
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, 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’).

(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 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’).

(4) On 12 January 2018, the Agency submitted to the Commission an opinion, 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.

(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,
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
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
 
 1.2. Product type(s) 


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
 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 KingdomEcolab Leeds, LOTHERTON WAY, GARFORTH, LEEDS LS25 2JY Leeds United KingdomEcolab Rovigo, Viale del Lavoro 10, 45100 Rovigo ItalyEcolab Biebesheim Nalco Deutschland Manufacturing GmbH und Co.KG, Justus-von-Liebig-Str. 11 D-64584 Biebesheim GermanyEcolab NETHERLANDS BV, NL01ECOLAB, BRUGWAL 11 3432NZ NIEUWEGEIN NetherlandsEcolab Weavergate, ECOLAB WEAVERGATE PLANT WINNINGTON AVENUE, NORTHWICH CHESHIRE CW8 3AA NORTHWICH United KingdomEcolab Mullingar, Forest Park, Mullingar Ind. Estate, Mullingar, Co. Zone C Westmeath IrelandEcolab Maribor, Ecolab d.o.o.,Vajngerlova 4 2000 Maribor SloveniaEcolab Rozzano, VIA GRANDI 9/11 20089 ROZZANO ItalyEcolab B.V.B.A, Havenlaan: 4 3980 Tessenderlo BelgiumEcolab CELRA, Nalco Española Manufacturing, SLU C/Tramuntana s/n, Polígono Industrial de Celrà 17460 CELRÀ SpainEcolab Chalons Ecolab production France SAS, BP509 Avenue de Général Patton 51006 Châlons-en-Champagne FranceEcolab Mandra, 25km Old National Road Athens Mandra, oo Attica GreeceNALCO 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 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 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

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
 2.2. Type(s) of formulation 


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
 1.2. Suffix to the authorisation number 


Number 1-1
 1.3. Product type(s) 


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


Formulation AL — Any other liquid
 
 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1 


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 disinfectionProduct Type PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use —
Target organism(s) (including development stage) BacteriaYeastsEnveloped viruses
Field(s) of use IndoorPost-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 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
 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
META SPC 2 
 1. META SPC 2 ADMINISTRATIVE INFORMATION 
 1.1. Meta SPC 2 identifier 


Identifier meta SPC 2
 1.2. Suffix to the authorisation number 


Number 1-2
 1.3. Product type(s) 


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


Formulation AL — Any other liquid
 
 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 


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 disinfectionProduct Type PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use —
Target organism(s) (including development stage) BacteriaYeastsEnveloped viruses
Field(s) of use IndoorPost-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 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 DIoShieldMEPA Barrier DBARIOPROTECTMS Cow Udder BLOCKIodocop 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) IoDarkIodocop EXTRA GREENMammizan ProtectMS 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
 1.2. Suffix to the authorisation number 


Number 1-3
 1.3. Product type(s) 


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


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



Table 3. Use # 1 – Teat dips or sprays for post-milking disinfectionProduct Type PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use —
Target organism(s) (including development stage) BacteriaYeastsEnveloped viruses
Field(s) of use IndoorPost-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)
Application method(s) Dipping or spraying:Manual dipping using a dip cup orManual spraying using a trigger sprayer orManual spraying using an electronic sprayer orAutomated spraying by robot.
Application rate(s) and frequency Post-milking application 1x – 3x per dayPer 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 disinfectionProduct Type PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use —
Target organism(s) (including development stage) BacteriaYeasts
Field(s) of use IndoorPre-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)
Application method(s) Dipping or spraying:Manual dipping using a dip cup orManual spraying using a trigger sprayer orManual spraying using an electronic sprayer.
Application rate(s) and frequency Pre-milking application 1x – 3x per dayPer 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 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 MultiMEPA Iospray Plus DASTRI-IODESINTEC 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
 1.2. Suffix to the authorisation number 


Number 1-4
 1.3. Product type(s) 


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


Formulation AL — Any other liquid
 
 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4 


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 disinfectionProduct Type PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use —
Target organism(s) (including development stage) BacteriaYeastsEnveloped viruses
Field(s) of use IndoorPost-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)
Application method(s) Dipping or spraying:Manual dipping using a dip cup orManual spraying using a trigger sprayer orManual spraying using an electronic sprayer orAutomated 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 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 DVelouCid SprayMEPA Soft Spray DASTRI-UCSAC 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
 1.2. Suffix to the authorisation number 


Number 1-5
 1.3. Product type(s) 


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


Formulation AL — Any other liquid
 
 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5 


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 disinfectionProduct Type PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use —
Target organism(s) (including development stage) BacteriaYeastsEnveloped viruses
Field(s) of use IndoorPost-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)
Application method(s) DippingManual dipping using a dip cup.
Application rate(s) and frequency Post-milking application 1x – 3x per dayPer 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 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 DVelouCidMEPA Care DCremadipMS 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
 1.2. Suffix to the authorisation number 


Number 1-6
 1.3. Product type(s) 


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


Formulation AL — Any other liquid
 
 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6 


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 disinfectionProduct Type PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use —
Target organism(s) (including development stage) BacteriaYeastsEnveloped viruses
Field(s) of use IndoorPost-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)
Application method(s) Dipping or spraying:Manual dipping using a dip cup orManual spraying using a trigger sprayer orManual spraying using an electronic sprayer orAutomated spraying by robot.
Application rate(s) and frequency Post-milking application 1x – 3x per dayPer 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 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 DIoShield SprayQUARESS-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
