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, 22 October 2019.

For the Commission

The President

Jean-Claude JUNCKER

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

( 2 ) Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council ( OJ L 301, 17.11.2017, p. 1 ).

( 3 ) ECHA opinion of 27 February 2019 on the Union authorisation of ‘BPF_Iodine_VET’ (ECHA/BPC/219/2019).

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

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

Applied Biocide GmbH

Address

Sprl 31, Rue Jules Melotte, 4350, Remicourt, Belgium

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

Ewabo Chemikalien GmbH & Co KG

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

IRCASERVICE

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 Maymo SA

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, 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 (%)

Iodine

Active Substance

7553-56-2

231-442-4

Phosphoric Acid

Trihydroxidooxidophosphorus phosphoric acid

Non-active substance

7664-38-2

231-633-2

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

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

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

1.3. 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 (%)

Iodine

Active Substance

7553-56-2

231-442-4

Phosphoric Acid

Trihydroxidooxidophosphorus phosphoric acid

Non-active substance

7664-38-2

231-633-2

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

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

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: 600-1 000 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

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

1.3. 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 (%)

Iodine

Active Substance

7553-56-2

231-442-4

Phosphoric Acid

Trihydroxidooxidophosphorus phosphoric acid

Non-active substance

7664-38-2

231-633-2

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

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

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: 600-1 000 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