REACH Compliance

REACH deals with the Registration, Evaluation, Authorization and Restriction of Chemical substances, and was effectuated in June 2007. The aim of REACH is to further improve the protection of human health and the environment through better and earlier identification of certain chemical substances.

All suppliers who want to sell, import or manufacture chemicals and/or products containing chemicals in the European Union have obligations under REACH. One obligation is to notify customers if your products contain any of the substances listed under REACH, which can be found in below lists.

  • Candidate List of Substances of Very High Concern (SVHC)
  • Restriction List, Annex 17
  • Authorization List, Annex 14


Identification of Substances of Very High Concern (SVHC)

Based on investigations and current knowledge, as well as information from our suppliers regarding REACH article 33, Oticon have identified the below listed SVHC´s of the current version of the candidate list in concentrations above the threshold level of 0,1% w/w, which may be present in the following Oticon products:


Product type Article Substance CAS no.

Hearing Instruments

Speaker units

Connectivity devices

Electronic or Electrical Accesories

Mechanical metal alloys* Lead 7439-92-1
Ceramic element, glass element* Lead titanium trioxide 12060-00-3
Inductive chargers Internal mechanical component Brominated aromatic compound N/A
ITE Solder mask Melamine 108-78-1


*Listed as exemptions for Electrical and Electronic Equipment in Annex III of EU RoHS directive 2011/65/EU


In addition, DEHP, one of the phthalates listed in SVHC candidate list, is commonly known to be present in cables, power cords, PVC gasket, PVC tube etc. Alongside phthalates in general, these substances have been phased out from production of other Oticon products several years ago. However, they might be present above 0.1% (w/w) for some articles produced in the past.