation measures.

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

After eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Obtain emergency medical attention if pain, blinking, tears or redness persist.

If medical advice is needed, have product container or label at hand.

After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice.

Have product container or label at hand.

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.

| — | |
| --- | --- |

—

| — | |
| --- | --- |

—

| — | |
| --- | --- |

—

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

Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

6.   OTHER INFORMATION

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

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

| Trade name(s) | Dodin 20
  Iodo 20
  Bio Tec Joddesinfektion
  Dufa dine 1,8 %
  Alfasan super disinfectant
  Iodes
  Streptoclean
  Iodin Surface Disinfectant 1,8 %
  IODINE | |
| --- | --- | --- |
| Authorisation number | EU-0022265-0010 1-7 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 1,8 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 0,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 5,29 |
| Alcohol C9-11 + 6 EO | Alcohol C9-11 + 6 EO | Non-active Substance | 68439-46-3 | | 5,0 |

Trade name(s)

Dodin 20

Iodo 20

Bio Tec Joddesinfektion

Dufa dine 1,8 %

Alfasan super disinfectant

Iodes

Streptoclean

Iodin Surface Disinfectant 1,8 %

IODINE

Authorisation number

EU-0022265-0010 1-7

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

Active Substance

7553-56-2

231-442-4

1,8

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

0,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

5,29

Alcohol C9-11 + 6 EO

Alcohol C9-11 + 6 EO

Non-active Substance

68439-46-3

5,0

META SPC 8

1.   META SPC 8 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 8 identifier

| Identifier | metaSPC 8: PT3 and PT4 – Concentrated Surface disinfectants Iodine |
| --- | --- |

Identifier

metaSPC 8: PT3 and PT4 – Concentrated Surface disinfectants Iodine

1.2.   Suffix to the authorisation number

| Number | 1-8 |
| --- | --- |

Number

1-8

1.3.   Product type(s)

| Product type(s) | PT03 – Veterinary hygiene (Disinfectants)
  PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT03 – Veterinary hygiene (Disinfectants)

PT04 – Food and feed area (Disinfectants)

2.   META SPC 8 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 8

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 2,5 | 3,0 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 0,0 | 0,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 3,15 | 9,45 |
| Phosphoric acid | Phosphoric acid | Non-active Substance | 7664-38-2 | 231-633-2 | 5,0 | 12,0 |
| Alcohol C9-11 + 6 EO | Alcohol C9-11 + 6 EO | Non-active Substance | 68439-46-3 | | 2,5 | 12,5 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

Active Substance

7553-56-2

231-442-4

2,5

3,0

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

0,0

0,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

3,15

9,45

Phosphoric acid

Phosphoric acid

Non-active Substance

7664-38-2

231-633-2

5,0

12,0

Alcohol C9-11 + 6 EO

Alcohol C9-11 + 6 EO

Non-active Substance

68439-46-3

2,5

12,5

2.2.   Type(s) of formulation of the meta SPC 8

| Formulation(s) | SL – Soluble concentrate |
| --- | --- |

Formulation(s)

SL – Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8

| Hazard statements | May be corrosive to metals.
  Causes skin irritation.
  Causes serious eye damage.
  May cause damage to organs (thyroid) through prolonged or repeated exposure (oral).
  Toxic to aquatic life with long lasting effects. |
| --- | --- |
| Precautionary statements | Wear protective gloves.
  Wear protective clothing.
  Wear eye protection.
  Wear face protection.
  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
  IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
  Immediately call a a POISON CENTER or doctor/physician.
  If experiencing respiratory symptoms: Call a a POISON CENTER or doctor/physician.
  Avoid release to the environment.
  Collect spillage.
  Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
  Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. |

Hazard statements

May be corrosive to metals.

Causes skin irritation.

Causes serious eye damage.

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

Toxic to aquatic life with long lasting effects.

Precautionary statements

Wear protective gloves.

Wear protective clothing.

Wear eye protection.

Wear face protection.

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

IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.

Immediately call a a POISON CENTER or doctor/physician.

If experiencing respiratory symptoms: Call a a POISON CENTER or doctor/physician.

Avoid release to the environment.

Collect spillage.

Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

4.   AUTHORISED USE(S) OF THE META SPC 8

4.1.   Use description

Table 10. Use # 1 – PT4 – Concentrated Surface disinfectant in kitchens and in food industry, Iodine

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria
   
   
  Yeasts |
| Field(s) of use | Indoor
  Non-porous surface disinfection in professional kitchens and in food industry |
| Application method(s) | By spraying with a manual or an automatic sprayer |
| Application rate(s) and frequency | Assume 0,04 L solution for every square meter that has to be disinfected. Bactericidal and yeasticidal activity: 0,015 % iodine
  Daily use |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
  HDPE |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Non-porous surface disinfection in professional kitchens and in food industry

Application method(s)

By spraying with a manual or an automatic sprayer

Application rate(s) and frequency

Assume 0,04 L solution for every square meter that has to be disinfected. Bactericidal and yeasticidal activity: 0,015 % iodine

Daily use

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L

HDPE

4.1.1.   Use-specific instructions for use

| — | Use in professional kitchens (PT4) and in food industry (PT4): |
| --- | --- |

—

Use in professional kitchens (PT4) and in food industry (PT4):

| — | The product must be diluted with water before use (according to table below). |
| --- | --- |

—

The product must be diluted with water before use (according to table below).

| — | Clean the surfaces thoroughly with a detergent before disinfection. Rinse with clean water and remove surplus water. |
| --- | --- |

—

Clean the surfaces thoroughly with a detergent before disinfection. Rinse with clean water and remove surplus water.

| — | The product is used in professional kitchens (surface disinfection): Frequency is once per day. |
| --- | --- |

—

The product is used in professional kitchens (surface disinfection): Frequency is once per day.

| — | The product is used in food industry (surface disinfection): Frequency is once per day. |
| --- | --- |

—

The product is used in food industry (surface disinfection): Frequency is once per day.

| — | Use at room temperature. |
| --- | --- |

—

Use at room temperature.

| — | The product is applied by spraying with a manual or an automatic sprayer. Make sure to wet the surface completely. Allow to take effect for at least 15 minutes, and rinse the surfaces afterwards with clean water. |
| --- | --- |

—

The product is applied by spraying with a manual or an automatic sprayer. Make sure to wet the surface completely. Allow to take effect for at least 15 minutes, and rinse the surfaces afterwards with clean water.

| Example for a product containing 3 % iodine (*3) | Dilution of the product | Contact time |
| --- | --- | --- |
| Bactericidal and yeasticidal activity | 0,5 % (5 ml product, add water up to 1 L) | 15 min |

Example for a product containing 3 % iodine (*3)

Dilution of the product

Contact time

Bactericidal and yeasticidal activity

0,5 % (5 ml product, add water up to 1 L)

15 min

Do not mix with other chemicals.

Do not prepare more fluid than necessary.

4.1.2.   Use-specific risk mitigation measures

| — | During pouring and pumping of the concentrated product: Wear chemical resistant gloves, coverall (material to be specified by the authorisation holder within the product information) and eye/face protection. |
| --- | --- |

—

During pouring and pumping of the concentrated product: Wear chemical resistant gloves, coverall (material to be specified by the authorisation holder within the product information) and eye/face protection.

| — | During spraying of the product: Wear chemical resistant gloves and protective coverall (at least type X, EN XXXXX) (glove and coverall material to be specified by the authorisation holder within the product information). |
| --- | --- |

—

During spraying of the product: Wear chemical resistant gloves and protective coverall (at least type X, EN XXXXX) (glove and coverall material to be specified by the authorisation holder within the product information).

| — | Keep out of reach of children. |
| --- | --- |

—

Keep out of reach of children.

| — | The general public and animals should be kept away from treated areas until surfaces are dry. |
| --- | --- |

—

The general public and animals should be kept away from treated areas until surfaces are dry.

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.

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

See general directions for use.

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.

4.2.   Use description

Table 11. Use # 2 – PT3 – Concentrated Surface disinfectant for veterinary use, Iodine

| Product type | PT03 – Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria
   
   
  Yeasts
   
   
  Viruses |
| Field(s) of use | Indoor
  Non-porous surface disinfection in veterinary field |
| Application method(s) | By spraying with a manual or an automatic sprayer |
| Application rate(s) and frequency | Assume 0,04 L solution for every square meter that has to be disinfected. Bactericidal and yeasticidal activity: 0,025 % in-use iodine Virucidal activity: 0,035 % in-use iodine |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
  HDPE |

Product type

PT03 – Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Bacteria

Yeasts

Viruses

Field(s) of use

Indoor

Non-porous surface disinfection in veterinary field

Application method(s)

By spraying with a manual or an automatic sprayer

Application rate(s) and frequency

Assume 0,04 L solution for every square meter that has to be disinfected. Bactericidal and yeasticidal activity: 0,025 % in-use iodine Virucidal activity: 0,035 % in-use iodine

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L

HDPE

4.2.1.   Use-specific instructions for use

Use in veterinary field (PT3), surface disinfection:

The product must be diluted with water before use (according to table below).

Clean the surfaces thoroughly with a detergent before disinfection. Rinse with clean water and remove surplus water.

The product is used to disinfect animal housings of pigs, cows and poultry.

Apply the product by spraying with a manual or an automatic sprayer. Make sure to wet the surface completely. Allow to take effect for at least 30 minutes. Animal housing must be empty of animals during application and re-entry of animals can be done 24h after the end of the application.

| Example for a product containing 2,5 % iodine (*4) | Dilution of the product | Contact time |
| --- | --- | --- |
| Bactericidal and yeasticidal activity | 1 % (10ml product, add water up to 1 L) | 30 min |
| Virucidal activity | 1,4 % (14ml product, add water up to 1 L) | 30 min |

Example for a product containing 2,5 % iodine (*4)

Dilution of the product

Contact time

Bactericidal and yeasticidal activity

1 % (10ml product, add water up to 1 L)

30 min

Virucidal activity

1,4 % (14ml product, add water up to 1 L)

30 min

Do not mix with other chemicals.

Do not prepare more fluid than necessary.

4.2.2.   Use-specific risk mitigation measures

| — | During pouring and pumping of the concentrated product: Wear chemical resistant gloves, coverall (material to be specified by the authorisation holder within the product information)and eye/face protection. |
| --- | --- |

—

During pouring and pumping of the concentrated product: Wear chemical resistant gloves, coverall (material to be specified by the authorisation holder within the product information)and eye/face protection.

| — | During spraying of the product: Wear chemical resistant gloves and protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product (glove and coverall material to be specified by the authorisation holder within the product information). |
| --- | --- |

—

During spraying of the product: Wear chemical resistant gloves and protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product (glove and coverall material to be specified by the authorisation holder within the product information).

| — | Only use one kind of Iodine-containing product per day. |
| --- | --- |

—

Only use one kind of Iodine-containing product per day.

| — | Due to potential concern for human health the same professional user shall not carry out animal house disinfection more than 3 times per month and shall not use Iodine products for other purposes during that period. |
| --- | --- |

—

Due to potential concern for human health the same professional user shall not carry out animal house disinfection more than 3 times per month and shall not use Iodine products for other purposes during that period.

| — | Due to potential concern for animal health, disinfection of stables should not be carried out more than once per year or once per lifetime for calves and pigs. Feeding troughs must be covered during application. |
| --- | --- |

—

Due to potential concern for animal health, disinfection of stables should not be carried out more than once per year or once per lifetime for calves and pigs. Feeding troughs must be covered during application.

| — | Keep out of reach of children. |
| --- | --- |

—

Keep out of reach of children.

| — | The general public and animals should be kept away from treated areas until surfaces are dry. |
| --- | --- |

—

The general public and animals should be kept away from treated areas until surfaces are dry.

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.

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

See general directions for use.

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.

5.   GENERAL DIRECTIONS FOR USE (8)
  OF THE META SPC 8

5.1.   Instructions for use

See use-specific instructions for use

5.2.   Risk mitigation measures

See use-specific risk mitigation measures.

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

After eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Obtain emergency medical attention if pain, blinking, tears or redness persist.

If medical advice is needed, have product container or label at hand.

After skin (or hair) contact: Remove contaminated clothing and shoes. Wash the affected area thoroughly with plenty of soap and water. Get medical attention if symptoms occur.

After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice.

Have product container or label at hand.

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.

| — | |
| --- | --- |

—

| — | |
| --- | --- |

—

| — | |
| --- | --- |

—

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

Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8

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

| Trade name(s) | Iocid 30
  Iodo 30
  Dufa dine
  Iodin Surface Disinfectant 2,8 % | |
| --- | --- | --- |
| Authorisation number | EU-0022265-0011 1-8 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 2,8 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 0,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 7,93 |
| Phosphoric acid | Phosphoric acid | Non-active Substance | 7664-38-2 | 231-633-2 | 11,25 |
| Alcohol C9-11 + 6 EO | Alcohol C9-11 + 6 EO | Non-active Substance | 68439-46-3 | | 12,5 |

Trade name(s)

Iocid 30

Iodo 30

Dufa dine

Iodin Surface Disinfectant 2,8 %

Authorisation number

EU-0022265-0011 1-8

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

Active Substance

7553-56-2

231-442-4

2,8

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

0,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

7,93

Phosphoric acid

Phosphoric acid

Non-active Substance

7664-38-2

231-633-2

11,25

Alcohol C9-11 + 6 EO

Alcohol C9-11 + 6 EO

Non-active Substance

68439-46-3

12,5

META SPC 9

1.   META SPC 9 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 9 identifier

| Identifier | metaSPC 9: PT4 – Concentrated CIP disinfectants Iodine |
| --- | --- |

Identifier

metaSPC 9: PT4 – Concentrated CIP disinfectants Iodine

1.2.   Suffix to the authorisation number

| Number | 1-9 |
| --- | --- |

Number

1-9

1.3.   Product type(s)

| Product type(s) | PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT04 – Food and feed area (Disinfectants)

2.   META SPC 9 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 9

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,5 | 0,99 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 0,0 | 0,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 0,0 | 0,0 |
| Phosphoric acid | Phosphoric acid | Non-active Substance | 7664-38-2 | 231-633-2 | 25,0 | 30,0 |
| Alcohol C9-11 + 6 EO | Alcohol C9-11 + 6 EO | Non-active Substance | 68439-46-3 | | 0,0 | 0,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

Active Substance

7553-56-2

231-442-4

0,5

0,99

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

0,0

0,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

0,0

0,0

Phosphoric acid

Phosphoric acid

Non-active Substance

7664-38-2

231-633-2

25,0

30,0

Alcohol C9-11 + 6 EO

Alcohol C9-11 + 6 EO

Non-active Substance

68439-46-3

0,0

0,0

2.2.   Type(s) of formulation of the meta SPC 9

| Formulation(s) | SL – Soluble concentrate |
| --- | --- |

Formulation(s)

SL – Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9

| Hazard statements | Causes severe skin burns and eye damage.
  Harmful to aquatic life with long lasting effects.
  May be corrosive to metals. |
| --- | --- |
| Precautionary statements | Wear protective gloves.
  Wear protective clothing.
  Wear eye protection.
  Wear face protection.
  Avoid release to the environment.
  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
  IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
  If experiencing respiratory symptoms: Call a doctor.
  Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
  Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
  Immediately call a doctor. |

Hazard statements

Causes severe skin burns and eye damage.

Harmful to aquatic life with long lasting effects.

May be corrosive to metals.

Precautionary statements

Wear protective gloves.

Wear protective clothing.

Wear eye protection.

Wear face protection.

Avoid release to the environment.

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

IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.

If experiencing respiratory symptoms: Call a doctor.

Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

Immediately call a doctor.

4.   AUTHORISED USE(S) OF THE META SPC 9

4.1.   Use description

Table 12. Use # 1 – PT4 – Concentrated Cleaning in place disinfectant, Iodine

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria
   
   
  Yeasts |
| Field(s) of use | Indoor
  Cleaning in place (CIP) disinfection for milking equipment and CIP installations in food industry |
| Application method(s) | CIP disinfection |
| Application rate(s) and frequency | Apply the product in the automatic system with an end concentration of 0,00125 % available iodine
  The product is used once per day in food industry and up to 2 times per day in milking parlours. |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
  HDPE |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Cleaning in place (CIP) disinfection for milking equipment and CIP installations in food industry

Application method(s)

CIP disinfection

Application rate(s) and frequency

Apply the product in the automatic system with an end concentration of 0,00125 % available iodine

The product is used once per day in food industry and up to 2 times per day in milking parlours.

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L

HDPE

4.1.1.   Use-specific instructions for use

See general instructions.

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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.

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

See general directions for use.

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.

5.   GENERAL DIRECTIONS FOR USE (9)
  OF THE META SPC 9

5.1.   Instructions for use

| — | Disinfection of milking machines or CIP installations in food industry |
| --- | --- |

—

Disinfection of milking machines or CIP installations in food industry

| — | Clean first the CIP installation. |
| --- | --- |

—

Clean first the CIP installation.

| — | Apply the product in the automatic system with a dilution of the product (according to table below) with water. |
| --- | --- |

—

Apply the product in the automatic system with a dilution of the product (according to table below) with water.

| — | Use at room temperature. |
| --- | --- |

—

Use at room temperature.

| — | Respect a contact time according to the table below. |
| --- | --- |

—

Respect a contact time according to the table below.

| — | Rinse the installation with water. |
| --- | --- |

—

Rinse the installation with water.

| Example for a product containing 0,5 % iodine (*5) | Dilution of the product | Contact time |
| --- | --- | --- |
| Bactericidal and yeasticidal activity | 0,25 % (2,5 ml product, add water up to 1 L) | 15 min |

Example for a product containing 0,5 % iodine (*5)

Dilution of the product

Contact time

Bactericidal and yeasticidal activity

0,25 % (2,5 ml product, add water up to 1 L)

15 min

Do not mix with other chemicals.

5.2.   Risk mitigation measures

During pouring and pumping of the concentrated product: Wear chemical resistant gloves and protective coverall (at least type X, EN XXXXX) (glove and coverall material to be specified by the authorisation holder within the product information) and eye/face protection.

Keep out of reach of children.

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

After inhalation: Remove person to fresh air and keep comfortable for breathing. Obtain medical attention if breathing difficulty persists.

After skin (or hair) contact: Remove contaminated clothing and shoes. Wash the affected area thoroughly with plenty of soap and water. Get medical attention if symptoms occur.

After eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Obtain emergency medical attention if pain, blinking, tears or redness persist.

After ingestion: Rinse mouth. Do NOT induce vomiting and immediately get medical advice.

Have product container or label at hand.

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.

| — | |
| --- | --- |

—

| — | |
| --- | --- |

—

| — | |
| --- | --- |

—

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

Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 9

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

| Trade name(s) | Iodo CIP
  Iocip
  Bio Tec Jodreiniger
  JODOPHOS SUPER 4001
  Bühning Jodreiniger
  Wynnsan Ice bank Tank Cleaner
  Bulk Tank Sanitizer
  Iodin CIP Disinfectant | |
| --- | --- | --- |
| Authorisation number | EU-0022265-0012 1-9 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,5 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 0,0 |
| Phosphoric acid | Phosphoric acid | Non-active Substance | 7664-38-2 | 231-633-2 | 26,3 |

Trade name(s)

Iodo CIP

Iocip

Bio Tec Jodreiniger

JODOPHOS SUPER 4001

Bühning Jodreiniger

Wynnsan Ice bank Tank Cleaner

Bulk Tank Sanitizer

Iodin CIP Disinfectant

Authorisation number

EU-0022265-0012 1-9

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

Active Substance

7553-56-2

231-442-4

0,5

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

0,0

Phosphoric acid

Phosphoric acid

Non-active Substance

7664-38-2

231-633-2

26,3

META SPC 10

1.   META SPC 10 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 10 identifier

| Identifier | metaSPC 10: PT3 – Concentrated teat disinfectants Iodine |
| --- | --- |

Identifier

metaSPC 10: PT3 – Concentrated teat disinfectants Iodine

1.2.   Suffix to the authorisation number

| Number | 1-10 |
| --- | --- |

Number

1-10

1.3.   Product type(s)

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

Product type(s)

PT03 – Veterinary hygiene (Disinfectants)

2.   META SPC 10 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 10

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 2,8 | 2,8 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 0,0 | 0,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 21,0 | 21,0 |
| Phosphoric acid | Phosphoric acid | Non-active Substance | 7664-38-2 | 231-633-2 | 0,0 | 0,0 |
| Alcohol C9-11 + 6 EO | Alcohol C9-11 + 6 EO | Non-active Substance | 68439-46-3 | | 0,0 | 0,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

Active Substance

7553-56-2

231-442-4

2,8

2,8

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

0,0

0,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

21,0

21,0

Phosphoric acid

Phosphoric acid

Non-active Substance

7664-38-2

231-633-2

0,0

0,0

Alcohol C9-11 + 6 EO

Alcohol C9-11 + 6 EO

Non-active Substance

68439-46-3

0,0

0,0

2.2.   Type(s) of formulation of the meta SPC 10

| Formulation(s) | SL – Soluble concentrate |
| --- | --- |

Formulation(s)

SL – Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 10

| Hazard statements | Causes serious eye damage.
  Toxic to aquatic life with long lasting effects.
  May cause damage to organs (thyroid) through prolonged or repeated exposure (oral route). |
| --- | --- |
| Precautionary statements | Wear protective gloves.
  Wear protective clothing.
  Wear eye protection.
  Wear face 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 doctor or a poison center.
  Avoid release to the environment.
  Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
  Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
  Collect spillage. |

Hazard statements

Causes serious eye damage.

Toxic to aquatic life with long lasting effects.

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

Precautionary statements

Wear protective gloves.

Wear protective clothing.

Wear eye protection.

Wear face 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 doctor or a poison center.

Avoid release to the environment.

Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

Collect spillage.

4.   AUTHORISED USE(S) OF THE META SPC 10

4.1.   Use description

Table 13. Use # 1 – PT3 – Concentrated teat disinfectant, Post-milking, Iodine

| Product type | PT03 – Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria
   
   
  Yeasts
   
   
  Viruses |
| Field(s) of use | Indoor
  Post-milking teat disinfection of milk producing animals |
| Application method(s) | By spraying with a manual sprayer or with an automatic sprayer on teats. |
| Application rate(s) and frequency | The product must be diluted before use in order to allow a final concentration of iodine of 0,3 %.
  Apply 2 times per day by using a manual sprayer and 3 times per day when using a robot (or automatic sprayer). |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
  HDPE |

Product type

PT03 – Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Bacteria

Yeasts

Viruses

Field(s) of use

Indoor

Post-milking teat disinfection of milk producing animals

Application method(s)

By spraying with a manual sprayer or with an automatic sprayer on teats.

Application rate(s) and frequency

The product must be diluted before use in order to allow a final concentration of iodine of 0,3 %.

Apply 2 times per day by using a manual sprayer and 3 times per day when using a robot (or automatic sprayer).

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L

HDPE

4.1.1.   Use-specific instructions for use

See general directions for use.

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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.

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

See general directions for use.

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.

5.   GENERAL DIRECTIONS FOR USE (10)
  OF THE META SPC 10

5.1.   Instructions for use

The product must be diluted before use in order to allow a final concentration of iodine of 0,3 %. The product should be diluted to 11 % (110mL product, add water up to 1 L).

Do not prepare more fluid than necessary. Assume 5 mL solution per cow per treatment. The use of a dosing pump for filling the product into the application equipment is recommended.

Use gloves and eye protection during the dilution step. The diluted product can be kept and used for 1 week.

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

Apply the diluted product on the teats with a manual sprayer or with an automatic sprayer.

The product should be used directly after milking 2 times per day by using a manual sprayer and 3 times per day by using a robot (automatic sprayer). Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Do not mix with other chemicals.

5.2.   Risk mitigation measures

| — | For mixing and loading of the product: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) and eye/face protection. |
| --- | --- |

—

For mixing and loading of the product: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) and eye/face protection.

| — | For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) and eye/face protection. |
| --- | --- |

—

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

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

—

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

| — | Keep out of reach of children. |
| --- | --- |

—

Keep out of reach of children.

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

After eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Obtain emergency medical attention if pain, blinking, tears or redness persist.

If medical advice is needed, have product container or label at hand.

After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice.

Have product container or label at hand.

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.

| — | |
| --- | --- |

—

| — | |
| --- | --- |

—

| — | |
| --- | --- |

—

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

Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

6.   OTHER INFORMATION

Dilutions of the product(s) are stable for 1 week.

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 10

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

| Trade name(s) | Kenodin SD 900
  IodoSD 900
  IDip+ concentrate
  Jodkonzentrat 1:9
  Bühning Jodkonzentrat 1:9
  Wynnsan Iodine Conc dip 9-1
  Kenodin 900
  Dufa Dip
  Kenostart 900
  Iodin Teat Spray 900
  HCP Iodine Concentrate
  Maxi Subliem CP
  Subliem Koncentrat Plus | |
| --- | --- | --- |
| Authorisation number | EU-0022265-0013 1-10 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 2,8 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 0,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 21,0 |

Trade name(s)

Kenodin SD 900

IodoSD 900

IDip+ concentrate

Jodkonzentrat 1:9

Bühning Jodkonzentrat 1:9

Wynnsan Iodine Conc dip 9-1

Kenodin 900

Dufa Dip

Kenostart 900

Iodin Teat Spray 900

HCP Iodine Concentrate

Maxi Subliem CP

Subliem Koncentrat Plus

Authorisation number

EU-0022265-0013 1-10

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

Active Substance

7553-56-2

231-442-4

2,8

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

0,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

21,0

META SPC 11

1.   META SPC 11 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 11 identifier

| Identifier | metaSPC 11: PT3 – RTU Teat disinfectants Iodine |
| --- | --- |

Identifier

metaSPC 11: PT3 – RTU Teat disinfectants Iodine

1.2.   Suffix to the authorisation number

| Number | 1-11 |
| --- | --- |

Number

1-11

1.3.   Product type(s)

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

Product type(s)

PT03 – Veterinary hygiene (Disinfectants)

2.   META SPC 11 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 11

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,25 | 0,25 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 0,0 | 0,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 2,1 | 2,1 |
| Phosphoric acid | Phosphoric acid | Non-active Substance | 7664-38-2 | 231-633-2 | 0,0 | 0,0 |
| Alcohol C9-11 + 6 EO | Alcohol C9-11 + 6 EO | Non-active Substance | 68439-46-3 | | 0,0 | 0,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

Active Substance

7553-56-2

231-442-4

0,25

0,25

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

0,0

0,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

2,1

2,1

Phosphoric acid

Phosphoric acid

Non-active Substance

7664-38-2

231-633-2

0,0

0,0

Alcohol C9-11 + 6 EO

Alcohol C9-11 + 6 EO

Non-active Substance

68439-46-3

0,0

0,0

2.2.   Type(s) of formulation of the meta SPC 11

| Formulation(s) | AL – Any other liquid |
| --- | --- |

Formulation(s)

AL – Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 11

| Hazard statements | Harmful to aquatic life with long lasting effects. |
| --- | --- |
| Precautionary statements | Avoid release to the environment.
  Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
  Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. |

Hazard statements

Harmful to aquatic life with long lasting effects.

Precautionary statements

Avoid release to the environment.

Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

4.   AUTHORISED USE(S) OF THE META SPC 11

4.1.   Use description

Table 14. Use # 1 – PT3 – RTU teats disinfectant, Post-milking, Iodine

| 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
  Post-milking teat disinfection of milk producing animals |
| Application method(s) | By dipping or spraying on teats |
| Application rate(s) and frequency | The product is ready to use.
  Apply 2 times per day when using a manual sprayer and 3 times per day when using a dip cup or a robot (automatic sprayer). |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
  HDPE |

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

Post-milking teat disinfection of milk producing animals

Application method(s)

By dipping or spraying on teats

Application rate(s) and frequency

The product is ready to use.

Apply 2 times per day when using a manual sprayer and 3 times per day when using a dip cup or a robot (automatic sprayer).

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L

HDPE

4.1.1.   Use-specific instructions for use

See general instructions.

4.1.2.   Use-specific risk mitigation measures

See general instructions.

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 instructions.

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

See general instructions.

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 instructions.

5.   GENERAL DIRECTIONS FOR USE (11)
  OF THE META SPC 11

5.1.   Instructions for use

Apply the product by dipping or by spraying:

| — | By dipping: Apply the product with a dip cup. Wash the dip cup with water after use. |
| --- | --- |

—

By dipping: Apply the product with a dip cup. Wash the dip cup with water after use.

| — | By spraying: Apply the product with a manual sprayer or with an automatic sprayer. |
| --- | --- |

—

By spraying: Apply the product with a manual sprayer or with an automatic sprayer.

Do not prepare more fluid than necessary; assume 5 mL solution per cow per treatment. 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.

The product should be used immediately after each milking, two times per day when using a manual sprayer or three times per day when using a dip cup or a robot (automatic sprayer). Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Do not mix with other chemicals.

5.2.   Risk mitigation measures

| — | For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information). |
| --- | --- |

—

For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).

| — | For manual dipping application: no PPE is necessary for safe use. |
| --- | --- |

—

For manual dipping application: no PPE is necessary for safe use.

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

—

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

| — | Keep out of reach of children. |
| --- | --- |

—

Keep out of reach of children.

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

After eye contact: Rinse immediately with water.

After ingestion: Rinse mouth. Spit.

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.

| — | |
| --- | --- |

—

| — | |
| --- | --- |

—

| — | |
| --- | --- |

—

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

Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 11

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

| Trade name(s) | Kenodin 2500
  Iodin Teat Dip 2500
  Jod 2500 | |
| --- | --- | --- |
| Authorisation number | EU-0022265-0014 1-11 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,25 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 0,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 2,1 |

Trade name(s)

Kenodin 2500

Iodin Teat Dip 2500

Jod 2500

Authorisation number

EU-0022265-0014 1-11

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

Active Substance

7553-56-2

231-442-4

0,25

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

0,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

2,1

META SPC 12

1.   META SPC 12 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 12 identifier

| Identifier | meta SPC 12: PT3 – RTU Teat disinfectants Iodine |
| --- | --- |

Identifier

meta SPC 12: PT3 – RTU Teat disinfectants Iodine

1.2.   Suffix to the authorisation number

| Number | 1-12 |
| --- | --- |

Number

1-12

1.3.   Product type(s)

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

Product type(s)

PT03 – Veterinary hygiene (Disinfectants)

2.   META SPC 12 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 12

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,3 | 0,5 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 0,0 | 0,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 2,1 | 2,9 |
| Phosphoric acid | Phosphoric acid | Non-active Substance | 7664-38-2 | 231-633-2 | 0,0 | 0,0 |
| Alcohol C9-11 + 6 EO | Alcohol C9-11 + 6 EO | Non-active Substance | 68439-46-3 | | 0,0 | 0,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

Active Substance

7553-56-2

231-442-4

0,3

0,5

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

0,0

0,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

2,1

2,9

Phosphoric acid

Phosphoric acid

Non-active Substance

7664-38-2

231-633-2

0,0

0,0

Alcohol C9-11 + 6 EO

Alcohol C9-11 + 6 EO

Non-active Substance

68439-46-3

0,0

0,0

2.2.   Type(s) of formulation of the meta SPC 12

| Formulation(s) | AL – Any other liquid |
| --- | --- |

Formulation(s)

AL – Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 12

| Hazard statements | Harmful to aquatic life with long lasting effects. |
| --- | --- |
| Precautionary statements | Avoid release to the environment.
  Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
  Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. |

Hazard statements

Harmful to aquatic life with long lasting effects.

Precautionary statements

Avoid release to the environment.

Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

4.   AUTHORISED USE(S) OF THE META SPC 12

4.1.   Use description

Table 15. Use # 1 – PT3– RTU Teat disinfectant, Post-milking, Iodine

| Product type | PT03 – Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria
   
   
  Yeasts
   
   
  Viruses |
| Field(s) of use | Indoor
  Post-milking teat disinfection of milk producing animals |
| Application method(s) | By dipping or spraying on teats |
| Application rate(s) and frequency | The product is ready to use.
  Apply 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot. |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
  HDPE |

Product type

PT03 – Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Bacteria

Yeasts

Viruses

Field(s) of use

Indoor

Post-milking teat disinfection of milk producing animals

Application method(s)

By dipping or spraying on teats

Application rate(s) and frequency

The product is ready to use.

Apply 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot.

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L

HDPE

4.1.1.   Use-specific instructions for use

See general directions for use.

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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.

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

See general directions for use.

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.

5.   GENERAL DIRECTIONS FOR USE (12)
  OF THE META SPC 12

5.1.   Instructions for use

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

Apply the product by dipping or by spraying:

| — | By dipping: Apply the product with a dip cup. Wash the dip cup with water after use |
| --- | --- |

—

By dipping: Apply the product with a dip cup. Wash the dip cup with water after use

| — | By spraying: Apply the product with a manual sprayer or with an automatic sprayer. |
| --- | --- |

—

By spraying: Apply the product with a manual sprayer or with an automatic sprayer.

Do not prepare more fluid than necessary; assume 5 mL solution per cow per treatment.

The product should be used immediately after each milking: 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot. Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Do not mix with other chemicals.

5.2.   Risk mitigation measures

| — | For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information). |
| --- | --- |

—

For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).

| — | For manual dipping application: no PPE is necessary for safe use. |
| --- | --- |

—

For manual dipping application: no PPE is necessary for safe use.

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

—

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

| — | Keep out of reach of children. |
| --- | --- |

—

Keep out of reach of children.

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

After eye contact: Rinse immediately with water.

After ingestion: Rinse mouth. Spit.

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.

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

Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 12

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

| Trade name(s) | Kenodin 5000
  IodoDip 5000
  JOD 5000
  Bio Tec Jodip 5000
  Bühning Jodfilmdip-Super
  Iocid 5000
  Iod protect 5000 Film
  IOD protect 5000 Film
  Iocid
  Iodip+
  Protetos cua
  Iodin Teat Dip 5000 | |
| --- | --- | --- |
| Authorisation number | EU-0022265-0015 1-12 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,5 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 0,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 2,9 |

Trade name(s)

Kenodin 5000

IodoDip 5000

JOD 5000

Bio Tec Jodip 5000

Bühning Jodfilmdip-Super

Iocid 5000

Iod protect 5000 Film

IOD protect 5000 Film

Iocid

Iodip+

Protetos cua

Iodin Teat Dip 5000

Authorisation number

EU-0022265-0015 1-12

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

Active Substance

7553-56-2

231-442-4

0,5

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

0,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

2,9

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

| Trade name(s) | Kenodin SD 5000
  IodoSD 5000
  IODOSPRAY 5000
  Bio Tec Jodspray 5000
  IDip+ 5000
  Bühning Jodspray 5000
  Iod protect 5000 Sprüh
  Kenodin Film Spray
  IOD protect 5000 Sprüh
  Iodin Spray & Dip 5000 | |
| --- | --- | --- |
| Authorisation number | EU-0022265-0016 1-12 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,5 |
| Polyvinylpyrrolidone iodine | | Active Substance | 25655-41-8 | | 0,0 |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active Substance | 68131-39-5 | 500-195-7 | 2,9 |

Trade name(s)

Kenodin SD 5000

IodoSD 5000

IODOSPRAY 5000

Bio Tec Jodspray 5000

IDip+ 5000

Bühning Jodspray 5000

Iod protect 5000 Sprüh

Kenodin Film Spray

IOD protect 5000 Sprüh

Iodin Spray & Dip 5000

Authorisation number

EU-0022265-0016 1-12

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

Active Substance

7553-56-2

231-442-4

0,5

Polyvinylpyrrolidone iodine

Active Substance

25655-41-8

0,0

Alcohols, C12-15, ethoxylated

Alcohols, C12-15, ethoxylated

Non-active Substance

68131-39-5

500-195-7

2,9

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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 SPC 1.

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

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

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

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

(6)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 6.

(*1)  Each product label should give information on how the dilution should be made. Since the concentration of iodine in products within this meta SPC can range from 1,8 to 2,49 % it is not possible to indicate all product dilutions here.

(*2)  Each product label should give information on how the dilution should be made. Since the concentration of iodine in products within this meta SPC can range from 1,8 to 2,49 % it is not possible to indicate all product dilutions here.

(7)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 7.

(*3)  Each product label should give information on how the dilution should be made. Since the concentration of iodine in products within this meta SPC can range from 2,5 to 3 % it is not possible to indicate all product dilutions here.

(*4)  Each product label should give information on how the dilution should be made. Since the concentration of iodine in products within this meta SPC can range from 2,5 to 3 % it is not possible to indicate all product dilutions here.

(8)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 8.

(9)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 9.

(*5)  Each product label should give information on how the dilution should be made. Since the concentration of iodine in products within this meta SPC can range from 0,5 to 0,99 % it is not possible to indicte all product dilutions here. An example is given for products with 0,5 % iodine.

(10)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 10.

(11)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 11.

(12)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 12.

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