COMMISSION IMPLEMENTING REGULATION (EU) 2023/1144

12.6.2023 | EN | Official Journal of the European Union | L 151/20 ---|---|---|--- * * * COMMISSION IMPLEMENTING REGULATION (EU) 2023/1144 of 9 June 2023 granting a Union authorisation for the single biocidal product ‘Bacticid IPA-N’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5), first subparagraph, thereof, Whereas: (1) | On 24 April 2019, Chemi-Pharm AS submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for Union authorisation of the same single biocidal product, as referred to in Article 1 of that Regulation, named ‘Bacticid IPA-N’, of product-types 2 and 4, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-SM051156-28 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference biocidal product family ‘Knieler & Team Propanol Family’, recorded in the Register under case number BC-AQ050985-22. ---|--- (2) | The same single biocidal product ‘Bacticid IPA-N’ contains propan-1-ol and propan-2-ol as the active substances, which are included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2 and 4. ---|--- (3) | On 8 December 2021, the Agency submitted to the Commission an opinion (3) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘Bacticid IPA-N’ in accordance with Article 6 of Implementing Regulation (EU) No 414/2013. ---|--- (4) | The opinion concludes that the proposed differences between the same single biocidal product and the related reference biocidal product are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 (4), and that based on the assessment of the related reference biocidal product family ‘Knieler & Team Propanol Family’ and subject to compliance with the draft SPC, the same single biocidal product meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012. ---|--- (5) | On 24 October 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. ---|--- (6) | The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same single biocidal product ‘Bacticid IPA-N’. ---|--- (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, ---|--- HAS ADOPTED THIS REGULATION: Article 1 A Union authorisation with authorisation number EU-0027679-0000 is granted to Chemi-Pharm AS for the making available on the market and use of the same single biocidal product ‘Bacticid IPA-N’ in accordance with the summary of the biocidal product characteristics set out in the Annex. The Union authorisation is valid from 2 July 2023 until 31 July 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. Done at Brussels, 9 June 2023. For the Commission The President Ursula VON DER LEYEN * * * (1) OJ L 167, 27.6.2012, p. 1. (2) Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4). (3) ECHA opinion for ‘Bacticid IPA-N’, 8 December 2021, https://echa.europa.eu/opinions-on-union-authorisation (4) Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4). * * * ANNEX Summary of product characteristics for a biocidal product Bacticid IPA-N Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Product type 4 – Food and feed area (Disinfectants) Authorisation number: EU-0027679-0000 R4BP asset number: EU-0027679-0000 1\. ADMINISTRATIVE INFORMATION 1.1. Trade name(s) of the product Trade name(s) | Bacticid IPA-N ---|--- 1.2. Authorisation holder Name and address of the authorisation holder | Name | Chemi-Pharm AS ---|---|--- Address | Tänassilma tee 11, 76406 Tänassilma küla, Saku vald Estonia Authorisation number | EU-0027679-0000 R4BP asset number | EU-0027679-0000 Date of the authorisation | 2.7.2023 Expiry date of the authorisation | 31.7.2032 1.3. Manufacturer(s) of the product Name of manufacturer | AS Chemi-Pharm ---|--- Address of manufacturer | Tänassilma tee 11, 76406 Tänassilma küla, Saku vald, Harju maakond Estonia Location of manufacturing sites | AS Chemi-Pharm, Tänassilma tee 11, 76406 Tänassilma küla, Saku vald, Harju maakond Estonia 1.4. Manufacturer(s) of the active substance(s) Active substance | Propan-1-ol ---|--- Name of manufacturer | OQ Chemicals GmbH (formerly Oxea GmbH) Address of manufacturer | Rheinpromenade 4a, 40789 Monheim am Rhein Germany Location of manufacturing sites | OQ Chemicals Corperation (formerly Oxea Coperation), 2001 FM 3057 TX, 77414 Bay City United States Active substance | Propan-1-ol ---|--- Name of manufacturer | BASF SE Address of manufacturer | Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany Location of manufacturing sites | BASF SE, Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany Active substance | Propan-1-ol ---|--- Name of manufacturer | SASOL Chemie GmbH & Co. KG Address of manufacturer | Secunda Chemical Operations, Sasol Place, 50 Katherine Street, 2090 Sandton South Africa Location of manufacturing sites | Secunda Chemical Operations, PDP Kruger Street, 2302 Secunda South Africa Active substance | Propan-2-ol ---|--- Name of manufacturer | INEOS Solvent Germany GmbH Address of manufacturer | Römerstrasse 733, 47443 Moers Germany Location of manufacturing sites | INEOS Solvent Germany GmbH, Römerstrasse 733, 47443 Moers Germany INEOS Solvent Germany GmbH, Shamrockstrasse 88, 44623 Herne Germany 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 (%) ---|---|---|---|---|--- Propan-1-ol | | Active Substance | 71-23-8 | 200-746-9 | 35,0 Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 35,0 2.2. Type of formulation AL – Any other liquid 3\. HAZARD AND PRECAUTIONARY STATEMENTS Hazard statements | Flammable liquid and vapour. Causes serious eye damage. May cause drowsiness or dizziness. Repeated exposure may cause skin dryness or cracking. ---|--- Precautionary statements | Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking. Keep container tightly closed. Avoid breathing vapours. Use only outdoors or in a well-ventilated area. Wear eye protection.. IF INHALED:Remove person to fresh air and keep comfortable for breathing. 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/doctor. Store in a well-ventilated place.Keep cool. Store locked up. Dispose of container to an authorised waste collection point. 4\. AUTHORISED USE(S) 4.1. Use description Table 1 Use # 1 – hard non-porous small surface disinfection RTU liquid Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | Not relevant 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 Scientific name: no data Common name: viruses (limited spectrum virucidal activity) Development stage: no data Field(s) of use | Indoor Health care facilities and pharmaceutical and cosmetic industry, for example patient-near surrounding, working areas/desks, general equipment (excluding food contact surfaces): disinfection of small hard/non-porous surfaces. For professional use only. Application method(s) | Method: Manual application Detailed description: Ready-to-use surface disinfectant at room temperature (20 ± 2 °C). The entire surface to be disinfected is wetted by pouring or spraying from a short distance and subsequently thoroughly wiped with a cloth. The amount of product should be sufficient (max. 50 ml/m2 to keep the surface wet during the contact time. Application rate(s) and frequency | Application Rate: Minimum exposure time: — for the control of bacteria, yeasts and enveloped viruses: 60 sec — for the control of viruses (limited spectrum virucidal activity): 5 min Dilution (%): Ready-to-use product Number and timing of application: A reasonable frequency of disinfection in a patient’s room is 1-2 per day. Maximum number of applications is 6 per day. No safety intervals need to be considered between the application phases. Category(ies) of users | Industrial Professional Pack sizes and packaging material | 100, 500, 750 and 1 000 ml transparent/white high-density polyethylene (HDPE) bottle with polypropylene (PP) flip top caps (accessory: PP screw closure with spray head); 5 000 ml transparent/white HDPE canister with HDPE screwed cap. 4.1.1. Use-specific instructions for use Surfaces should always be visibly clean prior to disinfection. Maximum number of applications is 6 per day. 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 4.2. Use description Table 2 Use # 2 – hard non-porous small surface disinfection RTU liquid Product type | PT04 – Food and feed area (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | Not relevant 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 Health care facilities and in food industry, for example food preparation and handling in kitchens/restaurants: disinfection of small hard/non-porous surfaces. For professional use only. Application method(s) | Method: Manual application Detailed description: Ready-to-use surface disinfectant at room temperature (20 ± 2 °C). The entire surface to be disinfected is wetted by pouring or spraying from a short distance and subsequently thoroughly wiped with a cloth. The amount of product should be sufficient (max. 50 ml/m2) to keep the surface wet during the contact time. Application rate(s) and frequency | Application Rate: Minimum exposure time: for the control of bacteria and yeasts at 20 °C: 60 sec Dilution (%): Ready-to-use product Number and timing of application: The products can be used as often as necessary. A reasonable frequency in kitchens is 1-2 per day. No safety intervals need to be considered between the application phases. Category(ies) of users | Industrial Professional Pack sizes and packaging material | 100, 500, 750 and 1 000 ml transparent/white high-density polyethylene (HDPE) bottle with polypropylene (PP) flip top caps (accessory: PP screw closure with spray head); 5 000 ml transparent/white HDPE canister with HDPE screwed cap. 4.2.1. Use-specific instructions for use Surfaces should always be visibly clean prior to disinfection. 4.2.2. Use-specific risk mitigation measures See general directions for use. 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 See general directions for use. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.2.5. 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 (1) 5.1. Instructions for use For professional use only. 5.2. Risk mitigation measures The use of eye protection during handling of the product is mandatory. Keep out of reach of children 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention if you feel unwell. If possible, show this sheet. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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/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, formic acid or propionic acid. 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. Accidental release measures:Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames. No smoking.Prevent entry to sewers and public waters.Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local regulations. 5.4. Instructions for safe disposal of the product and its packaging Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior to disposal. When totally empty, containers are recyclable like any other packing. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Shelf-life: 24 months Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight. Recommended storage temperature: 0– 30 °C Do not store at temperatures below 0 °C Do not store near food, drink and animal feedingstuff. Keep away from combustible material. 6\. OTHER INFORMATION * * * (1) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses. * * *