New rules for the use of lasers, light, and the like outside medicine

In the professional sector, lasers are used for the removal of tattoos Source: damiangretka iStock/Getty Images Plus

The protection of health from non-ionising radiation is to be improved. Lasers, strong light sources, strong electromagnetic fields, and ultrasound will be more strictly regulated when used for non-medical purposes. The new rules enter into force on 31 December 2020. They are laid down in the Ordinance on protection against the harmful effects of non-ionising radiation in human applications (NiSV).

Federal Environment Minister Svenja Schulze says: "The use of non-ionising radiation in cosmetics has become common practice. However, unbeknownst to providers, it is associated with health risks. To protect health, we have tightened the rules on this".

President of the Federal Office for Radiation Protection, Dr Inge Paulini

Dr Inge Paulini, President of the Federal Office for Radiation Protection (BfS): "Strong sources of optical radiation and electromagnetic fields as well as intense ultrasound should be used only by people who have the necessary expertise to do so. We are therefore pleased that the corresponding regulation will now come into force at the turn of the year after a two-year transitional period. This will strengthen health protection in a range of cosmetic applications".

In cosmetics, intense sources of optical radiation (e.g. lasers or strongly pulsed light sources) are used primarily for treating pigment disorders, smoothing wrinkles, and permanently removing hair. Tattoos are also removed with the help of lasers. High-frequency electromagnetic fields are used for fat reduction and skin rejuvenation, while low-frequency electric currents and magnetic fields are used for muscle and nerve stimulation.

Stricter requirements for operation and new duties

Until now, there have been no specific regulations in this area – even though the associated health risks for humans can be considerable. The risks range from burns and scarring to impeded diagnosis and treatment of skin cancers.

Providers of cosmetic applications with non-ionising radiation commercially will have to fulfil stricter requirements for operation and meet documentation and consultation obligations. These are also subject to a duty of disclosure. Certain applications of non-ionising radiation may now be carried out only by doctors with the appropriate training.

Ordinance enters into force after transitional period

From 31 December 2021, all other applications that fall under the NiSV (Ordinance on protection against the harmful effects of non-ionising radiation in human applications) may be offered only by qualified professionals. Together with the BfS, the federal states, industry, and associations, the Federal Ministry for the Environment has agreed on the requirements that must be met to acquire the necessary qualifications. On 25 March 2020, these requirements were published in the Federal Gazette as a joint directive of the Federal Government and the federal states (except for Saxony-Anhalt).

Applications for medical purposes – including ultrasound – and home devices for private use are not affected by the new regulation.

On 5 December 2018, the NiSV was announced in the Federal Law Gazette as part of the Ordinance on further modernisation of the radiation protection law. With the later entry into force, the businesses affected were granted a transitional period.