IN SHORT
- Importers of sunbeds must apply for approval at DSA.
- Distributors and importers must fulfil a number of requirements before a sunbed may be sold or rented out.
- Sunbeds are regulated by the Radiation Protection Regulations.
Regulations
DSA is the responsible authority for radiation from sunbeds in Norway. Sunbeds are regulated by the Regulations on Radiation Protection and Use of Radiation (Radiation Protection Regulations), authorized in the Act on Radiation Protection and Use of Radiation. In addition, the Internal control regulations applies to companies and organisations governed by this act.
The guide Veileder 4: Veileder til solarieforhandlere og importører (in Norwegian only) describes in detail the requirements in the Radiation Protection Regulations for distributors and importers of sunbeds for cosmetic use. All distributors and importers should be familiar with the contents of this guide.
If you have questions about the regulations and how to fulfil the requirements, please contact DSA ([email protected]).
Which requirements must distributors and importers comply with?
- All sunbeds in Norway must:
- Comply with the European Standard for sunbeds EN 60335-2-27 with amendments*.
- Be classified as UV type 3 according to EN 60335-2-27. From 2023, new sunbeds incorporating visual (400 to 780 nm) or infrared (IR) emitters must also be classified according to the international standard for lamps and lamp systems, IEC 62471:2006, and they shall not exceed the limits of risk group 1 for the visible and IR radiation.
- Be notified to DSA (applies to new models and new lamp combinations in existing models) and published on DSA's list of registered models, https://ems.dsa.no/solarieliste, before they are allowed to be sold, leased or used.
- Be equipped with lamps, filters etc. according to the specifications for the model in DSA’s list.
- Be labelled with warning text in Norwegian (see the yellow label below), “UV-type 3”, equivalency code ranges and specification of all permitted lamps other than tube lamps (e.g. high-pressure lamps and LEDs). If the luminance from the sunbed exceeds 100,000 cd/m, a label with the following text must also be attached to the sunbed: “Advarsel. Intens lysstyrke. Se ikke rett på lyskilden.”
- Sunbeds where the intended exposure distance is not controlled by the construction of the sunbed, must also be marked with symbol IEC 60417-6301 (2015-3), available at https://www.iso.org/obp/ui/#iec:grs:60417:6301, with the recommended exposure distance (in centimetres) included between the dimensional arrow heads.
- Be equipped with a user’s manual in Norwegian, including a recommended exposure schedule. The contents must be in accordance with the Radiation Protection Regulations and the European Standard EN 60335-2-27.
- Be equipped with at least two pairs of protective goggles when sold/rented.
- Distributors of sunbeds must register with DSA. DSA’s electronic registration system (EMS) must be used for this purpose, available on https://ems.dsa.no (login with “ID-porten”). First you register the company, then a registration of each sunbed is submitted to DSA. When a registered sunbed is resold, you transfer it to the buyer in EMS. For information on how to use EMS, please visit http://www.emshelp.no.
- Importers of sunbeds must apply for approval. This also applies if you import sunbeds for use in your own establishment without reselling them.
- For importers, the person responsible for the daily operations and the radiation protection coordinator must have passed the competence test “Solarieprøven".
- Employees and other associated persons must be given sufficient training and competence in radiation protection and safe handling of the sunbeds. There must be written procedures and work instructions.
- The company must have an internal control system with, among other things, risk assessment and systems for acceptance checks and action when products not fulfilling the requirements are discovered.
Notification of new sunbed models or lamp combinations
From 1 January 2017, all importers of sunbeds must have an authorisation from DSA, and one of the conditions in the authorisation is that the importer must ensure that new sunbed models are notified to DSA.
DSA’s electronic registration system for radiation sources (EMS) must be used for notifications of both new sunbed models and changes to existing models, i.e. new lamp combinations. In EMS, log in is done using "ID-porten". For more information about EMS, please visit http://www.emshelp.no. For information about "ID-porten", see http://idporten.no/en/online-public-services. “ID-porten” can only be used by Norwegian residents having a national ID number or a D number. Foreign companies/persons intending to notify new sunbed models or lamp combinations must contact DSA on [email protected] for further information about submission method.
Please be aware that to be able to notify new models or changes to existing ones your company must be registered as distributor in EMS.
Registration of a new model: Choose menu option “Solarium” and “Register new solarium model”. Fill in the notification form, including the model configuration (“Add new specifications”), upload all required documentation and click “Save and submit”.
Registration of changes to existing model: Choose menu option “Solarium”, find the model in the list, click “Display more information” and then “Add new specifications”. Fill in the specifications for all parts of the sunbed, upload all required documentation and click “Save and submit”.
The notifications must contain all information required in the electronic notification form, enclosing measurement reports, technical documentation and an instruction manual with exposure schedule in Norwegian. See the list of required documentation below.
DSA must also be notified when changes that may have an impact on the radiation level (i.e. new lamp types or filters) are made to previously accepted sunbed models, in addition to change of name or other identification of the model.
Only sunbeds classified as UV type 3 according to the current European Standard EN 60335-2-27 are allowed for cosmetic purposes in Norway. The importer/distributor of a sunbed is responsible for ensuring that all requirements are fulfilled, and all necessary measurements have been performed.
It is not legal to offer a sunbed, for sale, lease nor use, until the sunbed model in question has been published on DSA’s list of registered models, https://ems.dsa.no/solarieliste.
Requirements for the measuring laboratory
- The measurements must be performed according to the following standards:
- EN 60335-2-27 – Household and similar electrical appliances – Safety - Part 2-27: Particular requirements for appliances for skin exposure to ultraviolet and infrared radiation
- EN 61228 – Fluorescent ultraviolet lamps used for tanning – Measurement and specification method
- IEC 62471:2006 – Photobiological safety of lamps and lamp systems (applies to sunbeds incorporating visual and infrared (IR) emitters)
- DSA accepts measurement reports from laboratories accredited for measuring according to the current version of the sunbed standard EN 60335-2-27 and IEC or EN 62471:2006. We also accept measurement reports from laboratories that have a quality system and written procedures that document that the measurements are performed according to this standard and otherwise meets the requirements given in ISO 17025 concerning measurement quality.
- Traceability to a standard laboratory, calibration routines to ensure stability and prevent wavelength shifts, and temperature stabilisation of the measuring instrument must be documented.
- Written procedures for measuring methods must be available upon request
- Measurement results for the UVR from the sunbed must be documented with a measurement report, including among other things the actual measured values for each wavelength and the maximum values measured in each part of the sunbed.
- For sunbed incorporating visual and IR emitters, it must be documented that the sunbed does not exceed the limits of risk group 1 for the visible and IR radiation, according to IEC 62471:2006. The measurement report must include maximum values measured in each part of the sunbed.
Documentation that must accompany the notification of new sunbed models or changes to existing models
- Measurement report showing:
- Date and location for when and where the measurements were performed
- Accreditation and validity of the measurement laboratory, including which standard the accreditation applies to and year of expiry
- Which standard the measurements are done in accordance with (number and year of standard)
- The method of calibration and date of last calibration
- Uncertainty range for the measurements
- A description of the measuring apparatus, including bandwidth and diameter of the diffuser
- Name of the sunbed, all lamp types and filters and setting/effect of ballasts. All fluorescent UV lamps must be marked with equivalency code, and the code must be stated in the measurement report.
- The number of hours/minutes lamps are aged and warmed up before measurement
- The voltage and temperature at measurement time
- UV-type classification
- Maximum erythema-weighted short and long wave and total UV radiation in the canopy, bench, face, and shoulder positions or in the stand-up cabinet.
- Table of irradiance (W/m²) in the range 250-400 nm
- For sunbeds also incorporating visible and IR sources, measured maximum values for all parts of the sunbed and risk group classification according to IEC 62471:2006 for the visible and IR radiation must be included. The sunbed cannot exceed risk group 1 (RG1) for the visible and IR radiation.
- Technical documentation that indicates the sunbed type, operating voltage, power, number and type of all lamps in each part of the sunbed, filters, acrylic sheets, ballasts, ballast settings, electronic settings and anything else that may affect the radiation level.
- User manual in Norwegian according to the latest version of the EN 60335-2-27.
- Exposure schedule in Norwegian according to the latest version of the EN 60335-2-27.
- Stickers with UV type 3 and warning notice in Norwegian
- Sticker with equivalency code ranges for the sunbed model and type reference of emitters other than fluorescent UV lamps, e.g., high-pressure lamps and LEDs, that are to be used in the model. For sunbeds incorporating visible and IR emitters, these emitters must also be specified.
Please be aware that the Y component of the equivalency code range has been changed (from ± 15% to ± 25% of the Y on the tube equivalency code) according to the amendment to EN 60335-2-27:2013/A2:2020. In the transition period, up to the latest date of implementation of A2, both versions can be notified to DSA. - Photos of the logo of the various lamp types used in the sunbed during the measurements.
More information
- DSA’s electronic registration system (EMS)
- DSA’s list of registered sunbed models
- Competence test - Solarieprøven
Publications
- Guide 4 Veileder 4: Veileder til solarieforhandlere og importører (In Norwegian)
