Selgitustaotlus
| Dokumendiregister | Terviseamet |
| Viit | 10.1-5/25/424-1 |
| Registreeritud | 02.09.2025 |
| Sünkroonitud | 03.09.2025 |
| Liik | Sissetulev dokument |
| Funktsioon | 10.1 Kemikaaliohutusega seotud toimingud |
| Sari | 10.1-5 Biotsiidide käitlemist Eestis ja EL õigusruumis puudutav kirjavahetus, info- ja muud dokumendid |
| Toimik | 10.1-5/2025 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Urdí-Solé & Associats, S.L. |
| Saabumis/saatmisviis | Urdí-Solé & Associats, S.L. |
| Vastutaja | Riina Lahne (TA, Peadirektori asetäitja (1) vastutusvaldkond, Kemikaaliohutuse osakond) |
| Originaal | Ava uues aknas |
Failid
March 1st, 2024
LANXESS Deutschland GmbH
Nilsa Melo
Regulatory Affairs Manager
BU MPP / BL ACD Regulatory
Affairs
Kennedyplatz 1
50569 Köln, Germany
Phone +49 1517 4650587
www.lanxess.com
Executive Board:
Matthias Zachert
(Chairman)
Frederique van Baarle
Dr. Hubert Fink
Oliver Stratmann
Chairman of the Supervisory
Board
Dr. Matthias L. Wolfgruber
Registered Office: Cologne
Local Court Cologne
HRB 52600
VAT ID no. DE814000384
LANXESS Deutschland GmbH
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
To
Quimidroga S.A.
Declaration of non-biocidal activity of KMPS in swimming pool applications
at concentrations ≤ 120 ppm
As you may be aware, one of the intended uses supported by the KMPS active substance
dossier under EU BPR for PT2 is swimming pool disinfection, at a minimum in-use
concentration of 130 ppm1. However, LANXESS has performed additional efficacy tests with
OxoneTM, a KMPS technical grade, which demonstrates that the product possesses no
bactericidal activity for the reference strains when diluted at 120 ppm.
These tests were performed according to EN 1276:2019, modified with conditions from the
OECD guidance document2. As per the Efficacy Guidance on the Biocidal Products
Regulation3 the tests required for a pool disinfectant follow a tiered approach and EN 1276 is
a mandatory suspension test for the 1st tier (phase 2, step 1) to support the claim of reducing
risk of infection in swimming pools4.
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
concentration of 120 ppm or lower. At these concentration rates, the product does not
demonstrate a biocidal effect to be classified as a biocidal product under the EU BPR, for the
purpose of reducing risk of infections in swimming pools.
Further information can be delivered directly to authorities if required.
Yours sincerely,
LANXESS Deutschland GmbH
Nilsa Melo
Regulatory Affairs Manager
This document is valid without signature
Nilsa Melo
Regulatory Affairs Manager
March 1st, 2024
Please enter subject ONLY VIA DATA
DIALOG
Page 2 of 2
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
References:
1) KMPS Assessment Report published on https://echa.europa.eu/information-on-
chemicals/biocidal-active-substances/-/disas/factsheet/1339/PT02
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.
|
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
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.
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.
 |  |
|
| ||||||
| 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]. 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. | |||||||||
March 1st, 2024
LANXESS Deutschland GmbH
Nilsa Melo
Regulatory Affairs Manager
BU MPP / BL ACD Regulatory
Affairs
Kennedyplatz 1
50569 Köln, Germany
Phone +49 1517 4650587
www.lanxess.com
Executive Board:
Matthias Zachert
(Chairman)
Frederique van Baarle
Dr. Hubert Fink
Oliver Stratmann
Chairman of the Supervisory
Board
Dr. Matthias L. Wolfgruber
Registered Office: Cologne
Local Court Cologne
HRB 52600
VAT ID no. DE814000384
LANXESS Deutschland GmbH
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
To
Quimidroga S.A.
Declaration of non-biocidal activity of KMPS in swimming pool applications
at concentrations ≤ 120 ppm
As you may be aware, one of the intended uses supported by the KMPS active substance
dossier under EU BPR for PT2 is swimming pool disinfection, at a minimum in-use
concentration of 130 ppm1. However, LANXESS has performed additional efficacy tests with
OxoneTM, a KMPS technical grade, which demonstrates that the product possesses no
bactericidal activity for the reference strains when diluted at 120 ppm.
These tests were performed according to EN 1276:2019, modified with conditions from the
OECD guidance document2. As per the Efficacy Guidance on the Biocidal Products
Regulation3 the tests required for a pool disinfectant follow a tiered approach and EN 1276 is
a mandatory suspension test for the 1st tier (phase 2, step 1) to support the claim of reducing
risk of infection in swimming pools4.
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
concentration of 120 ppm or lower. At these concentration rates, the product does not
demonstrate a biocidal effect to be classified as a biocidal product under the EU BPR, for the
purpose of reducing risk of infections in swimming pools.
Further information can be delivered directly to authorities if required.
Yours sincerely,
LANXESS Deutschland GmbH
Nilsa Melo
Regulatory Affairs Manager
This document is valid without signature
Nilsa Melo
Regulatory Affairs Manager
March 1st, 2024
Please enter subject ONLY VIA DATA
DIALOG
Page 2 of 2
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
References:
1) KMPS Assessment Report published on https://echa.europa.eu/information-on-
chemicals/biocidal-active-substances/-/disas/factsheet/1339/PT02
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.
Chlorine-fee treatment. oxidant 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: 700 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+P378: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:
Chlorine-fee treatment. oxidant 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+P378: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:
Chlorine-fee treatment. oxidant 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: 700 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+P378: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:
Chlorine-fee treatment. oxidant 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+P378: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:
Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Vastuskiri | 05.09.2025 | 3 | 10.1-5/25/424-4 🔒 | Väljaminev dokument | ta | Urdí-Solé & Associats, S.L. |
| Vastuskiri | 03.09.2025 | 1 | 10.1-5/25/424-3 🔒 | Väljaminev dokument | ta | Urdí-Solé & Associats, S.L. |
| Selgitustaotlus | 02.09.2025 | 1 | 10.1-5/25/424-2 | Sissetulev dokument | ta | Urdí-Solé & Associats, S.L. |