Commission Implementing Regulation (EU) 2020/1187Show full title

META SPC 7 U.K.

1. META SPC 7 ADMINISTRATIVE INFORMATION U.K.

1.1. Meta SPC 7 identifier U.K.

Identifier

metaSPC 7: PT3 and PT4 – Concentrated Surface disinfectants Iodine

1.2. Suffix to the authorisation number U.K.

Number

1-7

1.3. Product type(s) U.K.

Product type(s)

PT03 – Veterinary hygiene (Disinfectants) PT04 – Food and feed area (Disinfectants)

2. META SPC 7 COMPOSITION U.K.

2.1. Qualitative and quantitative information on the composition of the meta SPC 7 U.K.

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
					Min	Max
Iodine		Active Substance	7553-56-2	231-442-4	1,8	2,49
Polyvinylpyrrolidone iodine		Active Substance	25655-41-8		0,0	0,0
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active Substance	68131-39-5	500-195-7	3,15	9,45
Phosphoric acid	Phosphoric acid	Non-active Substance	7664-38-2	231-633-2	0,0	0,0
Alcohol C9-11 + 6 EO	Alcohol C9-11 + 6 EO	Non-active Substance	68439-46-3		2,5	12,5

2.2. Type(s) of formulation of the meta SPC 7 U.K.

Formulation(s)

SL – Soluble concentrate

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7 U.K.

Hazard statements

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

Precautionary statements

Wear protective gloves. Wear protective clothing. Wear eye protection. Wear face protection. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a doctor or a POISON CENTER. Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. Collect spillage. Avoid release to the environment.

4. AUTHORISED USE(S) OF THE META SPC 7 U.K.

4.1. Use description U.K.

Table 8. Use # 1 – PT 4 – Concentrated Surface disinfectant in kitchens and in food industry, Iodine

Product type	PT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeasts
Field(s) of use	Indoor Non-porous surface disinfection in professional kitchens and in food industry
Application method(s)	By spraying with a manual or an automatic sprayer
Application rate(s) and frequency	Assume 0,04 L solution for every square meter that has to be disinfected. Bactericidal and yeasticidal activity: 0,015 % iodine Frequency is once per day.
Category(ies) of users	Professional
Pack sizes and packaging material	1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L HDPE

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

Use in professional kitchens (PT4) and in food industry (PT4):

The product must be diluted with water before use (according to the table below).

Clean the surfaces thoroughly with a detergent before disinfection. Rinse with clean water and remove surplus water.

The product is used in professional kitchens (surface disinfection): Frequency is once per day.

The product is used in food industry (surface disinfection): Frequency is once per day.

Use at room temperature.

Apply the product by spraying with a manual or an automatic sprayer. Make sure to wet the surface completely. Allow to take effect for at least 15 minutes and rinse the surfaces afterwards with clean water.

a Each product label should give information on how the dilution should be made. Since the concentration of iodine in products within this meta SPC can range from 1,8 to 2,49 % it is not possible to indicate all product dilutions here.
Example for a product containing 1 % iodinea	Dilution of the product	Contact time
Bactericidal and yeasticidal activity	1,5 % (15 ml product, add water up to 1 L)	15 min

Do not mix with other chemicals.

Do not prepare more fluid than necessary.

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

• During pouring and pumping of the concentrated product: Wear chemical resistant gloves (material to be specified by the authorisation holder within the product information) and eye/face protection.

• During spraying of the product: Wear chemical resistant gloves and protective coverall (at least type X, EN XXXXX) (glove and coverall material to be specified by the authorisation holder within the product information).

• Keep out of reach of children.

• The general public and animals should be kept away from treated areas until surfaces are dry.

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.

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.

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.

4.2. Use description U.K.

Table 9. Use # 2 – PT3 – Concentrated Surface disinfectant for veterinary use, Iodine

Product type	PT03 – Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	—
Target organism(s) (including development stage)	Bacteria Yeasts Viruses
Field(s) of use	Indoor Non-porous surface disinfection in veterinary field
Application method(s)	By spraying with a manual or an automatic sprayer
Application rate(s) and frequency	Assume 0,04 L solution for every square meter that has to be disinfected. Bactericidal and yeasticidal activity: 0,025 % in-use iodine Virucidal activity: 0,035 % in-use iodine
Category(ies) of users	Professional
Pack sizes and packaging material	1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L HDPE

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

Use in veterinary field (PT3), surface disinfection:

The product should be diluted with water before use (according to table below).

Clean the surfaces thoroughly with a detergent before disinfection. Rinse with clean water and remove surplus water.

The product is used to disinfect animal housings of pigs, cows and poultry.

Apply the product by spraying with a manual or an automatic sprayer. Make sure to wet the surface completely. Allow to take effect for at least 30 minutes. Animal housing must be empty of animals during application and animals can re-enter 24h after the end of the application.

a Each product label should give information on how the dilution should be made. Since the concentration of iodine in products within this meta SPC can range from 1,8 to 2,49 % it is not possible to indicate all product dilutions here.
Example for a product containing 2,49 % iodinea	Dilution of the product	Contact time
Bactericidal and yeasticidal activity	1 % (10ml product, add water up to 1 L)	30 min
Virucidal activity	1,4 % (14ml product, add water up to 1 L)	30 min

Do not mix with other chemicals.

Do not prepare more fluid than necessary.

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

• During pouring and pumping of the concentrated product: Wear chemical resistant gloves, coated coverall (material to be specified by the authorisation holder within the product information) and eye/face protection.

• During spraying of the product: Wear chemical resistant gloves and protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product (glove and coverall material to be specified by the authorisation holder within the product information).

• Only use one kind of Iodine-containing product per day.

• Due to potential concern for human health the same professional user shall not carry out animal house disinfection more than 3 times per month and shll not use Iodine products for other purposes during that period.

• Due to potential concern for animal health, disinfection of stables should not be carried out more than once per year or once per lifetime for calves and pigs. Feeding troughs must be covered during application.

• Keep out of reach of children.

• The general public and animals should be kept away from treated areas until surfaces are dry.

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.

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.

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.

5. GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 7 U.K.

5.1. Instructions for use U.K.

See use-specific instructions for use.

5.2. Risk mitigation measures U.K.

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 U.K.

After eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Obtain emergency medical attention if pain, blinking, tears or redness persist.

If medical advice is needed, have product container or label at hand.

After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice.

Have product container or label at hand.

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.

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

Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

6. OTHER INFORMATION U.K.

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

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

Trade name(s)	Dodin 20 Iodo 20 Bio Tec Joddesinfektion Dufa dine 1,8 % Alfasan super disinfectant Iodes Streptoclean Iodin Surface Disinfectant 1,8 % IODINE
Authorisation number	EU-0022265-0010 1-7
Common name	IUPAC name	Function	CAS number		EC number	Content (%)
Iodine		Active Substance	7553-56-2		231-442-4	1,8
Polyvinylpyrrolidone iodine		Active Substance	25655-41-8			0,0
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active Substance	68131-39-5		500-195-7	5,29
Alcohol C9-11 + 6 EO	Alcohol C9-11 + 6 EO	Non-active Substance	68439-46-3			5,0

(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 7.