COMMISSION IMPLEMENTING REGULATION (EU) 2020/580
of 27 April 2020
granting a Union authorisation for the biocidal product family ‘SOPURCLEAN’
(Text with EEA relevance)
Article 1
Article 2
ANNEX
Summary of product characteristics for a biocidal product family
PART I
FIRST INFORMATION LEVEL
1.
ADMINISTRATIVE INFORMATION
1.1.
Family name
Name |
SOPURCLEAN |
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 |
SOPURA N.V. |
Address |
Rue de Trazegnies 199, 6180 COURCELLES, Belgium |
|
Authorisation number |
EU-0021157-0000 |
|
R4BP asset number |
EU-0021157-0000 |
|
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 |
SOPURA N.V. |
Address of manufacturer |
Rue de Trazegnies 199, 6180 COURCELLES Belgium |
Location of manufacturing sites |
PIB de Tyberchamps 14, 7180 SENEFFE Belgium Rue de Trazegnies 199, 6180 COURCELLES Belgium |
Name of manufacturer |
SOPURA QUIMICA |
Address of manufacturer |
Poligon ‘La Canaleta’, Avinguda Júpiter 9, 25300 TARREGA Spain |
Location of manufacturing sites |
Poligon ‘La Canaleta’, Avinguda Júpiter 9, 25300 TARREGA Spain |
1.5.
Manufacturer(s) of the active substance(s)
Active substance |
Octanoic acid |
Name of manufacturer |
Emery Oleochemicals (M) Sdn Bhd (63112-D) |
Address of manufacturer |
Lot 4, Jalan Perak, Kawasan Perusahaan, Telok Panglima Garang, 42500 Selangor Malaysia |
Location of manufacturing sites |
Lot 4, Jalan Perak, Kawasan Perusahaan, Telok Panglima Garang, 42500 Selangor Malaysia |
Active substance |
Decanoic acid |
Name of manufacturer |
Emery Oleochemicals (M) Sdn Bhd (63112-D) |
Address of manufacturer |
Lot 4, Jalan Perak, Kawasan Perusahaan, Telok Panglima Garang, 42500 Selangor Malaysia |
Location of manufacturing sites |
Lot 4, Jalan Perak, Kawasan Perusahaan, Telok Panglima Garang, 42500 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 |
1,1 |
2,7 |
Decanoic acid |
|
Active Substance |
334-48-5 |
206-376-4 |
0,3 |
1,5 |
Sulfuric acid |
|
Non-active substance |
7664-93-9 |
231-639-5 |
0,0 |
31,2 |
Propionic acid |
|
Non-active substance |
79-09-4 |
201-176-3 |
0,0 |
19,5 |
Phosphoric acid |
|
Non-active substance |
7664-38-2 |
231-633-2 |
0,0 |
30,0 |
Nitric acid |
|
Non-active substance |
7697-37-2 |
231-714-2 |
0,0 |
18,0 |
Methane sulfonic acid |
|
Non-active substance |
75-75-2 |
200-898-6 |
0,0 |
20,3 |
Glycolic acid |
|
Non-active substance |
79-14-1 |
201-180-5 |
0,0 |
4,2 |
Lactic acid |
|
Non-active substance |
79-33-4 |
201-196-2 |
0,0 |
35,2 |
Citric acid |
|
Non-active substance |
77-92-9 |
201-069-1 |
0,0 |
3,0 |
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 |
1,1 |
1,8 |
Decanoic acid |
|
Active Substance |
334-48-5 |
206-376-4 |
0,75 |
1,5 |
Sulfuric acid |
|
Non-active substance |
7664-93-9 |
231-639-5 |
0,0 |
31,2 |
Propionic acid |
|
Non-active substance |
79-09-4 |
201-176-3 |
0,0 |
0,0 |
Phosphoric acid |
|
Non-active substance |
7664-38-2 |
231-633-2 |
0,0 |
30,0 |
Nitric acid |
|
Non-active substance |
7697-37-2 |
231-714-2 |
0,0 |
0,0 |
Methane sulfonic acid |
|
Non-active substance |
75-75-2 |
200-898-6 |
0,0 |
12,6 |
Glycolic acid |
|
Non-active substance |
79-14-1 |
201-180-5 |
0,0 |
4,2 |
Lactic acid |
|
Non-active substance |
79-33-4 |
201-196-2 |
0,0 |
0,0 |
Citric acid |
|
Non-active substance |
77-92-9 |
201-069-1 |
0,0 |
3,0 |
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. |
Precautionary statements |
Do not breathe vapours. 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. Immediately call a doctor. Wear eye protection. Wear face protection. Wear protective clothing. Wear protective gloves. IF SWALLOWED:Rinse mouth.Do NOT induce vomiting. IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water (or shower). Keep only in original container. Store in a well-ventilated place.Keep container tightly closed. Absorb spillage to prevent material damage. Dispose of contents in accordance with local/regional/national/international regulations. |
4.
AUTHORISED USE(S) OF THE META SPC 1
4.1.
Use description
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 In food and feed areas |
||||||||||||
Application method(s) |
Closed system For disinfection of pipes, tanks, and other parts of the closed system:
|
||||||||||||
Application rate(s) and frequency |
- |
||||||||||||
Category(ies) of users |
Industrial Trained professional |
||||||||||||
Pack sizes and packaging material |
|
4.1.1.
Use-specific instructions for use
4.1.2.
Use-specific risk mitigation measures
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
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.2.
Use description
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 In food and feed areas |
||||||||||||
Application method(s) |
Open system: immersion For disinfection of small hard non-porous parts (e.g. spare parts, tools, valves, hoses) used in the food manufacturing process:
|
||||||||||||
Application rate(s) and frequency |
- |
||||||||||||
Category(ies) of users |
Industrial Trained professional |
||||||||||||
Pack sizes and packaging material |
|
4.2.1.
Use-specific instructions for use
4.2.2.
Use-specific risk mitigation measures
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
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5.
GENERAL DIRECTIONS FOR USE
(1)
OF THE META SPC 1
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
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) |
SEPTACID BN |
||||
Authorisation number |
EU-0021157-0001 1-1 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Octanoic acid |
|
Active Substance |
124-07-2 |
204-677-5 |
1,5 |
Decanoic acid |
|
Active Substance |
334-48-5 |
206-376-4 |
1,5 |
Sulfuric acid |
|
Non-active substance |
7664-93-9 |
231-639-5 |
31,2 |
Glycolic acid |
|
Non-active substance |
79-14-1 |
201-180-5 |
4,2 |
7.2.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
SEPTACID BN PS |
||||
Authorisation number |
EU-0021157-0002 1-1 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Octanoic acid |
|
Active Substance |
124-07-2 |
204-677-5 |
1,5 |
Decanoic acid |
|
Active Substance |
334-48-5 |
206-376-4 |
1,5 |
Phosphoric acid |
|
Non-active substance |
7664-38-2 |
231-633-2 |
30,0 |
Glycolic acid |
|
Non-active substance |
79-14-1 |
201-180-5 |
4,2 |
7.3.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
SOPURCIP EC |
||||
Authorisation number |
EU-0021157-0003 1-1 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Octanoic acid |
|
Active Substance |
124-07-2 |
204-677-5 |
1,1 |
Decanoic acid |
|
Active Substance |
334-48-5 |
206-376-4 |
0,75 |
Sulfuric acid |
|
Non-active substance |
7664-93-9 |
231-639-5 |
7,8 |
Methane sulfonic acid |
|
Non-active substance |
75-75-2 |
200-898-6 |
12,6 |
7.4.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
SOPURCLEAN BN |
||||
Authorisation number |
EU-0021157-0004 1-1 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Octanoic acid |
|
Active Substance |
124-07-2 |
204-677-5 |
1,8 |
Decanoic acid |
|
Active Substance |
334-48-5 |
206-376-4 |
1,2 |
Sulfuric acid |
|
Non-active substance |
7664-93-9 |
231-639-5 |
29,64 |
Citric acid |
|
Non-active substance |
77-92-9 |
201-069-1 |
3,0 |
7.5.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
SOPURCLEAN BN PS |
||||
Authorisation number |
EU-0021157-0005 1-1 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Octanoic acid |
|
Active Substance |
124-07-2 |
204-677-5 |
1,8 |
Decanoic acid |
|
Active Substance |
334-48-5 |
206-376-4 |
1,2 |
Phosphoric acid |
|
Non-active substance |
7664-38-2 |
231-633-2 |
30,0 |
Citric acid |
|
Non-active substance |
77-92-9 |
201-069-1 |
2,5 |
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 |
2,7 |
2,7 |
Decanoic acid |
|
Active Substance |
334-48-5 |
206-376-4 |
0,3 |
0,3 |
Sulfuric acid |
|
Non-active substance |
7664-93-9 |
231-639-5 |
0,0 |
0,0 |
Propionic acid |
|
Non-active substance |
79-09-4 |
201-176-3 |
19,5 |
19,5 |
Phosphoric acid |
|
Non-active substance |
7664-38-2 |
231-633-2 |
3,8 |
3,8 |
Nitric acid |
|
Non-active substance |
7697-37-2 |
231-714-2 |
0,0 |
0,0 |
Methane sulfonic acid |
|
Non-active substance |
75-75-2 |
200-898-6 |
0,0 |
0,0 |
Glycolic acid |
|
Non-active substance |
79-14-1 |
201-180-5 |
0,0 |
0,0 |
Lactic acid |
|
Non-active substance |
79-33-4 |
201-196-2 |
35,2 |
35,2 |
Citric acid |
|
Non-active substance |
77-92-9 |
201-069-1 |
0,0 |
0,0 |
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. Causes severe skin burns and eye damage. May cause respiratory irritation. |
Precautionary statements |
Do not breathe vapours. Wear protective gloves. Wear protective clothing. Wear eye protection. Wear face protection. IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water (or shower). 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. Immediately call a doctor. Keep only in original container. Store in a well-ventilated place.Keep container tightly closed. IF SWALLOWED:Rinse mouth.Do NOT induce vomiting. Dispose of contents in accordance with local/regional/national/international regulations. |
4.
AUTHORISED USE(S) OF THE META SPC 2
4.1.
Use description
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 In food and feed areas |
||||||||||||
Application method(s) |
Closed system For disinfection of pipes, tanks, and other parts of the closed system:
|
||||||||||||
Application rate(s) and frequency |
- - For an effect on bacteria and on yeasts: Dilution rate: 1 %v/v In case of outbreaks of Pediococcus damnosus, the product must be used at 1,5 % v/v. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C. - |
||||||||||||
Category(ies) of users |
Industrial Trained professional |
||||||||||||
Pack sizes and packaging material |
|
4.1.1.
Use-specific instructions for use
4.1.2.
Use-specific risk mitigation measures
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
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.2.
Use description
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 In food and feed areas |
||||||||||
Application method(s) |
Spraying For disinfection of hard non-porous surfaces in contact with food processing:
|
||||||||||
Application rate(s) and frequency |
Maximum application rate: 100 mL/m2 – For an effect on bacteria and on yeasts: Dilution rate: 1 %v/v. In case of outbreaks of Pediococcus damnosus, the product must be used at 1,5 %. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C. - |
||||||||||
Category(ies) of users |
Industrial Trained professional |
||||||||||
Pack sizes and packaging material |
Jerrycan (PE-HD), containing: 10 to 12,5 kg (*4).
|
4.2.1.
Use-specific instructions for use
4.2.2.
Use-specific risk mitigation measures
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
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.3.
Use description
Product type |
PT04 – Food and feed area (Disinfectants) |
||||||||||
Where relevant, an exact description of the authorised use |
- |
||||||||||
Target organism(s) (including development stage) |
Bacteria Yeast |
||||||||||
Field(s) of use |
Indoor In food and feed areas |
||||||||||
Application method(s) |
Manual application For disinfection of hard non-porous small parts and surfaces used in the food manufacturing process:
|
||||||||||
Application rate(s) and frequency |
Maximum application rate: 100 mL/m2 – For an effect on bacteria and on yeasts: Dilution rate: 1 %v/v. In case of outbreaks of Pediococcus damnosus, the products must be used at 1,5 %. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C. - |
||||||||||
Category(ies) of users |
Industrial Trained professional |
||||||||||
Pack sizes and packaging material |
Jerrycan (PE-HD), containing: 10 to 12,5 kg (*5).
|
4.3.1.
Use-specific instructions for use
4.3.2.
Use-specific risk mitigation measures
4.3.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.3.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.3.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.4.
Use description
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 In food and feed areas |
||||
Application method(s) |
Open system: immersion For disinfection of hard non-porous small parts (e.g. spare parts, tools, valves, hoses) used in the food manufacturing process:
|
||||
Application rate(s) and frequency |
- |
||||
Category(ies) of users |
Industrial Trained professional |
||||
Pack sizes and packaging material |
Jerrycan (PE-HD), containing: 10 to 12,5 kg (*6). Jerrycan (PE-HD), containing: 20 to 25 kg (*6). Drums (PE-HD) containing 200 to 250 kg (*6). Containers (PE-HD) containing 600 to 750 kg (*6). IBC (Internal bulk containers, PE-HD) containing 1 100 to 1 250 kg (*6) Bulk delivery. |
4.4.1.
Use-specific instructions for use
4.4.2.
Use-specific risk mitigation measures
4.4.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.4.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.4.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5.
GENERAL DIRECTIONS FOR USE
(2)
OF THE META SPC 2
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
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) |
SOPURCLEAN NR |
||||
Authorisation number |
EU-0021157-0006 1-2 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Octanoic acid |
|
Active Substance |
124-07-2 |
204-677-5 |
2,7 |
Decanoic acid |
|
Active Substance |
334-48-5 |
206-376-4 |
0,3 |
Propionic acid |
|
Non-active substance |
79-09-4 |
201-176-3 |
19,5 |
Phosphoric acid |
|
Non-active substance |
7664-38-2 |
231-633-2 |
3,8 |
Lactic acid |
|
Non-active substance |
79-33-4 |
201-196-2 |
35,2 |
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 |
1,8 |
1,8 |
Decanoic acid |
|
Active Substance |
334-48-5 |
206-376-4 |
1,2 |
1,2 |
Sulfuric acid |
|
Non-active substance |
7664-93-9 |
231-639-5 |
0,0 |
0,0 |
Propionic acid |
|
Non-active substance |
79-09-4 |
201-176-3 |
0,0 |
0,0 |
Phosphoric acid |
|
Non-active substance |
7664-38-2 |
231-633-2 |
0,0 |
0,0 |
Nitric acid |
|
Non-active substance |
7697-37-2 |
231-714-2 |
18,0 |
18,0 |
Methane sulfonic acid |
|
Non-active substance |
75-75-2 |
200-898-6 |
0,0 |
0,0 |
Glycolic acid |
|
Non-active substance |
79-14-1 |
201-180-5 |
0,0 |
0,0 |
Lactic acid |
|
Non-active substance |
79-33-4 |
201-196-2 |
0,0 |
0,0 |
Citric acid |
|
Non-active substance |
77-92-9 |
201-069-1 |
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 if inhaled. |
Precautionary statements |
Do not breathe vapours. Wear protective clothing. Wear eye protection. Wear protective gloves. Wear face protection. 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 doctor. Immediately call a POISON CENTER. Keep only in original container. IF SWALLOWED:Rinse mouth.Do NOT induce vomiting. Store in a well-ventilated place.Keep container tightly closed. Absorb spillage to prevent material damage. Dispose of contents in accordance with local/regional/national/international regulations. |
4.
AUTHORISED USE(S) OF THE META SPC 3
4.1.
Use description
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 In food and feed areas |
||||||||||||
Application method(s) |
Closed system For disinfection of pipes, tanks, and other parts of the closed system.
|
||||||||||||
Application rate(s) and frequency |
- |
||||||||||||
Category(ies) of users |
Industrial Trained professional |
||||||||||||
Pack sizes and packaging material |
|
4.1.1.
Use-specific instructions for use
4.1.2.
Use-specific risk mitigation measures
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
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5.
GENERAL DIRECTIONS FOR USE
(3)
OF THE META SPC 3
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
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) |
SOPURCLEAN OP-N |
||||
Authorisation number |
EU-0021157-0007 1-3 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Octanoic acid |
|
Active Substance |
124-07-2 |
204-677-5 |
1,8 |
Decanoic acid |
|
Active Substance |
334-48-5 |
206-376-4 |
1,2 |
Nitric acid |
|
Non-active substance |
7697-37-2 |
231-714-2 |
18,0 |
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 |
1,8 |
1,8 |
Decanoic acid |
|
Active Substance |
334-48-5 |
206-376-4 |
1,2 |
1,2 |
Sulfuric acid |
|
Non-active substance |
7664-93-9 |
231-639-5 |
4,68 |
4,68 |
Propionic acid |
|
Non-active substance |
79-09-4 |
201-176-3 |
0,0 |
0,0 |
Phosphoric acid |
|
Non-active substance |
7664-38-2 |
231-633-2 |
0,0 |
0,0 |
Nitric acid |
|
Non-active substance |
7697-37-2 |
231-714-2 |
0,0 |
0,0 |
Methane sulfonic acid |
|
Non-active substance |
75-75-2 |
200-898-6 |
20,3 |
20,3 |
Glycolic acid |
|
Non-active substance |
79-14-1 |
201-180-5 |
0,0 |
0,0 |
Lactic acid |
|
Non-active substance |
79-33-4 |
201-196-2 |
0,0 |
0,0 |
Citric acid |
|
Non-active substance |
77-92-9 |
201-069-1 |
0,0 |
0,0 |
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. |
Precautionary statements |
Do not breathe vapours. Wear protective clothing. Wear eye protection. Wear protective gloves. Wear face protection. 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. Immediately call a doctor. IF SWALLOWED:Rinse mouth.Do NOT induce vomiting. Keep only in original container. Store in a well-ventilated place.Keep container tightly closed. Absorb spillage to prevent material damage. Dispose of contents in accordance with local/regional/national/international regulations. |
4.
AUTHORISED USE(S) OF THE META SPC 4
4.1. Use description
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 In food and feed areas |
||||||||||||
Application method(s) |
Closed system For disinfection of pipes, tanks, and other parts of the closed system.
|
||||||||||||
Application rate(s) and frequency |
|
||||||||||||
Category(ies) of users |
Industrial Trained professional |
||||||||||||
Pack sizes and packaging material |
|
4.1.1.
Use-specific instructions for use
4.1.2.
Use-specific risk mitigation measures
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
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5.
GENERAL DIRECTIONS FOR USE
(4)
OF THE META SPC 4
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6.
OTHER INFORMATION
- 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) |
SOPURCLEAN CIP OP |
||||
Authorisation number |
EU-0021157-0008 1-4 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Octanoic acid |
|
Active Substance |
124-07-2 |
204-677-5 |
1,8 |
Decanoic acid |
|
Active Substance |
334-48-5 |
206-376-4 |
1,2 |
Sulfuric acid |
|
Non-active substance |
7664-93-9 |
231-639-5 |
4,68 |
Methane sulfonic acid |
|
Non-active substance |
75-75-2 |
200-898-6 |
20,3 |