REACH Information
With the passing of the European Directive on the Registration, Evaluation and Authorisation of Chemicals (REACH) at the end of 2006, the most important and, as yet, most extensive piece of EU legislation for the European chemical industry came into force on June 1, 2007.
The aim of the directive is to improve the protection of human health and the environment by acquiring comprehensive information and also by imposing restrictions or bans on certain substances. Important elements of REACH are the autonomous compilation of data by the companies and the transfer of information to downstream users in a continuous chain right down to the end consumer.
In the past, risks which could be posed by medical products were extensively controlled by the European Medical Device Directive 93/42/EEC and were subject to monitoring by the named authorities within the framework of the CE marking. From now on, any chemicals used which are subject to an information requirement under the provisions of the REACH Directive must also be correspondingly disclosed.
The first candidate list in accordance with Article 59 (1, 10) of the Directive (EC) No. 1907/2006 (REACH) dated 28 October 2008 has now been published and we would like to inform you about our products accordingly.
The following product groups contain DEHP [Bis(2-ethylhexyl) phthalate] CAS No. 117-81-7 / EC_No. 204-211-0 in a concentration of more than 0.1% by weight:
Dialysis fistula needles
Y-adaptors
Extensions
Infusion delivery systems
Blood bags
Plasma transfer bags
Further information regarding the REACH Directive is also available via the European Chemicals Agency (EChA) at http://echa.europa.eu/chem_data_en.asp.