Commission Implementing Regulation (EU) 2020/579 of 27 April 2020 granting a Union authorisation for the biocidal product family ‘HYPRED’s octanoic acid based products’ (Text with EEA relevance)

ANNEXSummary of product characteristics for a biocidal product family
ANNEX
Summary of product characteristics for a biocidal product family
HYPRED‘s octanoic acid based products
Product type 4 – Food and feed area (Disinfectants)
Authorisation number: EU-0021020-0000
R4BP asset number: EU-0021020-0000
PART I
FIRST INFORMATION LEVEL
1.    ADMINISTRATIVE INFORMATION
1.1.    Family name
Name
HYPRED‘s octanoic acid based products
1.2.    Product type(s)
Product type(s)
PT04 – Food and feed area (Disinfectants)
1.3.    Authorisation holder
Name and address of the authorisation holder
Name
HYPRED SAS
Address
55 boulevard Jules Verger, 35803 DINARD, France
Authorisation number
EU-0021020-0000
R4BP asset number
EU-0021020-0000
Date of the authorisation
18 May 2020
Expiry date of the authorisation
30 April 2030
1.4.    Manufacturer(s) of the biocidal products
Name of manufacturer
HYPRED SAS
Address of manufacturer
55 Boulevard Jules Verger, 35803 DINARD France
Location of manufacturing sites
HYPRED SAS – 55 Boulevard Jules Verger – BP 10180, 35803 DINARD France
HYPRED POLSKA SP. Z O.O. NIEPRUSZEWO, KASZTANOWA 4, 64320 buk Poland
HYPRED IBERICA S.L Pol. Ind. Arazuri-Orcoyen C/C n° 32, 31160 Orcoyen – NAVARRA Spain
HYPRED GmbH Marie-Curie-Straße 23, 53332 Bornheim – Sechtem Germany
HYPRED Italia s.r.l. Strada Montodine-Gombito Loc. Cà Nova, 26010 Ripalta Arpina CR Italy
AG France S.A.S – Zone Industrielle Le Roineau, 72500 Vaas France
Anti-Germ Austria GmbH – ‘Pfongauer Straße 17, 5202 Neumarkt am Wallersee’ Austria
Anti-Germ Deutschland GmbH – Oberbrühlstraße 16-18, 87700 Memmingen Germany
1.5.    Manufacturer(s) of the active substance(s)
Active substance
Octanoic acid
Name of manufacturer
Emery Oleochemicals (M)
Address of manufacturer
Sdn Bhd (63112-D), Lot 4, Jalan Perak, Kawasan Perusahaan, 42500 Telok Panglima Garang, Selangor Malaysia
Location of manufacturing sites
Sdn Bhd (63112-D), Lot 4, Jalan Perak, Kawasan Perusahaan, 42500 Telok Panglima Garang, Selangor Malaysia
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
Octanoic acid
Active Substance
124-07-2
204-677-5
3,0
10,0
Methanesulfonic acid
Non-active substance
75-75-2
200-898-6
0,0
21,0
L-(+)-Lactic acid
Non-active substance
79-33-4
201-196-2
0,0
17,6
N,N-dimethyl-1-Decanamine, N-oxid
Non-active substance
2605-79-0
220-020-5
2,25
6,0
Ethoxylated alcohol
Ethoxylated alcohol
Non-active substance
31726-34-8
500-077-5
0,0
15,0
2.2.    Type(s) of formulation
Formulation(s)
SL – Soluble concentrate
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 1
1.2.    Suffix to the authorisation number
Number
1-1
1.3.    Product type(s)
Product type(s)
PT04 – Food and feed area (Disinfectants)
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
Octanoic acid
Active Substance
124-07-2
204-677-5
3,0
3,0
Methanesulfonic acid
Non-active substance
75-75-2
200-898-6
21,0
21,0
L-(+)-Lactic acid
Non-active substance
79-33-4
201-196-2
0,0
0,0
N,N-dimethyl-1-Decanamine, N-oxid
Non-active substance
2605-79-0
220-020-5
2,25
2,25
Ethoxylated alcohol
Ethoxylated alcohol
Non-active substance
31726-34-8
500-077-5
5,0
5,0
2.2.    Type(s) of formulation of the meta SPC 1
Formulation(s)
SL – Soluble concentrate
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
Hazard statements
May be corrosive to metals.
Causes severe skin burns and eye damage.
May cause respiratory irritation.
Harmful to aquatic life with long lasting effects.
Precautionary statements
Wear protective gloves.
Wear protective clothing.
Wear eye protection.
Wear face protection.
IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.
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.
Dispose of contents according to local/regional/national/international regulation.
Avoid release to the environment.
4.    AUTHORISED USE(S) OF THE META SPC 1
4.1.    Use description
Table 1. Use # 1 – Circulation in dairy industry
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
Cleaning – disinfection of circuits in dairy industry
Application method(s)
Closed system: Circulation
Clean-in-place (CIP), circulation
Application rate(s) and frequency
- Use 1 % product solution for bactericidal activity and 1,5 % product solution for yeasticidal activity
1 to 3 cycles per day, 208 to 360 days per year
Category(ies) of users
Professional
Pack sizes and packaging material
Opaque jerrycan High-density polyethylene (HDPE) 5L
Opaque jerrycan HDPE 10L
Opaque jerrycan HDPE 22L
Opaque drum HDPE 60L
Opaque drum HDPE 120L
Opaque drum HDPE 220L
Opaque container HDPE 640L
Opaque container HDPE 1000L
4.1.1.    Use-specific instructions for use
Rinse the circuits with drinking water before disinfection.
Apply the product by circulation.
Product concentration and contact time:
—
1 % bactericidal in 5 minutes
—
1,5 % yeasticidal in 15 minutes
Temperature of the product solution: 40 – 85 °C
Rinse with drinking water.
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
4.2.    Use description
Table 2. Use # 2 – Circulation in farms
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
Cleaning – disinfection of milking equipment and milking robots in farms
Application method(s)
Closed system: Circulation
Application rate(s) and frequency
- Use 0,8 % product solution for bactericidal activity and 1,5 % product solution for yeasticidal activity.
The milk installations cleaned and disinfected twice a day and the milk tank is cleaned and disinfected once every three days.
Category(ies) of users
Professional
Pack sizes and packaging material
Opaque jerrycan HDPE 5L
Opaque jerrycan HDPE 10L
Opaque jerrycan HDPE 22L
Opaque drum HDPE 60L
Opaque drum HDPE 120L
Opaque drum HDPE 220L
Opaque container HDPE 640L
Opaque container HDPE 1000L
4.2.1.    Use-specific instructions for use
Milk installations with or without a programmer.
(1)
After milking, rinse the equipment with warm drinking water.
(2)
Apply the solution by circulation at an initial recommended temperature of 60 °C minimum to achieve a final temperature of 40– 45 °C.
Product concentration and contact time:
0,8 % bactericidal in 10 minutes
1,5 % yeasticidal in 15 minutes
Do not use at temperature above 75 °C.
3)
Rinse with cold drinking water.
Use the product twice a day or once a day when alternating with another product.
When alternating, use an alternative cleaner-disinfectant or a cleaning product 1 to 4 times per week depending on the temperature reached in the system.
Contact your supplier for choosing the alternative product and the frequency of use.
Do not mix the product with an alkaline or chlorinated alkaline product.
4.2.2.    Use-specific risk mitigation measures
See general directions for use
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
See general directions for use
4.2.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
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
See general directions for use
5.    GENERAL DIRECTIONS FOR USE   ( 1 )
OF THE META SPC 1
5.1.    Instructions for use
See use specific instructions for use.
5.2.    Risk mitigation measures
—
Wear protective chemical resistant gloves, coverall and eye protection during product handling phase (protective material to be specified by the authorisation holder in the product information).
—
Ensure adequate ventilation during the application.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.
FIRST AID
—
IF INHALED: Remove person to fresh air and keep comfortable for breathing. Immediately call a POISON CENTER or doctor/physician.
—
IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower. Immediately call a POISON CENTER or doctor/physician.
—
IF IN EYES: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open. Remove contact lenses if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor/physician.
—
IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. Immediately call a POISON CENTER or doctor/physician.
See Safety Data Sheets. They contain an emergency phone number
When asking for medical advice keep packaging or label at hand and call a POISON CENTER or doctor/physician.
NEVER administer liquids/solids orally to an impaired or unconscious individual; place individual in left sideways position with the head lowered and the knees bent.
NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!
5.4.    Instructions for safe disposal of the product and its packaging
Do not discharge the product directly to sewer or to the environment.
Dispose the product and its packaging in accordance with applicable local and national regulations.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 2 years in HDPE
Conditions of storage: keep only in the original packaging. Keep container closed. Do not store at temperature above 40 °C.
6.    OTHER INFORMATION
The cleaning properties of the product has not been assessed as they are not covered by Regulation (EU) No 528/2012.
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)
HYPRACID ONE
DEPTACID BD
prevides®MS
Authorisation number
EU-0021020-0001 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Octanoic acid
Active Substance
124-07-2
204-677-5
3,0
Methanesulfonic acid
Non-active substance
75-75-2
200-898-6
21,0
N,N-dimethyl-1-Decanamine, N-oxid
Non-active substance
2605-79-0
220-020-5
2,25
Ethoxylated alcohol
Ethoxylated alcohol
Non-active substance
31726-34-8
500-077-5
5,0
META SPC 2
1.    META SPC 2 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 2 identifier
Identifier
Meta SPC 2
1.2.    Suffix to the authorisation number
Number
1-2
1.3.    Product type(s)
Product type(s)
PT04 – Food and feed area (Disinfectants)
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
Octanoic acid
Active Substance
124-07-2
204-677-5
10,0
10,0
Methanesulfonic acid
Non-active substance
75-75-2
200-898-6
14,0
14,0
L-(+)-Lactic acid
Non-active substance
79-33-4
201-196-2
0,0
0,0
N,N-dimethyl-1-Decanamine, N-oxid
Non-active substance
2605-79-0
220-020-5
4,5
4,5
Ethoxylated alcohol
Ethoxylated alcohol
Non-active substance
31726-34-8
500-077-5
15,0
15,0
2.2.    Type(s) of formulation of the meta SPC 2
Formulation(s)
SL – Soluble concentrate
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
Hazard statements
May be corrosive to metals.
Harmful if swallowed.
Causes severe skin burns and eye damage.
Harmful to aquatic life with long lasting effects.
Precautionary statements
Wear protective gloves.
Wear protective clothing.
Wear eye protection.
Wear face protection.
IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.
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.
Dispose of contents according to local/regional/national/international regulation.
Avoid release to the environment.
4.    AUTHORISED USE(S) OF THE META SPC 2
4.1.    Use description
Table 3. Use # 1 – Circulation
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
Disinfection of circuits in breweries, dairy and beverage industries
Application method(s)
Closed system: Circulation
CIP, circulation
Application rate(s) and frequency
- Use 0,4 % product solution for bactericidal activity and 0,6 % product solution for yeasticidal activity.
1 to 3 cycles per day, 208 to 360 days per year
Category(ies) of users
Professional
Pack sizes and packaging material
Opaque jerrycan HDPE 5L
Opaque jerrycan HDPE 10L
Opaque jerrycan HDPE 22L
Opaque drum HDPE 60L
Opaque drum HDPE 120L
Opaque drum HDPE 220L
Opaque container HDPE 640L
Opaque container HDPE 1000L
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
Prior to the application of the product, clean with a detergent and rinse with drinking water.
Apply the product by circulation.
Product concentration and contact time:
—
0,4 % bactericidal in 5 minutes
—
0,6 % yeasticidal in 15 minutes
Temperature of the product solution: 20 – 85 °C
Rinse with drinking water.
5.2.    Risk mitigation measures
—
Wear protective chemical resistant gloves, coverall and eye protection during product handling phase (protective material to be specified by the authorisation holder in the product information).
—
Ensure adequate ventilation during the application.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.
FIRST AID
—
IF INHALED: Remove person to fresh air and keep comfortable for breathing. Immediately call a POISON CENTER or doctor/physician.
—
IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower. Immediately call a POISON CENTER or doctor/physician.
—
IF IN EYES: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open. Remove contact lenses if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor/physician.
—
IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. Immediately call a POISON CENTER or doctor/physician.
See Safety Data Sheets. They contain an emergency phone number.
When asking for medical advice keep packaging or label at hand and call a POISON CENTER or doctor/physician.
NEVER administer liquids/solids orally to an impaired or unconscious individual; place individual in left sideways position with the head lowered and the knees bent.
NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!
5.4.    Instructions for safe disposal of the product and its packaging
Do not discharge the product directly to sewer or to the environment.
Dispose the product and its packaging in accordance with applicable local and national regulations.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 2 years in HDPE
Conditions of storage: keep only in the original packaging. Keep container closed. Keep in a cool place. Do not store at temperature above 40 °C.
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)
DEPTACID CCB
Authorisation number
EU-0021020-0002 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Octanoic acid
Active Substance
124-07-2
204-677-5
10,0
Methanesulfonic acid
Non-active substance
75-75-2
200-898-6
14,0
N,N-dimethyl-1-Decanamine, N-oxid
Non-active substance
2605-79-0
220-020-5
4,5
Ethoxylated alcohol
Ethoxylated alcohol
Non-active substance
31726-34-8
500-077-5
15,0
META SPC 3
1.    META SPC 3 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 3 identifier
Identifier
Meta SPC 3
1.2.    Suffix to the authorisation number
Number
1-3
1.3.    Product type(s)
Product type(s)
PT04 – Food and feed area (Disinfectants)
2.    META SPC 3 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 3
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Min
Max
Octanoic acid
Active Substance
124-07-2
204-677-5
10,0
10,0
Methanesulfonic acid
Non-active substance
75-75-2
200-898-6
0,0
0,0
L-(+)-Lactic acid
Non-active substance
79-33-4
201-196-2
17,6
17,6
N,N-dimethyl-1-Decanamine, N-oxid
Non-active substance
2605-79-0
220-020-5
6,0
6,0
Ethoxylated alcohol
Ethoxylated alcohol
Non-active substance
31726-34-8
500-077-5
0,0
0,0
2.2.    Type(s) of formulation of the meta SPC 3
Formulation(s)
SL – Soluble concentrate
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
Hazard statements
May be corrosive to metals.
Causes severe skin burns and eye damage.
Harmful to aquatic life with long lasting effects.
Precautionary statements
Wear protective gloves.
Wear protective clothing.
Wear eye protection.
Wear face protection.
IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.
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.
Dispose of contents according to local/regional/national/international regulation.
Avoid release to the environment.
4.    AUTHORISED USE(S) OF THE META SPC 3
4.1.    Use description
Table 4. Use # 1 – Circulation
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
Disinfection of circuits in breweries, dairy and beverage industries
Application method(s)
Closed system: Circulation
CIP, circulation
Application rate(s) and frequency
- Use 0,4 % product solution
1 to 3 cycles per day, 208 to 360 days per year
Category(ies) of users
Professional
Pack sizes and packaging material
Opaque jerrycan HDPE 5L
Opaque jerrycan HDPE 10L
Opaque jerrycan HDPE 22L
Opaque drum HDPE 60L
Opaque drum HDPE 120L
Opaque drum HDPE 220L
Opaque container HDPE 640L
Opaque container HDPE 1000L
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   ( 3 )
OF THE META SPC 3
5.1.    Instructions for use
Prior to the application of the product, clean with a detergent and rinse with drinking water.
Apply the product by circulation.
Product concentration: 0,4 %
Contact time:
—
5 minutes for bactericidal activity
—
15 minutes for yeasticidal activity
Temperature of the product solution: 20 – 85 °C
Rinse with drinking water.
5.2.    Risk mitigation measures
—
Wear protective chemical resistant gloves, coverall and eye protection during product handling phase (protective material to be specified by the authorisation holder in the product information).
—
Ensure adequate ventilation during the application.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.
FIRST AID
—
IF INHALED: Remove person to fresh air and keep comfortable for breathing. Immediately call a POISON CENTER or doctor/physician.
—
IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower. Immediately call a POISON CENTER or doctor/physician.
—
IF IN EYES: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open. Remove contact lenses if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor/physician.
—
IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. Immediately call a POISON CENTER or doctor/physician.
See Safety Data Sheets. They contain an emergency phone number.
When asking for medical advice keep packaging or label at hand and call a POISON CENTER or doctor/physician.
NEVER administer liquids/solids orally to an impaired or unconscious individual; place individual in left sideways position with the head lowered and the knees bent.
NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!
5.4.    Instructions for safe disposal of the product and its packaging
Do not discharge the product directly to sewer or to the environment.
Dispose the product and its packaging in accordance with applicable local and national regulations.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 2 years in HDPE
Conditions of storage: keep only in the original packaging. Keep container closed. Do not store at temperature above 40 °C.
6.    OTHER INFORMATION
7.    THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
7.1.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
DEPTACID CB
Authorisation number
EU-0021020-0003 1-3
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Octanoic acid
Active Substance
124-07-2
204-677-5
10,0
L-(+)-Lactic acid
Non-active substance
79-33-4
201-196-2
17,6
N,N-dimethyl-1-Decanamine, N-oxid
Non-active substance
2605-79-0
220-020-5
6,0
META SPC 4
1.    META SPC 4 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 4 identifier
Identifier
Meta SPC 4
1.2.    Suffix to the authorisation number
Number
1-4
1.3.    Product type(s)
Product type(s)
PT04 – Food and feed area (Disinfectants)
2.    META SPC 4 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 4
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Min
Max
Octanoic acid
Active Substance
124-07-2
204-677-5
3,0
3,0
Methanesulfonic acid
Non-active substance
75-75-2
200-898-6
21,0
21,0
L-(+)-Lactic acid
Non-active substance
79-33-4
201-196-2
0,0
0,0
N,N-dimethyl-1-Decanamine, N-oxid
Non-active substance
2605-79-0
220-020-5
3,0
3,0
Ethoxylated alcohol
Ethoxylated alcohol
Non-active substance
31726-34-8
500-077-5
5,0
5,0
2.2.    Type(s) of formulation of the meta SPC 4
Formulation(s)
SL – Soluble concentrate
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
Hazard statements
May be corrosive to metals.
Causes severe skin burns and eye damage.
May cause respiratory irritation.
Harmful to aquatic life with long lasting effects.
Precautionary statements
Wear protective gloves.
Wear protective clothing.
Wear eye protection.
Wear face protection.
IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.
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.
Dispose of contents according to local/regional/national/international regulation.
Avoid release to the environment.
4.    AUTHORISED USE(S) OF THE META SPC 4
4.1.    Use description
Table 5. Use # 1 – Separative membranes circulation
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
Disinfectant or cleaner-disinfectant for membranes used in reverse osmosis and nanofiltration in dairy and beverage industries.
Application method(s)
Closed system: Circulation
Application rate(s) and frequency
—
Use 0,75 % product solution if cleaning is applied prior to the disinfection
—
Use 1 % product solution if no cleaning is applied prior to the disinfection
1 to 3 cycles per day, 104 to 312 days per year
Category(ies) of users
Professional
Pack sizes and packaging material
Opaque jerrycan HDPE 5L
Opaque jerrycan HDPE 10L
Opaque jerrycan HDPE 22L
Opaque drum HDPE 60L
Opaque drum HDPE 120L
Opaque drum HDPE 220L
Opaque container HDPE 640L
Opaque container HDPE 1000L
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   ( 4 )
OF THE META SPC 4
5.1.    Instructions for use
Rinse the membranes with drinking water or clean and rinse with drinking water before disinfection.
Apply the product by circulation
Product concentration if no cleaning is applied prior to the disinfection: 1 %
Product concentration if cleaning is applied prior to the disinfection: 0,75 %
Contact time:
—
5 minutes for bactericidal activity
—
15 minutes for yeasticidal activity
Temperature of the product solution: 40 – 85 °C
Rinse with drinking water.
5.2.    Risk mitigation measures
—
Wear protective chemical resistant gloves, coverall and eye protection during product handling phase (protective material to be specified by the authorisation holder in the product information).
—
Ensure adequate ventilation during the application.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.
FIRST AID
—
IF INHALED: Remove person to fresh air and keep comfortable for breathing. Immediately call a POISON CENTER or doctor/physician.
—
IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower. Immediately call a POISON CENTER or doctor/physician.
—
IF IN EYES: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open. Remove contact lenses if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor/physician.
—
IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. Immediately call a POISON CENTER or doctor/physician.
See Safety Data Sheets. They contain an emergency phone number
When asking for medical advice keep packaging or label at hand and call a POISON CENTER or doctor/physician.
NEVER administer liquids/solids orally to an impaired or unconscious individual; place individual in left sideways position with the head lowered and the knees bent.
NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!
5.4.    Instructions for safe disposal of the product and its packaging
Do not discharge the product directly to sewer or to the environment.
Dispose the product and its packaging in accordance with applicable local and national regulations.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf life: 2 years in HDPE
Conditions of storage: keep only in the original packaging. Keep container closed. Do not store at temperature above 40 °C.
6.    OTHER INFORMATION
The cleaning properties of the product has not been assessed as they are not covered by Regulation (EU) No 528/2012.
7.    THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
7.1.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
DEPTACID WCM
Authorisation number
EU-0021020-0004 1-4
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Octanoic acid
Active Substance
124-07-2
204-677-5
3,0
Methanesulfonic acid
Non-active substance
75-75-2
200-898-6
21,0
N,N-dimethyl-1-Decanamine, N-oxid
Non-active substance
2605-79-0
220-020-5
3,0
Ethoxylated alcohol
Ethoxylated alcohol
Non-active substance
31726-34-8
500-077-5
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 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.
( 3 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.
( 4 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4.
Commission Implementing Regulation (EU) 2020/579 of 27 April 2020 granting a Union authorisation for the biocidal product family ‘HYPRED’s octanoic acid based products’ (Text with EEA relevance)

Schedules & Appendices

Cite this act
