LegalizeCommission Implementing Regulation (EU) 2024/1674 of 13 June 2024 granting a Union authorisation for the single biocidal product SANICALCO Q in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Article 1
A Union authorisation with authorisation number EU-0029399-0000 is granted to CARMEUSE EUROPE S.A. for the making available on the market and use of the same single biocidal product ‘SANICALCO Q’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 4 July 2024 until 30 November 2033.
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
SANACALCO Q
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT03: Veterinary hygiene
Authorisation number: EU-0029399-0000
R4BP asset number: EU-0029399-0000
1. ADMINISTRATIVE INFORMATION
1.1. Trade name(s) of the product
| Trade name(s) | SANACALCO Q SANACALCO CODECAL |
|---|---|
1.2. Authorisation holder
| Name and address of the authorisation holder | Name | CARMEUSE EUROPE S.A. |
|---|---|---|
| Address | Boulevard de Lauzelle , 65 1348 Ottignies Louvain-La-Neuve BE | |
| Authorisation number | EU-0029399-0000 | |
| R4BP asset number | EU-0029399-0000 | |
| Date of the authorisation | 4 July 2024 | |
| Expiry date of the authorisation | 30 November 2033 |
1.3. Manufacturer(s) of the product
| Name of manufacturer | Carmeuse Chaux |
|---|---|
| Address of manufacturer | 215 route d’Arras 62320 Bois Bernard France |
| Location of manufacturing sites | Carmeuse Chaux site 1 215 route d’Arras 62320 Bois Bernard France |
| Name of manufacturer | Carmeuse Czech Republic s.r.o. |
| --- | --- |
| Address of manufacturer | Mokrá 359, Mokrá 664 04 Mokrá, Czechia |
| Location of manufacturing sites | Carmeuse Czech Republic s.r.o. site 1 závod Vápenka Mokrá, Mokrá 359 664 04 Mokrá, Czechia |
| Name of manufacturer | Carmeuse Holding Srl |
| --- | --- |
| Address of manufacturer | Str.Carierei Nr.127A 500047 Brasov Romania |
| Location of manufacturing sites | Carmeuse Holding Srl site 1 Str Garii 2 135100 Fieni Romania Carmeuse Holding Srl site 2 Str Principala 1 337457 Com. Soimus Romania Carmeuse Holding Srl site 3 com. Valea Mare-Pravăț 117805 Campulung Romania |
| Name of manufacturer | Carmeuse Hungaria kft |
| --- | --- |
| Address of manufacturer | HRSZ 064/1 7827 Beremend Hungary |
| Location of manufacturing sites | Carmeuse Hungaria kft site 1 HRSZ 064/1 7827 Beremend Hungary |
| Name of manufacturer | Carmeuse SA |
| --- | --- |
| Address of manufacturer | Rue du Château 13a 5300 Seilles Belgium |
| Location of manufacturing sites | Carmeuse SA site 1 Rue de Boudjesse 1 5070 Aisemont Belgium Carmeuse SA site 2 Rue du Val Notre Dame 300 4520 Moha Belgium Carmeuse SA site 3 Rue du Château 13a 5300 Seilles Belgium |
| Name of manufacturer | Carmeuse Slovakia s.r.o. |
| --- | --- |
| Address of manufacturer | 04911 Slavec Slovakia |
| Location of manufacturing sites | Carmeuse Slovakia s.r.o. site 1 závod Vápenka Košice, Vstupný areál U.S. Steel 04454 Košice Slovakia Carmeuse Slovakia s.r.o. site 2 závod Vápenka Slavec, Slavec 179 049 11 Slavec Slovakia |
1.4. Manufacturer(s) of the active substance(s)
| Active substance | Calcium oxide/lime/burnt lime/quicklime |
|---|---|
| Name of manufacturer | Carmeuse Chaux |
| Address of manufacturer | 215 route d’Arras 62320 Bois Bernard France |
| Location of manufacturing sites | Carmeuse Chaux site 1 215 route d’Arras 62320 Bois Bernard France |
| Active substance | Calcium oxide/lime/burnt lime/quicklime |
| --- | --- |
| Name of manufacturer | Carmeuse Czech Republic s.r.o. |
| Address of manufacturer | závod Vápenka Mokrá, Mokrá 359, 664 04 Mokrá Czechia |
| Location of manufacturing sites | Carmeuse Czech Republic s.r.o. site 1 závod Vápenka Mokrá, Mokrá 359, 664 04 Mokrá Czechia |
| Active substance | Calcium oxide/lime/burnt lime/quicklime |
| --- | --- |
| Name of manufacturer | Carmeuse Holding Srl |
| Address of manufacturer | Str.Carierei Nr.127A, 500047 Brasov Romania |
| Location of manufacturing sites | Carmeuse Holding Srl site 1 Str Garii 2, 135100 Fieni Romania Carmeuse Holding Srl site 2 Str Principala 1, 337457 Com. Soimus Romania Carmeuse Holding Srl site 3 com. Valea Mare-Privăț, 117805 Campulung Romania |
| Active substance | Calcium oxide/lime/burnt lime/quicklime |
| --- | --- |
| Name of manufacturer | Carmeuse Hungaria kft |
| Address of manufacturer | HRSZ 064/1, 7827 Beremend Hungary |
| Location of manufacturing sites | Carmeuse Hungaria kft site 1 HRSZ 064/1, 7827 Beremend Hungary |
| Active substance | Calcium oxide/lime/burnt lime/quicklime |
| --- | --- |
| Name of manufacturer | Carmeuse SA |
| Address of manufacturer | Rue du Château 13a, 5300 Seilles Belgium |
| Location of manufacturing sites | Carmeuse SA site 1 Rue de Boudjesse 1, 5070 Aisemont Belgium Carmeuse SA site 2 Rue du Val Notre Dame 300, 4520 Moha Belgium Carmeuse SA site 3 Rue du Château 13a, 5300 Seilles, Belgium |
| Active substance | Calcium oxide/lime/burnt lime/quicklime |
| --- | --- |
| Name of manufacturer | Carmeuse Slovakia s.r.o |
| Address of manufacturer | závod Vápenka Slavec 179, 04911 Slavec Slovakia |
| Location of manufacturing sites | Carmeuse Slovakia s.r.o site 1 závod Vápenka Slavec 179, 04911 Slavec Slovakia Carmeuse Slovakia s.r.o site 2 závod Vápenka Košice, Vstupný areál U.S. Steel 0455 Košice Slovakia |
2. PRODUCT COMPOSITION AND FORMULATION
2.1. Qualitative and quantitative information on the composition of the product
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
|---|---|---|---|---|---|
| Calcium oxide/lime/burnt lime/quicklime | Active substance | 1305-78-8 | 215-138-9 | 100 % (w/w) |
2.2. Type(s) of formulation
DP Dustable powder
3. HAZARD AND PRECAUTIONARY STATEMENTS
| Hazard statements | H315: Causes skin irritation. H318: Causes serious eye damage. H335: May cause respiratory irritation. EUH014: Reacts violently with water. |
|---|---|
| Precautionary statements | P261: Avoid breathing dust. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P280: Wear protective gloves, protective clothing, eye protection and face protection. P302+P352: IF ON SKIN: Wash with plenty of water. P321: Specific treatment (see instructions on this label). P332+P313: If skin irritation occurs: Get medical advice. P362+P364: Take off contaminated clothing and wash it before reuse. 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 CENTRE or doctor/physician. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P312: Call a poison center/doctor if you feel unwell. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P501: Dispose of container to accordance with local regulations. P405: Store locked up. |
4. AUTHORISED USE(S)
4.1. Use description
| 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: Bacteria Common name: Bacteria Development stage: — Scientific name: Endoparasites Common name: Helminth eggs Development stage: — |
| Field(s) of use | Indoor use |
| Application method(s) | Method: automatic direct application Detailed description: The product is dosed into the sewage sludge and mixed by means of a blender. The dry product is mixed by means of a blender. The dry product is mixed with the sewage sludge in an open mixer. The product should be loaded by fully automated processes. |
| Application rate(s) and frequency | Application Rate: 0,15-1,5 kg product/kg dry weight of substance; typical dry solid content — 12-25 % in sewage sludge — Ready to use (RTU) product Number and timing of application: The application rate must be sufficient to maintain a pH of > 12 and a temperature > 50 °C during the contact time. Contact time: 24 hours |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Bulk powder Big bags or sacks (with Polypropylene (PP) or Polyethylene (PE) inner layer): 500-1 200 kg |
— The dose must be sufficient to maintain a pH of > 12 and a temperature > 50 °C during the 24-hour contact time.
— Application rate : 0,15-1,5 kg product/kg dry weight of substrate; typical dry solids content — 12-25 % in sewage sludge.
— The ratio may vary between application and treatment plant designs. The user must ensure that the treatment is effective through preliminary laboratory test that guarantee efficacy according to the legislation applicable to each case.
— The loading of the product into the treatment unit and the application must be done fully automatically.
— The loading into the treatment unit and the disposal of empty big bags or sacks (500-1 200 kg) must be performed using a telehandler (including a closed cabin).
— During the loading of the product and the disposal of empty bags or sacks, wear: — a respiratory protective equipment (RPE) at least assigned protection factor (APF) 40 (airtight face piece covering eyes, nose, mouth and chin according to European Standard (EN) 149 with a P3 filter or equivalent); — chemical resistant gloves EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information); — protective coverall in accordance with EN 13982 or equivalent (coverall material to be specified by the authorisation holder within the product information).
— During the treatment of sewage sludge, the wearing of air-fed or canister RPE specific for ammonia gas in accordance with EN 14387 or equivalent, is recommended in absence of collective management measures to estimate and prevent an exposure greater than the EU occupational exposure limit value (OEL) of 14 mg/m3 for that gas.
— During the manual handling of treated sewage sludge wear protective gloves in accordance with EN 374 or equivalent and protection coverall in accordance with EN 14126 or equivalent protecting against the intrinsic properties of the sewage sludge.
— The provisions on personal protective equipment are without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work.
— See section 6 for the full titles of the EN standards and legislation.
— The cleaning of the treatment unit must be avoided or performed with an automated process with no exposure of the professional.
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4.2. Use description
| Product type | PT03: Veterinary hygiene |
|---|---|
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: — Scientific name: Viruses Common name: Viruses Development stage: — Scientific name: Endoparasites Common name: Helminth eggs Development stage: — |
| Field(s) of use | Indoor use |
| Application method(s) | Method: Automatic direct application Detailed description: The product is mixed with the manure. The product is dosed into the manure and mixed by means of a blender. The product shall be loaded by fully automated processes. |
| Application rate(s) and frequency | Application Rate: — — RTU product Number and timing of application: The application rate must be sufficient to maintain a pH of > 12 and a temperature > 60 °C during the contact time. Contact time: 24 hours |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Bulk powder Big bags or sacks (with PP or PE inner layer): 500-1 200 kg |
— The application rate must be sufficient to maintain a pH of > 12 and a temperature > 60 °C during the 24-hour contact time.
— Do not apply more than 100 kg product/m3 of manure.
— The mixture should be moistened and any self-ignition that might occur should be extinguished with water.
— After the necessary contact time, remove the treated manure from the animal house. Use of the treated manure according to local legislation.
— The loading of the product into the treatment unit and the application must be done fully automatically.
— The loading into the treatment unit and the disposal of empty bags pr sacks must be performed using a telehandler (including a closed cabin).
— During the loading of the product and the disposal of empty bags or sacks, wear: — RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to EN 149 with a P3 filter or equivalant); — chemical resistant gloves in accordance with EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information); — protective coverall in accordance with EN 13982 or equivalant (coverall material to be specified by the authorisation holder within the product information).
— During the treatment of the manure, the wearing of air-fed or canister RPE specific for ammonia gas in accordance with EN 14387 or equivalent, is recommended in the absence of collective management measures to estimate and prevent an exposure greater than the EU OEL of 14 mg/m3 for that gas.
— During the manual handling of treated manure wear protective gloves in accordance with EN 374 or equivalent and protection coverall in accordance with EN 14126 or equivalent protecting against the intrinsic properties of the manure.
— The provisions on personal protective equipment are without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work.
— See section 6 for the full titles of the EN standards and legislations.
— The cleaning of the treatment unit must be avoided or performed with an automated process with no exposure of the professional.
— Do not apply the product if releases from animal housings or manure/slurry storage areas can be directed to a sewage treatment plant or directly to surface water.
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4.3. Use description
| Product type | PT03: Veterinary hygiene |
|---|---|
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: Bacteria Development stage: — Scientific name: Yeast Common name: Yeasts Development stage: — Scientific name: Fungi Common name: fungi Development stage: — Scientific name: viruses Common name: Viruses Development stage: — |
| Field(s) of use | Indoor use |
| Application method(s) | Method: Direct application Detailed description: The product is spread directly onto the floors of animal accommodations using manual or automated techniques. Manual spreading using a shovel or semi-automated using a low-impact spreader. |
| Application rate(s) and frequency | Application Rate: 800 g product/m2 — RTU product Number and timing of application: Frequency in animal housing: before each production cycle. Frequency in animal transportation: after each animal transport. Contact time: 48 hours |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Bulk powder Big bags or sacks (with PP or PE inner layer): 500-1 200 kg Paper sacks (with PP or PE inner layer): 25 kg |
— The product is spread onto the floors of animal accommodations and transportation using manual or automated techniques. Manual spreading using a shovel or semi-automated using a low-impact spreader.
— A long-handled shovel must be used for the manual spreading application.
A.On concrete floors:
Wash the surface with running water;
Sprinkle approximatively 800 g of product/m2 to cover the damp ground and add 0,9 litre/m2 of water;
Leave to act for at least 48 hours.
B.On beaten-earth floor:
Brush and wet the surface;
Sprinkle approximately 800 g of product/m2 on the damp ground and add 0,9 litre/m2 of water;
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