LegalizeCommission Implementing Regulation (EU) 2023/1311 of 27 June 2023 granting a Union authorisation for the biocidal product family ‘CVAS Biocidal Product Family based on L (+) Lactic Acid’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
| Identifier | Meta SPC: mSPC8 |
1.2. Suffix to the authorisation number
| Number | 1-8 |
1.3. Product type(s)
| Product type(s) | PT04: Food and feed area |
2. META SPC 8 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 8
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | active substance | 79-33-4 | 201-196-2 | 16 - 17,6 % (w/w) | |
| Methanesulphonic acid | Methanesulphonic acid | Non-Active substance | 75-75-2 | 200-898-6 | 0 - 10,5 % (w/w) |
| Phosphoric acid | Phosphoric acid | Non-Active substance | 7664-38-2 | 231-633-2 | 0 - 18,75 % (w/w) |
| Sulphuric acid | Sulphuric acid | Non-Active substance | 7664-93-9 | 231-639-5 | 4,5 - 4,5 % (w/w) |
| Isononanoic acid | Isononanoic acid | Non-Active substance | 3302-10-1 | 221-975-0 | 2,25 - 2,5 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 8
| Formulation type(s) | SL Soluble concentrate |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8
| Hazard statements | H290: May be corrosive to metals. H314: Causes severe skin burns and eye damage. EUH071: Corrosive to the respiratory tract. |
| Precautionary statements | P260: Do not breathe spray. P280: Wear protective gloves. P280: Wear protective clothing. P280: Wear eye protection. P280: Wear face protection. P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. 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. P310: Immediately call a doctor. P406: Store in a corrosion resistant container with a resistant inner liner. P501: Dispose of contents to in accordance with local regulations. P501: Dispose of container to in accordance with local regulations. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use # 8.1 – Hard surface disinfection by automated spraying in closed cleaning in place (CIP) system
| Product type | PT04: Food and feed area |
| 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 Hard surface disinfection |
| Application method(s) | Method: Spraying Detailed description: Hard surface disinfection Automated dosing and spraying in closed CIP systemCIP system: pipe work, fermentation and storage tanks |
| Application rate(s) and frequency | Application rate: Concentrated product, 16,0-17,6% L-(+)-lactic acid Bactericidal claim: 2,5% (w/w) dilution of the product, 0,40-0,44% L-(+)-lactic acid Yeasticidal claim: 2% (w/w) dilution of the product, 0,32-0,35% L-(+)-lactic acid Number and timing of application: once a day |
| Category(ies) of users | professional |
| Pack sizes and packaging material | HDPE jerrycan: 5-60 kg HDPE drum: 60-200 kg HDPE IBC: 600-1000 kg |
4.1.1. Use-specific instructions
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 OF THE META SPC 8
5.1. Instructions for use
Connect the jerrycan, drum or IBC containing the product with the dosing unit of the CIP system. Dosing and dilution are performed automatically via the dosing unit of the CIP system and monitored by conductivity measurements.
Avoid contact with aluminium, non-ferrous metals and galvanised materials.
Precleaning is not necessary.
Minimum contact time is 5 minutes for bacteria and 15 minutes for yeasts.
After application, rinse the treated system thoroughly with clean water.
5.2. Risk mitigation measures
Wear chemical goggles consistent with the European Standard EN ISO 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN ISO 374 or equivalent.
Google, gloves and coverall material to be specified by the authorisation holder within the product information.
Wear respiratory protection when handling the concentrated product. Respiratory protection to be specified by the authorisation holder within the product information. Avoid standing in areas with aerosol formation.
This is without prejudice to the application of Directive 98/24/EC and other Union legislation in the area of health and safety at work.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid instructions
IF INHALED: move to fresh air and keep at rest in a position comfortable for breathing.
If symptoms: call 112 or an ambulance for medical assistance.
If no symptoms: call a POISON CENTRE or a doctor.
IF ON SKIN: immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112 or an ambulance for medical assistance.
IF SWALLOWED: immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.
Emergency measure to protect the environment
Environmental precautions: do not allow product to reach sewage systems or water bodies.
Methods and material for containment and cleaning up: absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). Dispose of the material collected in accordance with local regulations.
5.4. Instructions for safe disposal of the product and its packaging
At the end of the application, dispose unused product and the packaging in accordance with local requirements.
Used product can be flushed to municipal sewer depending on local requirements.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf life: 24 months
Ensure good ventilation or exhaustion.
Do not store together with alkalis (caustic solutions).
Do not store at temperatures above 40°C.
Keep away from heat and direct sunlight.
Protect from frost.
Keep container tightly closed.
6. OTHER INFORMATION
Not relevant
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | calgonit Duocip | calgonit Duocip | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0028957-0020 1-8 | EU-0028957-0020 1-8 | |||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | active substance | active substance | 79-33-4 | 79-33-4 | 201-196-2 | 16 % (w/w) | |
| Methanesulphonic acid | Methanesulphonic acid | Non-Active substance | Non-Active substance | 75-75-2 | 75-75-2 | 200-898-6 | 10,5 % (w/w) |
| Sulphuric acid | Sulphuric acid | Non-Active substance | Non-Active substance | 7664-93-9 | 7664-93-9 | 231-639-5 | 4,5 % (w/w) |
| Isononanoic acid | Isononanoic acid | Non-Active substance | Non-Active substance | 3302-10-1 | 3302-10-1 | 221-975-0 | 2,5 % (w/w) |
7.2. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | calgonit Duocip P | calgonit Duocip P | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0028957-0021 1-8 | EU-0028957-0021 1-8 | |||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | active substance | active substance | 79-33-4 | 79-33-4 | 201-196-2 | 16 % (w/w) | |
| Phosphoric acid | Phosphoric acid | Non-Active substance | Non-Active substance | 7664-38-2 | 7664-38-2 | 231-633-2 | 18,75 % (w/w) |
| Sulphuric acid | Sulphuric acid | Non-Active substance | Non-Active substance | 7664-93-9 | 7664-93-9 | 231-639-5 | 4,5 % (w/w) |
| Isononanoic acid | Isononanoic acid | Non-Active substance | Non-Active substance | 3302-10-1 | 3302-10-1 | 221-975-0 | 2,5 % (w/w) |
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