SUBSTANCE DECLARATION


Date of declaration: 2020-10-07

EU RoHS Directive (2011/65/EC)

WS Audiology products are not expected to contain any restricted substances above the maximum concentration values of EU RoHS Directive (2011/65/EU) on Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment, except for RoHS exemptions that may apply – refer to note.

EU REACH Regulation (No. 1907/2006)

WS Audiology products are considered ‘articles’ (as defined in Article 3(3) of the REACH Regulation) which are not intended to release any substances under normal and reasonably foreseeable conditions of use, therefore our company has no obligation for registration nor to provide safety data sheets (SDS). 

In line with Article 33(1), if a substance is present above 0.1% w/w in our articles, we will forthwith communicate this information. Our products are not expected to contain the substances within the 209 entries currently on the SVHC Candidate List published by ECHA (last update: 2020-06-25), except for content that may apply – refer to note.

Disclaimer

The above information is provided to the best of our knowledge as of the date of this document based on the documentation provided by our suppliers; we do not analyze for the presence of these substances and cannot guarantee the absence of these substances. As use conditions and applicable laws may differ from one location to another and may change with time, the recipient of this document is responsible for determining whether the information is appropriate for its use. Since we have no control over how this information may be ultimately used, all liability is expressly disclaimed and we assume no obligation or liability therefore. No warranty, express or implied, is given nor is freedom from any patent owned by us or others to be inferred. Further, the above information does not constitute legal advice or guidance on any legislation or regulation and should not be relied upon as such. Neither us nor any of our affiliated companies will have any liability to the recipient of this document whatsoever howsoever arising from any reliance placed upon or use of this information by such recipient.


For more information, please contact our R&D Product Related Environmental Protection (PREP) department at RoHSmatters@sivantos.com.

Note:

  • The RoHS restriction of DEHP, BBP, DBP and DIBP for medical devices shall apply from 22 July 2021 onwards.
  • Some suppliers of SMD components have reported lead (EC no.: 231-100-4, CAS no.: 7439-92-1) which may be above 0.1% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use (RoHS exemption 6(c) applicable).
  • Some suppliers of SMD components have reported lead titanium trioxide (EC no.: 235-038-9, CAS no.: 12060-00-3) which may be above 0.1% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use (RoHS exemption 7(c)-I applicable).
  • Some suppliers of SMD components have reported lead monoxide (EC no.: 215-267-0, CAS no.: 1317-36-8) which may be above 0.1% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use (RoHS exemption 7(c)-I applicable).
  • Some suppliers of turned parts have reported lead dinitrate (EC no.: 233-245-9, CAS no.: 10099-74-8) which may be above 0.1% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use (RoHS exemption 6(a)-I applicable).
  • Some suppliers of SMD components have reported diboron trioxide (EC no.: 215-125-8, CAS no.: 1303-86-2) which may be above 0.1% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use.
  • Some suppliers of PCB underfill have reported 4,4′-isopropylidenediphenol (Bisphenol A, EC no.:  201-245-8, CAS no.: 80-05-7)  which may be above 0.1% w/w; however this substance, in its original molecular form, is contained in the material as residue and cannot be released under normal or reasonably foreseeable conditions.
  • Some suppliers of PCB underfill have reported hexahydromethylphthalic anhydride (EC no.: 247-094-1, CAS no.: 25550-51-0) which may be above 0.1% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use.
  • Some suppliers of silicone containing components have reported octamethylcyclotetrasiloxane (D4, EC no.: 209-136-7, CAS no.: 556-67-2), decamethylcyclopentasiloxane (D5, EC no.: 208-764-9, CAS no.: 541-02-6) and dodecamethylcyclohexasiloxane (D6, EC no.: 208-762-8, CAS no.: 540-97-6), which may be above 0.1% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use.
  • Some suppliers of components with adhesive cement in coil assembly have reported nonyl-phenol (EC no.: 284-325-5, CAS no.: 84852-15-3) which may be above 0.1% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use.
  • Some suppliers of PCB have reported 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one (EC no.: 71868-10-5, CAS no.: 400-600-6) as component in solder mask which may be above 0.1% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use.
  • Some suppliers of PCB have reported  2-benzyl-2-dimethylamino-4’morpholinobutyrophenone (EC no.: 119313-12-1CAS no.: 404-360-3) as component in solder mask  which may be above 0.1% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use.
  • In some of our accessories, Ag-Zn rechargeable battery cell may be used. Some suppliers have reported lead monoxide (EC no.: 215-267-0, CAS no.: 1317-36-8) as part of the battery cathode additive which may be above 0.5% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use. EU RoHS Directive does not apply to batteries. This battery model complies with the EU Battery Directive (2006/66/EC).
  • In some of our accessories, primary lithium button battery cell – CR2450 may be used. Some suppliers have reported 1,2-dimethoxyethane; ethylene glycol dimethyl ether (EGDME, EC no.: 203-794-9, CAS no.: 110‐71‐4) as part of the battery electrolyte solvent which may be above 0.1% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use.
  • In some of our accessories, rechargeable lithium-ion battery pack may be used. Some suppliers have reported 1,3-propanesultone (EC no.: 214-317-9, CAS no.: 1120-71-4) as part of the battery electrolyte solvent which may be above 0.1% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use.