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)
Article 1
Article 2
ANNEX
Summary of product characteristics for a biocidal product family
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 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 |
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
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
4.1.2.
Use-specific risk mitigation measures
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
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5. GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
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
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
4.1.2.
Use-specific risk mitigation measures
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
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5. GENERAL DIRECTIONS FOR USE (2) OF THE META SPC 2
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
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 |
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 |
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
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
4.1.2.
Use-specific risk mitigation measures
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
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.2.
Use description
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
4.2.2.
Use-specific risk mitigation measures
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
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5. GENERAL DIRECTIONS FOR USE (3) OF THE META SPC 3
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
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 |
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
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
4.1.2.
Use-specific risk mitigation measures
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
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5. GENERAL DIRECTIONS FOR USE (4) OF THE META SPC 4
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
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 |
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
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
4.1.2.
Use-specific risk mitigation measures
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
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5. GENERAL DIRECTIONS FOR USE (5) OF THE META SPC 5
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
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 |
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
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
4.1.2.
Use-specific risk mitigation measures
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
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5. GENERAL DIRECTIONS FOR USE (6) OF THE META SPC 6
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
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 |