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 3 U.K.

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

4.1. Use description U.K.

Table 4. Use # 1 – Manual or automated dipping, foaming or spraying before milking

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

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

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

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

Eliminate all visible dirt before applying the product.

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

Let the product act at least one minute.

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

See also general directions for use of meta SPC 3.

4.1.2. Use-specific risk mitigation measures 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 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 3

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 3

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 3

4.2. Use description U.K.

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

Product Type	PT03 - Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Bacteria Yeasts Algae Viruses
Field(s) of use	Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking
Application method(s)	Dipping, foaming, spraying - Manual or automated disinfection of teats by dipping, foaming or spraying after milking. Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine
Application rate(s) and frequency	For disinfection of bacteria, yeasts and algae a dilution at 10% (v/v: 10 ml product, add water up to 100ml) should be prepared. For disinfection of viruses a dilution at 20% (v/v: 20 ml product, add water up to 100ml) should be prepared Application rate for the diluted product: 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.

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

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

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

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

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

See also general directions for use of meta SPC 3

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

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

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

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

See general directions for use of meta SPC 3

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

See general directions for use of meta SPC 3

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

See general directions for use of meta SPC 3