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Kosmetik, Wellness Und Die Gesundheit – EMF-Quellen Ausserhalb Der Medizin

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Kosmetik, Wellness Und Die Gesundheit – EMF-Quellen Ausserhalb Der Medizin Tel. +41 44 632 59 78 Fax: +41 44 632 11 98 [email protected] www.emf.ethz.ch Projektschlussbericht Kosmetik, Wellness und die Gesundheit – EMF-Quellen ausserhalb der Medizin. Systematische Erfassung und Charakterisie- rung von hoch- und niederfrequenten Quellen einschl. Ultraschall im gewerblichen Bereich und in der Anwendung für zuhause C:\Users\gregor\Dropbox\BfS_Wellness\Berichte\Schlussbericht\SB_update_final_v5.docx Projektschlussbericht: Kosmetik, Wellness und die Gesundheit – EMF-Quellen ausserhalb der Medizin 2018 Datum: 05. September 2018 Ort: Zürich Auftraggeberin: Bundesrepublik Deutschland Vertreten durch: BMUB Vertreten durch: Präsidentin des Bundesamtes für Strahlenschutz (BfS) 38201 Salzgitter Auftragnehmer/in: FSM – Forschungsstiftung Strom und Mobilkommunikation c/o ETH Zürich Gloriastr. 35 CH-8092 Zürich www.emf.ethz.ch Autoren: Dr. Gregor Dürrenberger, [email protected] Dr. Jürg Fröhlich, [email protected] Krisztina Meya, [email protected] Dr. Martin Schmid, [email protected] BfS-Kontakt: Cornelia Egblomassé-Roidl, [email protected] Vertragsnummer: 3617S82444 Für den Inhalt und die Schlussfolgerungen sind ausschliesslich die Autoren dieses Berichts verantwortlich. 2/166 C:\Users\gregor\Dropbox\BfS_Wellness\Berichte\Schlussbericht\SB_update_final_v5.docx Projektschlussbericht: Kosmetik, Wellness und die Gesundheit – EMF-Quellen ausserhalb der Medizin 2018 Zusammenfassung EMF-, Plasma- und Ultraschallquellen werden zunehmend zu kosmetischen Zwecken, für die Well- ness und im Fitnessbereich eingesetzt. Sowohl gewerbliche als auch private Nutzungen sind üblich. Es dominiert die elektrische Stimulation. Verbreitet ist auch die magnetische Stimulation mit gepulsten Feldern. Es ist nicht immer klar, ob mit einzelnen Anwendungen gesundheitliche Gefährdungen ver- bunden sind. Deshalb werden hier: (i) eine systematische Erfassung und Charakterisierung der Ge- räte und ihrer Anwendungen vorgenommen, (ii) die relevanten Normen und Empfehlungen zum Ge- sundheitsschutz aufgelistet, (iii) die in der Fachliteratur dokumentierten Nebenwirkungen und Risiken dargestellt, (iv) die Resultate einer Befragung von Branchen- und Konsumentenorganisationen, sowie die Ergebnisse von Meldestellen zu potenziellen Nebenwirkungen diskutiert und (v) die Befunde einer Analyse der Sozialen Medien hinsichtlich negativer Erfahrungen mit solchen Geräten vorgestellt. Insgesamt liessen sich in der Fachliteratur, in den Sozialen Medien, in der Befragung und in der RAPEX-Datenbank nur wenige Belege für problematische Nebenwirkungen finden. Allerdings gibt es durchaus Hinweise auf Probleme oder Risiken, die man beachten sollte: einerseits können Fitness-, Wellness- und Kosmetikgeräte die NutzerInnen / PatientInnen über den Grenzwerten exponieren, wenn sie als Medizinprodukte zertifiziert sind. Viele Geräte im Markt sind tatsächlich als Medizinpro- dukte zertifiziert. Andererseits gibt es in der Fachliteratur, teilweise gestützt durch Meldungen in den Sozialen Medien, Diskussionen oder Warnungen zu einzelnen Anwendungen. Dazu zählen die elektri- sche Muskelstimulation (EMS-Training), die Hochfrequenzdiathermie (Kosmetik), die transkranielle Stimulation (kognitive Leistungssteigerung), die Ultraschall-Diathermie und die Ultraschall-Kavitation (kosmetische Lipolyse) sowie Plasmaanwendungen (kosmetische Hautverschönerung). Die vorliegende Studie kommt zu folgenden Empfehlungen: (i) Plasma- und Infraschallanwendungen im Kosmetik- und Wellnessbereich sind nicht durch Normen geregelt. Hier sollte man den Bedarf einer Normierung abklären. (ii) Es sollte eine Empfehlung zuhanden der staatlich anerkannten Prüfstellen (Benannte Stellen) ausgearbeitet werden, die regelt, wann Geräte als Medizingeräte für den nicht- ärztlichen Einsatz freigegeben werden sollen. Die Empfehlung sollte auch messbare Grössen hinsicht- lich der Expositionsbeurteilung enthalten. (iii) Der gewerbliche Einsatz solcher zertifizierten Geräte in Wellness-, Fitness- und Kosmetikstudios sollte nur durch entsprechend ausgebildetes Personal durch- geführt werden dürfen. (iv) Es sollte geprüft werden, ob der Einsatz von Ultraschall mit Intensitäten oberhalb von 50 mW/cm2 ausserhalb des ärztlichen und physiotherapeutischen Einsatzes untersagt werden soll. (v) Um offene Fragen abzuklären, bedarf es weiterer Forschung. Wichtigen Forschungs- bedarf hinsichtlich Gesundheitsschutz bei nicht-medizinischen Anwendungen identifizieren wir in fol- genden Bereichen: transkranielle Stimulationen, Ultraschall- und Infraschallstimulationen, gepulste Magnetfeldstimulation sowie Elektromyostimulation. Dabei geht es primär um Fragen zu langfristigen Wirkungen und biologisch sowie gesundheitlich relevanten Schwellenwerten. 3/166 C:\Users\gregor\Dropbox\BfS_Wellness\Berichte\Schlussbericht\SB_update_final_v5.docx Projektschlussbericht: Kosmetik, Wellness und die Gesundheit – EMF-Quellen ausserhalb der Medizin 2018 Summary Home as well as studio based cosmetic, wellness and fitness therapies increasingly employ devices which use electromagnetic fields, cold plasma and ultrasound as sources for stimulating physiology. Electric stimulation is the most popular application followed by magnetic stimulation with pulsed fields. It is not fully clear whether there are health risks associated with such therapies. Against this back- ground, this report: (i) lists cosmetic, wellness and fitness applications and devices with EMF, plasma or ultrasound sources, (ii) presents the relevant product standards and health regulations, (iii) anal- yses the scientific literature in the field, (iv) discusses the results of a survey conducted among profes- sional, consumer and certification organisations, and (v) shows the results of a social media analysis on the therapies under scrutiny. The analysis of the scientific literature and the social media, as well as the results from the survey and from a database check of the European rapid alert system for dangerous non-food products (RAPEX) did not elicit many cases of detrimental health impacts. However, some indications should be taken seriously and require further attention: First, many of the investigated cosmetic, wellness and fitness devices expose users above general population limits. These devices are marketed as medical prod- ucts. Second, in the scientific literature as well as in the social and print media there are reports and warnings related to the following applications: electromyostimulation (EMS-training), RF-diathermy (cosmetics: skin tightening), transcranial Stimulation with electric / magnetic fields (cognitive enhance- ment), ultrasound diathermy and ultrasound cavitation (cosmetics: lipolysis), and plasma therapies (skin resurfacing). The report draws the following conclusions: (i) devices employing plasma and ultrasound for cosmetic and wellness purposes are not covered by current product standards. The need for such standards should be discussed. (ii) Notified bodies should be provided with guidelines and recommendations concerning the approval of medical products for private cosmetic, wellness and fitness use. The rec- ommendations should include quantitative exposure measures. (iii) The commercial use of such medi- cal devices in professional studios should only be accredited to personnel with a formal training. (iv) It should be examined whether ultrasound devices with power levels above 50 mW/cm2 used by non- medical personnel should be prohibited. (v) Research addressing open questions should be sup- ported. The following research needs on health-issues associated with non-medical applications of EMF, plasma and ultrasound sources were identified: transcranial stimulations, ultrasound and infra- sound stimulations, pulsed magnetic field stimulation, and electromyostimulation. Research should fo- cus on long-term effects and biologically and health relevant thresholds. 4/166 C:\Users\gregor\Dropbox\BfS_Wellness\Berichte\Schlussbericht\SB_update_final_v5.docx Projektschlussbericht: Kosmetik, Wellness und die Gesundheit – EMF-Quellen ausserhalb der Medizin 2018 Inhaltsverzeichnis Zusammenfassung .............................................................................................................. 3 Summary .............................................................................................................................. 4 Inhaltsverzeichnis ................................................................................................................ 5 Danksagung ......................................................................................................................... 8 1. Ziel, Vorgehen, Aufbau ................................................................................................. 9 1.1 Ziel .......................................................................................................................................... 9 1.2 Vorgehen ................................................................................................................................ 9 1.3 Abgrenzung .......................................................................................................................... 11 1.4 Struktur des Berichts .......................................................................................................... 12 2. Datenbasis und Methodik........................................................................................... 13 2.1 Hersteller und Produkte .....................................................................................................
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