Information about REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals)

On December 18, 2006, the Council of the European Union adopted the REACH Regulation (EC) No 1907/2006. It entered into force on June 1, 2007. This regulation relates to chemical substances and their production and use in Europe. It is intended to better protect human health and the environment.

Bayer is aware of the obligations of this regulation and has implemented, amongst other REACH related tasks, an assessment and monitoring process for its Radiology medical devices. Bayer Radiology assesses items manufactured and imported into the European Union. With professional use, the articles produced are not intended to release substances. Based on the current information, these substances do not pose any risk, even in the context of disposal, if the articles are used as intended. Most SVHCs (Substances of Very High Concern) are contained within the electronic components of our electro-mechanical products and do not normally come into contact with operators or patients.

The following Bayer products contain parts with a SVHC substance above 0.1%:

Some of the sterile disposable tubing sets sold by Bayer contain DEHP above 0.1% weight by weight. Information regarding safe use of these tubing sets can be found in the accompanying instructions for use provided with the product. The catalog numbers of these tubing sets are:

LPDCT 50, SJS-LP-60-T-J, INT CPS, CVTS, MRTS, JTS-DCV