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 4 U.K.

1. META SPC 4 ADMINISTRATIVE INFORMATION U.K.

1.1. Meta SPC 4 identifier U.K.

Identifier

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

1.2. Suffix to the authorisation number U.K.

Number

1-4

1.3. Product type(s) U.K.

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

2. META SPC 4 COMPOSITION U.K.

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

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
					Min	Max
Iodine		Active substance	7553-56-2	231-442-4	0,5	0,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non active substance	68439-50-9		4,993	4,993

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

Formulation	AL - Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4 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 4 U.K.

4.1. Use description U.K.

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

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

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

See general directions for use of meta SPC 4

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

See general directions for use of meta SPC 4

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

See general directions for use of meta SPC 4

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

See general directions for use of meta SPC 4

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

See general directions for use of meta SPC 4

5. GENERAL DIRECTIONS FOR USE(1) OF THE META SPC 4 U.K.

5.1. Instructions for use U.K.

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

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

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

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

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

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

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

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

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

Where necessary, repeat the application after each milking.

Clean the application equipment regularly with warm water.

5.2. Risk mitigation measures U.K.

Wear eye protection.

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

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment 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 4 U.K.

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

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

(1)

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