LegalizeCommission Implementing Regulation (EU) 2026/473 of 14 October 2025 amending Implementing Regulation (EU) 2020/1187 granting a Union authorisation for the biocidal product family Iodine based products – CID LINES NV
This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.
| Image omitted; see official source | Official Journal of the European Union | EN L series |
| --- | --- | --- |
| 2026/473 | 27.2.2026 |
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 [^ntr1-L_202600473EN.000101-E0001], and in particular Article 48(1), point (a), thereof,
Whereas:
- (1) On 7 August 2020, a Union authorisation was granted to CID Lines NV for the making available on the market and use of the biocidal product family ‘Iodine based products – CID LINES NV’ (‘biocidal product family’) by Commission Implementing Regulation (EU) 2020/1187 [^ntr2-L_202600473EN.000101-E0002] for use of the products in product-types 3 and 4 as specified in the summary of product characteristics (‘SPC’) in the Annex to that Regulation.
- (2) The biocidal product family contains the active substances iodine and polyvinylpyrrolidone iodine. Both active substances were approved, among others, for product-types 3 and 4 by Commission Implementing Regulation (EU) No 94/2014 [^ntr3-L_202600473EN.000101-E0003] which provided the expiry date of approval of 31 August 2025.
- (3) For iodine and polyvinylpyrrolidone iodine, for product-type 4, no applications for renewal were submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 by the deadline. Therefore, the approval of both active substances for use in products for product-type 4 will expire on 31 August 2025.
- (4) Consequently, for the uses of the biocidal product family belonging to product-type 4 the condition for authorisation of Article 19(1), point (a), of Regulation (EU) No 528/2012 requiring that the active substances are included in Annex I or approved for the relevant product-type and any conditions specified for those active substances are met, will not be fulfilled as of 1 September 2025.
- (5) All the indications of product-type 4, including the related uses and the related information should therefore be removed from the SPC in initial meta SPCs 7 and 8, and the initial meta SPC 9 should be removed completely. The Union authorisation should be amended accordingly.
- (6) On 2 April 2025, the Commission informed CID Lines NV of its intention to amend the Union authorisation for the biocidal product family and gave it the opportunity to submit comments or additional information in accordance with Article 48(2) of Regulation (EU) No 528/2012. On 16 April 2025, CID Lines NV responded that it takes note of the information and does not have comments.
- (7) It is therefore appropriate to grant a period of grace for the making available on the market and the use of the existing stocks in accordance with Article 52 of Regulation (EU) No 528/2012.
- (8) In order to enhance clarity and ease the access of users and interested parties to the final version of the SPC which is to be published in the register of biocidal products, the Annex to Implementing Regulation (EU) 2020/1187 should be replaced in its entirety.
- (9) Implementing Regulation (EU) 2020/1187 should therefore be amended accordingly,
HAS ADOPTED THIS REGULATION:
Article 1
The Annex to Implementing Regulation (EU) 2020/1187 is replaced by the text set out in the Annex to this Regulation.
Article 2
Biocidal products of the biocidal product family ‘Iodine based products – CID LINES NV’ may be made available on the market for uses belonging to product-type 4 until 27 February 2026 and such biocidal products may be used until 26 August 2026.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 September 2025.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 October 2025.
For the Commission
The President
Ursula VON DER LEYEN
[^ntr1-L_202600473EN.000101-E0001]: OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.
[^ntr2-L_202600473EN.000101-E0002]: Commission Implementing Regulation (EU) 2020/1187 of 7 August 2020 granting a Union authorisation for the biocidal product family ‘Iodine based products – CID LINES NV’ (OJ L 268, 14.8.2020, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2020/1187/oj).
[^ntr3-L_202600473EN.000101-E0003]: Commission Implementing Regulation (EU) No 94/2014 of 31 January 2014 approving iodine, including polyvinylpyrrolidone iodine, as an existing active substance for use in biocidal products for product-types 1, 3, 4 and 22 (OJ L 32, 1.2.2014, p. 23, ELI: http://data.europa.eu/eli/reg_impl/2014/94/oj).
ANNEX
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
Iodine based products – CID LINES NV
Product type(s)
PT03: Veterinary hygiene
Authorisation number: EU-0022265-0000
R4BP asset number: EU-0022265-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
1.1. Family name
| Name | Iodine based products – CID LINES NV |
1.2. Product type(s)
| Product type(s) | PT03: Veterinary hygiene |
1.3. Authorisation holder
| Name and address of the authorisation holder | Name | CID LINES NV |
| Name and address of the authorisation holder | Address | Waterpoortstraat 2 8900 Ieper Belgium |
| Authorisation number | EU-0022265-0000 | |
| R4BP asset number | EU-0022265-0000 | |
| Date of the authorisation | 3 September 2020 | |
| Expiry date of the authorisation | 31 August 2030 |
1.4. Manufacturer(s) of the product
| Name of manufacturer | CID LINES NV |
| Address of manufacturer | Waterpoortstraat 2 8900 Ieper Belgium |
| Location of manufacturing sites | CID LINES NV site 1 Waterpoortstraat 2 8900 Ieper Belgium |
1.5. Manufacturer(s) of the active substance(s)
| Active substance | Iodine |
| Name of manufacturer | SQM S.A. |
| Address of manufacturer | Los Militares, Piso 4 4290 Santiago Chile |
| Location of manufacturing sites | SQM S.A. site 1 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 | Cosayach Nitratos S.A. site 1 Cala Cala 00 Pozo Almonte Chile |
| --- | --- |
| Active substance | Iodine |
| Name of manufacturer | ACF Minera S.A. |
| Address of manufacturer | San Martin No 499 00 Iquique Chile |
| Location of manufacturing sites | ACF Minera S.A. site 1 Lagunas mine 00 Pozo Almonte Chile |
| --- | --- |
| Active substance | Iodine |
| Name of manufacturer | ISE Chemicals Corporation |
| Address of manufacturer | 3-1, Kyobashi 1-Chome 104-0031 Tokyo Japan |
| Location of manufacturing sites | ISE Chemicals Corporation site 1 3695 Kitaimaizumi 299-3201 Oamishirasato city Japan |
| --- | --- |
| Active substance | Polyvinylpyrrolidone iodine |
| Name of manufacturer | ISP Chemicals LLC, Afiliate of Ashland Inc |
| Address of manufacturer | 455 N. main st (HWY 95) KY 42029 Calvert City United States (the) |
| Location of manufacturing sites | ISP Chemicals LLC, Afiliate of Ashland Inc site 1 455 N. main st (HWY 95) KY 42029 Calvert City United States (the) |
| --- | --- |
| Active substance | Polyvinylpyrrolidone iodine |
| Name of manufacturer | Pantheon FZE (DMCC branch) |
| Address of manufacturer | 403, Reef Tower, Jumeira Lake Tower Shaikh Zayed Road 00 Dubai United Arab Emirates (the) |
| Location of manufacturing sites | Pantheon FZE (DMCC branch) site 1 Cala Cala 00 Pozo Almonte Chile |
2. PRODUCT FAMILY COMPOSITION AND FORMULATION
2.1. Qualitative and quantitative information on the composition of the family
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
|---|---|---|---|---|---|
| Iodine | Active substance | 7553-56-2 | 231-442-4 | 0 -3 % (w/w) | |
| Polyvinylpyrrolidone iodine | Active substance | 25655-41-8 | 0 -10 % (w/w) | ||
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated láite | Non-active substance | 68131-39-5 | 500-195-7 | 0 -21 % (w/w) |
| Phosphoric acid | Phosphoric acid | Non-active substance | 7664-38-2 | 231-633-2 | 0 -30 % (w/w) |
| Alcohol C9-11 +6 EO | Alcohol C9-11 +6 EO | Non-active substance | 68439-46-3 | 0 -12,5 % (w/w) |
2.2. Type(s) of formulation
| Formulation type(s) | AL Any other liquid SL Soluble concentrate |
PART II
SECOND INFORMATION LEVEL META SPC(S)
1. META SPC 1 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 1 identifier
| Identifier | Meta SPC: metaSPC 1: PT3 – Concentrated teat disinfectants Iodine |
1.2. Suffix to the authorisation number
| Number | 1-1 |
1.3. Product type(s)
| Product type(s) | PT03: Veterinary hygiene |
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 (%) |
|---|---|---|---|---|---|
| Iodine | Active substance | 7553-56-2 | 231-442-4 | 1,5 -1,5 % (w/w) | |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active substance | 68131-39-5 | 500-195-7 | 12,05 -12,05 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 1
| Formulation type(s) | SL Soluble concentrate |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
| Hazard statements | H318: Causes serious eye damage. H412: Harmful to aquatic life with long lasting effects. H373: May cause damage to organs (thyroid) through prolonged or repeated exposure (oral). |
| Precautionary statements | P280: Wear eye protection. P280: Wear protective clothing. P280: Wear protective gloves. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a doctor, a poison center. P273: Avoid release to the environment. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
PT3 – Concentrated Teat disinfectant, post-milking, Iodine
| Product type | PT03: Veterinary hygiene |
| Where relevant, an exact description of the authorised use | – |
| Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data |
| Field(s) of use | Indoor use Post-milking teat disinfection of milk producing animals |
| Application method(s) | Method: Manual or automatic spraying on teats Detailed description: – |
| Application rate(s) and frequency | Application Rate: Dilute the product to a final concentration of 0,3% (w/w) available iodine. Number and timing of application: Apply 2 times per day with manual sprayer and 3 times per day with a robot. |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000 l HDPE (High Density Polyethylene) |
4.1.1. Use-specific instructions for use
See general directions for use.
4.1.2. Use-specific risk mitigation measures
See general directions for use.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1
5.1. Instructions for use
The product must be diluted before use with clean potable water to allow a final concentration of iodine of 0,3 % (200 ml product, add water up to 1 l).
The diluted product must be brought to a temperature above 20 °C before use.
Assume 5 ml diluted product per cow per treatment. The use of a dosing pump for filling the product into the application equipment is recommended. Use gloves and eye protection during the dilution step. The diluted product can be kept and used during 1 week but do not prepare more fluid than necessary.
Apply the diluted product on the teats with a manual sprayer or with an automatic sprayer.
The product should be used directly after milking 2 times per day by using a manual sprayer and 3 times per day when using a robot (automatic sprayer).
Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).
Do not mix with other chemicals.
5.2. Risk mitigation measures
- — For mixing and loading of the product: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) and eye/face protection.
- — For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).
- — If a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.
- — Keep out of reach of children.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
After eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Obtain emergency medical attention if pain, blinking, tears or redness persist.
If medical advice is needed, have product container or label at hand.
After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice.
Have product container or label at hand.
5.4. Instructions for safe disposal of the product and its packaging
At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
Protect from frost. Do not expose to temperatures > 40 °C.
The shelf-life of the products is 2 years.
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Kenodin SD 400 | Kenodin SD 400 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | IodoSD 400 | IodoSD 400 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Velvet Concentrate | Velvet Concentrate | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Wynnsan Iodine 3 - 1 conc | Wynnsan Iodine 3 - 1 conc | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodin Teat Spray 400 | Iodin Teat Spray 400 | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0022265-0001 1-1 | EU-0022265-0001 1-1 | EU-0022265-0001 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Iodine | Active substance | Active substance | 7553-56-2 | 7553-56-2 | 231-442-4 | 1,5 % (w/w) | |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active substance | Non-active substance | 68131-39-5 | 68131-39-5 | 500-195-7 | 12,05 % (w/w) |
1. META SPC 2 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 2 identifier
| Identifier | Meta SPC: metaSPC 2: PT3 – Ready to Use (RTU) Teat disinfectants Iodine |
1.2. Suffix to the authorisation number
| Number | 1-2 |
1.3. Product type(s)
| Product type(s) | PT03: Veterinary hygiene |
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 (%) |
|---|---|---|---|---|---|
| Iodine | Active substance | 7553-56-2 | 231-442-4 | 0,3 -0,3 % (w/w) | |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active substance | 68131-39-5 | 500-195-7 | 2,1 -2,9 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 2
| Formulation type(s) | AL Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
| Hazard statements | H412: Harmful to aquatic life with long lasting effects. |
| Precautionary statements | P273: Avoid release to the environment. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
PT3– RTU Teat disinfectant, post-milking, Iodine
| Product type | PT03: Veterinary hygiene |
| Where relevant, an exact description of the authorised use | – |
| Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data |
| Field(s) of use | Indoor use Post-milking teat disinfection of milk producing animals |
| Application method(s) | Method: By dipping or spraying on teats Detailed description: – |
| Application rate(s) and frequency | Application Rate: The product is ready to use. Number and timing of application: Apply 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000 l HDPE |
4.1.1. Use-specific instructions for use
See general directions for use.
4.1.2. Use-specific risk mitigation measures
See general directions for use.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2
5.1. Instructions for use
The product must be brought to a temperature above 20 °C before use.
Apply the product by dipping or by spraying:
- — By dipping: Apply the product with a dip cup. Wash the dip cup with water after use.
- — By spraying: Apply the product with a manual sprayer or with an automatic sprayer.
Do not prepare more fluid than necessary; assume 5 ml solution per cow per treatment. The use of a dosing pump for filling the product into the application equipment is recommended.
The product should be used immediately after each milking: 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot. Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).
Do not mix with other chemicals.
5.2. Risk mitigation measures
- — For manual dipping application: No special protection equipment is recommended under normal conditions of use.
- — For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information.
- — If a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.
- — Keep out of reach of children.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
After eye contact: Rinse immediately with water.
After ingestion: Rinse mouth. Spit.
5.4. Instructions for safe disposal of the product and its packaging
At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.
Protect from frost. Do not expose to temperatures > 40 °C.
The shelf-life of the products is 2 years.
6. OTHER INFORMATION
/
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | IodoDip 3000 | IodoDip 3000 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Bio Tec Jodip 3000 | Bio Tec Jodip 3000 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Recoïode | Recoïode | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Stalosan Io Dip | Stalosan Io Dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Stalosan Super Dip | Stalosan Super Dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Velvet High Visco | Velvet High Visco | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Bühning Joddip 3000 | Bühning Joddip 3000 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Kenodin | Kenodin | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Wynnsan trikill RTU | Wynnsan trikill RTU | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Wynnsan Iodine RTU teat dip | Wynnsan Iodine RTU teat dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Wynnsan Iodine dip RTU | Wynnsan Iodine dip RTU | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iocid | Iocid | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodip+ | Iodip+ | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Wynngold Iodine Dip | Wynngold Iodine Dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Pezerk iv plus | Pezerk iv plus | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iod protect 3000 Film | Iod protect 3000 Film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Seivit® Iode 3000 | Seivit® Iode 3000 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Kenostart | Kenostart | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | GAHERYOD | GAHERYOD | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Kenodin 3000 | Kenodin 3000 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodin Teat Dip 3000 | Iodin Teat Dip 3000 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iod 3000 dip | Iod 3000 dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodoschutz dip | Iodoschutz dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Ioschutz dip | Ioschutz dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodocoop dip | Iodocoop dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodotech dip | Iodotech dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodactiv’ dip | Iodactiv’ dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iododip | Iododip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | MIROX Dip Jod | MIROX Dip Jod | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HCP Iodine Dip | HCP Iodine Dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Agib Jodium Dip | Agib Jodium Dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Jod 3000 | Jod 3000 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iod dip | Iod dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iode 3000 | Iode 3000 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodoschutz | Iodoschutz | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Coopjod | Coopjod | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Coopiode | Coopiode | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Coopiode épais | Coopiode épais | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Semex jod | Semex jod | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodotech | Iodotech | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iododip green | Iododip green | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodip bio | Iodip bio | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iododip bio | Iododip bio | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodactive épais | Iodactive épais | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodactiv | Iodactiv | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodoactiv’ | Iodoactiv’ | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Bayley’s Premier Iodine Teat Dip | Bayley’s Premier Iodine Teat Dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Pearce Premier Iodine Teat Dip | Pearce Premier Iodine Teat Dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Diamond 1:3 Concentrate Iodine Post Dip Spray | Diamond 1:3 Concentrate Iodine Post Dip Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | JODOCARE | JODOCARE | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | KENOSTART DYP | KENOSTART DYP | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | STREPTOFIT | STREPTOFIT | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodall Film | Iodall Film | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0022265-0002 1-2 | EU-0022265-0002 1-2 | EU-0022265-0002 1-2 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Iodine | Active substance | Active substance | 7553-56-2 | 7553-56-2 | 231-442-4 | 0,3 % (w/w) | |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active substance | Non-active substance | 68131-39-5 | 68131-39-5 | 500-195-7 | 2,17 % (w/w) |
7.2. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Kenodin Film | Kenodin Film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | IodoFilm | IodoFilm | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Wynnsan Iofilm teat dip | Wynnsan Iofilm teat dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Kenodin Film Extra | Kenodin Film Extra | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Wynngold Film | Wynngold Film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Wynnsan trikill film teat dip | Wynnsan trikill film teat dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Kenodin Film Soft | Kenodin Film Soft | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iocid Film | Iocid Film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | TOP Film | TOP Film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Seivit® Iode Gel | Seivit® Iode Gel | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | IOD protect 3000 Film | IOD protect 3000 Film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodin Film Teat Dip 3000 | Iodin Film Teat Dip 3000 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodin Barrier Teat Dip 3000 | Iodin Barrier Teat Dip 3000 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodin Film Teat Dip | Iodin Film Teat Dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodin Barrier Teat Dip | Iodin Barrier Teat Dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iod 3000 film | Iod 3000 film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodoschutz film | Iodoschutz film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Ioschutz film | Ioschutz film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodocoop film | Iodocoop film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodotech film | Iodotech film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodactiv’ film | Iodactiv’ film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodofilm | Iodofilm | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HCP Iodine Film | HCP Iodine Film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iod 3000 film | Iod 3000 film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Coopjod film | Coopjod film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Coopiode film | Coopiode film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodocoop film | Iodocoop film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Semex jod film | Semex jod film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodofilm | Iodofilm | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodofilm bio | Iodofilm bio | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iofilm bio | Iofilm bio | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodactive film | Iodactive film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodactiv film | Iodactiv film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodactiv’ film | Iodactiv’ film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | SCUDO 3000 | SCUDO 3000 | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0022265-0003 1-2 | EU-0022265-0003 1-2 | EU-0022265-0003 1-2 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Iodine | Active substance | Active substance | 7553-56-2 | 7553-56-2 | 231-442-4 | 0,3 % (w/w) | |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active substance | Non-active substance | 68131-39-5 | 68131-39-5 | 500-195-7 | 2,9 % (w/w) |
1. META SPC 3 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 3 identifier
| Identifier | Meta SPC: metaSPC 3: PT3 – RTU Udder disinfectant Iodine |
1.2. Suffix to the authorisation number
| Number | 1-3 |
1.3. Product type(s)
| Product type(s) | PT03: Veterinary hygiene |
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 (%) |
|---|---|---|---|---|---|
| Iodine | Active substance | 7553-56-2 | 231-442-4 | 0,3 -0,99 % (w/w) | |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active substance | 68131-39-5 | 500-195-7 | 2,17 -2,95 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 3
| Formulation type(s) | AL Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
| Hazard statements | H412: Harmful to aquatic life with long lasting effects. |
| Precautionary statements | P273: Avoid release to the environment. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
PT3 – RTU Udder disinfectants, Iodine
| Product type | PT03: Veterinary hygiene |
| Where relevant, an exact description of the authorised use | – |
| Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data |
| Field(s) of use | Indoor use Skin disinfection only for use on intact skin of: — the udder of dairy and beef cattle before calving — the udder of sows before farrowing |
| Application method(s) | Method: spraying Detailed description: – |
| Application rate(s) and frequency | Application Rate: The product is ready to use. Number and timing of application: Apply to: — the udder of dairy and beef cattle: 1 spray on each teat (equivalent to 4,8 ml per application) — the udder of sows: 15 to 20 ml per animal |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000 l HDPE |
4.1.1. Use-specific instructions for use
See general directions for use.
4.1.2. Use-specific risk mitigation measures
See general directions for use.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 3
5.1. Instructions for use
For disinfection of the skin:
The product must be brought to a temperature above 20 °C before use. The use of a dosing pump for filling the product into the application equipment is recommended.
Apply by spraying on the animals’ intact skin for a topical disinfection:
- — on the udder of dairy and beef cattle before calving: 1 spray on each teat (equivalent to 4,8 ml per application). Disinfection takes place once, one day before calving and once, one day after calving. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing at least 5 minutes);
- — on the udder of sows before farrowing: Assume 15 to 20 ml per animal, once one day before farrowing and once every day during 4 days after farrowing. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).
Only for use on intact skin.
Do not mix with other chemicals.
5.2. Risk mitigation measures
For manual spraying application on cows and sows: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).
In case a combination of post-milking disinfection of cows and skin disinfection of cows is necessary, an iodine based product shall not be used by the same person to perform both disinfections.
Keep out of reach of children.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
After eye contact: Rinse immediately with water.
After ingestion: Rinse mouth. Spit
5.4. Instructions for safe disposal of the product and its packaging
At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.
Protect from frost. Do not expose to temperatures > 40 °C.
The shelf-life of the products is 2 years.
6. OTHER INFORMATION
/
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Animal Skin Disinfectant | Animal Skin Disinfectant | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Dermades 3000 | Dermades 3000 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodin Skin Disinfectant | Iodin Skin Disinfectant | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0022265-0004 1-3 | EU-0022265-0004 1-3 | EU-0022265-0004 1-3 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Iodine | Active substance | Active substance | 7553-56-2 | 7553-56-2 | 231-442-4 | 0,3 % (w/w) | |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active substance | Non-active substance | 68131-39-5 | 68131-39-5 | 500-195-7 | 2,17 % (w/w) |
7.2. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Dermades | Dermades | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Animal skin disinfectant 1 % | Animal skin disinfectant 1 % | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Dermades Strong | Dermades Strong | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodin Skin Disinfectant Strong | Iodin Skin Disinfectant Strong | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0022265-0005 1-3 | EU-0022265-0005 1-3 | EU-0022265-0005 1-3 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Iodine | Active substance | Active substance | 7553-56-2 | 7553-56-2 | 231-442-4 | 0,99 % (w/w) | |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active substance | Non-active substance | 68131-39-5 | 68131-39-5 | 500-195-7 | 2,95 % (w/w) |
1. META SPC 4 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 4 identifier
| Identifier | Meta SPC: metaSPC 4: PT3 – RTU Udder and Teat disinfectants Iodine |
1.2. Suffix to the authorisation number
| Number | 1-4 |
1.3. Product type(s)
| Product type(s) | PT03: Veterinary hygiene |
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 (%) |
|---|---|---|---|---|---|
| Iodine | Active substance | 7553-56-2 | 231-442-4 | 0,3 -0,3 % (w/w) | |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active substance | 68131-39-5 | 500-195-7 | 2,17 -2,17 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 4
| Formulation type(s) | AL Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
| Hazard statements | H412: Harmful to aquatic life with long lasting effects. |
| Precautionary statements | P273: Avoid release to the environment. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
PT3 – RTU Teat disinfectant, Post-milking, Iodine
| Product type | PT03: Veterinary hygiene |
| Where relevant, an exact description of the authorised use | – |
| Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data |
| Field(s) of use | Indoor use Ready to use teat disinfectant to be used post milking on milk producing animals. |
| Application method(s) | Method: Dipping or Spraying Detailed description: – |
| Application rate(s) and frequency | Application Rate: The product is ready to use. Number and timing of application: Apply 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot. |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000 l HDPE |
4.1.1. Use-specific instructions for use
For disinfection of the teats:
The product must be brought to a temperature above 20 °C before use.
- — By dipping: Apply the product on the teats with a dip cup. Wash the dip cup with water after use.
- — By spraying: Apply the product on the teats with a manual sprayer or with an automatic sprayer.
Do not prepare more fluid than necessary. Assume 5 ml solution per cow per treatment. The use of a dosing pump for filling the product into the application equipment is recommended.
The product should be used directly after milking by using a dipping cup or a manual or automatic sprayer. Ensure that the teat is completely covered to three quarters of its length.
The product is applied after milking: 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot.
Let the product dry on the teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).
Do not mix with other chemicals.
4.1.2. Use-specific risk mitigation measures
- — For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).
- — For manual dipping application: no Personal Protection Equipment (PPE) is necessary for safe use.
- — If a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.
- — Keep out of reach of children.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.2. Use description
Table 2
PT3 – RTU Udder disinfectant, Iodine
| Product type | PT03: Veterinary hygiene |
| Where relevant, an exact description of the authorised use | – |
| Target organism(s) (including development stage) | Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Bacteria Development stage: no data |
| Field(s) of use | Indoor use Ready to use skin disinfectant, only for use on intact skin of: — the udder of dairy and beef cattle before calving — the udder of sows before farrowing |
| Application method(s) | Method: Application on animal skin: by spraying Detailed description: – |
| Application rate(s) and frequency | Application Rate: The product is ready to use. Number and timing of application: Apply to: — the udder of dairy and beef cattle: 1 spray on each teat (equivalent to 4,8 ml per application) — the udder of sows: 15 to 20 ml per animal |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000 l HDPE |
4.2.1. Use-specific instructions for use
For disinfection of the skin:
The product must be brought to a temperature above 20 °C before use. The use of a dosing pump for filling the product into the application equipment is recommended.
Apply by spraying on the animals’ intact skin for a topical disinfection:
- — on the udder of dairy and beef cattle before calving: 1 spray on each teat (equivalent to 4,8 ml per application). Disinfection takes place once, one day before calving and once, one day after calving. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes);
- — on the udder of sows before farrowing: Assume 15 to 20 ml per animal, once one day before farrowing and once every day during 4 days after farrowing. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).
Let the product dry on skin.
Only for use on intact skin.
Do not mix with other chemicals.
4.2.2. Use-specific risk mitigation measures
- — For manual spraying application on cows and sows: no PPE is necessary for safe use.
- — Keep out of reach of children.
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 4
5.1. Instructions for use
See use-specific instructions for use.
5.2. Risk mitigation measures
See use-specific risk mitigation measures
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
After eye contact: Rinse immediately with water.
After ingestion: Rinse mouth. Spit.
5.4. Instructions for safe disposal of the product and its packaging
At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
Protect from frost. Do not expose to temperatures > 40 °C.
The shelf-life of the products is 2 years.
6. OTHER INFORMATION
/
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Kenodin SD | Kenodin SD | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | IodoSD 3000 | IodoSD 3000 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Bio Tec Jodspray 3000 | Bio Tec Jodspray 3000 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Q Farm Iodine Des | Q Farm Iodine Des | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | ANRO - Euterpflege Dip | ANRO - Euterpflege Dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Stalosan Io Spray | Stalosan Io Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Stalosan Super Spray | Stalosan Super Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | IDip+ | IDip+ | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Bühning Jodspray 3000 | Bühning Jodspray 3000 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Velvet RTU | Velvet RTU | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Wynnsan trikill spray | Wynnsan trikill spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Wynnsan Iodine spray RTU | Wynnsan Iodine spray RTU | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Wynngold Iodine Dip and spray | Wynngold Iodine Dip and spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Pezerk IL | Pezerk IL | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iod protect 3000 Sprüh | Iod protect 3000 Sprüh | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Seivit® Iode Spray | Seivit® Iode Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | IOD protect 3000 Sprüh | IOD protect 3000 Sprüh | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Kenodin SprayFilm | Kenodin SprayFilm | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodo SP | Iodo SP | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Kenostart SD | Kenostart SD | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | GAHERYOD SPRAY | GAHERYOD SPRAY | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodin Teat & Skin 3000 | Iodin Teat & Skin 3000 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iod 3000 sprüh | Iod 3000 sprüh | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodoschutz sprüh | Iodoschutz sprüh | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Ioschutz sprüh | Ioschutz sprüh | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodocoop sprüh | Iodocoop sprüh | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodotech sprüh | Iodotech sprüh | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodactiv’ sprüh | Iodactiv’ sprüh | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodosprüh | Iodosprüh | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | MIROX Spray Jod | MIROX Spray Jod | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HCP Iodine SD | HCP Iodine SD | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Agib Jodium Spray | Agib Jodium Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Jod 3000 spray | Jod 3000 spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iod sprüh | Iod sprüh | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Coopjod | Coopjod | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Coopiode spray | Coopiode spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodocoop spray | Iodocoop spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Semex jod spray | Semex jod spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iododip spray | Iododip spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iododip spray green | Iododip spray green | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodospray Bio | Iodospray Bio | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iospray bio | Iospray bio | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodactive spray | Iodactive spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodactiv spray | Iodactiv spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodactiv’ spray | Iodactiv’ spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Ark Iodine S+D | Ark Iodine S+D | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Agrihealth Iodine SD | Agrihealth Iodine SD | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | AGRO LOGIC JODOCARE SPRAY | AGRO LOGIC JODOCARE SPRAY | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | IODACTIVE | IODACTIVE | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0022265-0006 1-4 | EU-0022265-0006 1-4 | EU-0022265-0006 1-4 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Iodine | Active substance | Active substance | 7553-56-2 | 7553-56-2 | 231-442-4 | 0,3 % (w/w) | |
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active substance | Non-active substance | 68131-39-5 | 68131-39-5 | 500-195-7 | 2,17 % (w/w) |
1. META SPC 5 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 5 identifier
| Identifier | Meta SPC: metaSPC 5: PT3 – RTU Teat disinfectants PVP-Iodine |
1.2. Suffix to the authorisation number
| Number | 1-5 |
1.3. Product type(s)
| Product type(s) | PT03: Veterinary hygiene |
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 (%) |
|---|---|---|---|---|---|
| Polyvinylpyrrolidone iodine | Active substance | 25655-41-8 | 3 -3 % (w/w) | ||
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active substance | 68131-39-5 | 500-195-7 | 1,5 -2,9 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 5
| Formulation type(s) | AL Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
| Hazard statements | H412: Harmful to aquatic life with long lasting effects. |
| Precautionary statements | P273: Avoid release to the environment. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
PT3 – RTU Teat disinfectant, post milking, PVP-Iodine
| Product type | PT03: Veterinary hygiene |
| Where relevant, an exact description of the authorised use | – |
| Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data |
| Field(s) of use | Indoor use Post-milking disinfection on teats of milk producing animals |
| Application method(s) | Method: Dipping or spraying Detailed description: – |
| Application rate(s) and frequency | Application Rate: The product is ready to use. Number and timing of application: Apply 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot. |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000 l HDPE |
4.1.1. Use-specific instructions for use
See general directions for use.
4.1.2. Use-specific risk mitigation measures
See general directions for use.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 5
5.1. Instructions for use
The product must be brought to a temperature above 20 °C before use. The use of a dosing pump for filling the product into the application equipment is recommended.
Apply the product by dipping or by spraying:
- — By dipping: Apply the product with a dip cup. Wash the dip cup with water after use.
- — By spraying: Apply the product with a manual sprayer or with an automatic sprayer.
Do not prepare more fluid than necessary. Assume 5 ml solution per cow per treatment.
The product should be used immediately after each milking, two times per day for manual spraying and 3 times per day for manual dipping and spraying with robot. Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).
Do not mix with other chemicals.
5.2. Risk mitigation measures
- — For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information.
- — For manual dipping application: no PPE is necessary for safe use.
- — If a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.
- — Keep out of reach of children.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
After eye contact: Rinse immediately with water.
After ingestion: Rinse mouth. Spit.
5.4. Instructions for safe disposal of the product and its packaging
At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.
Protect from frost. Do not expose to temperatures > 40 °C.
The shelf-life of the products is 18 months.
6. OTHER INFORMATION
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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) | Trade name(s) | Trade name(s) | Iodo PVP | Iodo PVP | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodin Teat Dip 3000 PVP | Iodin Teat Dip 3000 PVP | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0022265-0007 1-5 | EU-0022265-0007 1-5 | EU-0022265-0007 1-5 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Polyvinylpyrrolidone iodine | Active substance | Active substance | 25655-41-8 | 25655-41-8 | 3 % (w/w) | ||
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active substance | Non-active substance | 68131-39-5 | 68131-39-5 | 500-195-7 | 2,5 % (w/w) |
7.2. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Iodo SD PVP | Iodo SD PVP | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Iodin Teat Spray & Dip 3000 PVP | Iodin Teat Spray & Dip 3000 PVP | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0022265-0008 1-5 | EU-0022265-0008 1-5 | EU-0022265-0008 1-5 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Polyvinylpyrrolidone iodine | Active substance | Active substance | 25655-41-8 | 25655-41-8 | 3 % (w/w) | ||
| Alcohols, C12-15, ethoxylated | Alcohols, C12-15, ethoxylated | Non-active substance | Non-active substance | 68131-39-5 | 68131-39-5 | 500-195-7 | 2,5 % (w/w) |
1. META SPC 6 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 6 identifier
| Identifier | Meta SPC: metaSPC 6: PT3 – RTU Udder disinfectants PVP-Iodine |
1.2. Suffix to the authorisation number
| Number | 1-6 |
1.3. Product type(s)
| Product type(s) | PT03: Veterinary hygiene |
2. META SPC 6 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 6
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