# L_2018238EN.01000301.xml

| 21.9.2018 | EN | Official Journal of the European Union | L 238/3 |
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21.9.2018

EN

Official Journal of the European Union

L 238/3

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1258

of 18 September 2018

granting a Union authorisation for the biocidal product family Ecolab Iodine PT3 Family

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

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

Whereas:

| (1) | On 23 July 2015, Ecolab Deutschland GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named Ecolab Iodine PT3 Family (‘the product family’) of product-type 3, as described in Annex V to that Regulation. The Netherlands agreed that their competent authority referred to in Article 43(1) of Regulation (EU) No 528/2012 evaluate this application. The application was recorded under the case number BC-VG018734-32 in the Register for Biocidal Products (‘the Register’). |
| --- | --- |

(1)

On 23 July 2015, Ecolab Deutschland GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named Ecolab Iodine PT3 Family (‘the product family’) of product-type 3, as described in Annex V to that Regulation. The Netherlands agreed that their competent authority referred to in Article 43(1) of Regulation (EU) No 528/2012 evaluate this application. The application was recorded under the case number BC-VG018734-32 in the Register for Biocidal Products (‘the Register’).

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

(2)

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

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

(3)

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

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

(4)

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

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

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

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

(6)

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

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

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

HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation is granted to Ecolab Deutschland GmbH for the biocidal product family Ecolab Iodine PT3 Family with authorisation number EU-0018398-0000.

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

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

Article 2

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

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

Done at Brussels, 18 September 2018.

For the Commission

The President

Jean-Claude JUNCKER

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

1

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

2

(3)  ECHA opinion of 12 December 2017 on the Union authorisation of Ecolab Iodine PT3 Family (ECHA/BPC/177/2017).

3

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ANNEX

Summary of product characteristics for a biocidal product family

Ecolab Iodine PT3 Family

Product type 3 — Veterinary hygiene (Disinfectants)

Authorisation number: EU-0018398-0000

R4BP asset number: EU-0018398-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

| Name | Ecolab Iodine PT3 Family |
| --- | --- |
| | |

Name

Ecolab Iodine PT3 Family

1.2.   Product type(s)

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

Product type(s)

PT03 — Veterinary hygiene (Disinfectants)

1.3.   Authorisation holder

| Name and address of the authorisation holder | Name | Ecolab Deutschland GmbH |
| --- | --- | --- |
| Address | Ecolab-Allee 1, 40789 Monheim, Germany |
| Authorisation number | EU-0018398-0000 |
| R4BP asset number | EU-0018398-0000 |
| Date of the authorisation | 11 October 2018 |
| Expiry date of the authorisation | 30 September 2028 |

Name and address of the authorisation holder

Name

Ecolab Deutschland GmbH

Address

Ecolab-Allee 1, 40789 Monheim, Germany

Authorisation number

EU-0018398-0000

R4BP asset number

EU-0018398-0000

Date of the authorisation

11 October 2018

Expiry date of the authorisation

30 September 2028

1.4.   Manufacturer(s) of the biocidal products

| Name of manufacturer | Ecolab Europe GmbH |
| --- | --- |
| Address of manufacturer | Richtistrasse 7, 8304 Walliselen Switzerland |
| Location of manufacturing sites | Ecolab Baglan, ECOLAB CONTAMINATION CONTROL BRUNEL WAY, BAGLAN ENERGY PARK, NEATH, SA11 2GA South Wales United Kingdom
  Ecolab Leeds, LOTHERTON WAY, GARFORTH, LEEDS LS25 2JY Leeds United Kingdom
  Ecolab Rovigo, Viale del Lavoro 10, 45100 Rovigo Italy
  Ecolab Biebesheim Nalco Deutschland Manufacturing GmbH und Co.KG, Justus-von-Liebig-Str. 11 D-64584 Biebesheim Germany
  Ecolab NETHERLANDS BV, NL01ECOLAB, BRUGWAL 11 3432NZ NIEUWEGEIN Netherlands
  Ecolab Weavergate, ECOLAB WEAVERGATE PLANT WINNINGTON AVENUE, NORTHWICH CHESHIRE CW8 3AA NORTHWICH United Kingdom
  Ecolab Mullingar, Forest Park, Mullingar Ind. Estate, Mullingar, Co. Zone C Westmeath Ireland
  Ecolab Maribor, Ecolab d.o.o.,Vajngerlova 4 2000 Maribor Slovenia
  Ecolab Rozzano, VIA GRANDI 9/11 20089 ROZZANO Italy
  Ecolab B.V.B.A, Havenlaan: 4 3980 Tessenderlo Belgium
  Ecolab CELRA, Nalco Española Manufacturing, SLU C/Tramuntana s/n, Polígono Industrial de Celrà 17460 CELRÀ Spain
  Ecolab Chalons Ecolab production France SAS, BP509 Avenue de Général Patton 51006 Châlons-en-Champagne France
  Ecolab Mandra, 25km Old National Road Athens Mandra, oo Attica Greece
  NALCO FINLAND MANUFACTURING OY, Kivikummuntie 1 FIN-07955 Tesjoki Finland |

Name of manufacturer

Ecolab Europe GmbH

Address of manufacturer

Richtistrasse 7, 8304 Walliselen Switzerland

Location of manufacturing sites

Ecolab Baglan, ECOLAB CONTAMINATION CONTROL BRUNEL WAY, BAGLAN ENERGY PARK, NEATH, SA11 2GA South Wales United Kingdom

Ecolab Leeds, LOTHERTON WAY, GARFORTH, LEEDS LS25 2JY Leeds United Kingdom

Ecolab Rovigo, Viale del Lavoro 10, 45100 Rovigo Italy

Ecolab Biebesheim Nalco Deutschland Manufacturing GmbH und Co.KG, Justus-von-Liebig-Str. 11 D-64584 Biebesheim Germany

Ecolab NETHERLANDS BV, NL01ECOLAB, BRUGWAL 11 3432NZ NIEUWEGEIN Netherlands

Ecolab Weavergate, ECOLAB WEAVERGATE PLANT WINNINGTON AVENUE, NORTHWICH CHESHIRE CW8 3AA NORTHWICH United Kingdom

Ecolab Mullingar, Forest Park, Mullingar Ind. Estate, Mullingar, Co. Zone C Westmeath Ireland

Ecolab Maribor, Ecolab d.o.o.,Vajngerlova 4 2000 Maribor Slovenia

Ecolab Rozzano, VIA GRANDI 9/11 20089 ROZZANO Italy

Ecolab B.V.B.A, Havenlaan: 4 3980 Tessenderlo Belgium

Ecolab CELRA, Nalco Española Manufacturing, SLU C/Tramuntana s/n, Polígono Industrial de Celrà 17460 CELRÀ Spain

Ecolab Chalons Ecolab production France SAS, BP509 Avenue de Général Patton 51006 Châlons-en-Champagne France

Ecolab Mandra, 25km Old National Road Athens Mandra, oo Attica Greece

NALCO FINLAND MANUFACTURING OY, Kivikummuntie 1 FIN-07955 Tesjoki Finland

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

| Active substance | Polyvinylpyrrolidone iodine |
| --- | --- |
| Name of manufacturer | ISP Chemicals LLC, Affiliate 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, Affiliate 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 | Iodine |
| --- | --- |
| Name of manufacturer | ACF Minera S.A. |
| Address of manufacturer | San Martín 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 Martín No 499 00 Iquique Chile

Location of manufacturing sites

Lagunas mine 00 Pozo Almonte Chile

| Active substance | Iodine |
| --- | --- |
| Name of manufacturer | SQM S.A. |
| Address of manufacturer | Los Militares 4290 Piso 4 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 4290 Piso 4 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 | S.C.M. Cosayach 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

S.C.M. Cosayach Cala Cala 00 Pozo Almonte Chile

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

Active substance

Iodine

Name of manufacturer

Nihon Tennen Gas Development Co., Ltd/ Kanto Natural Gas Development Co., Ltd

Address of manufacturer

661 Mobara Chiba 297-8550 Mobara City Japan

Location of manufacturing sites

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

2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

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

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Polyvinylpyrrolidone iodine | | Active substance | 25655-41-8 | | 1 | 3 |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,11 | 0,33 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Polyvinylpyrrolidone iodine

Active substance

25655-41-8

1

3

Iodine

Active substance

7553-56-2

231-442-4

0,11

0,33

2.2.   Type(s) of formulation

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

Formulation(s)

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 | meta SPC 1 |
| --- | --- |

Identifier

meta SPC 1

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 |
| Polyvinylpyrrolidone iodine | | Active substance | 25655-41-8 | | 1 | 1 |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,11 | 0,11 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Polyvinylpyrrolidone iodine

Active substance

25655-41-8

1

1

Iodine

Active substance

7553-56-2

231-442-4

0,11

0,11

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

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

Formulation

AL — Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

| Hazard statements | |
| --- | --- |
| Precautionary statements | |

Hazard statements

Precautionary statements

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

4.1.   Use description

Table 1. Use # 1 – Teat dips for post-milking disinfection

| Product Type | PT03 — Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria
  Yeasts
  Enveloped viruses |
| Field(s) of use | Indoor
  Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep) |
| Application method(s) | Manual dipping using a dip cup -
  3-10 ml (dipping)
  1-3 post-milking disinfections per day |
| Application rate(s) and frequency | 3-10 ml (dipping)
  Post-milking application 1x - 3x per day (apply after every milking).
  Per milking event 3-10 ml of product are needed (animals with four teats). |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | container, Plastic: HDPE, 0,5-1 000 l |

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Bacteria

Yeasts

Enveloped viruses

Field(s) of use

Indoor

Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)

Application method(s)

Manual dipping using a dip cup -

3-10 ml (dipping)

1-3 post-milking disinfections per day

Application rate(s) and frequency

3-10 ml (dipping)

Post-milking application 1x - 3x per day (apply after every milking).

Per milking event 3-10 ml of product are needed (animals with four teats).

Category(ies) of users

Professional

Pack sizes and packaging material

container, Plastic: HDPE, 0,5-1 000 l

4.1.1.   Use-specific instructions for use

See general directions for use of meta SPC 1

4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 1

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

See general directions for use of meta SPC 1

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

See general directions for use of meta SPC 1

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

See general directions for use of meta SPC 1

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

5.1.   Instructions for use

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

Product to be applied post-milking by use of a dipping cup.

The products must be brought to temperatures above 20 °C before use.

Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.

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

5.2.   Risk mitigation measures

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

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

Potential Health Effects

Eyes: Health injuries are not known or expected under normal use.

Skin: Health injuries are not known or expected under normal use.

Ingestion: Health injuries are not known or expected under normal use.

Inhalation: Health injuries are not known or expected under normal use.

Chronic Exposure: Health injuries are not known or expected under normal use.

First Aid Measures:

Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.

Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.

Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.

Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.

Environmental emergency measures: Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer If legally allowed.

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.

European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.

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

Store between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.

Shelf life: 24 months

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) | Ioklar Super Dip D |
| --- | --- |
| Authorisation number | EU-0018398-0001 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Polyvinylpyrrolidone iodine | | Active substance | 25655-41-8 | | 1 |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,11 |

Trade name(s)

Ioklar Super Dip D

Authorisation number

EU-0018398-0001 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Polyvinylpyrrolidone iodine

Active substance

25655-41-8

1

Iodine

Active substance

7553-56-2

231-442-4

0,11

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

| Trade name(s) | IoKlar Superdip |
| --- | --- |
| Authorisation number | EU-0018398-0002 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Polyvinylpyrrolidone iodine | | Active substance | 25655-41-8 | | 1 |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,11 |

Trade name(s)

IoKlar Superdip

Authorisation number

EU-0018398-0002 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Polyvinylpyrrolidone iodine

Active substance

25655-41-8

1

Iodine

Active substance

7553-56-2

231-442-4

0,11

META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

| Identifier | meta SPC 2 |
| --- | --- |

Identifier

meta SPC 2

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 |
| Polyvinylpyrrolidone iodine | | Active substance | 25655-41-8 | | 1,35 | 1,35 |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,15 | 0,15 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Polyvinylpyrrolidone iodine

Active substance

25655-41-8

1,35

1,35

Iodine

Active substance

7553-56-2

231-442-4

0,15

0,15

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

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

Formulation

AL — Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

| Hazard statements | |
| --- | --- |
| Precautionary statements | |

Hazard statements

Precautionary statements

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

4.1.   Use description

Table 2. Use # 1 – Teat dips for post-milking disinfection

| Product Type | PT03 — Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria
  Yeasts
  Enveloped viruses |
| Field(s) of use | Indoor
  Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep) |
| Application method(s) | Manual dipping using a dip cup |
| Application rate(s) and frequency | Post-milking application 1x - 3x per day (apply after every milking).
  Per milking event 3-10 ml of product are needed (animals with four teats). |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 0,5 l – 1 000 l HDPE container |

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Bacteria

Yeasts

Enveloped viruses

Field(s) of use

Indoor

Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)

Application method(s)

Manual dipping using a dip cup

Application rate(s) and frequency

Post-milking application 1x - 3x per day (apply after every milking).

Per milking event 3-10 ml of product are needed (animals with four teats).

Category(ies) of users

Professional

Pack sizes and packaging material

0,5 l – 1 000 l HDPE container

4.1.1.   Use-specific instructions for use

See general directions for use of meta SPC 2

4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 2

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

See general directions for use of meta SPC 2

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

See general directions for use of meta SPC 2

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

See general directions for use of meta SPC 2

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

5.1.   Instructions for use

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

The products must be brought to temperatures above 20 °C before use.

Product to be applied post-milking by use of a dipping cup.

Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.

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

5.2.   Risk mitigation measures

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

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

Potential Health Effects

Eyes: Health injuries are not known or expected under normal use.

Skin: Health injuries are not known or expected under normal use.

Ingestion: Health injuries are not known or expected under normal use.

Inhalation: Health injuries are not known or expected under normal use.

Chronic Exposure: Health injuries are not known or expected under normal use.

First Aid Measures:

Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.

Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.

Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.

Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.

Environmental emergency measures: Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer If legally allowed.

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.

European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.

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

Store between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.

Shelf life: 24 months

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) | Io-Shield D
  IoShield
  MEPA Barrier D
  BARIOPROTECT
  MS Cow Udder BLOCK
  Iodocop EXTRA |
| --- | --- |
| Authorisation number | EU-0018398-0003 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Polyvinylpyrrolidone iodine | | Active substance | 25655-41-8 | | 1,35 |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,15 |

Trade name(s)

Io-Shield D

IoShield

MEPA Barrier D

BARIOPROTECT

MS Cow Udder BLOCK

Iodocop EXTRA

Authorisation number

EU-0018398-0003 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Polyvinylpyrrolidone iodine

Active substance

25655-41-8

1,35

Iodine

Active substance

7553-56-2

231-442-4

0,15

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

| Trade name(s) | IoDark
  Iodocop EXTRA GREEN
  Mammizan Protect
  MS Cow Udder BLACK |
| --- | --- |
| Authorisation number | EU-0018398-0004 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Polyvinylpyrrolidone iodine | | Active substance | 25655-41-8 | | 1,35 |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,15 |

Trade name(s)

IoDark

Iodocop EXTRA GREEN

Mammizan Protect

MS Cow Udder BLACK

Authorisation number

EU-0018398-0004 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Polyvinylpyrrolidone iodine

Active substance

25655-41-8

1,35

Iodine

Active substance

7553-56-2

231-442-4

0,15

META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier

| Identifier | meta SPC 3 |
| --- | --- |

Identifier

meta SPC 3

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 |
| Polyvinylpyrrolidone iodine | | Active substance | 25655-41-8 | | 2,45 | 2,45 |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,27 | 0,27 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Polyvinylpyrrolidone iodine

Active substance

25655-41-8

2,45

2,45

Iodine

Active substance

7553-56-2

231-442-4

0,27

0,27

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

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

Formulation

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. |

Hazard statements

Harmful to aquatic life with long lasting effects.

Precautionary statements

Avoid release to the environment.

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

4.1.   Use description

Table 3. Use # 1 – Teat dips or sprays for post-milking disinfection

| Product Type | PT03 — Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria
  Yeasts
  Enveloped viruses |
| Field(s) of use | Indoor
  Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep) |
| Application method(s) | Dipping or spraying:
  Manual dipping using a dip cup or
  Manual spraying using a trigger sprayer or
  Manual spraying using an electronic sprayer or
  Automated spraying by robot. |
| Application rate(s) and frequency | Post-milking application 1x – 3x per day
  Per milking event 3-10 ml (dipping) to 10-15 ml (spraying) of product are needed (animals with four teats). |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 0,5 l – 1 000 l HDPE container |

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Bacteria

Yeasts

Enveloped viruses

Field(s) of use

Indoor

Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)

Application method(s)

Dipping or spraying:

Manual dipping using a dip cup or

Manual spraying using a trigger sprayer or

Manual spraying using an electronic sprayer or

Automated spraying by robot.

Application rate(s) and frequency

Post-milking application 1x – 3x per day

Per milking event 3-10 ml (dipping) to 10-15 ml (spraying) of product are needed (animals with four teats).

Category(ies) of users

Professional

Pack sizes and packaging material

0,5 l – 1 000 l HDPE container

4.1.1.   Use-specific instructions for use

Product to be applied by dipping or spraying on teats of milk-producing animals post-milking, using manual or automatic equipment. Post-milking: Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.

See also general instructions for use of meta SPC 3.

4.1.2.   Use-specific risk mitigation measures

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

See also general risk mitigation measures of meta SPC 3.

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

See general directions for use of meta SPC 3

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

See general directions for use of meta SPC 3

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

See general directions for use of meta SPC 3

4.2.   Use description

Table 4. Use # 2 – Teat dips or sprays for pre-milking disinfection

| 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
  Pre-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep) |
| Application method(s) | Dipping or spraying:
  Manual dipping using a dip cup or
  Manual spraying using a trigger sprayer or
  Manual spraying using an electronic sprayer. |
| Application rate(s) and frequency | Pre-milking application 1x – 3x per day
  Per milking event 3-10 ml (dipping) to 10-15 ml (spraying) of product are needed (animals with four teats). |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 0,5 l – 1 000 l HDPE container |

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

Pre-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)

Application method(s)

Dipping or spraying:

Manual dipping using a dip cup or

Manual spraying using a trigger sprayer or

Manual spraying using an electronic sprayer.

Application rate(s) and frequency

Pre-milking application 1x – 3x per day

Per milking event 3-10 ml (dipping) to 10-15 ml (spraying) of product are needed (animals with four teats).

Category(ies) of users

Professional

Pack sizes and packaging material

0,5 l – 1 000 l HDPE container

4.2.1.   Use-specific instructions for use

Product to be applied by dipping or spraying on teats of milk-producing animals pre-milking, using manual equipment.

Pre-milking: Clean teats by wiping with cloth before disinfection. Apply product on the whole teats and leave it for 1 min. Then wipe with a single use paper or a towel.

See also general instructions for use of meta SPC3.

4.2.2.   Use-specific risk mitigation measures

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

See also general risk mitigation measures of meta SPC3.

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

See general directions for use of meta SPC 3

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

See general directions for use of meta SPC 3

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

See general directions for use of meta SPC 3

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

5.1.   Instructions for use

See use-specific instructions for each use.

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

The products must be brought to temperatures above 20 °C before use.

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

5.2.   Risk mitigation measures

See use-specific risk mitigation measures for each use.

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

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

Potential Health Effects

Eyes: Health injuries are not known or expected under normal use.

Skin: Health injuries are not known or expected under normal use.

Ingestion: Health injuries are not known or expected under normal use.

Inhalation: Health injuries are not known or expected under normal use.

Chronic Exposure: Health injuries are not known or expected under normal use.

First Aid Measures:

Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.

Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.

Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.

Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.

Environmental emergency measures: Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer If legally allowed.

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.

European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.

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

Store between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.

Shelf life: 24 months

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) | IoKlar Multi
  MEPA Iospray Plus D
  ASTRI-IO
  DESINTEC MH-Iodine S |
| --- | --- |
| Authorisation number | EU-0018398-0005 1-3 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Polyvinylpyrrolidone iodine | | Active substance | 25655-41-8 | | 2,45 |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,27 |

Trade name(s)

IoKlar Multi

MEPA Iospray Plus D

ASTRI-IO

DESINTEC MH-Iodine S

Authorisation number

EU-0018398-0005 1-3

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Polyvinylpyrrolidone iodine

Active substance

25655-41-8

2,45

Iodine

Active substance

7553-56-2

231-442-4

0,27

META SPC 4

1.   META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier

| Identifier | meta SPC 4 |
| --- | --- |

Identifier

meta SPC 4

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 |
| Polyvinylpyrrolidone iodine | | Active substance | 25655-41-8 | | 1 | 1 |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,11 | 0,11 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Polyvinylpyrrolidone iodine

Active substance

25655-41-8

1

1

Iodine

Active substance

7553-56-2

231-442-4

0,11

0,11

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

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

Formulation

AL — Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

| Hazard statements | |
| --- | --- |
| Precautionary statements | |

Hazard statements

Precautionary statements

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

4.1.   Use description

Table 5. Use # 1 – Teat dips or sprays for post-milking disinfection

| Product Type | PT03 — Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria
  Yeasts
  Enveloped viruses |
| Field(s) of use | Indoor
  Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep) |
| Application method(s) | Dipping or spraying:
  Manual dipping using a dip cup or
  Manual spraying using a trigger sprayer or
  Manual spraying using an electronic sprayer or
  Automated spraying by robot. |
| Application rate(s) and frequency | Post-milking application 1x - 3x per day.
  Per milking event 3-10 ml (dipping) to 10-15 ml (spraying) of product are needed (animals with four teats). |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 0,5 l – 1 000 l HDPE container |

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Bacteria

Yeasts

Enveloped viruses

Field(s) of use

Indoor

Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)

Application method(s)

Dipping or spraying:

Manual dipping using a dip cup or

Manual spraying using a trigger sprayer or

Manual spraying using an electronic sprayer or

Automated spraying by robot.

Application rate(s) and frequency

Post-milking application 1x - 3x per day.

Per milking event 3-10 ml (dipping) to 10-15 ml (spraying) of product are needed (animals with four teats).

Category(ies) of users

Professional

Pack sizes and packaging material

0,5 l – 1 000 l HDPE container

4.1.1.   Use-specific instructions for use

See general directions for use of meta SPC 4

4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 4

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

See general directions for use of meta SPC 4

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

See general directions for use of meta SPC 4

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

See general directions for use of meta SPC 4

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

5.1.   Instructions for use

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

The products must be brought to temperatures above 20 °C before use.

Product to be applied by dipping or spraying on teats of milk-producing animals post-milking using manual or automatic equipment.

Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.

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

5.2.   Risk mitigation measures

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

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

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

Potential Health Effects

Eyes: Health injuries are not known or expected under normal use.

Skin: Health injuries are not known or expected under normal use.

Ingestion: Health injuries are not known or expected under normal use.

Inhalation: Health injuries are not known or expected under normal use.

Chronic Exposure: Health injuries are not known or expected under normal use.

First Aid Measures:

Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.

Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.

Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.

Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.

Environmental emergency measures: Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer If legally allowed.

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 municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.

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

Store between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.

Shelf life: 24 months

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) | Veloucid Spray D
  VelouCid Spray
  MEPA Soft Spray D
  ASTRI-UC
  SAC WINTERSPRAY |
| --- | --- |
| Authorisation number | EU-0018398-0006 1-4 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Polyvinylpyrrolidone iodine | | Active substance | 25655-41-8 | | 1 |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,11 |

Trade name(s)

Veloucid Spray D

VelouCid Spray

MEPA Soft Spray D

ASTRI-UC

SAC WINTERSPRAY

Authorisation number

EU-0018398-0006 1-4

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Polyvinylpyrrolidone iodine

Active substance

25655-41-8

1

Iodine

Active substance

7553-56-2

231-442-4

0,11

META SPC 5

1.   META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 5 identifier

| Identifier | meta SPC 5 |
| --- | --- |

Identifier

meta SPC 5

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 |
| Polyvinylpyrrolidone iodine | | Active substance | 25655-41-8 | | 1 | 1 |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,11 | 0,11 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Polyvinylpyrrolidone iodine

Active substance

25655-41-8

1

1

Iodine

Active substance

7553-56-2

231-442-4

0,11

0,11

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

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

Formulation

AL — Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

| Hazard statements | |
| --- | --- |
| Precautionary statements | |

Hazard statements

Precautionary statements

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

4.1.   Use description

Table 6. Use # 1 – Teat dips for post-milking disinfection

| Product Type | PT03 — Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria
  Yeasts
  Enveloped viruses |
| Field(s) of use | Indoor
  Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep) |
| Application method(s) | Dipping
  Manual dipping using a dip cup. |
| Application rate(s) and frequency | Post-milking application 1x – 3x per day
  Per milking event 3-10 ml of product are needed (animals with four teats). |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 0,5 l – 1 000 l HDPE container |

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Bacteria

Yeasts

Enveloped viruses

Field(s) of use

Indoor

Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)

Application method(s)

Dipping

Manual dipping using a dip cup.

Application rate(s) and frequency

Post-milking application 1x – 3x per day

Per milking event 3-10 ml of product are needed (animals with four teats).

Category(ies) of users

Professional

Pack sizes and packaging material

0,5 l – 1 000 l HDPE container

4.1.1.   Use-specific instructions for use

See general directions for use of meta SPC 5

4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 5

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

See general directions for use of meta SPC 5

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

See general directions for use of meta SPC 5

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

See general directions for use of meta SPC 5

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

5.1.   Instructions for use

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

The products must be brought to temperatures above 20 °C before use.

Product to be applied post-milking by use of a dipping cup.

Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.

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

5.2.   Risk mitigation measures

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

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

Potential Health Effects

Eyes: Health injuries are not known or expected under normal use.

Skin: Health injuries are not known or expected under normal use.

Ingestion: Health injuries are not known or expected under normal use.

Inhalation: Health injuries are not known or expected under normal use.

Chronic Exposure: Health injuries are not known or expected under normal use.

First Aid Measures:

Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.

Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.

Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.

Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.

Environmental emergency measures: Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer If legally allowed.

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.

European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.

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

Store between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.

Shelf life: 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) | Veloucid D
  VelouCid
  MEPA Care D
  Cremadip
  MS Cow Udder SEPIA |
| --- | --- |
| Authorisation number | EU-0018398-0007 1-5 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Polyvinylpyrrolidone iodine | | Active substance | 25655-41-8 | | 1 |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,11 |

Trade name(s)

Veloucid D

VelouCid

MEPA Care D

Cremadip

MS Cow Udder SEPIA

Authorisation number

EU-0018398-0007 1-5

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Polyvinylpyrrolidone iodine

Active substance

25655-41-8

1

Iodine

Active substance

7553-56-2

231-442-4

0,11

META SPC 6

1.   META SPC 6 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 6 identifier

| Identifier | meta SPC 6 |
| --- | --- |

Identifier

meta SPC 6

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 |
| Polyvinylpyrrolidone iodine | | Active substance | 25655-41-8 | | 1,35 | 1,35 |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,15 | 0,15 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Polyvinylpyrrolidone iodine

Active substance

25655-41-8

1,35

1,35

Iodine

Active substance

7553-56-2

231-442-4

0,15

0,15

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

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

Formulation

AL — Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6

| Hazard statements | |
| --- | --- |
| Precautionary statements | |

Hazard statements

Precautionary statements

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

4.1.   Use description

Table 7. Use # 1 – Teat dips or sprays for post-milking disinfection

| Product Type | PT03 — Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria
  Yeasts
  Enveloped viruses |
| Field(s) of use | Indoor
  Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep) |
| Application method(s) | Dipping or spraying:
  Manual dipping using a dip cup or
  Manual spraying using a trigger sprayer or
  Manual spraying using an electronic sprayer or
  Automated spraying by robot. |
| Application rate(s) and frequency | Post-milking application 1x – 3x per day
  Per milking event 3-10 ml (dipping) to 10-15 ml (spraying) of product are needed (animals with four teats). |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 0,5 l – 1 000 l HDPE container |

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

—

Target organism(s) (including development stage)

Bacteria

Yeasts

Enveloped viruses

Field(s) of use

Indoor

Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)

Application method(s)

Dipping or spraying:

Manual dipping using a dip cup or

Manual spraying using a trigger sprayer or

Manual spraying using an electronic sprayer or

Automated spraying by robot.

Application rate(s) and frequency

Post-milking application 1x – 3x per day

Per milking event 3-10 ml (dipping) to 10-15 ml (spraying) of product are needed (animals with four teats).

Category(ies) of users

Professional

Pack sizes and packaging material

0,5 l – 1 000 l HDPE container

4.1.1.   Use-specific instructions for use

See general directions for use of meta SPC 6

4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 6

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

See general directions for use of meta SPC 6

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

See general directions for use of meta SPC 6

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

See general directions for use of meta SPC 6

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

5.1.   Instructions for use

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

The products must be brought to temperatures above 20 °C before use.

Product to be applied by dipping or spraying post-milking using manual or automatic equipment.

Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.

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

5.2.   Risk mitigation measures

Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) for spraying application

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

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

Potential Health Effects

Eyes: Health injuries are not known or expected under normal use.

Skin: Health injuries are not known or expected under normal use.

Ingestion: Health injuries are not known or expected under normal use.

Inhalation: Health injuries are not known or expected under normal use.

Chronic Exposure: Health injuries are not known or expected under normal use.

First Aid Measures:

Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.

Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.

Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.

Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.

Environmental emergency measures: Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer If legally allowed.

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 municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.

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

Store between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.

Shelf life: 24 months

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) | MEPA Barrier Spray D
  IoShield Spray
  QUARESS-Barrier |
| --- | --- |
| Authorisation number | EU-0018398-0008 1-6 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Polyvinylpyrrolidone iodine | | Active substance | 25655-41-8 | | 1,35 |
| Iodine | | Active substance | 7553-56-2 | 231-442-4 | 0,15 |

Trade name(s)

MEPA Barrier Spray D

IoShield Spray

QUARESS-Barrier

Authorisation number

EU-0018398-0008 1-6

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Polyvinylpyrrolidone iodine

Active substance

25655-41-8

1,35

Iodine

Active substance

7553-56-2

231-442-4

0,15

---

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

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

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

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

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

(6)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC6.

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