REACH Compliance

REACH deals with the Registration, Evaluation, Authorization and Restriction of Chemical substances, and entered into force on June 1, 2007. The aim of REACH is to further improve the protection of human health and the environment through the better and earlier identification of certain chemical substances. It is legislation from the European Union, and applies to all suppliers (inside and outside Europe) that want to sell, import or manufacture chemicals and/or products containing certain chemicals in the European Union.

Bernafon supports the objective of REACH to further improve the European Union’s regulation on chemicals, including the aim to advance public health and safety and to protect the environment.

We have requested our component or finished product suppliers to provide us information on the relevant chemicals in their supplied products. This enables us to provide our customers and consumers with information about so called substances of very high concern (SVHC) from the candidate SVHC list of the REACH regulation, as required by article 33 of REACH. 

Bernafon REACH Declaration related to substances in articles

The European Court of Justice ruled on 10th September 2015, on EU REACH Regulation article definition, that each of the articles, that are assembled or joined together in a complex product, remain as articles and are covered by the relevant duties to notify and provide information when they contain a substance of very high concern in a concentration above 0.1% of their mass.

Based on investigations and current knowledge, as well as information from our suppliers regarding REACH article 33, Bernafon has 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 Bernafon products:

Product Type Article Substance CAS no.

Hearing Instruments

Speaker units

Connectivity devices

Electronic or Electrical Accessories

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, this substance has been phased out from production of other Bernafon products. However, they might be present above 0.1% (w/w) for some articles produced in the past.


Links on REACH


REACH FAQ for Hearing Care Professionals

The European Commission

European Chemicals Agency (ECHA)