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Ordinance on Protection against the Harmful Effects of Non-ionising Radiation in Human Applications (NiSV)

  • With the Ordinance on Protection against the Harmful Effects of Non-ionising Radiation in Human Applications (NiSV), the use of optical radiation and ultrasound as well as electric, magnetic, and electromagnetic fields for cosmetic purposes is regulated.
  • Some treatments may now be carried out only by licensed doctors with appropriate further training and education (medical proviso).
  • For applications that are not under medical proviso, the NiSV requires proof of the relevant expertise.
  • These requirements are laid down in the Ordinance on Protection against the Harmful Effects of Non-ionising Radiation in Human Applications (NiSV). The NiSV is included as Article 4 in the Ordinance on the Further Modernisation of the Radiation Protection Law.
  • The Guideline for the Requirements for the Acquisition of Expertise for Applications of Non-Ionising Radiation Sources to Humans (Expert Guideline NiSV) of 10.03.2022 came into force with its announcement on 18.03.2022.

Person mit verschiedenen Apparaten zur kosmetischen Anwendung Kosmetische Anwendungen am Menschen

The use of strong light sources, ultrasonic devices, low-frequency devices, high-frequency devices, direct current devices, and magnetic field devices in non-medical areas – especially in cosmetics – is associated with risks.

With the Ordinance on Protection against the Harmful Effects of Non-ionising Radiation in Human Applications (NiSV), the use of optical radiation and ultrasound as well as electric, magnetic, and electromagnetic fields for cosmetic purposes is regulated. The entry into force of the regulations on the proof of the required expertise of the providers is scheduled for 31 December 2022.

Requirements for commercial use

The ordinance regulates the commercial operation of laser equipment, intense light sources, high-frequency devices, and ultrasound devices as well as equipment for electrical nerve and muscle stimulation, magnetic field stimulation, and central nervous system stimulation.

Since the beginning of 2021, anyone who uses these devices commercially for cosmetic and other non-medical purposes must fulfil new requirements for operation as well as documentation and consultation obligations. In addition, the operation of used equipment must be reported to the competent authority.

Some treatments may now be carried out only by licensed doctors with appropriate further training and education (medical proviso). For applications that are not under medical proviso, the NiSV requires proof of the relevant expertise.

These requirements are laid down in the Ordinance on Protection against the Harmful Effects of Non-ionising Radiation in Human Applications (NiSV). The NiSV is included as Article 4 in the Ordinance on the Further Modernisation of the Radiation Protection Law.

The NiSV regulates, among other things

General requirements for the establishmentShow / Hide

The concrete requirements result from Section 3 of the NiSV. They concern, for example, equipment safety, counselling and education of customers, and protection of third parties (e.g. when using laser equipment) as well as documentation of equipment and applications..

Duty of notificationShow / Hide

The operation of the respective installation(s) must be reported to the competent authority at least two weeks before commissioning. For installations already in operation as of 31 December 2020, the Ordinance provides for a deadline of 31 March 2021. The addresses of the relevant enforcement authorities of the Federal States are compiled on the pages of the Federal Environment Ministry.

Medical provisoShow / Hide

As of 31 December 2020, some applications such as the removal of tattoos or pigmented skin changes or the treatment of vascular changes may be carried out only by licensed doctors with the appropriate further training or education.

The same applies to applications that serve to stimulate the central nervous system or reduce thermal fat tissue.

The full regulations on the medical proviso are found in Sections 5, 6 and 8 of the NiSV.

The enforcement of the NiSV is the responsibility of the federal states. If you have any questions regarding enforcement, please contact the state authority responsible for you.

Technical knowledgeShow / Hide

For applications that do not fall under the medical proviso, specialist knowledge will need to be proven by successful participation in a suitable training course. This applies, for example, to permanent hair removal with lasers or IPL devices as well as to electrical nerve or muscle stimulation.

Annex 3 of the NiSV defines 5 specialist knowledge modules to be completed depending on the field of application. These include basics of the skin and its appendages, optical radiation, electromagnetic fields (high-frequency devices) in cosmetics, electromagnetic fields (low-frequency, direct current, and magnetic field devices) for stimulation, and ultrasound.

The specific requirements for acquiring the necessary expertise are derived from the NiSV and in detail from the Joint Guideline of the Federal Government and the Federal States (Specialist guideline). The specialist guideline defines requirements for training concepts and training providers and contains detailed framework curricula for the respective technical knowledge modules.

Saxony-Anhalt is an exception here. In this federal state, the authorities responsible for enforcing the NiSV must be consulted regarding the recognition of training certificates.

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State of 2024.03.18

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