ANNEX
Summary of product characteristics for a biocidal product family
CMIT/MIT SOLVENT BASED
Product type 6 – Preservatives for products during storage (Preservatives)
Authorisation number: EU-0023657-0000
R4BP asset number: EU-0023657-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
1.1. Family name
Name
CMIT/MIT SOLVENT BASED
1.2. Product type(s)
Product type(s)
PT06 – Preservatives for products during storage (Preservatives)
1.3. Authorisation holder
Name and address of the authorisation holder
Name
MC (Netherlands) 1 B.V.
Address
Willem Einthovenstraat 4, 2342BH Oegstgeest Netherlands
Authorisation number
EU-0023657-0000
R4BP asset number
EU-0023657-0000
Date of the authorisation
15 March 2023
Expiry date of the authorisation
28 February 2033
1.4. Manufacturer(s) of the biocidal products
Name of manufacturer
Specialty Electronic Materials Switzerland GmbH
Address of manufacturer
Im Ochsensand, 9470 Buchs Switzerland
Location of manufacturing sites
Im Ochsensand, 9470 Buchs Switzerland
Name of manufacturer
AD Productions BV
Address of manufacturer
Markweg Zuid 27, 4794 SN Heijningen Netherlands
Location of manufacturing sites
Markweg Zuid 27, 4794 SN Heijningen Netherlands
1.5. Manufacturer(s) of the active substance(s)
Active substance
Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (Einecs 247-500-7) and 2-methyl-2H-isothiazol-3-one (Einecs 220-239-6) (Mixture of CMIT/MIT)
Name of manufacturer
Jiangsu FOPIA Chemicals Co., Ltd (Specialty Electronic Materials Switzerland GmbH)
Address of manufacturer
Touzeng Village, Binhuai Town, 224555 Binhai County, Yancheng City, Jiangsu China
Location of manufacturing sites
Touzeng Village, Binhuai Town, 224555 Binhai County, Yancheng City, Jiangsu China
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
Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (Einecs 247-500-7) and 2-methyl-2H-isothiazol-3-one (Einecs 220-239-6) (Mixture of CMIT/MIT)
Active Substance
55965-84-9
10,8
12,1
Butyl carbitol
2-(2-butoxyethoxy)ethanol
Non-active substance
112-34-5
203-961-6
0,0
89,2
2.2. Type(s) of formulation
Formulation(s)
AL – Any other liquid
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 KATHON FP
1.2. Suffix to the authorisation number
Number
1-1
1.3. Product type(s)
Product type(s)
PT06 – Preservatives for products during storage (Preservatives)
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
Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (Einecs 247-500-7) and 2-methyl-2H-isothiazol-3-one (Einecs 220-239-6) (Mixture of CMIT/MIT)
Active Substance
55965-84-9
10,8
12,1
2.2. Type(s) of formulation of the meta SPC 1
Formulation(s)
AL – Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
Hazard statements
Causes severe skin burns and eye damage.
May cause an allergic skin reaction.
Very toxic to aquatic life with long lasting effects.
Corrosive to the respiratory tract.
Precautionary statements
Do not breathe vapours.
Contaminated work clothing should not be allowed out of the workplace.
Avoid release to the environment.
Wear protective gloves/protective clothing/eye protection.
Specific treatment (see supplemental first aid instructions on this label).
IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
IF ON SKIN: Wash with plenty of water.
IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Immediately call a POISON CENTER/doctor.
Take off contaminated clothing. And wash it before reuse.
Collect spillage.
If skin irritation or rash occurs: Get medical advice.
Store locked up.
Dispose of contents to an approved facility in accordance with local, regional, national and international regulations.
4. AUTHORISED USE(S) OF THE META SPC 1
4.1. Use description
Table 1. Use # 1 – Preservation of de-watered crude oil and refined products (middle and light distillate fuels) with a maximum water content of 2 %
Product type
PT06 – Preservatives for products during storage (Preservatives)
Where relevant, an exact description of the authorised use
Preservation of de-watered crude oil and refined products (middle and light distillate fuels) with a maximum water content of 2 %
Target organism(s) (including development stage)
Scientific name: Fungi/moulds
Common name: mould
Development stage: vegetative cells and spores
Scientific name: Fungi/Yeast
Common name: yeast
Development stage: vegetative cells
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Field(s) of use
Indoor
The biocidal product family is recommended to control microorganisms in de-watered crude oil and refined products (middle and light distillate fuels) with a maximum water content of 2 %.
The biocidal product family is not to be used for the preservation of aviation fuels, naphthas, alkenes/olefins and aromatics (simple and more complex structures).
Application method(s)
Method: Loading of biocidal product into the blend tank containing de-watered crude oils or refined products (middle and light distillate fuels)
Detailed description:
The biocidal product is added as a single dose at the time of manufacture, storage or shipment.
Dose the biocidal product to the end use fluid at a point to ensure adequate mixing using automated metering or by manual pouring using a safe measuring dosing system.
The biocidal product should not be dispensed as supplied into an empty fuel tank. Fuel tanks being treated with the biocidal product should be at least 10 % full in order to ensure good homogenisation of the biocidal product, which aids effectiveness of the treatment.
Fuel tanks and sumps should be drained of water regularly. Following treatment, drain off dead microorganisms and other debris from the treated fuel which have accumulated at the bottom of the tank. Filters should also be checked frequently and examined for the build-up of suspended solids. Whenever periodic maintenance is carried out, tanks should be checked for microbial growth.
Application rate(s) and frequency
Application Rate: Preservation for mid and long term storage and curative treatment 50-100 ppm v/v of biocidal product as supplied. Refined products (middle and light distillate fuels) and de-watered crude oils – Mid/long term preservation: 50 to 150 ppm v/v of biocidal product as supplied – Curative treatment: 200 to 400 ppm v/v of biocidal product as supplied
Dilution (%): -
Number and timing of application:
De-watered crude oils:
Mid/long-term preservation:
—
50 to 150 ppm v/v of biocidal product as supplied (0,75 – 2,25 ppm v/v CMIT/MIT), contact time needs to be 1 to 4 weeks, depending on the dose used.
Curative treatment::
—
Bacteria: 200 to 400 ppm v/v of biocidal product as supplied (3 – 6 ppm v/v CMIT/MIT), contact time needs to be 1 to 3 days, depending on the dose used.
—
Fungi (Yeasts/Moulds): 400 ppm v/v of biocidal product as supplied (6 ppm v/v CMIT/MIT), contact time needs to be 1 to 3 days, depending on the dose used.
Refined products (middle and light distillate fuels):
Mid/long-term preservation:
—
50 to 150 ppm v/v of biocidal product as supplied (0,75 – 2,25 ppm v/v CMIT/MIT), contact time needs to be 1 to 4 weeks, depending on the dose used.
Curative treatment::
—
Bacteria: 200 to 400 ppm v/v of biocidal product as supplied (3 – 6 ppm v/v CMIT/MIT), contact time needs to be 1 to 3 days, depending on the dose used.
—
Fungi (Yeasts/Moulds): 400 ppm v/v of biocidal product as supplied (6 ppm v/v CMIT/MIT), contact time needs to be 1 to 3 days, depending on the dose used.
Repeat as necessary when contamination is detected.
Category(ies) of users
Professional
Pack sizes and packaging material
Flasks: 5 l nominal, material of construction is high density polyethylene (HDPE)
Pails: 20 l nominal, material of construction is HDPE
Pails: 25 l nominal, material of construction is HDPE
Drums: 215 l nominal, material of construction is HDPE
Drums: 220 l nominal, material of construction is HDPE
Intermediate bulk container (IBC): 1000 l nominal, material of construction is HDPE
4.1.1. Use-specific instructions for use
See general directions for use.
4.1.2. Use-specific risk mitigation measures
See general directions for use.
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.
5. GENERAL DIRECTIONS FOR USE ( 1 ) OF THE META SPC 1
5.1. Instructions for use
—
Always read the label or leaflet before use and follow all the instructions provided.
—
Respect the conditions of use of the biocidal product (concentration, contact time, temperature, pH, etc.)
—
For preservation during mid/long-term storage, contact time needs to be 1 to 4 weeks, depending on the dose used. For curative treatment, the biocidal effect is achieved after 1-3 days.
—
Products are to be used only for mid or long-term storage or for curative treatment. Do not use in case of high turnover systems.
—
Check regularly the residual concentration of the active substance (both in the fuel and aqueous phases) between fuel transfers in order to ensure lack of contamination between treatments. The choice of intervals between treatments is based on the check of the residual active substance concentrations.
—
Microbiological tests to prove adequacy of preservation have to be undertaken (both in the fuel and aqueous phases) by the user of the product in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
Not authorised for use in the Kingdom of Denmark and in the Kingdom of Belgium.
Applicable in the Federal Republic of Germany only: Do not use the products for the preservation of fuels for non rail bound on road motor vehicles, except for the purpose of research, development or analysis.
5.2. Risk mitigation measures
—
For preservation up to the dose of 6 ppm, the maximum amount of treated de-watered crude oil or refined products emptied daily per site is 15 000 m 3 .
—
For preservation up to the dose of 3 ppm, the maximum amount of treated de-watered crude oil or refined products emptied daily per site is 35 000 m 3 .
When handling the biocidal product:
—
Wear protective chemical resistant gloves meeting the requirements of the European Standard EN 374 (glove material to be specified by the authorisation holder within the product information) and a protective coverall (at least type 6 EN13034), during product handling phase.
—
Wear chemical goggles meeting the requirements of the European Standard EN 166 during product handling phase.
—
The following technical and organisational measures should be implemented:
—
regular cleaning of the equipment and work area;.
—
the use of a dosing pump for manual loading;
—
minimisation of manual phases;
—
adequate ventilation during application of product.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
—
IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. Call a POISON CENTER or doctor/physician if you feel unwell.
—
IF ON SKIN: Rinse skin with water (or shower). Take off immediately all contaminated clothing and wash it before reuse.
—
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
—
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
—
If skin irritation or rash occurs: Get medical advice/attention.
—
Keep the container or label available.
5.4. Instructions for safe disposal of the product and its packaging
—
Release only to an industrial sewage treatment plant (STP).
—
Dispose of unused product, its packaging and all other waste, in accordance with local regulations.
—
Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets) nor down the drain.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 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)
KATHON FP 1.5 Biocide
Market area: EU
BLUECIDE 832
Market area: EU
BIOCIDA CARBURANTE DIESEL-BIODIESEL
Market area: EU
T2642
Market area: EU
XC85957
Market area: EU
BIOSTOP 15 GL
Market area: EU
C 412 GP 10
Market area: EU
SPEC-AID 8Q700
Market area: EU
Predator 9015
Market area: EU
FuelClear M15
Market area: EU
MIRECIDE-KW/615
Market area: EU
BIOC41770A
Market area: EU
Bactron B1770
Market area: EU
Authorisation number
EU-0023657-0001 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (Einecs 247-500-7) and 2-methyl-2H-isothiazol-3-one (Einecs 220-239-6) (Mixture of CMIT/MIT)
Active Substance
55965-84-9
11,3
META SPC 2
1. META SPC 2 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 2 identifier
Identifier
Meta SPC KATHON HP
1.2. Suffix to the authorisation number
Number
1-2
1.3. Product type(s)
Product type(s)
PT06 – Preservatives for products during storage (Preservatives)
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
Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (Einecs 247-500-7) and 2-methyl-2H-isothiazol-3-one (Einecs 220-239-6) (Mixture of CMIT/MIT)
Active Substance
55965-84-9
10,8
12,1
Butyl carbitol
2-(2-butoxyethoxy)ethanol
Non-active substance
112-34-5
203-961-6
87,9
89,2
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
Causes severe skin burns and eye damage.
May cause an allergic skin reaction.
Very toxic to aquatic life with long lasting effects.
Corrosive to the respiratory tract.
Precautionary statements
Do not breathe vapours.
Contaminated work clothing should not be allowed out of the workplace.
Wear protective gloves meeting the requirements of the European Standard EN 374/protective clothing of at least type 6 EN13034/Wear chemical goggles meeting the requirements of the European Standard EN 166.
Specific treatment (see supplemental first aid instructions on this label).
IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
IF ON SKIN: Wash with plenty of water.
IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Immediately call a POISON CENTER/doctor.
Take off contaminated clothing. And wash it before reuse.
Wash contaminated clothing before reuse.
If skin irritation or rash occurs: Get medical advice.
Store locked up.
Dispose of contents to an approved facility in accordance with local, regional, national and international regulations.
Avoid release to the environment.
Collect spillage.
4. AUTHORISED USE(S) OF THE META SPC 2
4.1. Use description
Table 2. Use # 1 – Preservation of de-watered crude oil and refined products (middle and light distillate fuels) with a maximum water content of 2 %
Product type
PT06 – Preservatives for products during storage (Preservatives)
Where relevant, an exact description of the authorised use
Preservation of de-watered crude oil and refined products (middle and light distillate fuels) with a maximum water content of 2 %
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: bacteria
Development stage: vegetative cells
Scientific name: Fungi/Yeast
Common name: yeast
Development stage: vegetative cells
Scientific name: Fungi/moulds
Common name: mould
Development stage: vegetative cells
Field(s) of use
Indoor
The biocidal product family is recommended to control microorganisms in de-watered crude oil and refined products (middle and light distillate fuels) with a maximum water content of 2 %.
The biocidal product family is not to be used for the preservation of aviation fuels, naphthas, alkenes/olefins and aromatics (simple and more complex structures).
Application method(s)
Method: Loading of biocidal product into the blend tank containing de-watered crude oils or refined products (middle and light distillate fuels)
Detailed description:
The biocidal product is added as a single dose at the time of manufacture, storage or shipment.
Dose the biocidal product to the end use fluid at a point to ensure adequate mixing using automated metering or by manual pouring using a safe measuring dosing system.
The biocidal product should not be dispensed as supplied into an empty fuel tank. Fuel tanks being treated with the biocidal product should be at least 10 % full in order to ensure good homogenisation of the biocidal product, which aids effectiveness of the treatment.
Fuel tanks and sumps should be drained of water regularly. Following treatment, drain off dead microorganisms and other debris from the treated fuel which have accumulated at the bottom of the tank. Filters should also be checked frequently and examined for the build-up of suspended solids. Whenever periodic maintenance is carried out, tanks should be checked for microbial growth.
Application rate(s) and frequency
Application Rate: Refined products (middle and light distillate fuels) and de-watered crude oils – Mid/long term preservation: 50 to 150 ppm v/v of biocidal product as supplied – Curative treatment: 200 to 400 ppm v/v of biocidal product as supplied
Dilution (%):
Number and timing of application:
De-watered crude oils
Mid/long-term preservation:
—
Bacteria: 33 to 200 ppm v/v of biocidal product as supplied (0,5 – 3 ppm v/v CMIT/MIT),
—
Fungi (Yeasts/Moulds): 50 to 200 ppm v/v of biocidal product as supplied (0,75 – 3 ppm v/v CMIT/MIT), contact time needs to be 1-4 weeks, depending on the dose used.
Curative treatment:
—
Bacteria: 200 to 400 ppm v/v of biocidal product as supplied (3 – 6 ppm v/v CMIT/MIT), contact time needs to be 1 to 3 days, depending on the dose used.
—
Fungi (Yeasts/Moulds): 400 ppm v/v of biocidal product as supplied (6 ppm v/v CMIT/MIT), contact time needs to be 1 to 3 days, depending on the dose used.
Refined products (middle and light distillate fuels)
Mid/long-term preservation:
—
Bacteria: 33 to 200 ppm v/v of biocidal product as supplied (0,5 – 3 ppm v/v CMIT/MIT), contact time needs to be 1-4 weeks, depending on the dose used.
—
Fungi (Yeasts/Moulds): 50 to 200 ppm v/v of biocidal product as supplied (0,75 – 3 ppm v/v CMIT/MIT), contact time needs to be 1-4 weeks, depending on the dose used.
Curative treatment:
—
Bacteria: 200 to 400 ppm v/v of biocidal product as supplied (3 – 6 ppm v/v CMIT/MIT), contact time needs to be 1 to 3 days, depending on the dose used.
—
Fungi (Yeasts/Moulds): 400 ppm v/v of biocidal product as supplied (6 ppm v/v CMIT/MIT), contact time needs to be 1 to 3 days, depending on the dose used.
Repeat as necessary when contamination is detected.
Category(ies) of users
Professional
Pack sizes and packaging material
Flasks: 5 l nominal, material of construction is high density polyethylene (HDPE)
Pails: 20 l and 25 l nominal, material of construction is HDPE
Drums: 215 l and 220 l nominal, material of construction is HDPE
Intermediate bulk container (IBC): 1000 l nominal, material of construction is HDPE
4.1.1. Use-specific instructions for use
See general directions for use.
4.1.2. Use-specific risk mitigation measures
See general directions for use.
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.
5. GENERAL DIRECTIONS FOR USE ( 2 ) OF THE META SPC 2
5.1. Instructions for use
—
Always read the label or leaflet before use and follow all the instructions provided.
—
Respect the conditions of use of the biocidal product (concentration, contact time, temperature, pH, etc.)
—
For preservation during mid/long-term storage, contact time needs to be 1 to 4 weeks, depending on the dose used. For curative treatment, the biocidal effect is achieved after 1-3 days.
—
Products are to be used only for mid or long-term storage or for curative treatment. Do not use in case of high turnover systems.
—
Check regularly the residual concentration of the active substance (both in the fuel and aqueous phases) between fuel transfers in order to ensure lack of contamination between treatments. The choice of intervals between treatments is based on the check of the residual active substance concentrations.
—
Microbiological tests to prove adequacy of preservation have to be undertaken (both in the fuel and aqueous phases) by the user of the product in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
Not authorised for use in the Kingdom of Denmark and in the Kingdom of Belgium.
Applicable in the Federal Republic of Germany only: Do not use the products for the preservation of fuels for non rail bound on road motor vehicles, except for the purpose of research, development or analysis.
5.2. Risk mitigation measures
—
For preservation up to the dose of 6 ppm, the maximum amount of treated de-watered crude oil or refined products emptied daily per site is 15 000 m 3 .
—
For preservation up to the dose of 3 ppm, the maximum amount of treated de-watered crude oil or refined products emptied daily per site is 35 000 m 3 .
When handling the biocidal product:
—
Wear protective chemical resistant gloves meeting the requirements of the European Standard EN 374 (glove material to be specified by the authorisation holder within the product information) and a protective coverall (at least type 6 EN13034), during product handling phase.
—
Wear chemical goggles meeting the requirements of the European Standard EN 166 during product handling phase.
—
The following technical and organisational measures should be implemented:
—
regular cleaning of the equipment and work area;.
—
the use of a dosing pump for manual loading;
—
minimisation of manual phases;
—
adequate ventilation during application of product.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
—
IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. Call a POISON CENTER or doctor/physician if you feel unwell.
—
IF ON SKIN: Rinse skin with water (or shower). Take off immediately all contaminated clothing and wash it before reuse.
—
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
—
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
—
If skin irritation or rash occurs: Get medical advice/attention.
—
Keep the container or label available.
5.4. Instructions for safe disposal of the product and its packaging
—
Release only to an industrial sewage treatment plant (STP).
—
Dispose of unused product, its packaging and all other waste, in accordance with local regulations.
—
Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets) nor down the drain.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 3 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)
KATHON HP 120 Biocide
Market area: EU
BLUECIDE 833
Market area: EU
Predator 9000
Market area: EU
FuelClear M68 Pro
Market area: EU
MIRECIDE-KW/615.C
Market area: EU
Authorisation number
EU-0023657-0002 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (Einecs 247-500-7) and 2-methyl-2H-isothiazol-3-one (Einecs 220-239-6) (Mixture of CMIT/MIT)
Active Substance
55965-84-9
11,3
Butyl carbitol
2-(2-butoxyethoxy)ethanol
Non-active substance
112-34-5
203-961-6
88,7
( 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.
