Commission Implementing Regulation (EU) 2023/2703 of 4 December 2023 granting a Union authorisation for the single biocidal product EuLA oxi-lime 23 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

COMMISSION IMPLEMENTING REGULATION (EU) 2023/2703 of 4 December 2023 granting a Union authorisation for the single biocidal product ‘EuLA oxi-lime 23’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)

Article 1

A Union authorisation with authorisation number EU-0028963-0000 is hereby granted to European Lime Association aisbl for the making available on the market and use of the biocidal product ‘EuLA oxi-lime 23’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 25 December 2023 to 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

EuLA oxi-lime 23

Product type(s)

PT02: Disinfectants and algaecides not intended for direct application to humans or animals

PT03: Veterinary hygiene

Authorisation number: EU-0028963-0000

R4BP asset number: EU-0028963-0000

1. ADMINISTRATIVE INFORMATION

1.1.   Trade name(s) of the product

1.2.   Authorisation holder

1.3.   Manufacturer(s) of the product

1.4.   Manufacturer(s) of the active substance(s)3

2. PRODUCT COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the product

2.2.   Type(s) of formulation

DP Dustable powder

3. HAZARD AND PRECAUTIONARY STATEMENTS

4. AUTHORISED USE(S)

4.1.   Use description

— 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

— 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

— 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:

B. On beaten-earth floor:

— During the loading, the application 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 equivalent); — chemical resistant gloves in accordance with EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information); — a protective coverall in accordance with EN 13982 or equivalent (coverall material to be specified by the authorisation holder within the product information).

— For the use of big bags or sacks (500-1 200  kg), the loading of the product and the disposal of empty bags or sacks must be performed fully automatically using a telehandler (including a closed cabin).

— During the loading of small sacks (25 kg), thoroughly empty out the sacks in order to minimise the remaining powder.

— Fold carefully the small bag in order to avoid any spills.

— During the disposal of any residues of the product after the application, 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 equivalent); — 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 equivalent (coverall material to be specified by the authorisation holder within the product information).

— 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.

— Animals must not be present during the entire treatment duration.

— Remove residues of the product on the ground by sweeping before re-entry of animals.

— Feed and drinking water must be carefully covered or removed during the application of the product.

— Do not apply the product if releases from animal housings, manure/slurry storage areas or animal transportation disinfection areas can be directed to a sewage treatment plant or directly to surface water.

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— After treatment, remove the product by brushing. Collect the resulting dry waste and recycle it as agricultural liming material or dispose of the dry waste according to local requirements.

For animal transportation use only: after brushing, rinse and clean the vehicle.

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4.4.   Use description

Before the introduction of new animals:

— Brush and wet the floor.

— spread 600 - 800 g product/m² onto the ground then add 0,9 litre/m² of water.

— leave to act for at least 48 hours.

Do not apply in the case of wind or rain.

— During the loading, the application of the product on the floor and the disposal of empty bags, 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 equivalent); — chemical resistant gloves in accordance with EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information); — a protective coverall in accordance with EN 13982 or equivalent (coverall material to be specified by the authorisation holder within the product information).

— For the use of big bags or sacks (500-1 200  kg), the loading of the product and the disposal of empty bags or sacks must be performed fully automatically using a telehandler (including a closed cabin).

— During the loading of small sacks (25 kg), thoroughly empty out the sacks to minimise the remaining powder.

— Fold carefully the small bag in order to avoid any spills.

— During the disposal of the product after the application, wear: — RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to NF EN 149 with a P3 filter or equivalent); — 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 equivalent (coverall material to be specified by the authorisation holder within the product information).

— 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.

— Do not exceed two applications per year.

— Animals must not be present during the entire treatment duration.

— Remove the residues of the product on the ground by thorough sweeping before allowing re-entry of animals.

— Feed and drinking water must be carefully covered or removed during the application of the product.

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— After treatment, remove the product by brushing. Collect the resulting dry waste and recycle it as agricultural liming material or dispose of the dry waste according to local requirements.

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5. GENERAL DIRECTIONS FOR USE (¹)

5.1.   Instructions for use

— Comply with the instructions for use.

— Respect the conditions of use of the product.

— Refer to hygiene plan in place in order to ensure that necessary efficacy level is achieved.

— For outdoor uses, do not apply in the case of rain or wind

5.2.   Risk mitigation measures

— Do not let bystanders (including co-workers and children) and pets enter the treatment area during the entire treatment duration (including the loading, the application of the product, the disposal of empty bags or sacks, the required contact time and the subsequent removal of the product and its residues from the ground).

— Use only in a well-ventilated area.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

— IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.

— IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.

— 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 CENTER 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/ambulance for medical assistance.Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid or propionic acid.

5.4.   Instructions for safe disposal of the product and its packaging

— Do not discharge unused product on the ground, into water courses, into pipes (e.g. sink, toilets) or down the drains.

— Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

— Do not store at a temperature above 30 °C.

— Protect from humidity.

— Shelf-life: 15 months.

6. OTHER INFORMATION

Full titles of EN standards and legislation referred to in sections 4.1.2 - 4.4.2: