Product Compliance Resources provided by ProductIP

2022-01-07

Recall: Negative ions

Disclaimer: This document provides guidance and is not a legally binding interpretation and shall therefore not be relied upon as legal advice.

Ten products recalled

Dutch market surveillance authorities recalled ten products with “negative ions”. It concerns products with skin contact such as bracelets, necklaces and a sleeping-mask. The products emit ionising radiation. Even though the amount of radiation is low, health damage cannot be completely ruled out especially when the products are used continuously for a long time. What are the hazards of ionising radiation?

Negative ions

You probably recall from your science classes that atoms have electrons with a negative charge and protons with a positive charge. Ions are atoms that have either a positive or negative electrical charge. Atoms with more electrons than protons are negatively charged ions (also knows as anions). Atoms with fewer electrons than protons are positively charged ions (also knows as cations).

Ionising radiation

X-rays are an example of artificial ionising radiation and radioactivity is an example of ‘spontaneous’ natural radiation. 
Ionising radiation is an energy-rich radiation that can change atoms. It appears when small particles with sufficient energy “hit” an atom and as a result electrons escape from that atom. The atom is “ionised”, the electrical charge of the atom is changed. Exposure to ionising radiation can cause cell damage to living tissue and organ damage. When exposed to high doses or over a long period of time there is a risk on radiation sickness and cancer.

Legislation

Directive 2013/59/EURATOM lays down the basic safety standards for protection against the dangers arising from exposure to ionising radiation. “EURATOM” refers to the European Atomic Energy Community (EAEC or Euratom). EURATOM was established in 1957 as a research organisation for nuclear power in Europe but its scope has been increased since then and now includes also other sources of ionising radiation and radiation protection.

Consumer products

At first glance, the hazards of radioactivity and ionising radiation might be limited to professionals that are exposed to these materials in industry (occupational exposure) or to staff and patients in hospitals (medical exposure). But the legislation also sets ‘dose limits for public exposure’. This includes exposure of consumers to ionising radiation emitted by radioactive substances that may be found in ‘negative ion’ jewellery.

More information from the Dutch authority ‘Autoriteit Nucleaire Veiligheid en Stralingsbescherming (ANVS)’ regarding the recalls can be found in their news release (Dutch language).
A complete report about radioactivity measurement in ‘negative ion’ consumer products was published by the Dutch National Institute for Public Health and the Environment (RIVM) at the end of 2021.

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