Commission Implementing Regulation (EU) 2020/1995 of 4 December 2020 amending Implementing Regulation (EU) No 2018/1261 as regards administrative changes of the information related to the Union authorisation of the biocidal product family ‘Hypred’s iodine based products’ (Text with EEA relevance) (c. 1995)

ANNEX U.K. Summary of product characteristics for a biocidal product family

PART II U.K. SECOND INFORMATION LEVEL - META SPC(S)

META SPC 2 U.K.

1. META SPC 2 ADMINISTRATIVE INFORMATION U.K.

1.1. Meta SPC 2 identifier U.K.

Identifier

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

1.2. Suffix to the authorisation number U.K.

Number

1-2

1.3. Product type(s) U.K.

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

2. META SPC 2 COMPOSITION U.K.

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

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
					Min	Max
Iodine		Active substance	7553-56-2	231-442-4	0,25	0,49
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non active substance	68439-50-9		2,697	4,69

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

Formulation	AL - Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 U.K.

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

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

4.1. Use description U.K.

Table 2. Use # 1 – Manual or automated dipping, foaming or spraying before milking

Product Type	PT03 - Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Bacteria Yeasts
Field(s) of use	Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking
Application method(s)	Dipping, foaming or spraying before milking - Manual or automated disinfection of teats by dipping, foaming or spraying before milking Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine
Application rate(s) and frequency	cows and buffaloes (3 to 10ml : 5 to 8 ml recommended) sheep (1.5 to 5 ml : 1.5 to 3ml recommended) goats (2.5 to 6 ml : 2.5 to 4 ml recommended) Frequency : 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1000L

4.1.1. Use-specific instructions for use U.K.

Eliminate all visible dirt before applying the product.

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

Let the product act at least one minute.

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

See also general instructions for use of meta SPC 2.

4.1.2. Use-specific risk mitigation measures U.K.

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

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

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

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

See general directions for use of meta SPC 2

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

See general directions for use of meta SPC 2

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

See general directions for use of meta SPC 2

4.2. Use description U.K.

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

Product Type	PT03 - Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Bacteria Yeasts Algae
Field(s) of use	Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking
Application method(s)	Dipping, foaming, spraying after milking - Manual or automated disinfection of teats by dipping, foaming or spraying after milking Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine
Application rate(s) and frequency	cows and buffaloes (3 to 10ml : 5 to 8 ml recommended) sheep (1,5 to 5 ml : 1,5 to 3ml recommended) goats (2,5 to 6 ml : 2,5 to 4 ml recommended) Frequency : 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1000L

4.2.1. Use-specific instructions for use U.K.

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

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

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

See also general instructions for use of meta SPC 2.

4.2.2. Use-specific risk mitigation measures U.K.

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

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

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

See general directions for use of meta SPC 2

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

See general directions for use of meta SPC 2

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

See general directions for use of meta SPC 2

5. GENERAL DIRECTIONS FOR USE(1) OF THE META SPC 2 U.K.

5.1. Instructions for use U.K.

See use-specific instructions for each use.

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

The product must be brought to a temperature above 20°C before use.

The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping/foaming cup/sprayer manually or automatically with the ready to use product.

Where necessary repeat the application at each milking

Clean the application equipment regularly with warm water.

5.2. Risk mitigation measures U.K.

See use-specific risk mitigation measures for each use.

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

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

FIRST AID INSTRUCTIONS

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

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

• In the event of contact with the eyes :

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

If eye irritation persists: Get medical advice/attention.

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

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

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

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

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

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

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

Shelf life : 2 years in HDPE

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

6. OTHER INFORMATION U.K.

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

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

Trade name(s)	Liq-io 2500 JOD SPRAY IODINE 3000 RTU IODEX 2500 Usual Iod Liquid Iodoliquid Iodospray DESINTEAT IODYSPRAY RBT 2500 IODY’FLASH INO IODE SPRAY IODYPRO 2500 IODYPRO BL2500 Robot Liq-io 25 ADF iDip+ ASiRAL Dip Spray J IODIPACK HELIO IODE LIQUIDE POLY-IODE CERTIODE LIQUIDE IOSAPIS FLUID GELAPIS ROBOT ZENCARE SPRAY HELIO IODE SPRAY + IODIP + KRONI Jod Spray 2500 WÜBBELMANN JOD LIQUID PRECEPT ANGLIA FARMERS PRECLENZ H&M PREDIP FULLWOOD PRECLEANSE M WILLIAMS PRECEPT STANTON PREDIP RTU WYNNSAN IODINE PREDIP RTU PREMIER GOLD PRE-DIP HODGES & MOSS PREDIP LANODIP PREPOST DAIRYSAN MULTICARE EMPRASAN ADVANCE UDDERWASH IODINE ANGLIA FARMERS PREPOST-IO PREMIER GOLD PRE/POST FULLWOOD PRE/POST IODINE HODGES & MOSS ADVANCE WYNNSAN IODINE PREPOST
Authorisation number	EU-0018397-0003 1-2
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active substance	7553-56-2	231-442-4	0,25
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non active substance	68439-50-9		2,697

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

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

(1)

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