ANNEX

Summary of product characteristics for a biocidal product family

Iodine Teat dip products

Product type 3 — Veterinary hygiene (Disinfectants)

Authorisation number: EU-0020125-0000

R4BP asset number: EU-0020125-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

Name	Iodine Teat dip 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	GEA Farm Technologies GmbH
	Address	Siemensstraße 25-27, 59199, Bönen, Germany
Authorisation number	EU-0020125-0000
R4BP asset number	EU-0020125-0000
Date of the authorisation	19 November 2019
Expiry date of the authorisation	31 October 2029

1.4.   Manufacturer(s) of the biocidal products

Name of manufacturer	GEA Farm Technologies
Address of manufacturer	Wylye Works, BA12 9HT Warminster United Kingdom
Location of manufacturing sites	Wylye Works, Watery Lane, BA12 9HT Warminster United Kingdom Gewerbestraße 5, 5325 Plainfeld Austria ul. Olowiana 10, 85-461 Bydgoszcz Poland

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

Active substance	Iodine
Name of manufacturer	SQM Europe N.V.
Address of manufacturer	St Pietersvliet 7„ bus 8 2000 Antwerp Belgium
Location of manufacturing sites	Sociedad Quimica y Minera SA, Los Militares, Las Condes, 4290 Piso 4 Santiago Chile

Active substance	Iodine
Name of manufacturer	Nihon Tennen Gas Co., Ltd (Via Mitsui & Co Europe PLC)
Address of manufacturer	Chiba Plant, 2508 Minami-Hinata, Shirako-Machi, Chosei-Gun„ 299-4205 Chosei-Gun Japan
Location of manufacturing sites	Chiba Plant, 2508 Minami-Hinata, Shirako-Machi, Chosei-Gun„ 299-4205 Chosei-Gun Japan

Active substance	Iodine
Name of manufacturer	Norkem Ltd
Address of manufacturer	Norkem House, Bexton Lane„ WA16 9FB Knutsford United Kingdom
Location of manufacturing sites	OFICINA CALA CALA S/N, Unknown 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	0,16	2,47
C9-11 Alcohol Ethoxylate	C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060	Non-active substance	68439-46-3	614-482-0	0,0	2,35

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 — Concentrates — Professional concentrates with 1:3, 1:4 and 1:7 dilution rates

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	1,58	2,47
C9-11 Alcohol Ethoxylate	C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060	Non-active substance	68439-46-3	614-482-0	1,51	2,35

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

Formulation(s)

SL — Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements

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

Precautionary statements

Do not breathe vapours. 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. Get medical attention if you feel unwell. If eye irritation persists: Get medical advice. Collect spillage. Dispose of container according to local regulations. Dispose of contents according to local regulations.

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

4.1.   Use description

Table 1

Use # 1 – Concentrates — Professional concentrates with 1:3, 1:4 and 1:7 dilution rates, for post milking — Dipping

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeast
Field(s) of use	Indoor
Application method(s)	Open system: dip treatment Application via dip Cup: Using a traditional dip cup with non-return valves, dispense diluted product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking The same solution can be applied to multiple animals during the same milking session. Cups should be refilled with fresh solution before starting new milking session
Application rate(s) and frequency	Quantity of diluted product to be applied per application: — 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) Product to be diluted by the relevant rate stated on the label. Either: 25 % (1 part product to 3 parts water) 20 % (1 part product to 4 parts water) 12,5 % (1 part product to 7 parts water) In use concentration of products between 0,29 and 0,52 % (w/w) iodine. 2 post milking applications per animal, per day
Category(ies) of users	Trained professional Professional
Pack sizes and packaging material	Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.1.1.   Use-specific instructions for use

Dip at least 2/3 of the teat length with diluted product immediately after milking

4.1.2.   Use-specific risk mitigation measures

Wear protective chemical resistant gloves and eye protection when handling the concentrate

(glove material to be specified by the authorisation holder within the product information).

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

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.2.   Use description

Table 2

Use # 2 – Concentrates — Professional concentrates with 1:3, 1:4 and 1:7 dilution rates, for post milking — Spraying

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeast
Field(s) of use	Indoor
Application method(s)	Open system: spray treatment Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the diluted product. The diluted product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the diluted product Application via manual trigger spray: Fill trigger spray bottle with diluted product. Use trigger spray to cover the bottom two thirds of each teat with diluted product
Application rate(s) and frequency	Quantity of diluted product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Product to be diluted by the relevant rate stated on the label. Either: 25 % (1 part product to 3 parts water) 20 % (1 part product to 4 parts water) 12,5 % (1 part product to 7 parts water) In use concentration of products between 0,29 and 0,52 % (w/w) iodine. 2 post milking applications per animal, per day
Category(ies) of users	Trained professional Professional
Pack sizes and packaging material	Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.2.1.   Use-specific instructions for use

Spray at least 2/3 of the teat length with diluted product immediately after milking

4.2.2.   Use-specific risk mitigation measures

Wear protective chemical resistant gloves and eye protection when handling the concentrate

(glove material to be specified by the authorisation holder within the product information).

Wear protective chemical resistant gloves and boots when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)

A protective coverall (at least type 6, EN 13034) shall be worn.

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

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.3.   Use description

Table 3

Use # 3 – Concentrates — Professional concentrates with 1:3, 1:4 and 1:7 dilution rates, for post milking — Foaming

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeast
Field(s) of use	Indoor
Application method(s)	Open system: dip treatment Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder The same solution can be applied to multiple animals during the same milking session.
Application rate(s) and frequency	Quantity of diluted product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Product to be diluted by the relevant rate stated on the label. Either: 25 % (1 part product to 3 parts water) 20 % (1 part product to 4 parts water) 12,5 % (1 part product to 7 parts water) In use concentration of products between 0,29 and 0,52 % (w/w) iodine. 2 post milking applications per animal, per day
Category(ies) of users	Trained professional Professional
Pack sizes and packaging material	Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.3.1.   Use-specific instructions for use

Dip at least 2/3 of the teat length with diluted product immediately after milking

4.3.2.   Use-specific risk mitigation measures

Wear protective chemical resistant gloves and eye protection when handling the concentrate

(glove material to be specified by the authorisation holder within the product information).

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

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1

5.1.   Instructions for use

Keep out of reach of children

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.

Dilute product before application according to the ratio specified on the product label

Formanual dilution of the concentrate; Add the ratio of concentrate and water, specified on the product label, to a suitably sized container to achieve the required dilution rate. Mix to a uniform solution.

Before attaching the milking cluster, all teat-dip residues should be removed with either a single use towel or re-usable cloth. One cloth should be used per cow

For effective use against bacteria and yeast, product must be left in contact with the skin for at least 60 seconds

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

Product can be used during the entire lactation period

5.2.   Risk mitigation measures

See use specific risk mitigation measures

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

Remove and wash contaminated clothing before re-use.

After inhalation: Move to fresh air in case of accidental inhalation of fumes from overheating or combustion.

If you feel unwell, seek medical advice.

After contact with skin: Wash with water and soap as a precaution. Consult a doctor if skin irritation persists.

After contact with eyes: Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes. Seek medical treatment by eye specialist.

After ingestion: Rinse out mouth and give plenty of water to drink. Never give anything by mouth to an unconscious person. Consult a physician.

Large spills should be contained using a chemical spill kit, soaked up using absorbent material such as kieselguhr and disposed of as hazardous waste.

5.4.   Instructions for safe disposal of the product and its packaging

At the end of the treatment, dispose of 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 farm based waste water treatment plant.

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

Protect from frost

Do not store at temperatures above 30 °C

Shelf life 12 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)	Ioklene Concentrate. Coars Dual
Authorisation number	EU-0020125-0001 1-1
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active Substance	7553-56-2	231-442-4	1,58
C9-11 Alcohol Ethoxylate	C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060	Non-active substance	68439-46-3	614-482-0	1,51

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

Trade name(s)	Clinidip L Concentrate, Maxadine C, Diamond 3:1 Concentrate, Kristal 321, IO Spray 3:1 Concentrate, Coars Shield
Authorisation number	EU-0020125-0002 1-1
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active Substance	7553-56-2	231-442-4	2,06
C9-11 Alcohol Ethoxylate	C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060	Non-active substance	68439-46-3	614-482-0	1,96

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

Trade name(s)	Clinidip Superconcentrate, Dunglinson Super IO 421 Concentrate, Ceanodine 4:1, Iodosan
Authorisation number	EU-0020125-0003 1-1
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active Substance	7553-56-2	231-442-4	2,47
C9-11 Alcohol Ethoxylate	C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060	Non-active substance	68439-46-3	614-482-0	2,35

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

Trade name(s)	Priodine, Diamond Predip
Authorisation number	EU-0020125-0004 1-1
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active Substance	7553-56-2	231-442-4	2,32
C9-11 Alcohol Ethoxylate	C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060	Non-active substance	68439-46-3	614-482-0	2,21

META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

Identifier

Meta SPC 2 — RTU Products — Professional RTU Liquid for application pre and post milking

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	0,16	0,5
C9-11 Alcohol Ethoxylate	C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060	Non-active substance	68439-46-3	614-482-0	0,0	0,56

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

Formulation(s)

AL — Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

Hazard statements	May be corrosive to metals. Harmful to aquatic life with long lasting effects.
Precautionary statements	Avoid release to the environment. Collect spillage. Dispose of contents in accordance with local regulations. Dispose of container in accordance with local regulations.

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

4.1.   Use description

Table 4

Use # 1 – RTU Products — Professional RTU Liquid, for application pre-milking — Dipping

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeast
Field(s) of use	Indoor
Application method(s)	Open system: dip treatment Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking The same solution can be applied to multiple animals during the same milking session.
Application rate(s) and frequency	Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation in use concentration 0,16-0,30 % (w/w) iodine. 2 pre milking applications per animal, per day
Category(ies) of users	Trained professional Professional
Pack sizes and packaging material	Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.1.1.   Use-specific instructions for use

See general directions for use.

4.1.2.   Use-specific risk mitigation measures

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

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

See general directions for use.

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

See general directions for use.

4.2.   Use description

Table 5

Use # 2 – RTU Products — Professional RTU Liquid, for application pre milking — Spraying

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeast All
Field(s) of use	Indoor
Application method(s)	Open system: spray treatment Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product
Application rate(s) and frequency	Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16-0,30 % (w/w) iodine. 2 pre milking applications per animal, per day
Category(ies) of users	Trained professional Professional
Pack sizes and packaging material	Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.2.1.   Use-specific instructions for use

See general directions for use.

4.2.2.   Use-specific risk mitigation measures

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

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

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

See general directions for use.

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

See general directions for use.

4.3.   Use description

Table 6

Use # 3 – RTU Products — Professional RTU Liquid, for application pre milking – Foaming

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeast All
Field(s) of use	Indoor
Application method(s)	Open system: dip treatment Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder The same solution can be applied to multiple animals during the same milking session.
Application rate(s) and frequency	Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation. In use concentration 0,16-0,30 % (w/w) iodine. 2 pre milking applications per animal, per day
Category(ies) of users	Trained professional Professional
Pack sizes and packaging material	Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.3.1.   Use-specific instructions for use

See general directions for use.

4.3.2.   Use-specific risk mitigation measures

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

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.4.   Use description

Table 7

Use # 4 – RTU Products — Professional RTU Liquid, for application post milking – Dipping

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeast
Field(s) of use	Indoor
Application method(s)	Open system: dip treatment Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking The same solution can be applied to multiple animals during the same milking session.
Application rate(s) and frequency	Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation. In use concentration 0,16-0,50 % (w/w) iodine. 2 post milking applications per animal, per day
Category(ies) of users	Trained professional Professional
Pack sizes and packaging material	Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.4.1.   Use-specific instructions for use

Dip at least 2/3 of the teat length with RTU product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

4.4.2.   Use-specific risk mitigation measures

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

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.5.   Use description

Table 8

Use # 5 – RTU Products — Professional RTU Liquid, for application post milking – Spraying

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeast
Field(s) of use	Indoor
Application method(s)	Open system: spray treatment Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product
Application rate(s) and frequency	Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation. In use concentration 0,16-0,50 % (w/w) iodine. 2 post milking applications per animal, per day
Category(ies) of users	Trained professional Professional
Pack sizes and packaging material	Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.5.1.   Use-specific instructions for use

Spray at least 2/3 of the teat length with RTU product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

4.5.2.   Use-specific risk mitigation measures

Wear protective chemical resistant gloves and boots when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)

A protective coverall (at least type 6, EN 13034) shall be worn

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

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.6.   Use description

Table 9

Use # 6 – RTU Products — Professional RTU Liquid, for application post milking – Foaming

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeast
Field(s) of use	Indoor
Application method(s)	Open system: dip treatment Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder The same solution can be applied to multiple animals during the same milking session.
Application rate(s) and frequency	Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16-0,50 % (w/w) iodine. 2 post milking applications per animal, per day
Category(ies) of users	Trained professional Professional
Pack sizes and packaging material	Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.6.1.   Use-specific instructions for use

Dip at least 2/3 of the teat length with RTU product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

4.6.2.   Use-specific risk mitigation measures

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

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.7.   Use description

Table 10

Use # 7 – RTU Products — Professional RTU Liquid, for application pre and post milking-Dipping

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeast
Field(s) of use	Indoor
Application method(s)	Open system: dip treatment Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking The same solution can be applied to multiple animals during the same milking session.
Application rate(s) and frequency	Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16-0,30 % (w/w) iodine. 2 pre milking applications per animal, per day 2 post milking applications per animal, per day
Category(ies) of users	Trained professional Professional
Pack sizes and packaging material	Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.7.1.   Use-specific instructions for use

Post milking:

Dip at least 2/3 of the teat length with RTU product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

4.7.2.   Use-specific risk mitigation measures

Wear protective chemical resistant gloves when applying the product by dipping (glove material to be specified by the authorisation holder within the product information).

This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.8.   Use description

Table 11

Use # 8 – RTU Products — Professional RTU Liquid, for application pre and post milking- Spraying

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeast
Field(s) of use	Indoor
Application method(s)	Open system: spray treatment Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product
Application rate(s) and frequency	Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) – Ready to use formulation In use concentration 0,16-0,30 % (w/w) iodine. 2 pre milking applications per animal, per day 2 post milking applications per animal, per day
Category(ies) of users	Trained professional Professional
Pack sizes and packaging material	Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.8.1.   Use-specific instructions for use

Post milking:

Spray at least 2/3 of the teat length with RTU product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

4.8.2.   Use-specific risk mitigation measures

Wear protective chemical resistant gloves and boots when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)

A protective coverall (at least type 6, EN 13034) shall be worn

This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.9.   Use description

Table 12

Use # 9 – RTU Products — Professional RTU Liquid, for application pre and post milking — Foaming

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeast
Field(s) of use	Indoor
Application method(s)	Open system: dip treatment Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder The same solution can be applied to multiple animals during the same milking session.
Application rate(s) and frequency	Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1.5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16-0,30 % (w/w) iodine. 2 pre milking applications per animal, per day 2 post milking applications per animal, per day
Category(ies) of users	Trained professional Professional
Pack sizes and packaging material	Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.9.1.   Use-specific instructions for use

Post milking:

Dip at least 2/3 of the teat length with RTU product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

4.9.2.   Use-specific risk mitigation measures

Wear protective chemical resistant gloves when applying the product by foaming application method (glove material to be specified by the authorisation holder within the product information).

This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

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

5.1.   Instructions for use

Keep out of reach of children

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.

Product can be used during the entire lactation period

Before attaching the milking cluster, all teat-dip residues should be removed with either a single use towel or re-usable cloth. One cloth should be used per cow

For effective use against bacteria and yeast, product must be left in contact with the skin for at least 60 seconds

5.2.   Risk mitigation measures

See use specific risk mitigation measures.

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

Remove and wash contaminated clothing before re-use.

After inhalation: Move to fresh air in case of accidental inhalation of fumes from overheating or combustion.

If you feel unwell, seek medical advice.

After contact with skin: Wash with water and soap as a precaution. Consult a doctor if skin irritation persists.

After contact with eyes: Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes. Seek medical treatment by eye specialist.

After ingestion: Rinse out mouth and give plenty of water to drink. Never give anything by mouth to an unconscious person. Consult a physician.

Large spills should be contained using a chemical spill kit, soaked up using absorbent material such as kieselguhr and disposed of as hazardous waste.

5.4.   Instructions for safe disposal of the product and its packaging

At the end of the treatment, dispose of 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 farm based waste water treatment plant.

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

Protect from frost

Do not store at temperatures above 30 °C

Shelf life 12 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)	LuxSpray 30, Ioklene RTU, Corston Pre/Post Sprayable, Kristal Iocare Plus, PrePost, Autodine, Coars Super Pre
Authorisation number	EU-0020125-0005 1-2
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active Substance	7553-56-2	231-442-4	0,3
C9-11 Alcohol Ethoxylate	C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060	Non-active substance	68439-46-3	614-482-0	0,305

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

Trade name(s)	LuxSpray 50, Silkidip, Ceanodine, IoSpray 10, Maxadine RTU, Diamond Superdip, Kristal Iocare Post, KiwiDip, Superdip Excel, Ioguard RTU, Shepherd’s IoSpray 50
Authorisation number	EU-0020125-0006 1-2
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active Substance	7553-56-2	231-442-4	0,5
C9-11 Alcohol Ethoxylate	C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060	Non-active substance	68439-46-3	614-482-0	0,56

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

Trade name(s)	LuxDip 50B, Postguard
Authorisation number	EU-0020125-0007 1-2
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active Substance	7553-56-2	231-442-4	0,5

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

Trade name(s)	LuxDip 25, Kote It, Corston Barracide Post Film Forming Dip, Pro-Tect, Kristal Iocare Film, Coars Iodinegel, Coars Iodogel, LuxDip 20B
Authorisation number	EU-0020125-0008 1-2
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active Substance	7553-56-2	231-442-4	0,25
C9-11 Alcohol Ethoxylate	C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060	Non-active substance	68439-46-3	614-482-0	0,5

META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier

Identifier

Meta SPC 3 — RTU Products — Professiona RTU Liquid for application pre and post milking (LuxSpray 15)

1.2.   Suffix to the authorisation number

Number

1-3

1.3.   Product type(s)

Product type(s)

PT03 — Veterinary hygiene (Disinfectants)

2.   META SPC 3 COMPOSITION

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

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
					Min	Max
Iodine		Active Substance	7553-56-2	231-442-4	0,16	0,16
C9-11 Alcohol Ethoxylate	C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060	Non-active substance	68439-46-3	614-482-0	0.166	0.166

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

Formulation(s)

AL — Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

Hazard statements	May be corrosive to metals.
Precautionary statements	Avoid release to the environment. Collect spillage. Dispose of contents in accordance with local regulations. Dispose of container in accordance with local regulations.

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

4.1.   Use description

Table 13

Use # 1 – RTU Products — Professional RTU Liquid, for application pre-milking — Dipping

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeast
Field(s) of use	Indoor
Application method(s)	Open system: dip treatment Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking The same solution can be applied to multiple animals during the same milking session.
Application rate(s) and frequency	Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation. In use concentration 0,16 % (w/w) iodine. 2 pre milking applications per animal, per day
Category(ies) of users	Trained professional Professional
Pack sizes and packaging material	Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.1.1.   Use-specific instructions for use

See general directions for use.

4.1.2.   Use-specific risk mitigation measures

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

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

See general directions for use.

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

See general directions for use.

4.2.   Use description

Table 14

Use # 2 – RTU Products — Professional RTU Liquid, for application pre milking — spraying

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeast
Field(s) of use	Indoor
Application method(s)	Open system: spray treatment Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product
Application rate(s) and frequency	Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 pre milking applications per animal, per day
Category(ies) of users	Trained professional Professional
Pack sizes and packaging material	Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.2.1.   Use-specific instructions for use

See general directions for use.

4.2.2.   Use-specific risk mitigation measures

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

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

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

See general directions for use.

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

See general directions for use.

4.3.   Use description

Table 15

Use # 3 – RTU Products — Professional RTU Liquid, for application pre milking – Foaming

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeast
Field(s) of use	Indoor
Application method(s)	Open system: dip treatment Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder The same solution can be applied to multiple animals during the same milking session.
Application rate(s) and frequency	Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 pre milking applications per animal, per day
Category(ies) of users	Trained professional Professional
Pack sizes and packaging material	Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.3.1.   Use-specific instructions for use

See general directions for use.

4.3.2.   Use-specific risk mitigation measures

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

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.4.   Use description

Table 16

Use # 4 – RTU Products — Professional RTU Liquid, for application post milking – Dipping

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeast
Field(s) of use	Indoor
Application method(s)	Open system: dip treatment Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking The same solution can be applied to multiple animals during the same milking session.
Application rate(s) and frequency	Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 post milking applications per animal, per day
Category(ies) of users	Trained professional Professional
Pack sizes and packaging material	Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.4.1.   Use-specific instructions for use

Dip at least 2/3 of the teat length with diluted product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

4.4.2.   Use-specific risk mitigation measures

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

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.5.   Use description

Table 17

Use # 5 – RTU Products — Professional RTU Liquid, for application post milking – Spraying

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeast All
Field(s) of use	Indoor
Application method(s)	Open system: spray treatment Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product
Application rate(s) and frequency	Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 post milking applications per animal, per day
Category(ies) of users	Trained professional Professional
Pack sizes and packaging material	Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.5.1.   Use-specific instructions for use

Spray at least 2/3 of the teat length with RTU product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

4.5.2.   Use-specific risk mitigation measures

Wear protective chemical resistant gloves and boots when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)

A protective coverall (at least type 6, EN 13034) shall be worn

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

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.6.   Use description

Table 18

Use # 6 – RTU Products — Professional RTU Liquid, for application post milking – Foaming

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeast
Field(s) of use	Indoor
Application method(s)	Open system: dip treatment Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder The same solution can be applied to multiple animals during the same milking session.
Application rate(s) and frequency	Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 post milking applications per animal, per day
Category(ies) of users	Trained professional Professional
Pack sizes and packaging material	Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.6.1.   Use-specific instructions for use

Dip at least 2/3 of the teat length with RTU product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

4.6.2.   Use-specific risk mitigation measures

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

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.7.   Use description

Table 19

Use # 7 – Use # 3.7 – RTU Products — Professional RTU Liquid, for application pre and post milking-Dipping

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeast
Field(s) of use	Indoor
Application method(s)	Open system: dip treatment Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking The same solution can be applied to multiple animals during the same milking session.
Application rate(s) and frequency	Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 pre milking applications per animal, per day 2 post milking applications per animal, per day
Category(ies) of users	Trained professional Professional
Pack sizes and packaging material	Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.7.1.   Use-specific instructions for use

Post milking:

Dip at least 2/3 of the teat length with RTU product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

4.7.2.   Use-specific risk mitigation measures

Wear protective chemical resistant gloves when applying the product by dipping (glove material to be specified by the authorisation holder within the product information).

This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.8.   Use description

Table 20

Use # 8 – RTU Products — Professional RTU Liquid, for application pre and post milking- Spraying

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeast
Field(s) of use	Indoor
Application method(s)	Open system: spray treatment Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product
Application rate(s) and frequency	Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 pre milking applications per animal, per day 2 post milking applications per animal, per day
Category(ies) of users	Trained professional Professional
Pack sizes and packaging material	Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.8.1.   Use-specific instructions for use

Post milking:

Spray at least 2/3 of the teat length with RTU product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

4.8.2.   Use-specific risk mitigation measures

Wear protective chemical resistant gloves and boots when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)

A protective coverall (at least type 6, EN 13034) shall be worn

This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.9.   Use description

Table 21

Use # 9 – RTU Products — Professional RTU Liquid, for application pre and post milking — Foaming

Product type	PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeast
Field(s) of use	Indoor
Application method(s)	Open system: dip treatment Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder The same solution can be applied to multiple animals during the same milking session.
Application rate(s) and frequency	Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 pre milking applications per animal, per day 2 post milking applications per animal, per day
Category(ies) of users	Trained professional Professional
Pack sizes and packaging material	Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.9.1.   Use-specific instructions for use

Post milking:

Dip at least 2/3 of the teat length with RTU product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

4.9.2.   Use-specific risk mitigation measures

Wear protective chemical resistant gloves when applying the product by foaming application method

(glove material to be specified by the authorisation holder within the product information).

This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

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

5.1.   Instructions for use

Keep out of reach of children

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.

Product can be used during the entire lactation period

Before attaching the milking cluster, all teat-dip residues should be removed with either a single use towel or re-usable cloth. One cloth should be used per cow

For effective use against bacteria and yeast, product must be left in contact with the skin for at least 60 seconds

5.2.   Risk mitigation measures

See use specific risk mitigation measures.

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

Remove and wash contaminated clothing before re-use.

After inhalation: Move to fresh air in case of accidental inhalation of fumes from overheating or combustion.

If you feel unwell, seek medical advice.

After contact with skin: Wash with water and soap as a precaution. Consult a doctor if skin irritation persists.

After contact with eyes: Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes. Seek medical treatment by eye specialist.

After ingestion: Rinse out mouth and give plenty of water to drink. Never give anything by mouth to an unconscious person. Consult a physician.

Large spills should be contained using a chemical spill kit, soaked up using absorbent material such as kieselguhr and disposed of as hazardous waste.

5.4.   Instructions for safe disposal of the product and its packaging

At the end of the treatment, dispose of 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 farm based waste water treatment plant.

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

Protect from frost

Do not store at temperatures above 30 °C

Shelf life 12 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)	LuxSpray 15 — Priodine RTU/Kristal Iocare Pre/Super Pre
Authorisation number	EU-0020125-0009 1-3
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active Substance	7553-56-2	231-442-4	0,16
C9-11 Alcohol Ethoxylate	C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060	Non-active substance	68439-46-3	614-482-0	0,166

---

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

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

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

ANNEX I

PROVISIONS ON VEHICLE CLASSIFICATION

1.   General provisions

1.1.

A toll charger must publish the correspondence between the set of vehicle classification parameters used and its vehicle tariff classes for each tariff scheme applied in an EETS domain under its responsibility at least three months before the use of the tariff scheme. This obligation does not refer to any changes made by the toll charger to specific tariffs within a tariff scheme.

1.2.

A toll charger must publish the correspondence of its vehicle tariff classes with its tariffs structure for each tariff scheme applied in an EETS domain under its responsibility. It must update the publication immediately when that correspondence changes.

2.   Vehicle classification parameters

2.1.

A toll charger may use vehicle classification parameters according to at least one of the following provisions: (a) any vehicle classification parameter that can be measured by its roadside equipment (b) the vehicle parameters that are listed in vehicles registration documents (1) and standardised in clause 8.4 of EN ISO 14906:2018 (2); If an OBE is used, the OBE is required only to support storage and transmission of possible vehicle classification parameters that can be retrieved from the OBE using dedicated short-range communication at 5,8 GHz as defined by standards EN 15509:2014 (3) and ETSI ES 200674-1 V2.4.1 (4); for GNSS based schemes, in addition, any vehicle parameter may be retrieved from the OBE using CEN-DSRC as defined by EN ISO 12813:2019 (5).

2.2.

When circulating in a toll domain, vehicle on-board equipment must be able to communicate the on-board equipment status information and, where applicable, its vehicle classification parameters to the toll declaration monitoring equipment of the toll charger, as defined in Annex I of Commission Implementing Regulation (EU) 2020/204 (6).

3.   New tariff schemes

3.1.

Where a newly introduced tariff scheme is based on vehicle classification parameters already in use in at least one EETS domain, EETS providers must implement the new tariff scheme as of the date of its entry into force.

3.2.

Where a new tariff scheme introduces one or more new vehicle classification parameters, the procedure under Article 2.2 of the Delegated Regulation must be followed.

---

(1)  Commission Directive 2003/127/EC of 23 December 2003 amending Council Directive 1999/37/EC on the registration documents for vehicles (OJ L 010, 16.1.2004, p. 0029-0053).

(2)  Electronic fee collection – Application interface definition for dedicated short-range communication.

(3)  Electronic fee collection — Interoperability application profile for DSRC.

(4)  Intelligent Transport Systems (ITS); Road Transport and Traffic Telematics (RTTT); Dedicated Short Range Communications (DSRC); Part 1: Technical characteristics and test methods for High Data Rate (HDR) data transmission equipment operating in the 5,8 GHz Industrial, Scientific and Medical (ISM) band.

(5)  Electronic fee collection – Compliance check communication for autonomous systems.

(6)  Commission Implementing Regulation (EU) 2020/204 of 28 November 2019 on detailed obligations of European Electronic Toll Service providers, minimum content of the European Electronic Toll Service domain statement, electronic interfaces, requirements for interoperability constituents and repealing Decision 2009/750/EC (OJ L 43 17.2.2020, p. 49).

ANNEX II

REQUIREMENTS FOR INTEROPERABILITY CONSTITUENTS

1.   GENERAL REQUIREMENTS

1.1.   Reliability and availability

1.1.1.

The monitoring and maintenance of fixed or movable components that are used in EETS must be organised, carried out and quantified in such a manner as to maintain their operation under the intended conditions.

1.1.2.

EETS design should enable the system to continue working if the components malfunction or fail, possibly in a degraded mode, but with the least disruption for EETS users.

1.2.   Technical compatibility

Where they are interfacing, the technical characteristics of the equipment of EETS providers and toll chargers must be compatible and in line with the provisions laid down in Annex I of the Implementing Regulation (EU) 2020/204.

1.3.   Security/privacy and protection of personal data

1.3.1.

EETS must provide security features relative to the protection of data stored, handled and transferred between stakeholders in the EETS environment. The security features shall integrate the necessary safeguards into the processing in order to protect the rights and interests of EETS stakeholders, in particular protect them from risks or damage caused by lack of availability, confidentiality, integrity, authentication, non-repudiation and protection from unauthorised access to user data in a European multi-user environment, in compliance with the relevant legislation on the protection of individuals with regard to the processing of personal data.

1.3.2.

EETS must comply with EU data protection legislation. In particular, compliance with Regulation (EU) 2016/679 and the national laws, regulations or administrative provisions turning Directive 2002/58/EC into national law must be ensured.

2.   SPECIFIC REQUIREMENTS

2.1.   Infrastructure requirements

2.1.1.

EETS infrastructure must allow for the accuracy of toll declaration data to correspond with the toll regime requirements to guarantee equal and fair treatment between EETS users in respect of tolls and charges.

2.1.2.

The on-board equipment must enable toll chargers to identify the responsible EETS provider. The on-board equipment must regularly monitor this information, invalidate itself if an irregularity is detected and, where possible, inform the EETS provider of the anomaly.

2.1.3.

Where applicable, EETS equipment must be designed so that its interoperability constituents use standards issued by European Standardisation Organisations.

2.1.4.

On-board equipment must be integrated in a safe and secure way. Its fitment will be compliant with requirements for vehicles forward vision. (1)

2.1.5.

Toll chargers must inform drivers, through signalisation or other means chosen by Member States,, of the requirement to pay a toll or charge for driving a vehicle in an EETS domain, and of the roads covered by an EETS domain.

2.2.   Operation and management requirements

2.2.1.

Toll chargers and EETS providers must determine contingency plans in order to avoid major traffic flow disruptions if the EETS is unavailable.

2.2.2.

With respect to evaluating the performance of on-board equipment using satellite-positioning technology provided under Article 3.3 of Directive (EU) 2019/520, the EGNOS/Galileo eCall conformance test specifications (2) may be applied

---

(1)  Commission Directive 90/630/EEC of 30 October 1990 adapting to technical progress Council Directive 77/649/EEC on the approximation of the laws of the Member States relating to the field of vision of motor vehicle drivers (OJ L 341, 6.12.1990, p. 20).

(2)  Implementation guidelines for On-Board Unit manufacturers, test solution vendors and technical centres, by European Global Navigation Satellite Systems Agency and EC Joint Research Centre (Dec 2017, version 1.0).

ANNEX III

MINIMUM ELIGIBILITY CRITERIA FOR NOTIFIED BODIES

---

(1)  Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93.

ANNEX I

EUROPEAN ELECTRONIC TOLL SERVICE INTERFACES

European Electronic Toll Service (EETS) providers and toll chargers shall use the following electronic interfaces:

1.

Electronic radio interfaces at the roadside between the EETS provider’s on-board equipment (OBE) and the toll charger’s fixed or mobile equipment. As a minimum, standardised roadside interfaces between OBE and toll chargers’ fixed and mobile roadside equipment shall support: (a) Dedicated Short-Range Communication (DSRC) charging transactions, complying with the following requirements: (i) EETS providers’ OBE shall support EN 15509:2014 (1) as well as those clauses of ETSI ES 200674-1 V2.4.1 (2) that relate to interoperability; (ii) toll chargers’ fixed and mobile roadside equipment shall support EN 15509:2014. Within Italy, toll chargers’ fixed and mobile roadside equipment may support instead those clauses of ETSI ES 200674-1 V2.4.1 that relate to interoperability; (b) real-time compliance checking transactions compliant to EN ISO 12813:2015 (3); (c) localisation augmentation (where applicable) compliant to EN ISO 13141:2015 (4). EETS OBEs shall comply with points 1(a), 1(b) and 1(c). EETS OBEs provided for users of light-duty vehicles must comply with the provisions referred to in point 1(a) as referred to in Article 3(6) of Directive (EU) 2019/520. Toll chargers may implement any of the provisions referred to in points 1(a), 1(b) 1(c) and 2 in their fixed or mobile roadside equipment according to their requirements. Where the toll charger implements a new version of a standard for an interface between the roadside equipment and the OBE, the interface shall continue to support the previous version of the standard for a limited period to allow for the continued compatibility of its electronic toll collection system with the OBEs in operation. The duration of this period shall be published by the toll charger in its EETS domain statement and may not be shorter than two years.

2.	Electro-optical imaging systems at the toll charger’s fixed or mobile equipment at the roadside, providing means for automatic number plate recognition (ANPR), in toll systems where the installation and use of an OBE is not required.

3.	Electronic interfaces between the respective back office systems. Toll chargers shall only implement those aspects of the interface that are linked to the technology used on the EETS domain under their responsibility (GNSS, DSRC and/or ANPR).

3.1.

The following back office interfaces shall be implemented by both EETS providers and toll chargers independently of the technology used in the EETS toll domain: (a) exchange of information to support exception handling from toll chargers to EETS providers. (b) exchange of EETS user-related lists from EETS providers and toll chargers. (c) exchange of trust objects. (d) exchange of toll context data. (e) optionally, exchange of payment claims according to the adopted business model.

3.2.

The following back office interfaces shall be additionally implemented by both EETS providers and toll chargers for EETS domains, which implement the GNSS technology: (a) submission and validation of global navigation satellite system (GNSS) toll declarations. (b) optionally, exchange of payment announcements according to the adopted business model. (c) optionally, exchange of billing details according to the adopted business model.

3.3.

The following back office interfaces shall be additionally implemented by both EETS providers and toll chargers for EETS domains that implement the DSRC technology: (a) exchange of billing details. (b) optionally, exchange of payment claims based on dedicated short-range communication (DSRC) charging transactions.

3.4.

The following back office interfaces shall be additionally implemented by both EETS providers and toll chargers for EETS domains that implement the ANPR technology: (a) optionally, exchange of billing details. (b) optionally, exchange of payment claims based on ANPR charging transactions. The electronic interfaces for DSRC- and GNSS-based schemes between the respective back office systems of the toll charger and those of the EETS provider shall comply with CEN/TS 16986:2016 (5), as corrected by CEN/TS 16986:2016/AC:2017, at the latest five years from date of applicability of this Implementing Regulation. Where the toll charger or EETS provider implements a new version of a standard, it shall continue to support, for a limited period, lasting not less than two years, data exchange compatible with the previous version of the standard to ensure the continuous compatibility of the back offices.

---

(1)  Electronic fee collection — Interoperability application profile for DSRC.

(2)  Intelligent Transport Systems (ITS); Road Transport and Traffic Telematics (RTTT); Dedicated Short Range Communications (DSRC); Part 1: Technical characteristics and test methods for High Data Rate (HDR) data transmission equipment operating in the 5,8 GHz Industrial, Scientific and Medical (ISM) band.

(3)  Electronic fee collection — Compliance check communication for autonomous systems.

(4)  Electronic fee collection — Localisation augmentation communication for autonomous systems.

(5)  Electronic Fee Collection — Interoperable application profiles for information exchange between Service Provision and Toll Charging.

ANNEX II

MINIMUM CONTENTS OF A EUROPEAN ELECTRONIC TOLL SERVICE DOMAIN STATEMENT

A European Electronic Tolling Service (EETS) domain statement shall contain the following information:

1.

A section on procedural conditions, which shall be non-discriminatory and shall include at least: (a) the toll transaction policy (including authorisation parameters, toll context data, black lists); (b) the procedures and Service Level Agreement, including the format for communicating toll declaration data or billing data, times and frequency for the transfer of toll declaration data, accepted percentage of missed/erroneous tolls, accuracy of toll declaration data, operational availability performance; (c) the invoicing policy; (d) the payment policy; (e) a reference to the relevant conciliation body and its competences related to disputes concerning the remuneration of EETS-providers and of the main service provider; (f) the commercial conditions.

1.1.

The section on the commercial conditions shall include at least the following elements applicable to the EETS providers: (a) any applicable fixed charge based on the costs incurred by the toll charger, for providing, operating and maintaining an EETS compliant system. The toll charger may not impose on EETS providers the fixed charge based on these costs if the costs of providing, operating and maintaining an EETS compliant system are included in the toll; (b) any applicable fixed charge to be paid by EETS providers based on the cost of the accreditation procedure, as referred to in Article 2(20) of Directive (EU) 2019/520, including the cost of the assessment of conformity to specifications or suitability for use of interoperability constituents; (c) any applicable requirements for a bank guarantee or equivalent financial instrument, which may not exceed the average monthly toll transaction amount paid by the EETS provider for this toll domain. This amount shall be determined based on the total toll transaction amount paid by the EETS provider for this toll domain in the previous year. For new EETS providers and for new toll domains, the amount shall be based on the expected average toll transactions payable by the EETS provider for this toll domain within the invoicing period based on the number of contracts and average toll per contract estimated in the EETS provider’s business plan for the specific toll domain.

1.2.

The commercial conditions shall also include, as a minimum, a description of the elements used to define the fixed and/or variable remuneration paid by the toll charger to the EETS provider. The remuneration may vary according to the following elements: (a) the amount of the toll collected by the EETS provider on behalf of the toll charger; (b) the number of active pieces of on-board-equipment (OBE) provided by the EETS provider, which are in use in the EETS domain of the toll charger concerned; (c) where applicable, the number of toll transactions, or another indication of the cost of mobile communications between the OBE and the back office of the EETS provider; (d) the invoices issued by the EETS provider to EETS users for tolls due for the use of the EETS domain concerned; (e) the nature of other services outsourced by the toll charger to the EETS provider.

1.3.

The domain statement shall also include a description of the specific requirements and obligations of the main service provider, which differ from the ones of the EETS providers and, which justify any differences in the remuneration of the main service provider compared to that of the EETS providers.

2.

A section defining ex ante the steps of the accreditation of an EETS provider to the EETS domain and an indicative duration of the accreditation procedure. This section shall set out the complete procedure for the assessment of the conformity to specifications and the suitability for use of interoperability constituents. It shall include a list of required certificates, laboratory and field tests and their indicative costs, and measurable criteria or parameters indicating conformity to specifications. The section shall contain references to all applicable international or European standards related to electronic tolling and exceptions to their application in the EETS domain. It shall also specify all technical requirements that are specific to the EETS domain and not covered by the international or European standards. The same acceptance procedure shall apply to all EETS providers.

3.	A section on the toll context data.

ANNEX III

CONFORMITY TO SPECIFICATIONS AND SUITABILITY FOR USE OF INTEROPERABILITY CONSTITUENTS

CONFORMITY TO SPECIFICATIONS

Compliance of interoperability constituents (including road side equipment and interfaces) with the requirements referred to in Article 15(4) and 15(5) of Directive (EU) 2019/520 and with all relevant technical specifications and standards shall, prior to their placing on the market, be demonstrated by means of either of the following conformity assessment procedures, adapted to the specificity of the sector based on the modules provided by Decision No 768/2008/EC (1):

(a)	internal production control as set out in section I (module A);

(b)	EU type examination as set out in section II (Module B) which is followed by Conformity to type based on internal production control set out in section III (Module C).

I.   Module A — Internal production control

Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points (a), (b) and (c), and ensures and declares on his sole responsibility that the interoperability constituents concerned satisfy the requirements referred to in Article 15(4) and 15(5) of Directive (EU) 2019/520.

(a)

Technical documentation The manufacturer shall prepare the technical documentation. The documentation shall make it possible to assess the interoperability constituent’s conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the interoperability constituent. The technical documentation shall, wherever applicable, contain at least the following elements: (i) a general description of the interoperability constituent, (ii) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc. (iii) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the interoperability constituent, (iv) reference to the category of interfaces as set out in Annex I, (v) a list of the standards and/or other relevant technical specifications, applied in full or in part, and descriptions of the solutions adopted to meet the requirements referred to in Section I, (vi) results of design calculations made, examinations carried out, etc., and (vii) test reports.

(b)

Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured interoperability constituents with the technical documentation referred to in point (a) and with the requirements of the legislative instruments that apply to them.

(c)

‘EC’ declaration of conformity The manufacturer shall draw up a written ‘EC’ declaration of conformity for an interoperability constituent model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the interoperability constituent has been placed on the market. The ‘EC’ declaration of conformity shall identify the interoperability constituent for which it has been drawn up. A copy of the ‘EC’ declaration of conformity shall be made available to the relevant authorities upon request.

(d)	Authorised representative The manufacturer’s obligations set out in point (b) may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

II.   Module B — EU-type examination

1.

EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of an interoperability constituent and verifies and attests that the technical design of the interoperability constituent meets the requirements of the legislative instrument that apply to it.

2.

EU-type examination may be carried out in one of the following ways: — examination of a specimen, representative of the production envisaged, of the complete interoperability constituent (production type), — assessment of the adequacy of the technical design of the interoperability constituent through examination of the technical documentation and supporting evidence referred to in point 3, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the interoperability constituent (combination of production type and design type), — assessment of the adequacy of the technical design of the interoperability constituent through examination of the technical documentation and supporting evidence referred to in point 3, without examination of a specimen (design type).

3.

The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice. The application shall include: (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well, (b) a written declaration that the same application has not been lodged with any other notified body, (c) the technical documentation, which shall make it possible to assess the interoperability constituent’s conformity with the applicable requirements of the legislative instrument and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the interoperability constituent. The technical documentation shall contain, wherever applicable, at least the following elements: (i) a general description of the interoperability constituent, (ii) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc., (iii) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the interoperability constituent, (iv) a list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the legislative instrument where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied, (v) results of design calculations made, examinations carried out, etc., and (vi) test reports, (d) the specimens representative of the production envisaged. The notified body may request further specimens if needed for carrying out the test programme, (e) the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards and/or technical specifications have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.

4.

The notified body shall: With regard to the interoperability constituent:

4.1.

examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the interoperability constituent; With regard to the specimen(s):

4.2.

verify that the specimen(s) have been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards and/or technical specifications, as well as the elements which have been designed without applying the relevant provisions of those standards;

4.3.

carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards and/or technical specifications, these have been applied correctly;

4.4.

carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards and/or technical specifications have not been applied, the solutions adopted by the manufacturer meet the corresponding essential requirements of the legislative instrument;

4.5.

agree with the manufacturer on a location where the examinations and tests will be carried out.

5.

The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.

6.

Where the type meets the requirements of the specific legislative instrument that apply to the interoperability constituent concerned, the notified body shall issue an EU-type examination certificate to the manufacturer. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The certificate may have one or more annexes attached. The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured interoperability constituents with the examined type to be evaluated and to allow for in-service control. Where the type does not satisfy the applicable requirements of the legislative instrument, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

7.

The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of the legislative instrument, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly. The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the interoperability constituent with the essential requirements of the legislative instrument or the conditions for validity of the certificate. Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate.

8.

Each notified body shall inform its notifying authorities concerning the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and/or any additions thereto, which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and/or additions thereto which it has issued. The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.

9.

The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the interoperability constituent has been placed on the market.

10.

The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate.

III.   Module C — Conformity to type based on internal production control

1.

Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 3, and ensures and declares that the interoperability constituents concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of the legislative instrument that apply to them.

2.

Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured interoperability constituents with the approved type described in the EU-type examination certificate and with the requirements of the legislative instrument that apply to them.

3.

Conformity marking and declaration of conformity 3.1. The manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual interoperability constituent that is in conformity with the type described in the EC-type examination certificate and satisfies the applicable requirements of the legislative instrument. 3.2. The manufacturer shall draw up a written declaration of conformity for a interoperability constituent model and keep it at the disposal of the national authorities for 10 years after the interoperability constituent has been placed on the market. The declaration of conformity shall identify the interoperability constituent model for which it has been drawn up. A copy of the declaration of conformity shall be made available to the relevant authorities upon request.

4.

Authorised representative The manufacturer’s obligations set out in point 3 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

IV.   Tests specifications

The conformity evaluation of implementation to the requirements referred under point 1 of Annex I of this Implementing Regulation and in Article 5(4) of Directive (EU) 2019/520 may be evaluated by applying the following tests specifications:

—	Annex I 1(a) of this Implementing Regulation related to the DSRC charging transactions: EN 15876-1:2016 (2), ETSI TS 102 708-1-1:2010 (3), ETSI TS 102 708-1-2:2010 (4), ETSI TS 102 708-2-1:2013 (5) and ETSI TS 102 708-2-2:2018 (6), respectively;

—	Annex I 1(b) of this Implementing Regulation related to the real-time compliance checking transactions: EN ISO 13143-1:2016 (7);

—	Annex I 1(c) of this Implementing Regulation related to the localisation augmentation: EN ISO 13140-1:2016 (8).

V.   Suitability for use (interoperability of service)

The suitability for use of interoperability constituents is assessed by operation or use of the constituents in service, integrated representatively into the EETS toll system (including test environments) of the toll charger(s) on whose domain the on-board equipment must circulate over a specified operation time. The assessment of suitability for use may include tests predefined in the EETS domain statement or pilots with real users. The toll charger or its authorised representative as well as the EETS provider, the manufacturer or an authorised representative and the notified body to which the EETS provider applied to, shall comply with each step of the suitability-for-use assessment based on measurable criteria or parameters defined in the EETS domain statement in accordance with Annex II.

To carry out such an assessment by means of in-service experience for demonstrating the in-service interoperability of the constituents, the manufacturer, EETS provider or an authorised representative shall either collaborate directly with the toll charger(s) or apply to a notified body, subject to requirements in points (a) and (b). The relevant toll charger may require that tests and/or pilots are carried out by means of the infrastructure provided for by the toll charger, regardless of whether the EETS provider choses to directly collaborate with the toll charger or applies to a notified body.

(a)

Where the EETS provider collaborates directly with the toll charger(s) on whose domain the on-board equipment shall circulate: The manufacturer, EETS provider or an authorised representative shall: (1) provide for tests or place in service one or more specimens representative of the interoperability constituent(s), as required by the toll charger(s); (2) monitor the in-service behaviour of the interoperability constituent(s) by a procedure agreed and surveyed by the toll charger(s); (3) give evidence to the toll charger(s) that the interoperability constituents meet all the interoperability requirements of this (these) Toll Charger(s); (4) draw up a declaration of suitability for use, conditional to obtaining a suitability for use attestation delivered by the toll charger(s). The declaration of suitability for use covers the assessment by the toll charger(s) of the suitability for use of the EETS interoperability constituents within the EETS environment of this (these) Toll Charger(s); The toll charger shall: (1) clearly define the programme for validation by in-service experience (2) approve the monitoring procedure of the in-service behaviour in its toll domains and carry out specific verifications; (3) assess the in-service interoperability with its system; (4) attest the suitability for use on its toll domains in cases where the behaviour of the interoperability constituents is successful.

(b)

Where the EETS provider applies to a notified body, the manufacturer, EETS provider or an authorised representative shall: (1) provide for tests or place in service one or more specimens representative of the interoperability constituent(s), as required and specified by the toll charger(s); (2) monitor the in-service behaviour of the interoperability constituents using a procedure approved and surveyed by the notified body. (3) provide evidence to the notified body that the interoperability constituent(s) meet(s) all the interoperability requirements of the toll charger(s), including the results of in-service experience; (4) draw up the ‘EC’ declaration of suitability-for-use, conditional to obtaining a suitability-for-use certificate delivered by the notified body. The ‘EC’ declaration of suitability for use covers the assessment/judgement by the notified body of the suitability for use of the EETS interoperability constituents, considered within the EETS domain and environment of the selected toll charger(s) and, particularly in cases where interfaces are involved, in relation to the technical specifications, particularly those of a functional nature, which are to be checked; The notified body shall: (1) take into consideration the ‘EC’ declaration of conformity to specifications as well as the requirements laid down in the EETS domain statement of the toll charger(s). (2) organise collaboration with the relevant toll charger(s); (3) verify the technical documentation and the programme for validation by in-service experience; (4) approve the monitoring procedure of the in-service behaviour and carry out specific surveillance; (5) assess in-service interoperability with toll charger systems and operational processes; (6) issue a suitability-for-use certificate in cases where the behaviour of the interoperability constituents is successful; (7) issue an explanatory report in case where the behaviour of the interoperability constituent(s)is unsuccessful. The report shall also consider problems that may arise because of non-compliance of a toll charger’s systems and processes with relevant standards and technical specifications. If appropriate, the report shall make recommendations with a view to resolving the problems.

VI.   Content and format of the declarations of conformity to specifications and declarations of suitability for use

1.

Content of the ‘EC’ Declaration of conformity The EC declaration of conformity shall state that the fulfilment of requirements set out in Article 15(4), (5) an (6) of Directive (EU) 2019/520 has been demonstrated. The EC declaration of conformity shall have the model structure set out in point 2 of this Section. It shall contain the elements specified in the relevant modules set out in this Annex and shall be continuously updated. It shall be translated into the language or languages required by the Member State in which market the interoperability constituent is placed or made available. By drawing up the EC declaration of conformity, the manufacturer shall assume responsibility for the compliance of the interoperability constituent.

2.

Model the EC Declaration of conformity (1) No … (unique identification of the interoperability constituent): (2) Name and address of the manufacturer or his authorised representative: (3) This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer): (4) Object of the declaration (identification of interoperability constituent allowing traceability. It may include a photograph, where appropriate): (5) The object of the declaration described above is in conformity with the relevant Union harmonisation legislation: … (6) References to the relevant harmonised standards used or references to the specifications in relation to which conformity is declared: (7) Where applicable, the notified body … (name, number) … performed …(description of intervention) … and issued the certificate: … (8) Additional information:

Signed for and on behalf of: …

(place and date of issue):

(name, function) (signature):

‘EC’ declarations of suitability for use and the accompanying documents must be dated and signed.

The declarations shall be written in the same language as the instructions and must contain the following:

(a)	references to the relevant legislation;

(b)	the name and address of the manufacturer, EETS provider or authorised representative established within the Union (provide the trade name and full address of the authorised representative and the trade name of the manufacturer);

(c)	description of interoperability constituent(s) (make, type, version, etc.);

(d)	description of the procedure followed in order to declare conformity to specifications or suitability for use;

(e)	all the relevant requirements met by the interoperability constituents and, in particular, their conditions of use;

(f)	where applicable, name and address of the toll charger(s)/notified body(ies) involved in the procedure followed for the assessment of conformity to specifications or suitability for use;

(g)	where appropriate, reference to the technical specifications;

(h)	identification of the signatory empowered to enter into commitments on behalf of the manufacturer or of the manufacturer’s authorised representative established within the Union.

---

(1)  Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products and repealing Council Decision 93/465/EEC (Text with EEA relevance).

(2)  Electronic fee collection — Evaluation of on-board and roadside equipment for conformity to EN 15509

(3)  Intelligent Transport Systems (ITS); RTTT; Test specifications for High Data Rate (HDR) data transmission equipment operating in the 5,8 GHz ISM band; Part 1: Data Link Layer; Sub-Part 1: Protocol Implementation Conformance Statement (PICS) proforma specification.

(4)  Intelligent Transport Systems (ITS); RTTT; Test specifications for High Data Rate (HDR) data transmission equipment operating in the 5,8 GHz ISM band; Part 1: Data Link Layer; Sub-Part 2: Test Suite Structure and Test Purposes (TSS&TP).

(5)  Intelligent Transport Systems (ITS); RTTT; Test specifications for High Data Rate (HDR) data transmission equipment operating in the 5,8 GHz ISM band; Part 2: Application Layer; Sub-part 1: Protocol Implementation Conformance Statement (PICS) proforma specification.

(6)  Intelligent Transport Systems (ITS); RTTT; Test specifications for High Data Rate (HDR) data transmission equipment operating in the 5,8 GHz ISM band; Part 2: Application Layer; Sub-Part 2: Test Suite Structure and Test Purposes (TSS & TP).

(7)  Electronic fee collection — Evaluation of on-board and roadside equipment for conformity to ISO 12813 — Part 1: Test suite structure and test purposes.

(8)  Electronic fee collection — Evaluation of on-board and roadside equipment for conformity to ISO 13141 — Part 1: Test suite structure and test purposes.

ANNEX

Annex I to Regulation (EC) No 2073/2005 is amended as follows:

(1)

in Chapter 1, the following row 1.30 is added: Food category Micro-organisms/their toxins, metabolites Sampling plan Limits Analytical reference method Stage where the criterion applies n c m M ‘1.30 Reptile meat Salmonella 5 0 Not detected in 25 g EN ISO 6579-1 Products placed on the market during their shelf-life’

(2)	in Chapter 1, footnote 2 is replaced by the following: ‘(2) For points 1.1-1.24, 1.27a, 1.28-1.30 m = M.’

ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

(1)

The following entry is inserted in Table 1 (Authorised novel foods) in alphabetical order: Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements ‘Fruit pulp, pulp juice, concentrated pulp juice from Theobroma cacao L. (Traditional food from a third country) Not specified The designation of the novel food on the labelling of the foodstuffs containing it shall be “cocoa (Theobroma cacao L.) pulp”, “cocoa (Theobroma cacao L.) pulp juice” or “cocoa (Theobroma cacao L.) concentrated pulp juice” depending on the form used.’

(2)

The following entry is inserted in Table 2 (Specifications) in alphabetical order: Authorised Novel Food Specifications ‘Fruit pulp, pulp juice, concentrated pulp juice from Theobroma cacao L. (Traditional food from a third country) Description/Definition The traditional food is the fruit pulp from the cocoa (Theobroma cacao L) plant, which is the “aqueous, mucilaginous and acidic substance in which the seeds are embedded”. Cocoa fruit pulp is obtained by splitting cocoa pods followed by separation from husks and beans; the pulp is then subject to pasteurisation and freezing. Cocoa pulp juice and/or cocoa concentrated pulp juice are produced following processing (enzymatic treatment, pasteurization, filtration, and concentration). Typical compositional data of cocoa fruit pulp, pulp juice, concentrated pulp juice Protein (g/100 g): 0,0 to 2,0 Total fat (g/100 g): 0,0 to 0,2 Total sugars (g/100 g): > 11,0 Brix level (° Brix): ≥ 14 pH: 3,3 to 4,0 Microbiological criteria Total Plate Count (aerobic): < 10 000 cfu (1)/g Enterobacteriaceae: ≤ 10 cfu/g Salmonella: Absence in 25 g

---

(1)  Cfu: Colony forming unit.’

ANNEX

In Table 2 of Section 1 of Chapter II of Annex XIV to Regulation (EU) No 142/2011, row 12 is replaced by the following:

ANNEX

In Annex III to Regulation (EC) No 29/2009, paragraph 11 is replaced by the following:

ANNEX

Greece	Areas as referred to in Article 1	Date applicable until
Protection zone	Municipality of Visaltias (Serres Regional Unit)	6 April 2020
Surveillance zone	In Thessaloniki Regional Unit: — Municipality of Lagada, — Municipality of Volvis. In Serres Regional Unit: — Munipality of Iraklia, — Municipality of Serron, — Municipality of Amfipolis, — Municipality of Emmanouil Pappa, — Municipality of Neas Zichnis.	6 April 2020