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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)

Commission Implementing Regulation (EU) 2021/977of 7 June 2021amending 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 productsOJ L 167, 27.6.2012, p. 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) 2019/1844Commission 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). 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 354/2013Commission 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)., 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 opinionECHA 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 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 1The Annex to Implementing Regulation (EU) 2019/1844 is replaced by the Annex to this Regulation.

Article 2This 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 CommissionThe PresidentUrsula von der LeyenANNEXSummary of product characteristics for a biocidal product familyBPF_Iodine_VETProduct type 3 – Veterinary hygiene (Disinfectants)Authorisation number: EU-0020540-0000R4BP asset number: EU-0020540-0000PART IFIRST INFORMATION LEVEL1.ADMINISTRATIVE INFORMATION1.1.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 ChilePedro de Valdivia, 1240000 Antofagasta Chile

2.PRODUCT FAMILY COMPOSITION AND FORMULATION2.1.Qualitative and quantitative information on the composition of the family

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	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 liquidmeta SPC 6-8: SL – soluble concentrate

PART IISECOND INFORMATION LEVEL – META SPC(S)META SPC 11.META SPC 1 ADMINISTRATIVE INFORMATION1.1.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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 1

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	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 14.1.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)	BacteriaYeasts
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 PPJerry can HDPE: 5 – 60 litersDrum HDPE: 200 litersIBC 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 USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.OF THE META SPC 15.1.Instructions for useAlways 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 measuresKeep 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 emergencymeasures to protect the environmentAfter 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 packagingAt 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 storageStore 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 HDPE6.OTHER INFORMATION7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 17.1.Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)	FINK – Io Spray 15FINK – Euter-DIP PVP-SFINK Pattedyp PVPIOSpray 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 21.META SPC 2 ADMINISTRATIVE INFORMATION1.1.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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 2

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	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 24.1.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)	BacteriaYeasts
Field(s) of use	Indoor
Application method(s)	Open system: spray treatmentSpraying: 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 cowApplication 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 PPJerry can HDPE: 5 – 60 litersDrum HDPE: 200 litersIBC 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 USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.OF THE META SPC 25.1.Instructions for useAlways 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 measuresKeep 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 environmentAfter 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 packagingAt 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 storageStore 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 HDPE6.OTHER INFORMATION7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 27.1.Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)	FINK – Io Spray 30ST-Io SprayDESINTEC MH Iodine SDESINTEC MH Raidip plusIodine Spray 3000Iodine SprayIo Spray 30Iodine 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 50DESINTEC MH Raidip 5000Iodine 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 31.META SPC 3 ADMINISTRATIVE INFORMATION1.1.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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 3

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	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 34.1.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)	BacteriaYeasts
Field(s) of use	Indoor
Application method(s)	Open system: spray treatmentSpraying: 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 cowApplication 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 PPJerry can HDPE: 5 – 60 litersDrum HDPE: 200 litersIBC 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 USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.OF THE META SPC 35.1.Instructions for useAlways 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 measuresKeep 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 environmentAfter 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 packagingAt 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 storageStore 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 HDPE6.OTHER INFORMATION7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 37.1.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 41.META SPC 4 ADMINISTRATIVE INFORMATION1.1.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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 4

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	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 44.1.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)	BacteriaYeasts
Field(s) of use	Indoor
Application method(s)	Open system: dip treatmentTeat-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 cowApplication 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 PPJerry can HDPE: 5 – 60 litersDrum HDPE: 200 litersIBC 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 USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4.OF THE META SPC 45.1.Instructions for useAlways 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 measuresKeep 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 environmentAfter 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 packagingAt 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 storageStore 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 HDPE6.OTHER INFORMATION7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 47.1.Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)	FINK – Io Dip 10IODip 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 ProtectDESINTEC MH Iodine BarrierTvP – 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 51.META SPC 5 ADMINISTRATIVE INFORMATION1.1.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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 5

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	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 54.1.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)	BacteriaYeasts
Field(s) of use	Indoor
Application method(s)	Open system: dip treatmentTeat-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 cowApplication 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 PPJerry can HDPE: 5 – 60 litersDrum HDPE: 200 litersIBC 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 USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 5.OF THE META SPC 55.1.Instructions for useAlways 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 measuresKeep 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 environmentAfter 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 packagingAt 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 storageStore 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 HDPE6.OTHER INFORMATION7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 57.1.Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)	Jodofilm 75/5 4500 ppmIOFILMO SUPERSUPERIO 4.5PROTEGO 4500TIGER 50ASSOLUTO 5REDFOX SSUPER MANGUSTAUGUSTO P5IO-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 ppmJODOFILM 75/3IOFILMOSUPERIO 3.0PROTEGO 3000TIGER 30ASSOLUTO 3REDFOX EMANGUSTAUGUSTO P3IO-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 61.META SPC 6 ADMINISTRATIVE INFORMATION1.1.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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 6

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	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 64.1.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)	BacteriaYeastsViruses
Field(s) of use	Indoor
Application method(s)	Open system: spray treatmentDisinfectant 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: 1Beef cattle: 1Veal calves: 4Sows, in individual pens: 5Sows in groups: 5Fattening pigs: 3Laying hens in battery cages without treatment: 1Laying hens in battery cages with aeration (belt drying): 1Laying hens in battery cages with forced drying (deep pit, high rise): 1Laying hens in compact battery cages: 1Laying hens in free range with litter floor (partly litter floor, partly slatted): 1Broilers in free range with litter floor: 7Laying hens in free range with grating floor (aviery system): 1Parent broilers in free range with grating floor: 1Parent broilers in rearing with grating floor: 3Turkeys in free range with litter floor: 2Ducks in free range with litter floor: 13Geese 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 PPJerry can HDPE: 5 – 60 litersDrum HDPE: 200 litersIBC HDPE: 600 – 1000 liters

4.1.1.Use-specific instructions for useIodosan 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 USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 6.OF THE META SPC 65.1.Instructions for useAlways 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 measuresKeep 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 environmentAfter 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 individualWhen 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 packagingAt 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 storageStore the product away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.Shelf-life: 24 months in HDPE6.OTHER INFORMATION7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 67.1.Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)	IODOSAN 30IODOSANJODATDESINTEC FL-JODESROTIE-SOL JDisinfect JodFINK – Jodophos 15Jod-Reiniger sauerTankrein 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 71.META SPC 7 ADMINISTRATIVE INFORMATION1.1.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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 7

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	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

Precautionary statements

4.AUTHORISED USE(S) OF THE META SPC 74.1.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)	BacteriaYeastsViruses
Field(s) of use	Indoor
Application method(s)	Open system: spray treatmentDisinfectant 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: 1Beef cattle: 1Veal calves: 4Sows, in individual pens: 5Sows in groups: 5Fattening pigs: 3Laying hens in battery cages without treatment: 1Laying hens in battery cages with aeration (belt drying): 1Laying hens in battery cages with forced drying (deep pit, high rise): 1Laying hens in compact battery cages: 1Laying hens in free range with litter floor (partly litter floor, partly slatted): 1Broilers in free range with litter floor: 7Laying hens in free range with grating floor (aviery system): 1Parent broilers in free range with grating floor: 1Parent broilers in rearing with grating floor: 3Turkeys in free range with litter floor: 2Ducks in free range with litter floor: 13Geese 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 PPJerry can HDPE: 5 – 60 litersDrum HDPE: 200 litersIBC HDPE: 600 – 1000 liters

4.1.1.Use-specific instructions for useIodosan 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 USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 7.OF THE META SPC 75.1.Instructions for useAlways 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 measuresKeep 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 environmentAfter 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 packagingAt 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 storageStore the product away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.Shelf-life: 24 months in HDPE6.OTHER INFORMATION7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 77.1.Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)	IODOSAN 30 PlusYODO CONTROLYODIVEN
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 81.META SPC 8 ADMINISTRATIVE INFORMATION1.1.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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 8

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	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

4.AUTHORISED USE(S) OF THE META SPC 84.1.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)	BacteriaYeastsViruses
Field(s) of use	Indoor
Application method(s)	Open system: spray treatmentDisinfectant 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: 1Beef cattle: 1Veal calves: 4Sows, in individual pens: 5Sows in groups: 5Fattening pigs: 3Laying hens in battery cages without treatment: 1Laying hens in battery cages with aeration (belt drying): 1Laying hens in battery cages with forced drying (deep pit, high rise): 1Laying hens in compact battery cages: 1Laying hens in free range with litter floor (partly litter floor, partly slatted): 1Broilers in free range with litter floor: 7Laying hens in free range with grating floor (aviery system): 1Parent broilers in free range with grating floor: 1Parent broilers in rearing with grating floor: 3Turkeys in free range with litter floor: 2Ducks in free range with litter floor: 13Geese 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 PPJerry can HDPE: 5 – 60 litersDrum HDPE: 200 litersIBC HDPE: 600 – 1000 liters

4.1.1.Use-specific instructions for useIodosan 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 USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 8.OF THE META SPC 85.1.Instructions for useAlways 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 measuresKeep 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 environmentAfter 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 packagingAt 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 storageStore the product away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.Shelf-life: 24 months in HDPE6.OTHER INFORMATION7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 87.1.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