LegalizeCommission Implementing Regulation (EU) 2022/964 of 10 June 2022 granting a Union authorisation for the biocidal product family ‘SOPUROXID’ (Text with EEA relevance)
Article 1
A Union authorisation with authorisation number EU-0026179-0000 is granted to SOPURA N.V. for the making available on the market and use of the biocidal product family ‘SOPUROXID’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 12 July 2022 until 30 June 2032.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX
SOPUROXID
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT03: Veterinary hygiene
PT04: Food and feed area
Authorisation number: EU-0026179-0000
R4BP asset number: EU-0026179-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
| Name | SOPUROXID |
|---|---|
| Product type(s) | PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT03: Veterinary hygiene PT04: Food and feed area |
| --- | --- |
| Name and address of the authorisation holder | Name |
| --- | --- |
| Address | Parc paysager de Tyberchamps 14 7180 SENEFFE Belgium |
| Authorisation number | |
| R4BP asset number | |
| Date of the authorisation | |
| Expiry date of the authorisation | |
| Name of manufacturer | SOPURA N.V. |
| --- | --- |
| Address of manufacturer | Rue de Trazegnies 199 6180 COURCELLES Belgium |
| Location of manufacturing sites | SOPURA N.V. site 1 Rue de Trazegnies 199 6180 COURCELLES Belgium |
| Name of manufacturer | SOPURA QUIMICA |
| --- | --- |
| Address of manufacturer | Poligon ‘La Canaleta’, Avinguda Júpiter 7 25300 TARREGA Spain |
| Location of manufacturing sites | SOPURA QUIMICA site 1 Poligon ‘La Canaleta’, Avinguda Júpiter 7 25300 TARREGA Spain |
| Name of manufacturer | HYPRED SAS (KERSIA Group) |
| --- | --- |
| Address of manufacturer | 55, Boulevard Jules Verger (BP 10180) 35803 DINARD France |
| Location of manufacturing sites | HYPRED SAS (KERSIA Group) site 1 55, Boulevard Jules Verger (BP 10180) 35803 DINARD France HYPRED SAS (KERSIA Group) site 2 Niepruszewo, ul. Kasztanowa 64-320 Buk Poland |
| Active substance | Peracetic acid |
| --- | --- |
| Name of manufacturer | SOPURA N.V. |
| Address of manufacturer | Rue de Trazegnies 199 6180 COURCELLES Belgium |
| Location of manufacturing sites | SOPURA N.V. site 1 Rue de Trazegnies 199 6180 COURCELLES Belgium |
| Active substance | Peracetic acid |
| --- | --- |
| Name of manufacturer | SOPURA QUIMICA |
| Address of manufacturer | Poligon ‘La Canaleta’, Avinguda Júpiter 7 25300 TARREGA Spain |
| Location of manufacturing sites | SOPURA QUIMICA site 1 Poligon ‘La Canaleta’, Avinguda Júpiter 7 25300 TARREGA Spain |
| Active substance | Peracetic acid |
| --- | --- |
| Name of manufacturer | HYPRED SAS (KERSIA Group) |
| Address of manufacturer | 55, Boulevard Jules Verger (BP 10180) 35803 DINARD France |
| Location of manufacturing sites | HYPRED SAS (KERSIA Group) site 1 55, Boulevard Jules Verger (BP 10180) 35803 DINARD France HYPRED SAS (KERSIA Group) site 2 Niepruszewo, ul. Kasztanowa 64-320 Buk Poland |
2. PRODUCT FAMILY COMPOSITION AND FORMULATION
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
|---|---|---|---|---|---|
| Peracetic acid | Active substance | 79-21-0 | 201-186-8 | 3,2 -15 % (w/w) | |
| Hydrogen peroxide | Non-active substance | 7722-84-1 | 231-765-0 | 16,5 -23,5 % (w/w) | |
| Acetic acid | Non-active substance | 64-19-7 | 200-580-7 | 5,5 -16,7 % (w/w) | |
| Sulfuric acid | Non-active substance | 7664-93-9 | 231-639-5 | 0,2 -24,04 % (w/w) | |
| Formulation type(s) | SL Soluble concentrate | ||||
| --- | --- |
PART II
SECOND INFORMATION LEVEL META SPC(S)
1. META SPC 1 ADMINISTRATIVE INFORMATION
| Identifier | Meta SPC: Meta SPC1 |
|---|---|
| Number | 1-1 |
| --- | --- |
| Product type(s) | PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT03: Veterinary hygiene PT04: Food and feed area |
| --- | --- |
2. META SPC 1 COMPOSITION
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
|---|---|---|---|---|---|
| Peracetic acid | Active substance | 79-21-0 | 201-186-8 | 5 -5 % (w/w) | |
| Hydrogen peroxide | Non-active substance | 7722-84-1 | 231-765-0 | 16,5 -22 % (w/w) | |
| Acetic acid | Non-active substance | 64-19-7 | 200-580-7 | 5,5 -9,55 % (w/w) | |
| Sulfuric acid | Non-active substance | 7664-93-9 | 231-639-5 | 0,2 -24,04 % (w/w) | |
| Formulation type(s) | SL Soluble concentrate | ||||
| --- | --- |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
| Hazard statements | H272: May intensify fire; oxidiser. H290: May be corrosive to metals. H302+H312+H332: Harmful if swallowed, in contact with skin or if inhaled. H314: Causes severe skin burns and eye damage. H318: Causes serious eye damage. H335: May cause respiratory irritation. H410: Very toxic to aquatic life with long lasting effects. |
|---|---|
| Precautionary statements | P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P280: Wear protective gloves. P280: Wear eye protection. P280: Wear face protection. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER/doctor. P221: Take any precaution to avoid mixing with combustibles. P261: Avoid breathing vapours. P264: Wash hands thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P271: Use only outdoors or in a well-ventilated area. P321: Specific treatment (see information on this label). P330: Rinse mouth. P363: Wash contaminated clothing before reuse. P301+P312: IF SWALLOWED: Call a POISON CENTER/doctor if you feel unwell. P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. P302+P352: IF ON SKIN: Wash with plenty of water. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P361+P364: Take off immediately all contaminated clothing and wash it before reuse. P405: Store locked up. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P501: Dispose of contents to in accordance with local/regional/national/international regulations. P280: Wear protective clothing. P501: Dispose of container to in accordance with local/regional/national/international regulations. P235: Keep cool. P273: Avoid release to the environment. P391: Collect spillage. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P261: Avoid breathing spray. P260: Do not breathe spray. P260: Do not breathe vapours. |
4. AUTHORISED USE(S) OF THE META SPC
| Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
|---|---|
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Scientific name: No data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data |
| Field(s) of use | Indoor use In Industrial, public and non-medical healthcare areas: Disinfection of hard/non-porous surfaces by manual treatment (mopping) with prior cleaning |
| Application method(s) | Method: Manual treatment (mopping). Detailed description: Diluted product is applied by mopping with the appropriate tool (e.g. flat mop or cleaning cloths). After application, the diluted product is drained. |
| Application rate(s) and frequency | Application Rate: Against bacteria and yeasts: Non-medical healthcare areas With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 ml/100 l) at Room Temperature in 5 min contact time. Application rate: 20 ml/m2 Use other than in HEALTHCARE With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 ml/100 l) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature. Application rate: 30 ml/m2 Number and timing of application: / |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | HDPE with screw and venting caps (weight depends on density of product): Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 l bottles, bulk delivery. |
Items to be disinfected by mopping have to stay sufficiently wet during the required contact time to allow optimal disinfection.
Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing and loading.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 20 is mandatory during the application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.
Re-entry is only permitted once the air concentrations of peracetic acid and hydrogen peroxide have dropped below the respective reference values (AEC). After the application, the room must be ventilated, preferably by mechanical ventilation. The duration of the ventilation period has to be established by measurement with suitable measurement equipment (specified by the authorization holder).
See general directions for use.
See general directions for use.
See general directions for use.
| Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
|---|---|
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data |
| Field(s) of use | Indoor use In Industrial, public and and non-medical healthcare areas: Disinfection of hard/non-porous surfaces by manual treatment (spraying) with prior cleaning |
| Application method(s) | Method: Manual treatment (spraying) Detailed description: Diluted product is applied by spraying using a small spraying can |
| Application rate(s) and frequency | Application Rate: Against bacteria and yeasts: Non-medical healthcare areas: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 ml/100 l) at Room Temperature in 5 min contact time. Application rate: 20 ml/m2. Use other than in HEALTHCARE With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 ml/100 l) in 15 min contact time, efficient use temperature from + 4° C up to Room Temperature. Application rate: 30 ml/m2. Number and timing of application: / |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | HDPE with screw and venting caps (weight depends on density of product): Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 l bottles, bulk delivery. |
See general directions for use.
Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.
Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during the application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.
Rinse the pump and disconnect it from the installation before maintenance.
The treated surface should not be allowed to dry prior to rinsing.
Re-entry of the general public only when surfaces are dried and after sufficient ventilation.
See general directions for use.
See general directions for use.
See general directions for use.
| Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
|---|---|
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data |
| Field(s) of use | Indoor use In pharmaceutical and cosmetic industry: Disinfection of hard/non-porous surfaces by CIP procedures (with circulation) with prior cleaning |
| Application method(s) | Method: By CIP procedure Detailed description: Diluted product does automatically circulate from the CIP holding tanks through closed pipework and installations. After the disinfection procedure, the vessels (pipework and tanks) are drained and rinsed with water under closed system conditions. |
| Application rate(s) and frequency | Application Rate: Against bacteria and yeasts: With 0,032 % PAA (Dilution of the product at 0,64 % i.e. 640 ml/100 l) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature. Number and timing of application: / |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | HDPE with screw and venting caps (weight depends on density of product): Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 l bottles, bulk delivery. |
See general directions for use.
Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing & loading phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.
Rinse the pump and disconnect it from the installation before maintenance.
See general directions for use.
See general directions for use.
See general directions for use.
| Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
|---|---|
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data |
| Field(s) of use | Indoor use In greenhouses: Disinfection of hard/non-porous surfaces by spraying |
| Application method(s) | Method: open system: spray treatment Detailed description: Diluted product is automatically applied in all directions via a spraying device The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device) |
| Application rate(s) and frequency | Application Rate: Between 20 and 200 ml/m2 Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 ml/100 l) in 60 min contact time. Number and timing of application: / |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | HDPE with screw and venting caps (weight depends on density of product): Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 l bottles, bulk delivery. |
See general directions for use
Dermal protection:
Use appropriate safety glasses and/or face shield during the mixing & loading phase.
Respiratory protection:
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading and application phase.
When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.
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