ANEC position on claim of defective standard

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POSITION PAPER EN 16708 Beauty salon services ANEC position on claim of defective standard September 2016 Contact Person: Michela Vuerich, Sustainability & Services Programme Manager (tel. 02 743 24 70, anec@anec.eu) ANEC-PT-2016-HGS-005 European Association for the Co-ordination of Consumer Representation in Standardisation aisbl Av. de Tervueren 32, Box 27 B-1040 Brussels, Belgium / t: +32-2-7432470 / f: +32-2-7065430 / e: anec@anec.eu www.anec.eu

The consumer issues ANEC notes there is a strong and growing consumer demand for services to improve personal appearance and beauty. Aesthetic beauty treatments and aesthetic nonsurgical medical treatments - administered by professionals - can help consumers gain confidence, improve mental health and enjoy greater wellbeing. Indeed, crossborder purchases of these treatments continue to increase. Nevertheless, many of the procedures used to improve personal appearance involve risk. In the absence of an EU harmonising framework on the safety of services, the level of safety offered to the consumers of these services therefore depends on the degree of legislative oversight offered in each country. Although standards cannot replace legislation, ANEC believes a European Standard, implemented as a national standard, can provide a state-of-the-art reference in countries where these services are not regulated, especially when the consumer needs to seek redress. ANEC has welcomed CEN developing standards for aesthetic medicine treatment & beauty treatment in recognition that the market requires separate standards for the different categories of service provision. We have participated in the development of both EN 16708 Beauty salon services in CEN/TC 409, and pren 16844 Aesthetic medicine services in CEN/TC 403, contributing to the consumer-relevant aspects. We have also drawn attention to the risk of certain treatments being addressed by both standards and have proposed that the scope of each standard defines precisely the field of application of the standard and the kind of treatments covered. We have also stressed the importance of staff training and qualification in order to ensure the beauty therapists have the necessary core competences and skills regarding safety, security and hygiene aspects of the services they provide. We expressed support for development of certification services to EN 16708 in order to provide an incentive to beauty salons to implement the standard and achieve a competitive advantage in the market. Overlaps between CEN/TC 403 and CEN/TC 409 standards There are two main constituencies providing the services to meet these consumer demands: the beauty salon industry, employing beauty therapists on one hand; and the medical healthcare profession, employing clinicians, on the other. ANEC recognises these constituencies take very different approaches, particularly in the areas of staff training; equipment used; the regulations & standards applicable; premises, marketing & advertising. However, the consumer perception is influenced - and perhaps distorted - by the offer of apparently similar treatments. *2

ANEC believes the risk of overlap has been addressed in EN 16708. The standard is explicit in its exclusion of medical procedures. We also find it clearly expresses the competence and skill levels required for different kinds of treatment. As in the case of all service standards, the expectation is that a standard on beauty salon services will cover the treatments provided in daily life. Many treatments in question have been offered for 20 years or more by well-trained beauty therapists. Over the past years, we believe CEN/TC 409 made several efforts to accommodate the misunderstandings related to treatments that are provided by both doctors and beauticians. There is a key difference between the two services: a beauty therapist is competent to address only non-medical aspects. If medical treatment is needed, a reputable therapist will recommend that the client visits a medical professional. However, we believe more efforts need to be made to avoid ambiguity in application of EN 16708 and the expected application of (pr)en 16844: The scope and intended users of the standard EN 16708 should be better defined so that the distinction between medical and non-medical procedures becomes clearer. pren 16844 differs from EN 16708 in its definitions of micro-needling and mesotherapy. pren 16844 uses these as specific medical terms. Clinicians define mesotherapy as a specific intravenous or intramuscular means of administering a drug and this definition is used in pren 16844, but EN 16708 seems to see mesotherapy as a synonym for micro-needling. We understand TC 409 agreed to delete mesotherapy from the standard to avoid confusion and this change should be made. Where legislation does not state the professional skills required for the provision of a treatment, standards can at least state a level of competence required (i.e. referring to EQF). It is thus crucial that the qualification requirements now in the informative annex become normative. This would help to clarify the following: - pren 16844 requires that radiofrequency should be used only by medical professionals at restricted levels, whilst EN 16708 allows radiofrequency but specifying higher requirements for staff qualifications. More powerful devices are being developed that will be able to cause deep tissue burns and EN 16708 allows for unlimited power. This will place protection of the consumer in the hands of the beauty therapist and his/her degree of competence. - EN 16708 allows beauty therapists to administer chemical peels with different requirements from those specified in pren 16844. - EN 16708 allows beauty therapists to use IPL and class 3b and 4 lasers, while pren 16844 states these can be used only with medical supervision. In summary, because pren 16844 has its origin in the healthcare profession, which deals with surgical aspects going beyond aesthetic non-surgical medicine, pren 16844 is far more concerned about the risks of non-surgical intervention. *3

EN 16708 needs better definitions of non-surgical medical interventions. CEN cannot allow EN 16708 to permit non-medical personnel to carry out aesthetic non-surgical medical treatments while EN 16844 prohibits it. ANEC invites CEN to address the ambiguities between EN 16708 and (pr)en 16844. These will lead to increased risks to consumers if not solved. We would be pleased to contribute to the work. ANEC conclusions on claim of defective standard In conclusion, ANEC supports publication of EN 16708 but does so on the condition that the remaining ambiguities between EN 16708 and (pr)en 16844 are resolved in line with our comments above. TC 409 has featured the greater participation of professionals from the beauty salon industry, while TC 403 has featured the greater participation of clinical professionals from the medical healthcare sector. Hence each technical committee has worked from a distinct knowledge base. This had led EN 16708 and (pr)en 16844 to set different requirements for notionally similar treatments. ANEC has welcomed CEN s attempts to address the conflict between the standards and does not blame CEN for the residual overlap which arises more from the nature of the market and the two constituencies involved. That said, the concerns put forward by the complainants do raise questions, but the sale to beauticians of equipment and chemicals for medical use is an issue that can be solved only by the regulator: it will not be solved through cancelling EN 16708. Moreover, the failure to publish EN 16708 will lead to countries without regulation not having a state-of the-art reference document available at the national level for the purpose of consumer redress. We would prefer CEN to bring these problems in the supply of equipment and chemicals to the notice of the European Commission which may in turn decide to bring them to the attention of Member States. ENDS. *4

About ANEC ANEC is the European consumer voice in standardisation, defending consumer interests in the processes of technical standardisation and conformity assessment, as well as related legislation and public policies. ANEC was established in 1995 as an international non-profit association under Belgian law and is open to the representation of national consumer organisations in 33 countries. ANEC is funded by the European Union and EFTA, with national consumer organisations contributing in kind. Its Secretariat is based in Brussels. European association for the coordination of consumer representation in standardisation aisbl Avenue de Tervuren 32, box 27, B-1040 Brussels, Belgium Tel.: +32 2 743 24 70 / Fax: +32 2 706 54 30 E-mail: anec@anec.eu EC Register of Interest Representatives: Identification number 507800799-30 www.anec.eu @anectweet www.facebook.com/anec.standards ANEC is supported financially by the European Union & EFTA This document may be quoted and reproduced, provided the source is given. This document is available in English upon request from the ANEC Secretariat or from the ANEC website at www.anec.eu Copyright ANEC 2016 *5