Material Declarations

Material Declarations

Phonak AG’s compliance with Product related chemical regulations
Rev. 4, July 2014

Phonak AG is committed to compliance with all applicable laws and regulations, including any new material restriction requirements that may be adopted under the European Union Recast RoHS Directive, otherwise known as RoHS 2 as well as to fulfilling all the relevant obligations of the European Union’s REACH Regulation.

REACH (“Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)”) is a European Union (EU) chemicals regulation that entered into force on 1 June 2007, with phased deadlines to 2018.

Phonak AG supports the overall REACH objective of improving the protection of human health and the environment. Phonak AG is committed to providing products that are safe to use and have a low environmental impact throughout their lifecycle.

As a medical device manufacturer Phonak AG is taking a proactive approach to evaluating materials in its products and components to assess environmental, health or safety risks. Phonak AG may restrict substances because of customer or legal requirements, or because Phonak AG believes it is appropriate based on a precautionary approach. Phonak AG strives to replace legally permitted materials when scientific data has established a potential health or environmental risk. Phonak AG is also committed to lower the risk if commercially and technically viable alternatives are available on the market. At Phonak AG the evaluation of alternative materials is a continuous process.

Phonak AG will meet all applicable REACH requirements and is committed to providing our customers with information about the chemicals in our components or products. Phonak AG works cohesively with suppliers in the industry to ensure that Phonak AG products comply with REACH.

Phonak AG and its suppliers have taken the necessary action to meet the requirements of REACH to ensure that Phonak AG Products can continue to be supplied in the EEA.

Phonak AG REACH Declaration related to substances in articles:

In accordance with REACH Regulation Article 33 (Communication of information on substances in articles) the table below indicates which substance(s) of very high concern (SVHC) may be present in Phonak AG products above the threshold level of 0.1% by weight of the article. Based on our current knowledge and current supplier information, no other SVHC are present in our components or products.

Substance of Very High Concern (SVHC)

CAS Number

Comments

DEHP, bis(2-ethyl(hexyl)phthalate)
117-81-7
This substance may be present in separately sold PVC tubing and cables or in components made of PVC within the product; this substance may be present in decorative parts.