Article 1

The signing on behalf of the Union of the Agreement to Prevent Unregulated High Seas Fisheries in the Central Arctic Ocean (‘the Agreement’) is hereby authorised, subject to the conclusion of the said Agreement (4).

Article 2

The President of the Council shall designate the person(s) empowered to sign the Agreement on behalf of the Union.

Article 3

This Decision shall enter into force on the date of its adoption.

Article 1

A Union authorisation is granted to Ecolab Deutschland GmbH for the biocidal product family Ecolab Iodine PT3 Family with authorisation number EU-0018398-0000.

The Union authorisation is valid from 11 October 2018 until 30 September 2028.

The Union authorisation is subject to compliance with the SPC set out in the Annex.

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.

ANNEX

Summary of product characteristics for a biocidal product family

Ecolab Iodine PT3 Family

Product type 3 — Veterinary hygiene (Disinfectants)

Authorisation number: EU-0018398-0000

R4BP asset number: EU-0018398-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

Name	Ecolab Iodine PT3 Family

1.2.   Product type(s)

Product type(s)	PT03 — Veterinary hygiene (Disinfectants)

1.3.   Authorisation holder

Name and address of the authorisation holder	Name	Ecolab Deutschland GmbH
	Address	Ecolab-Allee 1, 40789 Monheim, Germany
Authorisation number	EU-0018398-0000
R4BP asset number	EU-0018398-0000
Date of the authorisation	11 October 2018
Expiry date of the authorisation	30 September 2028

1.4.   Manufacturer(s) of the biocidal products

Name of manufacturer	Ecolab Europe GmbH
Address of manufacturer	Richtistrasse 7, 8304 Walliselen Switzerland
Location of manufacturing sites	Ecolab Baglan, ECOLAB CONTAMINATION CONTROL BRUNEL WAY, BAGLAN ENERGY PARK, NEATH, SA11 2GA South Wales United Kingdom Ecolab Leeds, LOTHERTON WAY, GARFORTH, LEEDS LS25 2JY Leeds United Kingdom Ecolab Rovigo, Viale del Lavoro 10, 45100 Rovigo Italy Ecolab Biebesheim Nalco Deutschland Manufacturing GmbH und Co.KG, Justus-von-Liebig-Str. 11 D-64584 Biebesheim Germany Ecolab NETHERLANDS BV, NL01ECOLAB, BRUGWAL 11 3432NZ NIEUWEGEIN Netherlands Ecolab Weavergate, ECOLAB WEAVERGATE PLANT WINNINGTON AVENUE, NORTHWICH CHESHIRE CW8 3AA NORTHWICH United Kingdom Ecolab Mullingar, Forest Park, Mullingar Ind. Estate, Mullingar, Co. Zone C Westmeath Ireland Ecolab Maribor, Ecolab d.o.o.,Vajngerlova 4 2000 Maribor Slovenia Ecolab Rozzano, VIA GRANDI 9/11 20089 ROZZANO Italy Ecolab B.V.B.A, Havenlaan: 4 3980 Tessenderlo Belgium Ecolab CELRA, Nalco Española Manufacturing, SLU C/Tramuntana s/n, Polígono Industrial de Celrà 17460 CELRÀ Spain Ecolab Chalons Ecolab production France SAS, BP509 Avenue de Général Patton 51006 Châlons-en-Champagne France Ecolab Mandra, 25km Old National Road Athens Mandra, oo Attica Greece NALCO FINLAND MANUFACTURING OY, Kivikummuntie 1 FIN-07955 Tesjoki Finland

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

Active substance	Polyvinylpyrrolidone iodine
Name of manufacturer	ISP Chemicals LLC, Affiliate of Ashland Inc.
Address of manufacturer	455 N. MAIN ST. (HWY 95) KY 42029 CALVERT CITY United States
Location of manufacturing sites	455 N. MAIN ST. (HWY 95) KY 42029 CALVERT CITY United States

Active substance	Iodine
Name of manufacturer	ACF Minera S.A.
Address of manufacturer	San Martín No 499 00 Iquique Chile
Location of manufacturing sites	Lagunas mine 00 Pozo Almonte Chile

Active substance	Iodine
Name of manufacturer	SQM S.A.
Address of manufacturer	Los Militares 4290 Piso 4 Santiago Chile
Location of manufacturing sites	Nueva Victoria plant 00 Pedro de Valdivia Chile

Active substance	Iodine
Name of manufacturer	Cosayach Nitratos S.A.
Address of manufacturer	Amunategui 178 00 Santiago Chile
Location of manufacturing sites	S.C.M. Cosayach Cala Cala 00 Pozo Almonte Chile

Active substance	Iodine
Name of manufacturer	Nihon Tennen Gas Development Co., Ltd/ Kanto Natural Gas Development Co., Ltd
Address of manufacturer	661 Mobara Chiba 297-8550 Mobara City Japan
Location of manufacturing sites	Chiba Plant, 2508 Minami-Hinata, Shirako-Machi, Chosei-Gun 299-4205 Chiba Japan

2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

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

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
					Min	Max
Polyvinylpyrrolidone iodine		Active substance	25655-41-8		1	3
Iodine		Active substance	7553-56-2	231-442-4	0,11	0,33

2.2.   Type(s) of formulation

Formulation(s)	AL — Any other liquid

PART II

SECOND INFORMATION LEVEL — META SPC(S)

META SPC 1

1.   META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier

Identifier

meta SPC 1

1.2.   Suffix to the authorisation number

Number

1-1

1.3.   Product type(s)

Product type(s)	PT03 — Veterinary hygiene (Disinfectants)

2.   META SPC 1 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 1

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
					Min	Max
Polyvinylpyrrolidone iodine		Active substance	25655-41-8		1	1
Iodine		Active substance	7553-56-2	231-442-4	0,11	0,11

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

Formulation	AL — Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements
Precautionary statements

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

4.1.   Use description

Table 1. Use # 1 – Teat dips for post-milking disinfection

Product Type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeasts Enveloped viruses
Field(s) of use	Indoor Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)
Application method(s)	Manual dipping using a dip cup - 3-10 ml (dipping) 1-3 post-milking disinfections per day
Application rate(s) and frequency	3-10 ml (dipping) Post-milking application 1x - 3x per day (apply after every milking). Per milking event 3-10 ml of product are needed (animals with four teats).
Category(ies) of users	Professional
Pack sizes and packaging material	container, Plastic: HDPE, 0,5-1 000 l

4.1.1.   Use-specific instructions for use

See general directions for use of meta SPC 1

4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 1

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 1

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 1

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 1

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.

Product to be applied post-milking by use of a dipping cup.

The products must be brought to temperatures above 20 °C before use.

Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.

The use of a dosing pump for filling the product into the application equipment is recommended.

5.2.   Risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Potential Health Effects

Eyes: Health injuries are not known or expected under normal use.

Skin: Health injuries are not known or expected under normal use.

Ingestion: Health injuries are not known or expected under normal use.

Inhalation: Health injuries are not known or expected under normal use.

Chronic Exposure: Health injuries are not known or expected under normal use.

First Aid Measures:

Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.

Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.

Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.

Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.

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 between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.

Shelf life: 24 months

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1

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

Trade name(s)	Ioklar Super Dip D
Authorisation number	EU-0018398-0001 1-1
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Polyvinylpyrrolidone iodine		Active substance	25655-41-8		1
Iodine		Active substance	7553-56-2	231-442-4	0,11

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

Trade name(s)	IoKlar Superdip
Authorisation number	EU-0018398-0002 1-1
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Polyvinylpyrrolidone iodine		Active substance	25655-41-8		1
Iodine		Active substance	7553-56-2	231-442-4	0,11

META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

Identifier

meta SPC 2

1.2.   Suffix to the authorisation number

Number

1-2

1.3.   Product type(s)

Product type(s)	PT03 — Veterinary hygiene (Disinfectants)

2.   META SPC 2 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 2

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
					Min	Max
Polyvinylpyrrolidone iodine		Active substance	25655-41-8		1,35	1,35
Iodine		Active substance	7553-56-2	231-442-4	0,15	0,15

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

Formulation	AL — Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

Hazard statements
Precautionary statements

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

4.1.   Use description

Table 2. Use # 1 – Teat dips for post-milking disinfection

Product Type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeasts Enveloped viruses
Field(s) of use	Indoor Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)
Application method(s)	Manual dipping using a dip cup
Application rate(s) and frequency	Post-milking application 1x - 3x per day (apply after every milking). Per milking event 3-10 ml of product are needed (animals with four teats).
Category(ies) of users	Professional
Pack sizes and packaging material	0,5 l – 1 000 l HDPE container

4.1.1.   Use-specific instructions for use

See general directions for use of meta SPC 2

4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 2

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 2

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 2

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 2

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 products must be brought to temperatures above 20 °C before use.

Product to be applied post-milking by use of a dipping cup.

Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.

The use of a dosing pump for filling the product into the application equipment is recommended.

5.2.   Risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Potential Health Effects

Eyes: Health injuries are not known or expected under normal use.

Skin: Health injuries are not known or expected under normal use.

Ingestion: Health injuries are not known or expected under normal use.

Inhalation: Health injuries are not known or expected under normal use.

Chronic Exposure: Health injuries are not known or expected under normal use.

First Aid Measures:

Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.

Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.

Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.

Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.

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 between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.

Shelf life: 24 months

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2

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

Trade name(s)	Io-Shield D IoShield MEPA Barrier D BARIOPROTECT MS Cow Udder BLOCK Iodocop EXTRA
Authorisation number	EU-0018398-0003 1-2
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Polyvinylpyrrolidone iodine		Active substance	25655-41-8		1,35
Iodine		Active substance	7553-56-2	231-442-4	0,15

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

Trade name(s)	IoDark Iodocop EXTRA GREEN Mammizan Protect MS Cow Udder BLACK
Authorisation number	EU-0018398-0004 1-2
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Polyvinylpyrrolidone iodine		Active substance	25655-41-8		1,35
Iodine		Active substance	7553-56-2	231-442-4	0,15

META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier

Identifier

meta SPC 3

1.2.   Suffix to the authorisation number

Number

1-3

1.3.   Product type(s)

Product type(s)	PT03 — Veterinary hygiene (Disinfectants)

2.   META SPC 3 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 3

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
					Min	Max
Polyvinylpyrrolidone iodine		Active substance	25655-41-8		2,45	2,45
Iodine		Active substance	7553-56-2	231-442-4	0,27	0,27

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

Formulation	AL — Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

Hazard statements	Harmful to aquatic life with long lasting effects.
Precautionary statements	Avoid release to the environment.

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

4.1.   Use description

Table 3. Use # 1 – Teat dips or sprays for post-milking disinfection

Product Type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeasts Enveloped viruses
Field(s) of use	Indoor Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)
Application method(s)	Dipping or spraying: Manual dipping using a dip cup or Manual spraying using a trigger sprayer or Manual spraying using an electronic sprayer or Automated spraying by robot.
Application rate(s) and frequency	Post-milking application 1x – 3x per day Per milking event 3-10 ml (dipping) to 10-15 ml (spraying) of product are needed (animals with four teats).
Category(ies) of users	Professional
Pack sizes and packaging material	0,5 l – 1 000 l HDPE container

4.1.1.   Use-specific instructions for use

Product to be applied by dipping or spraying on teats of milk-producing animals post-milking, using manual or automatic equipment. Post-milking: Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.

See also general instructions for use of meta SPC 3.

4.1.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

See also general risk mitigation measures of meta SPC 3.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 3

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 3

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 3

4.2.   Use description

Table 4. Use # 2 – Teat dips or sprays for pre-milking disinfection

Product Type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeasts
Field(s) of use	Indoor Pre-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)
Application method(s)	Dipping or spraying: Manual dipping using a dip cup or Manual spraying using a trigger sprayer or Manual spraying using an electronic sprayer.
Application rate(s) and frequency	Pre-milking application 1x – 3x per day Per milking event 3-10 ml (dipping) to 10-15 ml (spraying) of product are needed (animals with four teats).
Category(ies) of users	Professional
Pack sizes and packaging material	0,5 l – 1 000 l HDPE container

4.2.1.   Use-specific instructions for use

Product to be applied by dipping or spraying on teats of milk-producing animals pre-milking, using manual equipment.

Pre-milking: Clean teats by wiping with cloth before disinfection. Apply product on the whole teats and leave it for 1 min. Then wipe with a single use paper or a towel.

See also general instructions for use of meta SPC3.

4.2.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection.

See also general risk mitigation measures of meta SPC3.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 3

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 3

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 3

5.   GENERAL DIRECTIONS FOR USE (3) OF THE META SPC 3

5.1.   Instructions for use

See use-specific instructions for each use.

Always read the label or leaflet before use and follow all the instructions provided.

The products must be brought to temperatures above 20 °C before use.

The use of a dosing pump for filling the product into the application equipment is recommended

5.2.   Risk mitigation measures

See use-specific risk mitigation measures for each use.

Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) for spraying application.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Potential Health Effects

Eyes: Health injuries are not known or expected under normal use.

Skin: Health injuries are not known or expected under normal use.

Ingestion: Health injuries are not known or expected under normal use.

Inhalation: Health injuries are not known or expected under normal use.

Chronic Exposure: Health injuries are not known or expected under normal use.

First Aid Measures:

Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.

Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.

Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.

Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.

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 between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.

Shelf life: 24 months

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3

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

Trade name(s)	IoKlar Multi MEPA Iospray Plus D ASTRI-IO DESINTEC MH-Iodine S
Authorisation number	EU-0018398-0005 1-3
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Polyvinylpyrrolidone iodine		Active substance	25655-41-8		2,45
Iodine		Active substance	7553-56-2	231-442-4	0,27

META SPC 4

1.   META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier

Identifier

meta SPC 4

1.2.   Suffix to the authorisation number

Number

1-4

1.3.   Product type(s)

Product type(s)	PT03 — Veterinary hygiene (Disinfectants)

2.   META SPC 4 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 4

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
					Min	Max
Polyvinylpyrrolidone iodine		Active substance	25655-41-8		1	1
Iodine		Active substance	7553-56-2	231-442-4	0,11	0,11

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

Formulation	AL — Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

Hazard statements
Precautionary statements

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

4.1.   Use description

Table 5. Use # 1 – Teat dips or sprays for post-milking disinfection

Product Type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeasts Enveloped viruses
Field(s) of use	Indoor Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)
Application method(s)	Dipping or spraying: Manual dipping using a dip cup or Manual spraying using a trigger sprayer or Manual spraying using an electronic sprayer or Automated spraying by robot.
Application rate(s) and frequency	Post-milking application 1x - 3x per day. Per milking event 3-10 ml (dipping) to 10-15 ml (spraying) of product are needed (animals with four teats).
Category(ies) of users	Professional
Pack sizes and packaging material	0,5 l – 1 000 l HDPE container

4.1.1.   Use-specific instructions for use

See general directions for use of meta SPC 4

4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 4

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 4

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 4

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 4

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 products must be brought to temperatures above 20 °C before use.

Product to be applied by dipping or spraying on teats of milk-producing animals post-milking using manual or automatic equipment.

Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.

The use of a dosing pump for filling the product into the application equipment is recommended.

5.2.   Risk mitigation measures

Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) for spraying application.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Potential Health Effects

Eyes: Health injuries are not known or expected under normal use.

Skin: Health injuries are not known or expected under normal use.

Ingestion: Health injuries are not known or expected under normal use.

Inhalation: Health injuries are not known or expected under normal use.

Chronic Exposure: Health injuries are not known or expected under normal use.

First Aid Measures:

Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.

Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.

Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.

Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.

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 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 between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.

Shelf life: 24 months

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4

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

Trade name(s)	Veloucid Spray D VelouCid Spray MEPA Soft Spray D ASTRI-UC SAC WINTERSPRAY
Authorisation number	EU-0018398-0006 1-4
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Polyvinylpyrrolidone iodine		Active substance	25655-41-8		1
Iodine		Active substance	7553-56-2	231-442-4	0,11

META SPC 5

1.   META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 5 identifier

Identifier

meta SPC 5

1.2.   Suffix to the authorisation number

Number

1-5

1.3.   Product type(s)

Product type(s)	PT03 — Veterinary hygiene (Disinfectants)

2.   META SPC 5 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 5

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
					Min	Max
Polyvinylpyrrolidone iodine		Active substance	25655-41-8		1	1
Iodine		Active substance	7553-56-2	231-442-4	0,11	0,11

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

Formulation	AL — Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

Hazard statements
Precautionary statements

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

4.1.   Use description

Table 6. Use # 1 – Teat dips for post-milking disinfection

Product Type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeasts Enveloped viruses
Field(s) of use	Indoor Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)
Application method(s)	Dipping Manual dipping using a dip cup.
Application rate(s) and frequency	Post-milking application 1x – 3x per day Per milking event 3-10 ml of product are needed (animals with four teats).
Category(ies) of users	Professional
Pack sizes and packaging material	0,5 l – 1 000 l HDPE container

4.1.1.   Use-specific instructions for use

See general directions for use of meta SPC 5

4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 5

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 5

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 5

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 5

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 products must be brought to temperatures above 20 °C before use.

Product to be applied post-milking by use of a dipping cup.

Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.

The use of a dosing pump for filling the product into the application equipment is recommended.

5.2.   Risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Potential Health Effects

Eyes: Health injuries are not known or expected under normal use.

Skin: Health injuries are not known or expected under normal use.

Ingestion: Health injuries are not known or expected under normal use.

Inhalation: Health injuries are not known or expected under normal use.

Chronic Exposure: Health injuries are not known or expected under normal use.

First Aid Measures:

Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.

Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.

Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.

Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.

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 between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.

Shelf life: 18 months

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5

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

Trade name(s)	Veloucid D VelouCid MEPA Care D Cremadip MS Cow Udder SEPIA
Authorisation number	EU-0018398-0007 1-5
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Polyvinylpyrrolidone iodine		Active substance	25655-41-8		1
Iodine		Active substance	7553-56-2	231-442-4	0,11

META SPC 6

1.   META SPC 6 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 6 identifier

Identifier

meta SPC 6

1.2.   Suffix to the authorisation number

Number

1-6

1.3.   Product type(s)

Product type(s)	PT03 — Veterinary hygiene (Disinfectants)

2.   META SPC 6 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 6

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
					Min	Max
Polyvinylpyrrolidone iodine		Active substance	25655-41-8		1,35	1,35
Iodine		Active substance	7553-56-2	231-442-4	0,15	0,15

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

Formulation	AL — Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6

Hazard statements
Precautionary statements

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

4.1.   Use description

Table 7. Use # 1 – Teat dips or sprays for post-milking disinfection

Product Type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeasts Enveloped viruses
Field(s) of use	Indoor Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)
Application method(s)	Dipping or spraying: Manual dipping using a dip cup or Manual spraying using a trigger sprayer or Manual spraying using an electronic sprayer or Automated spraying by robot.
Application rate(s) and frequency	Post-milking application 1x – 3x per day Per milking event 3-10 ml (dipping) to 10-15 ml (spraying) of product are needed (animals with four teats).
Category(ies) of users	Professional
Pack sizes and packaging material	0,5 l – 1 000 l HDPE container

4.1.1.   Use-specific instructions for use

See general directions for use of meta SPC 6

4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 6

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 6

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 6

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 6

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.

The products must be brought to temperatures above 20 °C before use.

Product to be applied by dipping or spraying post-milking using manual or automatic equipment.

Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.

The use of a dosing pump for filling the product into the application equipment is recommended.

5.2.   Risk mitigation measures

Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) for spraying application

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Potential Health Effects

Eyes: Health injuries are not known or expected under normal use.

Skin: Health injuries are not known or expected under normal use.

Ingestion: Health injuries are not known or expected under normal use.

Inhalation: Health injuries are not known or expected under normal use.

Chronic Exposure: Health injuries are not known or expected under normal use.

First Aid Measures:

Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.

Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.

Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.

Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.

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 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 between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.

Shelf life: 24 months

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6

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

Trade name(s)	MEPA Barrier Spray D IoShield Spray QUARESS-Barrier
Authorisation number	EU-0018398-0008 1-6
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Polyvinylpyrrolidone iodine		Active substance	25655-41-8		1,35
Iodine		Active substance	7553-56-2	231-442-4	0,15

---

(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC1.

(2)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC2.

(3)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC3.

(4)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC4.

(5)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC5.

(6)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC6.

Article 1

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.

It shall be applicable from 23 April 2018.

Article 1

Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with 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.

ANNEX

Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

(1)	in the sixth column, expiration of approval, of row 311, Quinmerac, the date is replaced by ‘30 April 2024’;

(2)	in the sixth column, expiration of approval, of row 313, Pyridaben, the date is replaced by ‘30 April 2023’;

(3)	in the sixth column, expiration of approval, of row 314, Zinc phosphide, the date is replaced by ‘30 April 2024’.

Article 1

A Union authorisation is granted to Hypred SAS for the biocidal product family Hypred's iodine based products with authorisation number EU-0018397-0000.

The Union authorisation is valid from 11 October 2018 until 30 September 2028.

The Union authorisation is subject to compliance with the SPC set out in the Annex.

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.

ANNEX

Summary of product characteristics for a biocidal product family

HYPRED's iodine based products

Product type 3 — Veterinary hygiene (Disinfectants)

Authorisation number: EU-0018397-0000

R4BP asset number: EU-0018397-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

Name	HYPRED's iodine based products

1.2.   Product type(s)

Product type(s)	PT03 - Veterinary hygiene (Disinfectants)

1.3.   Authorisation holder

Name and address of the authorisation holder	Name	Hypred SAS
	Address	55, Boulevard Jules Verger - BP10180 35803 DINARD Cedex France
Authorisation number	EU-0018397-0000
R4BP asset number	EU-0018397-0000
Date of the authorisation	11 October 2018
Expiry date of the authorisation	30 September 2028

1.4.   Manufacturer(s) of the biocidal products

Name of manufacturer	HYPRED SAS
Address of manufacturer	55, Boulevard Jules Verger - BP10180 35803 DINARD France
Location of manufacturing sites	HYPRED SAS - 55, Boulevard Jules Verger - BP10180 35803 DINARD France HYPRED POLSKA SP. Z O.O. NIEPRUSZEWO, KASZTANOWA 4 64320 Buk Poland HYPRED IBERICA S.L Pol. Ind. Arazuri-Orcoyen C/C no 32 31160 Orcoyen – NAVARRA Spain HYPRED GmbH Marie-Curie-Straße 23 53332 Bornheim – Sechtem Germany HYPRED Italia s.r.l. Strada Montodine-Gombito Loc. Cà Nova 26010 Ripalta Arpina CR Italy

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

Active substance	Iodine
Name of manufacturer	COSAYACH: SCM Cía. Cosayach Minera Negreiros, Rut. N°96.625.710-5
Address of manufacturer	Terrenos de Elena S/N Terrenos de Elena S/N Huara, Región de Tarapacá Chile
Location of manufacturing sites	Mined at: S.C.M. Cía. Minera Negreiros, S.C.M. Cosayach Soledad. Refined at: S.C.M. Cía. Minera Negreiros. Pozo Almonte Chile

Active substance	Iodine
Name of manufacturer	ACF MINERA SA
Address of manufacturer	San Martín 499 Iquique Chile
Location of manufacturing sites	Faena Lagunas KM. 1.722 Ruta A-5, Pozo Almonte Chile

Active substance	Iodine
Name of manufacturer	SOCIEDAD QUIMICA y MINERA SA
Address of manufacturer	Los Militares 4290 SANTIAGO DE CHILE Chile
Location of manufacturing sites	Pedro de Valdivia (PV) Route B 180 Antofagasta Chile Nueva Victoria (NV) Route 5 North, Km 1925 Pozo Almonte Chile

2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

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

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
					Min	Max
Iodine		Active substance	7553-56-2	231-442-4	0,25	2,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy	Non active substance	68439-50-9		2,697	24,199

2.2.   Type(s) of formulation

Formulation(s)	AL - Any other liquid 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: Dipping products - ready to use

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	0,25	0,49
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy	Non active substance	68439-50-9		2,697	4,993

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

Formulation	AL - Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements	Causes serious eye irritation. Harmful to aquatic life with long lasting effects.
Precautionary statements	Keep out of reach of children. Wash hands thoroughly after handling. Wear protective gloves. Wear protective clothing. Wear eye protection. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

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

4.1.   Use description

Table 1. Use # 1 – Manual or automated dipping after milking

Product Type	PT03 - Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeasts Algae
Field(s) of use	Indoor Disinfection of teats of milk producing animals by dipping after milking
Application method(s)	Dipping - Manual or automated disinfection of teats by dipping after milking. Dipping cup or automated dipping machine.
Application rate(s) and frequency	— cows and buffaloes (3 to 10 ml: 5 ml recommended) — sheep (1,5 to 5 ml: 1,5 ml recommended) — goats (2,5 to 6 ml: 2,5 ml recommended) Frequency: 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1 000  L

4.1.1.   Use-specific instructions for use

See general directions for use of meta SPC 1

4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 1

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 1

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

None: See general directions for use of meta SPC 1

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 1

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.

Fill the dipping cup manually or automatically with the ready to use product.

Apply by dipping manually or automatically on animal's teats on the full length of the teat after milking.

—	cows and buffaloes (3 to 10 ml: 5 ml recommended)

—	sheep (1,5 to 5 ml: 1,5 ml recommended)

—	goats (2,5 to 6 ml: 2,5 ml recommended)

Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).

At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

Where necessary, repeat the application after each milking.

Clean the application equipment regularly with warm water.

5.2.   Risk mitigation measures

Wear eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

FIRST AID INSTRUCTIONS

—	In the event of inhalation: Bring to fresh air.

—	In the event of contact with the skin: Wash with water.

—	In the event of contact with the eyes: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

—	In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

Refer to the safety data sheet available for professional user: it contains an emergency phone number.

Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

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.

The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf life: 2 years in HDPE

Do not store at a temperature higher than 30 °C.

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)	Dip-io 2500 JOD DIP IODERM PSP DERMINO FR Iododip IODEX EXTRA Iodystrong DERMIODE INO IODE EPAIS INO STAR + IODACTIV 2500 IODIUM BX2500 Usual Iod Post ASiRAL Dip Coat IODOCAN EXTRA UDDER PLUS PRIMADIODE CERTIODE EPAIS IODIPACK GEL HELIO IODE EPAIS VAGEL GELAPIS ACTIV IOSAPIS GEL ZENCARE FLASH REPROGEL DERMADINE + KRONI Jod Dipp 2500 WÜBBELMANN JOD DIP Iodine Cleaner&Sanitizer MUNGIFILM ZEP FS FILMIODINE NIPPLE NP
Authorisation number	EU-0018397-0001 1-1
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active substance	7553-56-2	231-442-4	0,25
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy	Non active substance	68439-50-9		2,697

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

Trade name(s)	Dip-io YB MAX INO Io Dip MAX JOD DIP YB MAX IodoDip YB MAX Iodium Dip YB MAX JodyDip YB MAX Delta IoDip YB MAX
Authorisation number	EU-0018397-0002 1-1
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active substance	7553-56-2	231-442-4	0,49
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy	Non active substance	68439-50-9		4,993

META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

Identifier

meta SPC 2: Dipping, foaming, spraying products - Ready to use

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	0,25	0,49
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy	Non active substance	68439-50-9		2,697	4,69

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

Formulation	AL - Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

Hazard statements	Causes serious eye irritation. Harmful to aquatic life with long lasting effects.
Precautionary statements	Keep out of reach of children. Wash hands thoroughly after handling. Wear protective gloves. Wear protective clothing. Wear eye protection. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

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

4.1.   Use description

Table 2. Use # 1 – Manual or automated dipping, foaming or spraying before 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 Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking
Application method(s)	Dipping, foaming or spraying before milking - Manual or automated disinfection of teats by dipping, foaming or spraying before milking Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine
Application rate(s) and frequency	— cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) — sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) — goats (2,5 to 6 ml: 2,5 to 4 ml recommended) Frequency: 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1 000 L

4.1.1.   Use-specific instructions for use

Eliminate all visible dirt before applying the product.

Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat before milking.

Let the product act at least one minute.

Use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general instructions for use of meta SPC 2.

4.1.2.   Use-specific risk mitigation measures

For manual dipping/foaming application: Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/eye protection.

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 2

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 2

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 2

4.2.   Use description

Table 3. Use # 2 – Manual or automated dipping, foaming or spraying after milking

Product Type	PT03 - Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeasts Algae
Field(s) of use	Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking
Application method(s)	Dipping, foaming, spraying after milking - Manual or automated disinfection of teats by dipping, foaming or spraying after milking Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine
Application rate(s) and frequency	— cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) — sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) — goats (2,5 to 6 ml: 2,5 to 4 ml recommended) Frequency: 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1 000 L

4.2.1.   Use-specific instructions for use

Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat after milking.

Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).

At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general instructions for use of meta SPC 2.

4.2.2.   Use-specific risk mitigation measures

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 2

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 2

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 2

5.   GENERAL DIRECTIONS FOR USE (2) OF THE META SPC 2

5.1.   Instructions for use

See use-specific instructions for each 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 the dipping/foaming cup/sprayer manually or automatically with the ready to use product.

Where necessary repeat the application at each milking

Clean the application equipment regularly with warm water.

5.2.   Risk mitigation measures

See use-specific risk mitigation measures for each use.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

FIRST AID INSTRUCTIONS

—	In the event of inhalation: Bring to fresh air.

—	In the event of contact with the skin: Wash with water.

—	In the event of contact with the eyes: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

—	In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

Refer to the safety data sheet available for professional user: it contains an emergency phone number.

Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

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.

The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf life: 2 years in HDPE

Do not store at a temperature higher than 30 °C.

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)	Liq-io 2500 JOD SPRAY IODINE 3000 RTU IODEX 2500 Usual Iod Liquid Iodoliquid Iodospray DESINTEAT IODYSPRAY RBT 2500 IODY'FLASH INO IODE SPRAY IODYPRO 2500 IODYPRO BL2500 Robot Liq-io 25 ADF iDip+ ASiRAL Dip Spray J IODIPACK HELIO IODE LIQUIDE POLY-IODE CERTIODE LIQUIDE IOSAPIS FLUID GELAPIS ROBOT ZENCARE SPRAY HELIO IODE SPRAY + IODIP + KRONI Jod Spray 2500 WÜBBELMANN JOD LIQUID
Authorisation number	EU-0018397-0003 1-2
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active substance	7553-56-2	231-442-4	0,25
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy	Non active substance	68439-50-9		2,697

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

Trade name(s)	Liq-io YB MAX INO Io Liquid Max Iodoliquid YB MAX Iodospray YB MAX Desinteat YB MAX Iodium Spray YB MAX JodySpray YB MAX Delta IoSpray YB MAX
Authorisation number	EU-0018397-0004 1-2
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active substance	7553-56-2	231-442-4	0,49
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy	Non active substance	68439-50-9		4,69

META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier

Identifier

meta SPC 3: Dipping, foaming, spraying concentrated products

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	2,5	2,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy	Non active substance	68439-50-9		24,199	24,199

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

Formulation	SL - Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

Hazard statements

Causes serious eye damage. May cause damage to organs (thyroid) through prolonged or repeated exposure oral. Toxic to aquatic life with long lasting effects. May be corrosive to metals.

Precautionary statements

Keep out of reach of children. Do not breathe mist. Do not breathe vapours. Do not breathe spray. Wash hands thoroughly after handling. Wear protective gloves. Wear protective clothing. Wear eye protection. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a poison center/doctor. Get medical advice/attention if you feel unwell. Dispose of contents to in accordance with local/regional/national/international regulations. Dispose of container to in accordance with local/regional/national/international regulations. Keep only in original container. Absorb spillage to prevent material damage.

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

4.1.   Use description

Table 4. Use # 1 – Manual or automated dipping, foaming or spraying before 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 Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking
Application method(s)	Dipping, foaming, spraying - Manual or automated disinfection of teats by dipping, foaming or spraying before milking. Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine
Application rate(s) and frequency	A dilution at 10 % (v/v) should be prepared Application rate for the diluted product: — cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) — sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) — goats (2,5 to 6 ml: 2,5 to 4 ml recommended) Frequency: 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1 000 L

4.1.1.   Use-specific instructions for use

Prepare a dilution at 10 % (v/v: 10 ml product, add water up to 100 ml) for bactericidal and yeasticidal activity.

Fill the dipping/foaming cup/sprayer manually or automatically with the prepared dilution.

Eliminate all visible dirt before applying the product.

Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat before milking.

Let the product act at least one minute.

Use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general directions for use of meta SPC 3.

4.1.2.   Use-specific risk mitigation measures

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 3

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 3

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 3

4.2.   Use description

Table 5. Use # 2 – Manual or automated dipping, foaming or spraying after milking

Product Type	PT03 - Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeasts Algae Viruses
Field(s) of use	Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking
Application method(s)	Dipping, foaming, spraying - Manual or automated disinfection of teats by dipping, foaming or spraying after milking. Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine
Application rate(s) and frequency	For disinfection of bacteria, yeasts and algae a dilution at 10 % (v/v: 10 ml product, add water up to 100 ml) should be prepared. For disinfection of viruses a dilution at 20 % (v/v: 20 ml product, add water up to 100 ml) should be prepared Application rate for the diluted product: — cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) — sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) — goats (2,5 to 6 ml: 2,5 to 4 ml recommended) Frequency: 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1 000 L

4.2.1.   Use-specific instructions for use

Prepare a dilution at 10 % (v/v: 10 ml product, add water up to 100 ml) for bactericidal, yeasticidal and algaecidal activity or 20 % (v/v: 20 ml product, add water up to 100 ml) in case virucidal activity is also needed.

Fill the dipping/foaming cup/sprayer manually or automatically with the prepared dilution.

Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat after milking.

Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).

At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general directions for use of meta SPC 3.

4.2.2.   Use-specific risk mitigation measures

For manual spraying applications wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 3

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 3

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 3

5.   GENERAL DIRECTIONS FOR USE (3) OF THE META SPC 3

5.1.   Instructions for use

See use-specific instructions for each 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 the dipping/foaming cup/sprayer manually or automatically with the prepared dilution.

Where necessary, repeat the application at each milking

Clean the application equipment regularly with warm water.

5.2.   Risk mitigation measures

See use-specific risk mitigation measures for each use.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

In case of faintness, get medical advice/attention. Show this safety data sheet to the doctor.

FIRST AID INSTRUCTIONS

—	In the event of inhalation: Bring to fresh air.

—	In the event of contact with the skin: Wash with water.

—	In the event of contact with the eyes: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open. Remove contact lenses if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor/physician.

—	In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

Refer to the safety data sheet available for professional user: it contains an emergency phone number.

Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

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.

The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf life: 2 years in HDPE

Do not store at a temperature higher than 30 °C.

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)	Liq-io concentrate INO Jod Konzentrat Usual Iod Concent Iodoconcentrat D 10 IODINE D 5 IODINE Liq-io C INO IODE C D 4 IODINE ADF iDip+ concentrate Mammizan Concentré
Authorisation number	EU-0018397-0005 1-3
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active substance	7553-56-2	231-442-4	2,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy	Non active substance	68439-50-9		24,199

META SPC 4

1.   META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier

Identifier

meta SPC 4: Dipping products reaching virucidal activity – Ready to use

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	0,5	0,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy	Non active substance	68439-50-9		4,993	4,993

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

Formulation	AL - Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

Hazard statements	Causes serious eye irritation. Harmful to aquatic life with long lasting effects.
Precautionary statements	Keep out of reach of children. Wash hands thoroughly after handling. Wear protective gloves. Wear protective clothing. Wear eye protection. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

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

4.1.   Use description

Table 6. Use # 1 – Manual or automated dipping after milking

Product Type	PT03 - Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeasts Algae Viruses
Field(s) of use	Indoor Disinfection of teats of milk producing animals by dipping after milking
Application method(s)	Dipping - Manual or automated disinfection of teats by dipping after milking. Dipping cup or automated dipping machine.
Application rate(s) and frequency	— cows and buffaloes (3 to 10 ml: 5 ml recommended) — sheep (1,5 to 5 ml: 1,5 ml recommended) — goats (2,5 to 6 ml: 2,5 ml recommended) Frequency: 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1 000 L

4.1.1.   Use-specific instructions for use

See general directions for use of meta SPC 4

4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 4

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 4

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 4

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 4

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 the dipping cup manually or automatically with the ready to use product.

Apply by dipping manually or automatically on animal's teats on the full length of the teat after milking.

—	cows and buffaloes (3 to 10 ml: 5 ml recommended)

—	sheep (1,5 to 5 ml: 1,5 ml recommended)

—	goats (2,5 to 6 ml: 2,5 ml recommended)

Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).

At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

Where necessary, repeat the application after each milking.

Clean the application equipment regularly with warm water.

5.2.   Risk mitigation measures

Wear eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

FIRST AID INSTRUCTIONS

—	In the event of inhalation: Bring to fresh air.

—	In the event of contact with the skin: Wash with water.

—	In the event of contact with the eyes: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

—	In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

Refer to the safety data sheet available for professional user: it contains an emergency phone number.

Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

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.

The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf life: 2 years in HDPE

Do not store at a temperature higher than 30 °C.

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)	Dip-io 5000 IODIUM TX INO JOD 50 DIP Usual Iod Post + IODIUM PRO DIP IODERM PSP + IODEX EXTRA + Iododip + IODYSTRONG PLUS INO TREMP INO STAR IODACTIV 5000 DERMINO IODERM 5000 IODIUM BX5000 HOEVE-PLUS DIP TREMPASEPT IODE DERMADINE MAMMO-DERM KRONI Jod Dipp 5000
Authorisation number	EU-0018397-0006 1-4
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active substance	7553-56-2	231-442-4	0,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy	Non active substance	68439-50-9		4,993

META SPC 5

1.   META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 5 identifier

Identifier

meta SPC 5: Dipping, foaming, spraying products 5 500  ppm – Ready to use

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	0,55	0,55
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy	Non active substance	68439-50-9		4,69	4,69

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

Formulation	AL - Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

Hazard statements	Causes serious eye irritation. Harmful to aquatic life with long lasting effects.
Precautionary statements	Keep out of reach of children. Wash hands thoroughly after handling. Wear protective gloves. Wear protective clothing. Wear eye protection. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

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

4.1.   Use description

Table 7. Use # 1 – Manual or automated dipping, foaming or spraying before 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 Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking
Application method(s)	Dipping, foaming, spraying - Manual or automated disinfection of teats by dipping, foaming or spraying before milking Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine
Application rate(s) and frequency	— cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) — sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) — goats (2,5 to 6 ml: 2,5 to 4 ml recommended) Frequency: 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1 000 L

4.1.1.   Use-specific instructions for use

Fill the dipping/foaming cup/sprayer manually or automatically with the ready to use product.

Eliminate all visible dirt before applying the product.

Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat before milking.

Let the product act at least one minute.

Use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general instructions for use of meta SPC5.

4.1.2.   Use-specific risk mitigation measures

For manual dipping/foaming application: Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/eye protection.

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 5

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 5

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 5

4.2.   Use description

Table 8. Use # 2 – Manual or automated dipping, foaming or spraying after milking

Product Type	PT03 - Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeasts Algae Viruses
Field(s) of use	Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking
Application method(s)	Dipping, foaming, spraying - Manual or automated disinfection of teats by dipping, foaming or spraying after milking. Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine.
Application rate(s) and frequency	— cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) — sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) — goats (2,5 to 6 ml: 2,5 to 4 ml recommended) Frequency: 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1 000 L

4.2.1.   Use-specific instructions for use

Fill the dipping/foaming cup/sprayer manually or automatically with the ready to use product.

Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat after milking.

Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).

At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general instructions for use of meta SPC 5.

4.2.2.   Use-specific risk mitigation measures

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 5

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 5

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 5

5.   GENERAL DIRECTIONS FOR USE (5) OF THE META SPC 5

5.1.   Instructions for use

See use-specific instructions for each 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.

Where necessary repeat the application at each milking.

Clean the application equipment regularly with warm water.

5.2.   Risk mitigation measures

See use-specific risk mitigation measures for each use.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

FIRST AID INSTRUCTIONS

—	In the event of inhalation: Bring to fresh air.

—	In the event of contact with the skin: Wash with water.

—	In the event of contact with the eyes: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

—	In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

Refer to the safety data sheet available for professional user: it contains an emergency phone number.

Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

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.

The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf life: 2 years in HDPE

Do not store at a temperature higher than 30 °C.

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)	Liq-io 5500 IODYPRO INO JOD 50 Liquid Usual Iod Liquid + IODIUM PRO SPRAY IODEX Iodoliquid + Iodospray Plus DESINTEAT PLUS ROBOSPRAY IODE INOTRAYON IODYPRO 5500 Robot Liq-io 55 IODYPRO BL5500 ADF iDip+ 5500 HOEVE-JODIUM SPRAY GRUPAIODE IODOCAN JOFO JODI PLUS K-AGRO PRODIP ID IODIP HELIO IODE SPRAY MAMMO-JOD KRONI Jod Spray 5500 MUNGI-IOD LELY QUARESS-Iodine
Authorisation number	EU-0018397-0007 1-5
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active substance	7553-56-2	231-442-4	0,55
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy	Non active substance	68439-50-9		4,69

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(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC1.

(2)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC2.

(3)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC3.

(4)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC4.

(5)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC5.

Article 1

Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.

Article 2

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

ANNEX

Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

(1)	in the sixth column, expiration of approval, of row 40, Deltamethrin, the date is replaced by ‘31 October 2019’;

(2)	in the sixth column, expiration of approval, of row 48, Beta-cyfluthrin, the date is replaced by ‘31 October 2019’;

(3)	in the sixth column, expiration of approval, of row 64, Flurtamone, the date is replaced by ‘31 October 2019’;

(4)	in the sixth column, expiration of approval, of row 65, Flufenacet, the date is replaced by ‘31 October 2019’;

(5)	in the sixth column, expiration of approval, of row 67, Dimethenamid-p, the date is replaced by ‘31 October 2019’;

(6)	in the sixth column, expiration of approval, of row 69, Fosthiazate, the date is replaced by ‘31 October 2019’;

(7)	in the sixth column, expiration of approval, of row 101, Chlorothalonil, the date is replaced by ‘31 October 2019’;

(8)	in the sixth column, expiration of approval, of row 102, Chlorotoluron, the date is replaced by ‘31 October 2019’;

(9)	in the sixth column, expiration of approval, of row 103, Cypermethrin, the date is replaced by ‘31 October 2019’;

(10)	in the sixth column, expiration of approval, of row 104, Daminozide, the date is replaced by ‘31 October 2019’;

(11)	in the sixth column, expiration of approval, of row 105, Thiophanate-methyl, the date is replaced by ‘31 October 2019’;

(12)	in the sixth column, expiration of approval, of row 106, Tribenuron, the date is replaced by ‘31 October 2019’;

(13)	in the sixth column, expiration of approval, of row 107, MCPA, the date is replaced by ‘31 October 2019’;

(14)	in the sixth column, expiration of approval, of row 108, MCPB, the date is replaced by ‘31 October 2019’;

(15)	in the sixth column, expiration of approval, of row 117, 1-methylcyclopropene, the date is replaced by ‘31 October 2019’;

(16)	in the sixth column, expiration of approval, of row 119, Indoxacarb, the date is replaced by ‘31 October 2019’;

(17)	in the sixth column, expiration of approval, of row 160, Prosulfocarb, the date is replaced by ‘31 October 2019’;

(18)	in the sixth column, expiration of approval, of row 161, Fludioxonil, the date is replaced by ‘31 October 2019’;

(19)	in the sixth column, expiration of approval, of row 162, Clomazone, the date is replaced by ‘31 October 2019’;

(20)	in the sixth column, expiration of approval, of row 192, Diuron, the date is replaced by ‘30 September 2019’.

Article 1

The forms for the submission of the information referred to in paragraphs 1 and 3 of Article 4 of Regulation (EU) 2018/644 are set out in Annexes I and II 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.

ANNEX I

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ANNEX II

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Article 1

Renewal of the approval of the active substance

The approval of the active substance pethoxamid is renewed as set out in Annex I.

Article 2

Amendments to Implementing Regulation (EU) No 540/2011

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Article 3

Entry into force and date of application

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

It shall apply from 1 December 2018.

ANNEX I

Common Name, Identification Numbers	IUPAC Name	Purity (1)	Date of approval	Expiration of approval	Specific provisions
Pethoxamid CAS No 106700-29-2 CIPAC No 665	2-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1-enyl) acetamide	≥ 940 g/kg Impurities: Toluene: max 3 g/kg.	1 December 2018	30 November 2033	PART A Use shall be limited to one application every two years in the same field at a maximum dose of 1 200 g active substance per hectare. PART B For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on pethoxamid, and in particular Appendices I and II thereto, shall be taken into account. In their overall assessment Member States shall pay particular attention to: — the risk of groundwater metabolites when pethoxamid is applied in regions with vulnerable soil and/or climatic conditions; — the risk to aquatic organisms and earthworms; — the risk to consumers from residues in the succeeding crops or in case of crop failure. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: 1. the relevance of the metabolites that may occur in groundwater, taking into account any relevant classification for pethoxamid in accordance with Regulation (EC) No 1272/2008 of the Parliament and of the Council (2), in particular as carcinogen category 2; 2. the effect of water treatment processes on the nature of residues present in drinking water; 3. the endocrine disrupting potential of pethoxamid as regards the thyroid modality/pathway as a minimum providing mechanistic data to clarify whether there is a thyroid endocrine disrupting mode of action. The applicant shall submit the information requested under point 1 within one year after the publication of the opinion adopted by the Committee for Risk Assessment of the European Chemicals Agency in accordance with Article 37(4) Regulation (EC) No 1272/2008 of the European Parliament and of the Council with respect to pethoxamid and the information requested. The applicant shall submit the information requested under point 2 within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission. The applicant shall submit the information requested under point 3 by 10 November 2020 in accordance with Commission Regulation (EU) 2018/605 (3) amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties and the joint guidance document to identify endocrine disrupting substances as adopted by EFSA and ECHA.

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(1)  Further details on identity and specification of active substance are provided in the renewal report.

(2)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

(3)  Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.4.2018, p. 33).

ANNEX II

The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

(1)	in Part A, entry 122 on pethoxamid is deleted;

(2)

in Part B, the following entry is added: No Common Name, Identification Numbers IUPAC Name Purity (1) Date of approval Expiration of approval Specific provisions ‘127 Pethoxamid CAS No 106700-29-2 CIPAC No 665 2-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1-enyl) acetamide ≥ 940 g/kg Impurities: Toluene: max 3 g/kg. 1 December 2018 30 November 2033 PART A Use shall be limited to one application every two years in the same field at a maximum dose of 1 200 g active substance per hectare. PART B For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on pethoxamid, and in particular Appendices I and II thereto, shall be taken into account. In their overall assessment Member States shall pay particular attention to: — the risk of groundwater metabolites when pethoxamid is applied in regions with vulnerable soil and/or climatic conditions; — the risk to aquatic organisms and earthworms; — the risk to consumers from residues in the succeeding crops or in case of crop failure. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: 1. the relevance of the metabolites that may occur in groundwater, taking into account any relevant classification for pethoxamid in accordance with Regulation (EC) No 1272/2008 of the Parliament and of the Council (2), in particular as carcinogen category 2; 2. the effect of water treatment processes on the nature of residues present in drinking water; 3. the endocrine disrupting potential of pethoxamid as regards the thyroid modality/pathway as a minimum providing mechanistic data to clarify whether there is a thyroid endocrine disrupting mode of action. The applicant shall submit the information requested under point 1 within one year after the publication of the opinion adopted by the Committee for Risk Assessment of the European Chemicals Agency in accordance with Article 37(4) Regulation (EC) No 1272/2008 of the European Parliament and of the Council with respect to pethoxamid and the information requested. The applicant shall submit the information requested under point 2 within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission. The applicant shall submit the information requested under point 3 by 10 November 2020 in accordance with Commission Regulation (EU) 2018/605 (3) amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties and the joint guidance document to identify endocrine disrupting substances as adopted by EFSA and ECHA.’

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(1)  Further details on identity and specification of active substance are provided in the renewal report.

(2)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

(3)  Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.4.2018, p. 33).

Article 1

Approval of active substance

The active substance fenpicoxamid, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

Article 2

Amendment to Implementing Regulation (EU) No 540/2011

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Article 3

Entry into force

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

ANNEX I

Common Name, Identification Numbers	IUPAC Name	Purity (1)	Date of approval	Expiration of approval	Specific provisions
Fenpicoxamid CAS No: 517875-34-2 CIPAC No: 991	(3S,6S,7R,8R)-8-benzyl-3-{3-[(isobutyryloxy)methoxy]-4-methoxypyridine-2-carboxamido}-6-methyl-4,9-dioxo-1,5-dioxonan-7-yl isobutyrate	≥ 750 g/kg	11 October 2018	11 October 2028	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenpicoxamid, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the impact of processing on the consumer risk assessment, — the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: 1. the technical specification of the active substance as manufactured (based on commercial scale production) and the compliance of the toxicity batches with the confirmed technical specification; 2. the effect of water treatment processes on the nature of residues present in drinking water; 3. the endocrine disrupting potential of fenpicoxamid as regards the thyroid modality/pathway, providing in particular mechanistic data to clarify according to Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605 (2), whether the effects observed in the studies submitted for approval are or are not related to a thyroid endocrine disrupting mode of action. The applicant shall submit to the Commission, the Member States and the Authority the information referred to in point 1 by 11 October 2019, in point 2 within 2 years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission and in point 3 by 10 November 2020.

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(1)  Further details on identity and specification of active substance are provided in the review report.

(2)  Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.4.2018, p. 33).

ANNEX II

In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

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(1)  Further details on identity and specification of active substance are provided in the review report.

(2)  Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties. (OJ L 101, 20.4.2018, p. 33).