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Saatja: "Regulatory UaSolucions" <[email protected]> Saaja: "undisclosed-recipients:" Teema: Chemical products with KMPS as oxidising agents for swimming pool water Kuupäev: 2025-09-02 09:14 Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Sirs, We would like to seek clarification regarding the active substance trihydrogen pentapotassium di(peroxomonosulfate) di(sulfate) (KMPS) with CAS 70693-62-8, which has been approved as a biocide for surface disinfection and has demonstrated efficacy at 5 g/L. As outlined in the active substance dossier under the EU Biocidal Products Regulation (BPR) for PT2, one of the supported uses is swimming pool disinfection, with a minimum in-use concentration of 130 ppm. However, according to the declaration provided by LANXESS (active substance notifier), additional efficacy studies conducted with Oxone™ (KMPS technical grade) demonstrated that the product exhibits no bactericidal activity at 120 ppm when tested against reference strains in accordance with EN 1276:2019, modified with the conditions outlined in the OECD guidance document. In line with the Efficacy Guidance under the BPR, EN 1276 constitutes a mandatory suspension test at the first tier (phase 2, step 1) to support claims related to the reduction of infection risks in swimming pools. Based on the results of these tests, LANXESS concluded that at concentrations of 120 ppm or lower, Oxone™ exhibits solely an oxidising effect and does not demonstrate the biocidal activity required to support a disinfection claim under the EU BPR. In practice, this means that at such concentrations, the substance contributes only to the oxidation of organic matter (e.g. sweat, body oils, and other residues) and the breakdown of nitrogenous compounds. These effects help to mitigate odours and improve water clarity, but do not provide effective microbial control. Furthermore, as can be verified on the product labelling (attached), the recommended application doses are 1 kg per 50 m³ for the initial treatment and 700 g per 50 m³ for weekly maintenance. These correspond to concentrations of approximately 20 ppm and 14 ppm, respectively. Such levels are far below the concentrations (5 g/l) demonstrated to be necessary to achieve a biocidal effect, thereby confirming that the marketed product functions solely as an oxidising agent in swimming pool applications. We kindly request your confirmation of this interpretation, and whether KMPS chemical products could be placed on the market as oxidising agents for use in swimming pool water in your country, specifically to improve clarity and mitigate odours, in compliance with Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP). Your sincerely, Laia Urdí <https://uasolucions.com/wp-content/uploads/2022/02/logo_uasolucions-01.jpg> <https://uasolucions.com/wp-content/uploads/2022/02/filet-01.jpg> [email protected] <mailto:[email protected]> T.( <tel:+34932477844> +34) 93 247 78 44Urdí-Solé & Associats, S.L.Travessera de Dalt, 126 Local E08024 Barcelonawww.uasolucions.com <https://uasolucions.com/> _____ This message and its attachments may contain confidential information and may not be communicated, reproduced or distributed to third parties. If you are not the intended recipient, please delete it and inform us by email. By the current GDPR (UE2016/679), we advise you that personal data will be processed under the responsibility of URDI SOLE I ASSOCIATS SL for a legitimate interest and will not be transferred to third parties unless legally obliged to do so. You can exercise your rights or get more information by sending a message to [email protected] <mailto:[email protected]> . If you consider that the processing does not comply with current legislation, you may file a complaint with the Spanish supervisory authority www.aepd.es <http://www.aepd.es> . OXYGEN ACTIVE GRANULAR . Chlorine-fee treatment. o xidant used to remove organic matter (sweat, body oils and other wastes.. ) and destroys nitrogenous compounds. It helps neutralize unpleasant odors and unwanted smell in the water, so all this contributes to the improvement and clarification of the pool water. Instructions of use and aplication : Add at the rate of: Start up: 1 kg/ 50 m3. Maintenance: 7 00 g/ 50 m3/ weekly. Application by professional personnel. Composition: Pentapotassium bis ( peroxymonosulphate ) bis (sulphate) 1000 g/Kg. (CAS: 70693-62-8) Hazard statements: H272: May intensify fire; oxidiser . H302: Harmful if swallowed.H314: Causes severe skin burns and eye damage. H334: May cause allergy or asthma symptoms or breathing difficulties if inhalation. H317: May cause an allergic skin reaction. H412: Harmful to aquatic life with long lasting effects. Precautionary statements: P102+ P405: Keep out of the reach of children. Save under lock and key. P221+P210: Take any precaution to avoid mixing with combustibles. Keep away from heat, hot surfaces from sparks, open flames and all other sources of ignition. No Smoking. P270+P260: Do not eat, drink or smoke during use. Avoid breathing dust. P273: Avoid release to the environment. P280+P264+P363: Wear protective gloves / clothing / eye protection / face protection. Wash thoroughly after handling. Wash contaminated clothing before reuse. P370+P 378:In case of fire: Use water in bulk to turn it off. P501: Dispose of contents/container to in accordance with hazardous waste regulations. Recommendations for cases of intoxication or accident: In contact with eyes, wash with plenty of water for at least 15 minutes. Don't forget to remove the lenses. In contact with the skin, wash with plenty of soap and water without rubbing. In case of ingestion: DO NOT induce vomiting.. If the person is unconscious, lie on their side with their head lower than the rest of the body and their knees semi-bent. If necessary, transfer the poisoned person to a health centre , and whenever possible carry the label or packaging. DO NOT LEAVE THE INTOXICATED ALONE IN ANY CASE. IF MEDICAL ADVICE IS NEEDED, KEEP THE LABEL OR CONTAINER HANDY EXPIRATION: 2 years from packaging date (see date on packaging) UFI: D7J5-60V9-G00Y-SKAY Manufactured by: PRODUCTOS QP, S. A.Ctra . Logroño, Km.10,200 50180 UTEBO (Zaragoza) Tel. +34 976 78 64 64 www.productosqp.com Content: Manufacturing date: LANXESS Deutschland GmbH To Quimidroga S.A. Declaration of non-biocidal activity of KMPS in swimming pool applications March 1st, 2024 at concentrations ≤ 120 ppm LANXESS Deutschland GmbH Nilsa Melo Regulatory Affairs Manager As you may be aware, one of the intended uses supported by the KMPS active substance BU MPP / BL ACD Regulatory dossier under EU BPR for PT2 is swimming pool disinfection, at a minimum in-use Affairs Kennedyplatz 1 concentration of 130 ppm1. However, LANXESS has performed additional efficacy tests with 50569 Köln, Germany OxoneTM, a KMPS technical grade, which demonstrates that the product possesses no bactericidal activity for the reference strains when diluted at 120 ppm. Phone +49 1517 4650587 [email protected] These tests were performed according to EN 1276:2019, modified with conditions from the www.lanxess.com OECD guidance document2. As per the Efficacy Guidance on the Biocidal Products Executive Board: Regulation3 the tests required for a pool disinfectant follow a tiered approach and EN 1276 is Matthias Zachert (Chairman) a mandatory suspension test for the 1st tier (phase 2, step 1) to support the claim of reducing Frederique van Baarle risk of infection in swimming pools4. Dr. Hubert Fink Oliver Stratmann It is LANXESS’ understanding, based on the results of these tests, that OxoneTM exhibits solely an oxidizer effect when used for swimming pool water treatment at an in-use Chairman of the Supervisory Board concentration of 120 ppm or lower. At these concentration rates, the product does not Dr. Matthias L. Wolfgruber demonstrate a biocidal effect to be classified as a biocidal product under the EU BPR, for the Registered Office: Cologne purpose of reducing risk of infections in swimming pools. Local Court Cologne HRB 52600 Further information can be delivered directly to authorities if required. VAT ID no. DE814000384 Yours sincerely, LANXESS Deutschland GmbH Nilsa Melo Regulatory Affairs Manager This document is valid without signature DISCLAIMER: This information relates solely to the LANXESS Deutschland GmbH (“LANXESS”) product set forth above as currently manufactured by LANXESS and not as incorporated in any other product or used in any process. Information provided is as of the date hereof and LANXESS assumes no responsibility to update, revise or amend this information. The application, use and processing of LANXESS products and the products manufactured by the purchaser and / or the purchaser´s customers on the basis of the information are beyond the control of LANXESS and, therefore, entirely purchaser´s own responsibility. LANXESS specifically disclaims any warranty of merchantability or fitness for a particular purpose. The information is given in good faith but without warranty or guarantee, express or implied with respect to the accuracy or completeness of the information. The presence, absence or lack of information herein with respect to any particular international, national, federal, state, or local law, statute, regulation, order or rule ("Laws") should not be construed to mean that the LANXESS product set forth above is regulated under, complies with or is exempt from such Laws. It is the purchaser´s own responsibility to verify compliance of the use or process of the LANXESS product with applicable Laws. Our products ae sold in accordance with the current version of our General Conditions of Sale and Delivery  Nilsa Melo References: Regulatory Affairs Manager 1) KMPS Assessment Report published on https://echa.europa.eu/information-on- March 1st, 2024 Please enter subject ONLY VIA DATA chemicals/biocidal-active-substances/-/disas/factsheet/1339/PT02 DIALOG Page 2 of 2 2) “Guidance Document for Demonstrating Efficacy of Pool and Spa Disinfectants in Laboratory and Field testing” (OECD Series of Testing and Assessment No 170, version dated 08 October 2012 ). 3) Guidance on the Biocidal Products Regulation, Volume II: Efficacy - Parts B+C: Assessment and Evaluation. Version 6.0, August 2023 4) Appendix 1 from “Guidance on the Biocidal Products Regulation”: Claim Matrices – November 2022. DISCLAIMER: This information relates solely to the LANXESS Deutschland GmbH (“LANXESS”) product set forth above as currently manufactured by LANXESS and not as incorporated in any other product or used in any process. Information provided is as of the date hereof and LANXESS assumes no responsibility to update, revise or amend this information. The application, use and processing of LANXESS products and the products manufactured by the purchaser and / or the purchaser´s customers on the basis of the information are beyond the control of LANXESS and, therefore, entirely purchaser´s own responsibility. LANXESS specifically disclaims any warranty of merchantability or fitness for a particular purpose. The information is given in good faith but without warranty or guarantee, express or implied with respect to the accuracy or completeness of the information. The presence, absence or lack of information herein with respect to any particular international, national, federal, state, or local law, statute, regulation, order or rule ("Laws") should not be construed to mean that the LANXESS product set forth above is regulated under, complies with or is exempt from such Laws. It is the purchaser´s own responsibility to verify compliance of the use or process of the LANXESS product with applicable Laws. Our products ae sold in accordance with the current version of our General Conditions of Sale and Delivery OXYGEN ACTIVE TABS . Chlorine-fee treatment. o xidant used to remove organic matter (sweat, body oils and other wastes.. ) and destroys nitrogenous compounds. It helps neutralize unpleasant odors and unwanted smell in the water, so all this contributes to the improvement and clarification of the pool water. Instructions of use and aplication : Add at the rate of: Start up: 5 tablets 200 g / 50 m3 Maintenance: 1-2 tablets 200 g / 50 m3/ 2 days . Application by professional personnel. Composition: Pentapotassium bis ( peroxymonosulphate ) bis (sulphate) 1000 g/Kg. (CAS: 70693-62-8) Hazard statements: H272: May intensify fire; oxidiser . H302: Harmful if swallowed.H314: Causes severe skin burns and eye damage. H334: May cause allergy or asthma symptoms or breathing difficulties if inhalation. H317: May cause an allergic skin reaction. H412: Harmful to aquatic life with long lasting effects. Precautionary statements: P102+ P405: Keep out of the reach of children. Save under lock and key. P221+P210: Take any precaution to avoid mixing with combustibles. Keep away from heat, hot surfaces from sparks, open flames and all other sources of ignition. No Smoking. P270+P260: Do not eat, drink or smoke during use. Avoid breathing dust. P273: Avoid release to the environment. P280+P264+P363: Wear protective gloves / clothing / eye protection / face protection. Wash thoroughly after handling. Wash contaminated clothing before reuse. P370+P 378:In case of fire: Use water in bulk to turn it off. P501: Dispose of contents/container to in accordance with hazardous waste regulations. Recommendations for cases of intoxication or accident: In contact with eyes, wash with plenty of water for at least 15 minutes. Don't forget to remove the lenses. In contact with the skin, wash with plenty of soap and water without rubbing. In case of ingestion: DO NOT induce vomiting.. If the person is unconscious, lie on their side with their head lower than the rest of the body and their knees semi-bent. If necessary, transfer the poisoned person to a health centre , and whenever possible carry the label or packaging. DO NOT LEAVE THE INTOXICATED ALONE IN ANY CASE. IF MEDICAL ADVICE IS NEEDED, KEEP THE LABEL OR CONTAINER HANDY EXPIRATION: 2 years from packaging date (see date on packaging) UFI: D7J5-60V9-G00Y-SKAY Manufactured by: PRODUCTOS QP, S. A.Ctra . Logroño, Km.10,200 50180 UTEBO (Zaragoza) Tel. +34 976 78 64 64 www.productosqp.com Content: Manufacturing date: