Commission Implementing Regulation (EU) 2021/977 of 7 June 2021 amending Implementing Regulation (EU) 2019/1844 to make administrative changes to the Union authorisation of the biocidal product family ‘BPF_Iodine_VET’ (Text with EEA relevance)
Date: 2021-06-07
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal health, chemical product, dairy cow, decontamination, iodine, market approval








L_2021216EN.01002601.xml










18.6.2021   


EN


Official Journal of the European Union


L 216/26








            COMMISSION IMPLEMENTING REGULATION (EU) 2021/977
of 7 June 2021
         
amending Implementing Regulation (EU) 2019/1844 to make administrative changes to the Union authorisation of the biocidal product family ‘BPF_Iodine_VET’
         
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

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


Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the first subparagraph of Article 44(5) and Article 50(2) thereof,

Whereas:







(1)


On 22 October 2019, Commission Implementing Regulation (EU) 2019/1844 (2) granted a Union authorisation with authorisation number EU-0020540-0000 to Applied Biocide GmbH for the making available on the market and use of the biocidal product family ‘BPF_Iodine_VET’.












(2)


On 10 April 2020, Applied Biocide GmbH submitted a notification to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013 (3), regarding administrative changes to the Union authorisation for the biocidal product family ‘BPF_Iodine_VET’ as referred to in Sections 1 and 2 of Title 1 of the Annex to that Regulation.












(3)


Applied Biocide GmbH proposed the changes in the names of the manufacturers of the biocidal products in the first information level, administrative information, the changes in the names of one product in the third information level in meta-SPC 2 and one product in meta-SPC 6 and the addition of trade names for the individual products in meta SPCs 2 and 5, in the summary of the product characteristics for the biocidal product family ‘BPF_Iodine_VET’ as set out in the Annex to Implementing Regulation (EU) 2019/1844. The notification was recorded under the case number BC-VD058524-35 in the Register for Biocidal Products.












(4)


On 9 June 2020, the Agency submitted an opinion (4) on the proposed changes to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013. The opinion concludes that the amendments to the existing authorisation sought by the authorisation holder fall under Article 50(3)(a) of Regulation (EU) No 528/2012, and that after the implementation of the changes the conditions of Article 19 of that Regulation are still met. On the same date, the Agency transmitted to the Commission the revised summary of the biocidal product characteristics in all the official languages of the Union in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.












(5)


The Commission concurs with the opinion of the Agency and therefore considers it appropriate to amend the Union authorisation of the biocidal product family ‘BPF_Iodine_VET’.












(6)


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
The Annex to Implementing Regulation (EU) 2019/1844 is replaced by the Annex to this Regulation.


Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 7 June 2021.


For the Commission


The President

Ursula VON DER LEYEN
            





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

(2)  Commission Implementing Regulation (EU) 2019/1844 of 22 October 2019 granting a Union authorisation for the biocidal product family BPF_Iodine_VET (OJ L 283, 5.11.2019, p. 1).

(3)  Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4).

(4)  ECHA opinion of 9 June 2020 on the administrative change of the Union authorisation of the biocidal product family ‘BPF_Iodine_VET’, https://echa.europa.eu/documents/10162/22836226/opinion_for_ua-admin_changes_bc-vd058524-35_en.pdf/b95474e7-89d4-a601-8d02-b42d95cecde5




ANNEX

Summary of product characteristics for a biocidal product family

BPF_Iodine_VET
Product type 3 – Veterinary hygiene (Disinfectants)
Authorisation number: EU-0020540-0000
R4BP asset number: EU-0020540-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name







Name


BPF_Iodine_VET




1.2.   Product type(s)







Product type(s)


PT03 – Veterinary hygiene (Disinfectants)




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


Applied Biocide GmbH




Address


Siemensstraße 42, 59199 Bönen, Germany




Authorisation number


EU-0020540-0000





R4BP asset number



EU-0020540-0000




Date of the authorisation


25 November 2019




Expiry date of the authorisation


31 October 2029




1.4.   Manufacturer(s) of the biocidal products







Name of manufacturer


THESEO Deutschland GmbH




Address of manufacturer


Kolpingstrasse 4, 49835 Wietmarschen Germany




Location of manufacturing sites


Kolpingstrasse 4, 49835 Wietmarschen Germany













Name of manufacturer


FINK TEC GmbH




Address of manufacturer


Oberster Kamp 23, 59069 Hamm Germany




Location of manufacturing sites


Oberster Kamp 23, 59069 Hamm Germany













Name of manufacturer


I.R.C.A. SERVICE S.p.A.




Address of manufacturer


S.S. Cremasca 591 no. 10, 24040 Fornovo S. Giovanni (BG) Italy




Location of manufacturing sites


S.S. Cremasca 591 no. 10, 24040 Fornovo S. Giovanni (BG) Italy













Name of manufacturer


Laboratorios Maymó S.A.




Address of manufacturer


Via Augusta, 302, 08017 Barcelona Spain




Location of manufacturing sites


Via Augusta, 302, 08017 Barcelona Spain




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







Active substance


Iodine




Name of manufacturer


Cosayach S.A. Compania de Salitre y Yodo




Address of manufacturer


Amunátegui 178, 7th Floor, 8320000 Santiago Chile




Location of manufacturing sites


S.C.M. Cosayach Cala Cala, 1180000 Pozo Almonte Chile Chile













Active substance


Iodine




Name of manufacturer


ACF Minera S.A.




Address of manufacturer


San Martin 499, 1100000 Iquique Chile




Location of manufacturing sites


Lagunas mine, 1180000 Pozo Almonte Chile













Active substance


Iodine




Name of manufacturer


Sociedad Quimica y Minera SA




Address of manufacturer


Los Militares 4290, 7550000 Las Condes Chile




Location of manufacturing sites


Nueva Victoria, 1180000 Pozo Almonte Chile
Pedro de Valdivia, 1240000 Antofagasta Chile




2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

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












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Iodine


 


Active Substance


7553-56-2


231-442-4


0,1


3,0




Phosphoric Acid


Trihydroxidooxidophosphorus phosphoric acid


Non-active substance


7664-38-2


231-633-2


0,0


10,0




Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched


Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched


Non-active substance


69011-36-5


500-241-6


0,0


31,8




Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate


Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate


Non-active substance


68439-46-3


614-482-0


0,0


31,8




2.2.   Type(s) of formulation







Formulation(s)


meta SPC 1-5: AL – any other liquid
meta SPC 6-8: SL – soluble concentrate




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




Iodine


 


Active Substance


7553-56-2


231-442-4


0,15


0,15




Phosphoric Acid


Trihydroxidooxidophosphorus phosphoric acid


Non-active substance


7664-38-2


231-633-2


0,0


0,0




Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched


Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched


Non-active substance


69011-36-5


500-241-6


0,0


0,0




Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate


Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate


Non-active substance


68439-46-3


614-482-0


0,0


0,0




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







Formulation(s)


AL – any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1







Hazard statements


May be corrosive to metals.




Precautionary statements


Keep only in original packaging.
Absorb spillage to prevent material damage.
Store in corrosive resistant container with a resistant inner liner.




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

4.1.   Use description


Table 1. Use # 1 – Veterinary hygiene – animal husbandry – teat disinfectant – professional – indoors – spraying (post milking)







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




Application method(s)


Open system: spray treatment




 


Spraying: Manual and automated non-medical disinfection of teats with a ready-to-use spray (on cows, post-milking)




Application rate(s) and frequency


Application rate: 10-15 mL per cow




 


Application frequency:
During lactation period:






•


manual: 2 applications per day (post-milking)










•


automated: 3 applications per day (post-milking)




During dry period: 1 application per day




Category(ies) of users


Professional




Pack sizes and packaging material


Bottle high-density polyethylene (HDPE): 1 liter, cap is made of PP
Jerry can HDPE: 5 – 60 liters
Drum HDPE: 200 liters
IBC HDPE: 600 – 1000 liters




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

Always read the label or leaflet before use and follow all the instructions provided.
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.
Immediately after each cow has been milked, spray the entire surface of each teat with the solution. Leave the product until next milking. Do not clean the teats directly after disinfection.
Keep the cows standing until the product has dried (at least 5 minutes).
Product can be applied manually or by means of automatic teat sprayer.
Before the next milking the teats have to be cleaned, preferably with one new wet cloth per cow.
Application frequency must not exceed two applications per cow and day considering manual spraying and must not exceed three applications per cow and day considering automatic teat sprayer (post-milking).
5.2.   Risk mitigation measures

Keep out of reach of children.
Wear protective chemical resistant gloves, coated coverall and boots during product handling and application phase (material to be specified by the authorisation holder in the product information).
In case a combination of pre- and post-milking disinfection is necessary, using another 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

After inhalation: Supply fresh air; consult doctor in case of complaints.
After skin contact: Wash skin thoroughly.
After eye contact: Rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor.
After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately.
When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here].
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 the product at room temperature, away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
Shelf-life: 12 months in HDPE
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)


FINK – Io Spray 15
FINK – Euter-DIP PVP-S
FINK Pattedyp PVP
IOSpray 15 PVP




Authorisation number


EU-0020540-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Iodine


 


Active Substance


7553-56-2


231-442-4


0,15





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




Iodine


 


Active Substance


7553-56-2


231-442-4


0,3


0,5




Phosphoric Acid


Trihydroxidooxidophosphorus phosphoric acid


Non-active substance


7664-38-2


231-633-2


0,0


0,0




Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched


Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched


Non-active substance


69011-36-5


500-241-6


0,0


0,0




Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate


Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate


Non-active substance


68439-46-3


614-482-0


0,0


0,0




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







Formulation(s)


AL – any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2







Hazard statements


May be corrosive to metals.
Harmful to aquatic life with long lasting effects.




Precautionary statements


Keep only in original packaging.
Avoid release to the environment.
Absorb spillage to prevent material damage.
Store in corrosive resistant container with a resistant inner liner.
Dispose of contents to/container in accordance with the local/national regulations.




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

4.1.   Use description


Table 2. Use # 1 – Veterinary hygiene – animal husbandry – teat disinfectant – professional – indoors – spraying (post milking)







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




Application method(s)


Open system: spray treatment
Spraying: Manual and automated non-medical disinfection of teats with a ready-to-use spray (on cows, post-milking)




Application rate(s) and frequency


Application rate: 10-15 mL per cow
Application frequency:
During lactation period:






•


manual: 2 applications per day (post-milking)










•


automated: 3 applications per day (post-milking)




During dry period: 1 application per day




Category(ies) of users


Professional




Pack sizes and packaging material


Bottle HDPE: 1 liter, cap is made of PP
Jerry can HDPE: 5 – 60 liters
Drum HDPE: 200 liters
IBC HDPE: 600 – 1000 liters




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

Always read the label or leaflet before use and follow all the instructions provided.
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.
Immediately after each cow has been milked, spray the entire surface of each teat with the solution. Leave the product until next milking. Do not clean the teats directly after disinfection.
Keep the cows standing until the product has dried (at least 5 minutes).
Product can be applied manually or by means of automatic teat sprayer.
Before the next milking the teats have to be cleaned, preferably with one new wet cloth per cow.
Application frequency must not exceed two applications per cow and day considering manual spraying and must not exceed three applications per cow and day considering automatic teat sprayer (post-milking).
5.2.   Risk mitigation measures

Keep out of reach of children.
Wear protective chemical resistant gloves, coated coverall and boots during product handling and application phase (material to be specified by the authorisation holder in the product information).
In case a combination of pre- and post-milking disinfection is necessary, using another 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

After inhalation: Supply fresh air; consult doctor in case of complaints.
After skin contact: Wash skin thoroughly.
After eye contact: Rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor.
After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately.
When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here].
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 the product at room temperature, away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
Shelf-life: 12 months in HDPE
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)


FINK – Io Spray 30
ST-Io Spray
DESINTEC MH Iodine S
DESINTEC MH Raidip plus
Iodine Spray 3000
Iodine Spray
Io Spray 30
Iodine Spray 30




Authorisation number


EU-0020540-0002 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Iodine


 


Active Substance


7553-56-2


231-442-4


0,3




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











Trade name(s)


Fink – Io Spray 50
DESINTEC MH Raidip 5000
Iodine Spray 5000




Authorisation number


EU-0020540-0003 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Iodine


 


Active Substance


7553-56-2


231-442-4


0,5





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




Iodine


 


Active Substance


7553-56-2


231-442-4


0,5


0,5




Phosphoric Acid


Trihydroxidooxidophosphorus phosphoric acid


Non-active substance


7664-38-2


231-633-2


0,0


0,0




Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched


Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched


Non-active substance


69011-36-5


500-241-6


0,0


0,0




Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate


Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate


Non-active substance


68439-46-3


614-482-0


0,0


0,0




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







Formulation(s)


AL – any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3







Hazard statements


May be corrosive to metals.
Harmful to aquatic life with long lasting effects.




Precautionary statements


Keep only in original packaging.
Avoid release to the environment.
Absorb spillage to prevent material damage.
Store in corrosive resistant container with a resistant inner liner.
Dispose of contents to/container in accordance with the local/national regulations.




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

4.1.   Use description


Table 3. Use # 1 – Veterinary hygiene – animal husbandry – teat disinfectant – professional – indoors – spraying (post milking)







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




Application method(s)


Open system: spray treatment
Spraying: Manual and automated non-medical disinfection of teats with a ready-to-use spray (on cows, post-milking)




Application rate(s) and frequency


Application rate: 10-15 mL per cow
Application frequency:
During lactation period:






•


manual: 2 applications per day (post-milking)










•


automated: 3 applications per day (post-milking)




During dry period: 1 application per day




Category(ies) of users


Professional




Pack sizes and packaging material


Bottle HDPE: 1 liter, cap is made of PP
Jerry can HDPE: 5 – 60 liters
Drum HDPE: 200 liters
IBC HDPE: 600 – 1000 liters




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 (3)
OF THE META SPC 3

5.1.   Instructions for use

Always read the label or leaflet before use and follow all the instructions provided.
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.
Immediately after each cow has been milked, spray the entire surface of each teat with the solution. Leave the product until next milking. Do not clean the teats directly after disinfection.
Keep the cows standing until the product has dried (at least 5 minutes).
Product can be applied manually or by means of automatic teat sprayer.
Before the next milking the teats have to be cleaned, preferably with one new wet cloth per cow.
Application frequency must not exceed two applications per cow and day considering manual spraying and must not exceed three applications per cow and day considering automatic teat sprayer (post-milking).
5.2.   Risk mitigation measures

Keep out of reach of children.
Wear protective chemical resistant gloves, coated coverall and boots during product handling and application phase (material to be specified by the authorisation holder in the product information).
In case a combination of pre- and post-milking disinfection is necessary, using another 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

After inhalation: Supply fresh air; consult doctor in case of complaints.
After skin contact: Wash skin thoroughly.
After eye contact: Rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor.
After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately.
When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here].
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 the product at room temperature, away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
Shelf-life: 12 months in HDPE
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)


Fink – Io Spray 50 (Jodophor)
Fink – Io Spray 50 (Iodophor)




Authorisation number


EU-0020540-0004 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Iodine


 


Active Substance


7553-56-2


231-442-4


0,5





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




Iodine


 


Active Substance


7553-56-2


231-442-4


0,1


0,15




Phosphoric Acid


Trihydroxidooxidophosphorus phosphoric acid


Non-active substance


7664-38-2


231-633-2


0,0


0,0




Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched


Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched


Non-active substance


69011-36-5


500-241-6


0,0


0,0




Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate


Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate


Non-active substance


68439-46-3


614-482-0


0,0


0,0




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







Formulation(s)


AL – any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4







Hazard statements


May be corrosive to metals.




Precautionary statements


Keep only in original packaging.
Absorb spillage to prevent material damage.
Store in corrosive resistant container with a resistant inner liner.




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

4.1.   Use description


Table 4. Use # 1 – Veterinary hygiene – animal husbandry – teat disinfectant – professional – indoors – dipping (post milking)







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




Application method(s)


Open system: dip treatment
Teat-dipping: Manual non-medical disinfection of teats with a ready-to-use liquid (on cows, post-milking)




Application rate(s) and frequency


Application rate: 5-10 mL per cow
Application frequency:
During lactation period:






•


2 applications per day (post-milking)




During dry period: 1 application per day




Category(ies) of users


Professional




Pack sizes and packaging material


Bottle HDPE: 1 liter, cap is made of PP
Jerry can HDPE: 5 – 60 liters
Drum HDPE: 200 liters
IBC HDPE: 600 – 1000 liters




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

Always read the label or leaflet before use and follow all the instructions provided.
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.
Fill up a teat dipping cup with 2/3 of product. Immediately after each cow has been milked, dip each teat manually in the solution. Ensure that at least two thirds of the teats, preferably the entire teats, come in contact with the solution.
Do not clean the teats directly after disinfection. Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).
Refill the cup as necessary.
Teat dipping cups should be emptied after milking and washed before re-use. Before the next milking the teats have to be cleaned, preferably with one new wet cloth per cow.
Application frequency must not exceed two applications per cow and day (post-milking).
5.2.   Risk mitigation measures

Keep out of reach of children.
In case a combination of pre- and post-milking disinfection is necessary, using another 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

After inhalation: Supply fresh air; consult doctor in case of complaints.
After skin contact: Wash skin thoroughly.
After eye contact: Rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor.
After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately.
When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here].
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 the product at room temperature, away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
Shelf-life: 12 months in HDPE
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)


FINK – Io Dip 10
IODip 10 PVP




Authorisation number


EU-0020540-0005 1-4




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Iodine


 


Active Substance


7553-56-2


231-442-4


0,1




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











Trade name(s)


FINK – Io Dip Protect
DESINTEC MH Iodine Barrier
TvP – Barrier Dip




Authorisation number


EU-0020540-0006 1-4




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Iodine


 


Active Substance


7553-56-2


231-442-4


0,15





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




Iodine


 


Active Substance


7553-56-2


231-442-4


0,3


0,45




Phosphoric Acid


Trihydroxidooxidophosphorus phosphoric acid


Non-active substance


7664-38-2


231-633-2


0,35


0,4




Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched


Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched


Non-active substance


69011-36-5


500-241-6


0,0


0,0




Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate


Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate


Non-active substance


68439-46-3


614-482-0


0,0


0,0




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







Formulation(s)


AL – any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5







Hazard statements


May be corrosive to metals.
Harmful to aquatic life with long lasting effects.




Precautionary statements


Keep only in original packaging.
Avoid release to the environment.
Absorb spillage to prevent material damage.
Store in corrosive resistant container with a resistant inner liner.
Dispose of contents to/container in accordance with the local/national regulations.




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

4.1.   Use description


Table 5. Use # 1 – Veterinary hygiene – animal husbandry – teat disinfectant – professional – indoors – dipping (post milking)







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




Application method(s)


Open system: dip treatment
Teat-dipping: Manual non-medical disinfection of teats with a ready-to-use liquid (on cows, post-milking)




Application rate(s) and frequency


Application rate: 5-10 mL per cow
Application frequency:
During lactation period:






•


2 applications per day (post-milking)




During dry period: 1 application per day




Category(ies) of users


Professional




Pack sizes and packaging material


Bottle HDPE: 1 liter, cap is made of PP
Jerry can HDPE: 5 – 60 liters
Drum HDPE: 200 liters
IBC HDPE: 600 – 1000 liters




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

Always read the label or leaflet before use and follow all the instructions provided.
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.
Fill up a teat dipping cup with 2/3 of product. Immediately after each cow has been milked, dip each teat manually in the solution. Ensure that at least two thirds of the teats, preferably the entire teats, come in contact with the solution.
Do not clean the teats directly after disinfection. Leave the product until next milking.
Keep the cows standing until the product has dried (at least 5 minutes).
Refill the cup as necessary.
Teat dipping cups should be emptied after milking and washed before re-use. Before the next milking the teats have to be cleaned, preferably with one new wet cloth per cow.
Application frequency must not exceed two applications per cow and day (post-milking).
5.2.   Risk mitigation measures

Keep out of reach of children.
In case a combination of pre- and post-milking disinfection is necessary, using another 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

After inhalation: Supply fresh air; consult doctor in case of complaints.
After skin contact: Wash skin thoroughly.
After eye contact: Rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor.
After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately.
When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here].
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 the product at room temperature, away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
Shelf-life: 12 months in HDPE
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)


Jodofilm 75/5 4500 ppm
IOFILMO SUPER
SUPERIO 4.5
PROTEGO 4500
TIGER 50
ASSOLUTO 5
REDFOX S
SUPER MANGUST
AUGUSTO P5
IO-DIN 45




Authorisation number


EU-0020540-0007 1-5




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Iodine


 


Active Substance


7553-56-2


231-442-4


0,45




Phosphoric Acid


Trihydroxidooxidophosphorus phosphoric acid


Non-active substance


7664-38-2


231-633-2


0,4




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











Trade name(s)


Jodofilm 75/5 3000 ppm
JODOFILM 75/3
IOFILMO
SUPERIO 3.0
PROTEGO 3000
TIGER 30
ASSOLUTO 3
REDFOX E
MANGUST
AUGUSTO P3
IO-DIN 30




Authorisation number


EU-0020540-0008 1-5




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Iodine


 


Active Substance


7553-56-2


231-442-4


0,3




Phosphoric Acid


Trihydroxidooxidophosphorus phosphoric acid


Non-active substance


7664-38-2


231-633-2


0,35





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




Iodine


 


Active Substance


7553-56-2


231-442-4


1,75


2,4




Phosphoric Acid


Trihydroxidooxidophosphorus phosphoric acid


Non-active substance


7664-38-2


231-633-2


3,0


10,0




Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched


Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched


Non-active substance


69011-36-5


500-241-6


0,0


25,6




Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate


Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate


Non-active substance


68439-46-3


614-482-0


0,0


31,8




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







Formulation(s)


SL – soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6







Hazard statements


May be corrosive to metals.
Harmful if swallowed.
Causes severe skin burns and eye damage.
Causes serious eye damage.
May cause damage to thyroid gland through prolonged or repeated exposure.
Harmful to aquatic life with long lasting effects.




Precautionary statements


Keep only in original packaging.
Do not breathe mist.
Do not breathe spray.
Avoid release to the environment.
Wear protective gloves.
Wear protective clothing.
Wear face protection.
IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Absorb spillage to prevent material damage.
Store locked up.
Keep out of reach of children.




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

4.1.   Use description


Table 6. Use # 1 – Veterinary hygiene – animal husbandry – hard surface disinfectant – professional – indoors – spraying







Product type


PT03 – Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Bacteria
Yeasts
Viruses




Field(s) of use


Indoor




Application method(s)


Open system: spray treatment
Disinfectant for hard surfaces in stables (excluding hatcheries). Spraying of diluted concentrate by means of a hand-held knapsack sprayer (4-7 bar)




Application rate(s) and frequency


100 mL/m2 – Concentration of Iodine in application solution: 750 ppm (0,075 %w/w).
Application frequency per year:






 


Dairy cows: 1










 


Beef cattle: 1










 


Veal calves: 4










 


Sows, in individual pens: 5










 


Sows in groups: 5










 


Fattening pigs: 3










 


Laying hens in battery cages without treatment: 1










 


Laying hens in battery cages with aeration (belt drying): 1










 


Laying hens in battery cages with forced drying (deep pit, high rise): 1










 


Laying hens in compact battery cages: 1










 


Laying hens in free range with litter floor (partly litter floor, partly slatted): 1










 


Broilers in free range with litter floor: 7










 


Laying hens in free range with grating floor (aviery system): 1










 


Parent broilers in free range with grating floor: 1










 


Parent broilers in rearing with grating floor: 3










 


Turkeys in free range with litter floor: 2










 


Ducks in free range with litter floor: 13










 


Geese in free range with litter floor: 6








Category(ies) of users


Professional




Pack sizes and packaging material


Bottle HDPE: 1 liter, cap is made of PP
Jerry can HDPE: 5 – 60 liters
Drum HDPE: 200 liters
IBC HDPE: 600 – 1000 liters




4.1.1.   Use-specific instructions for use

Iodosan 30: Mix 29 mL product with 971 mL water to obtain 1 L application solution.
Iodosan 18: Mix 40 mL product with 960 mL water to obtain 1 L application solution.
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

Always read the label or leaflet before use and follow all the instructions provided.
To prepare the disinfectant solution, mix the liquid product with water. Always pour in water first and then carefully stir in the product.
Use max. 100 mL application solution per m2 treated area. Do not prepare more fluid than strictly necessary.
The product shall only be applied in empty (unpopulated) animal houses after surfaces have been thoroughly cleaned with a suitable cleaner.
Pre-cleaning is mandatory. Rinse or wipe the surfaces which will be treated afterwards. Leave them to dry for about 24 up to 36h before disinfection to obtain earth-moist surfaces. Soak installations and equipment thoroughly with a thin layer of the prepared solution by spraying, using suitable devices (4 to 7 bar). During the process and for the duration of contact time (min. 30 minutes), all openings have to be closed and the ventilation has to be switched off.
5.2.   Risk mitigation measures

Keep out of reach of children.
The form of the bottle of the product should minimise risk for splashes in order to prevent eye and skin exposure during diluting the product.

During the mixing and loading phase: The use of a face shield and protection gloves (glove material to be specified by the authorisation holder in the product information) is mandatory.

During the application phase of the in use dilution by spraying: Gloves and a protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product shall be worn (glove and coverall material to be specified by the authorisation holder in the product information). Use new gloves for each work shift.
Professionals must not carry out animal house disinfection more than 3 times per month. These professionals should not use Iodine products for additional purposes.
Only use one kind of Iodine-containing product per day.
Stable disinfection should not be carried out more than once per year or once per lifetime for calf and pigs. Feeding troughs must be covered during application.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

After inhalation: Supply fresh air; consult doctor in case of complaints.
After skin contact: Immediately take off contaminated clothing and wash skin thoroughly.
After eye contact: Immediately rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor.
After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately.
In case of unconsciousness place patient stably in left side position for transportation. Never give anything by mouth to an unconscious individual
When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here].
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.
Methods and material for containment and cleaning up:
Stop leak if safe to do so. Absorb spillage with liquid-binding material (sand, earth, diatomite, acid binders, universal binders, sawdust) and place in container for disposal according to local/national regulations.
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 the product away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
Shelf-life: 24 months in HDPE
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)


IODOSAN 30
IODOSAN
JODAT
DESINTEC FL-JODES
ROTIE-SOL J
Disinfect Jod
FINK – Jodophos 15
Jod-Reiniger sauer
Tankrein extra




Authorisation number


EU-0020540-0009 1-6




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Iodine


 


Active Substance


7553-56-2


231-442-4


2,4




Phosphoric Acid


Trihydroxidooxidophosphorus phosphoric acid


Non-active substance


7664-38-2


231-633-2


10,0




Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched


Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched


Non-active substance


69011-36-5


500-241-6


25,6




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











Trade name(s)


IODOSAN 18




Authorisation number


EU-0020540-0010 1-6




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Iodine


 


Active Substance


7553-56-2


231-442-4


1,75




Phosphoric Acid


Trihydroxidooxidophosphorus phosphoric acid


Non-active substance


7664-38-2


231-633-2


3,0




Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate


Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate


Non-active substance


68439-46-3


614-482-0


31,8





META SPC 7

1.   META SPC 7 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 7 identifier







Identifier


Meta SPC 7




1.2.   Suffix to the authorisation number







Number


1-7




1.3.   Product type(s)







Product type(s)


PT03 – Veterinary hygiene (Disinfectants)




2.   META SPC 7 COMPOSITION

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












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Iodine


 


Active Substance


7553-56-2


231-442-4


3,0


3,0




Phosphoric Acid


Trihydroxidooxidophosphorus phosphoric acid


Non-active substance


7664-38-2


231-633-2


10,0


10,0




Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched


Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched


Non-active substance


69011-36-5


500-241-6


31,8


31,8




Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate


Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate


Non-active substance


68439-46-3


614-482-0


0,0


0,0




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







Formulation(s)


SL – soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7







Hazard statements


May be corrosive to metals.
Harmful if swallowed.
Causes severe skin burns and eye damage.
Causes serious eye damage.
May cause damage to thyroid gland through prolonged or repeated exposure.
Toxic to aquatic life with long lasting effects.




Precautionary statements


Keep only in original packaging.
Do not breathe mist.
Do not breathe spray.
Avoid release to the environment.
Wear protective gloves.
Wear protective clothing.
Wear face protection.
IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Absorb spillage to prevent material damage.
Store locked up.
Keep out of reach of children.




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

4.1.   Use description


Table 7. Use # 1 – Veterinary hygiene – animal husbandry – hard surface disinfectant – professional – indoors – spraying







Product type


PT03 – Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Bacteria
Yeasts
Viruses




Field(s) of use


Indoor




Application method(s)


Open system: spray treatment
Disinfectant for hard surfaces in stables (excluding hatcheries). Spraying of diluted concentrate by means of a hand-held knapsack sprayer (4-7 bar)




Application rate(s) and frequency


100 mL/m2 – Concentration of Iodine in application solution: 750 ppm (0,075 %w/w).
Application frequency per year:






 


Dairy cows: 1










 


Beef cattle: 1










 


Veal calves: 4










 


Sows, in individual pens: 5










 


Sows in groups: 5










 


Fattening pigs: 3










 


Laying hens in battery cages without treatment: 1










 


Laying hens in battery cages with aeration (belt drying): 1










 


Laying hens in battery cages with forced drying (deep pit, high rise): 1










 


Laying hens in compact battery cages: 1










 


Laying hens in free range with litter floor (partly litter floor, partly slatted): 1










 


Broilers in free range with litter floor: 7










 


Laying hens in free range with grating floor (aviery system): 1










 


Parent broilers in free range with grating floor: 1










 


Parent broilers in rearing with grating floor: 3










 


Turkeys in free range with litter floor: 2










 


Ducks in free range with litter floor: 13










 


Geese in free range with litter floor: 6








Category(ies) of users


Professional




Pack sizes and packaging material


Bottle HDPE: 1 liter, cap is made of PP
Jerry can HDPE: 5 – 60 liters
Drum HDPE: 200 liters
IBC HDPE: 600 – 1000 liters




4.1.1.   Use-specific instructions for use

Iodosan 30 plus: Mix 23 mL product with 977 mL water to obtain 1 L application solution.
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 (7)
OF THE META SPC 7

5.1.   Instructions for use

Always read the label or leaflet before use and follow all the instructions provided.
To prepare the disinfectant solution, mix the liquid product with water. Always pour in water first and then carefully stir in the product.
Use max. 100 mL application solution per m2 treated area. Do not prepare more fluid than strictly necessary.
The product shall only be applied in empty (unpopulated) animal houses after surfaces have been thoroughly cleaned with a suitable cleaner.
Pre-cleaning is mandatory. Rinse or wipe the surfaces which will be treated afterwards. Leave them to dry for about 24 up to 36h before disinfection to obtain earth-moist surfaces. Soak installations and equipment thoroughly with a thin layer of the prepared solution by spraying, using suitable devices (4 to 7 bar). During the process and for the duration of contact time (min. 30 minutes), all openings have to be closed and the ventilation has to be switched off.
5.2.   Risk mitigation measures

Keep out of reach of children.
The form of the bottle of the product should minimise risk for splashes in order to prevent eye and skin exposure during diluting the product.

During the mixing and loading phase: The use of a face shield and protection gloves (glove material to be specified by the authorisation holder in the product information) is mandatory.

During the application phase of the in use dilution by spraying: Gloves and a protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product shall be worn (glove and coverall material to be specified by the authorisation holder in the product information). Use new gloves for each work shift.
Professionals must not carry out animal house disinfection more than 3 times per month. These professionals should not use Iodine products for additional purposes.
Only use one kind of Iodine-containing product per day.
Stable disinfection should not be carried out more than once per year or once per lifetime for calf and pigs. Feeding troughs must be covered during application.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

After inhalation: Supply fresh air; consult doctor in case of complaints.
After skin contact: Immediately take off contaminated clothing and wash skin thoroughly.
After eye contact: Immediately rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor.
After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately.
In case of unconsciousness place patient stably in left side position for transportation. Never give anything by mouth to an unconscious individual.
When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here].
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.
Methods and material for containment and cleaning up:
Stop leak if safe to do so. Absorb spillage with liquid-binding material (sand, earth, diatomite, acid binders, universal binders, sawdust) and place in container for disposal according to local/national regulations.
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 the product away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
Shelf-life: 24 months in HDPE
6.   OTHER INFORMATION

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

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











Trade name(s)


IODOSAN 30 Plus
YODO CONTROL
YODIVEN




Authorisation number


EU-0020540-0011 1-7




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Iodine


 


Active Substance


7553-56-2


231-442-4


3,0




Phosphoric Acid


Trihydroxidooxidophosphorus phosphoric acid


Non-active substance


7664-38-2


231-633-2


10,0




Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched


Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched


Non-active substance


69011-36-5


500-241-6


31,8





META SPC 8

1.   META SPC 8 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 8 identifier







Identifier


Meta SPC 8




1.2.   Suffix to the authorisation number







Number


1-8




1.3.   Product type(s)







Product type(s)


PT03 – Veterinary hygiene (Disinfectants)




2.   META SPC 8 COMPOSITION

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












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Iodine


 


Active Substance


7553-56-2


231-442-4


1,5


1,5




Phosphoric Acid


Trihydroxidooxidophosphorus phosphoric acid


Non-active substance


7664-38-2


231-633-2


3,0


3,0




Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched


Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched


Non-active substance


69011-36-5


500-241-6


18,0


18,0




Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate


Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate


Non-active substance


68439-46-3


614-482-0


0,0


0,0




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







Formulation(s)


SL – soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8







Hazard statements


May be corrosive to metals.
Causes severe skin burns and eye damage.
Causes serious eye damage.
May cause damage to thyroid gland through prolonged or repeated exposure.
Harmful to aquatic life with long lasting effects.




Precautionary statements


Keep only in original packaging.
Do not breathe mist.
Do not breathe spray.
Avoid release to the environment.
Wear protective gloves.
Wear protective clothing.
Wear face protection.
IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Absorb spillage to prevent material damage.
Store locked up.
Keep out of reach of children.




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

4.1.   Use description


Table 8. Use # 1 – Veterinary hygiene – animal husbandry – hard surface disinfectant – professional – indoors – spraying







Product type


PT03 – Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Bacteria
Yeasts
Viruses




Field(s) of use


Indoor




Application method(s)


Open system: spray treatment
Disinfectant for hard surfaces in stables (excluding hatcheries). Spraying of diluted concentrate by means of a hand-held knapsack sprayer (4-7 bar)




Application rate(s) and frequency


100 mL/m2 – Concentration of Iodine in application solution: 750 ppm (0,075 %w/w).
Application frequency per year:






 


Dairy cows: 1










 


Beef cattle: 1










 


Veal calves: 4










 


Sows, in individual pens: 5










 


Sows in groups: 5










 


Fattening pigs: 3










 


Laying hens in battery cages without treatment: 1










 


Laying hens in battery cages with aeration (belt drying): 1










 


Laying hens in battery cages with forced drying (deep pit, high rise): 1










 


Laying hens in compact battery cages: 1










 


Laying hens in free range with litter floor (partly litter floor, partly slatted): 1










 


Broilers in free range with litter floor: 7










 


Laying hens in free range with grating floor (aviery system): 1










 


Parent broilers in free range with grating floor: 1










 


Parent broilers in rearing with grating floor: 3










 


Turkeys in free range with litter floor: 2










 


Ducks in free range with litter floor: 13










 


Geese in free range with litter floor: 6








Category(ies) of users


Professional




Pack sizes and packaging material


Bottle HDPE: 1 liter, cap is made of PP
Jerry can HDPE: 5 – 60 liters
Drum HDPE: 200 liters
IBC HDPE: 600 – 1000 liters




4.1.1.   Use-specific instructions for use

Iodosan 15: Mix 46 mL product with 954 mL water to obtain 1 L application solution.
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 (8)
OF THE META SPC 8

5.1.   Instructions for use

Always read the label or leaflet before use and follow all the instructions provided.
To prepare the disinfectant solution, mix the liquid product with water. Always pour in water first and then carefully stir in the product.
Use max. 100 mL application solution per m2 treated area. Do not prepare more fluid than strictly necessary.
The product shall only be applied in empty (unpopulated) animal houses after surfaces have been thoroughly cleaned with a suitable cleaner.
Pre-cleaning is mandatory. Rinse or wipe the surfaces which will be treated afterwards. Leave them to dry for about 24 up to 36h before disinfection to obtain earth-moist surfaces. Soak installations and equipment thoroughly with a thin layer of the prepared solution by spraying, using suitable devices (4 to 7 bar). During the process and for the duration of contact time (min. 30 minutes), all openings have to be closed and the ventilation has to be switched off.
5.2.   Risk mitigation measures

Keep out of reach of children.
The form of the bottle of the product should minimise risk for splashes in order to prevent eye and skin exposure during diluting the product.

During the mixing and loading phase: The use of a face shield and protection gloves (glove material to be specified by the authorisation holder in the product information) is mandatory.

During the application phase of the in use dilution by spraying: Gloves and a protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product shall be worn (glove and coverall material to be specified by the authorisation holder in the product information). Use new gloves for each work shift.
Professionals must not carry out animal house disinfection more than 3 times per month. These professionals should not use Iodine products for additional purposes.
Only use one kind of Iodine-containing product per day.
Stable disinfection should not be carried out more than once per year or once per lifetime for calf and pigs. Feeding troughs must be covered during application.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

After inhalation: Supply fresh air; consult doctor in case of complaints.
After skin contact: Immediately take off contaminated clothing and wash skin thoroughly.
After eye contact: Immediately rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor.
After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately.
In case of unconsciousness place patient stably in left side position for transportation. Never give anything by mouth to an unconscious individual.
When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here].
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.
Methods and material for containment and cleaning up:
Stop leak if safe to do so. Absorb spillage with liquid-binding material (sand, earth, diatomite, acid binders, universal binders, sawdust) and place in container for disposal according to local/national regulations.
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 the product away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
Shelf-life: 24 months in HDPE
6.   OTHER INFORMATION

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

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










Trade name(s)


IODOSAN 15




Authorisation number


EU-0020540-0012 1-8




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Iodine


 


Active Substance


7553-56-2


231-442-4


1,5




Phosphoric Acid


Trihydroxidooxidophosphorus phosphoric acid


Non-active substance


7664-38-2


231-633-2


3,0




Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched


Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched


Non-active substance


69011-36-5


500-241-6


18,0






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

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

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

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

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

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

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

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