REACH - the regulation concerning Registration, Evaluation, Authorization and Restriction of Chemicals - is a law within the European Union. REACH applies to all EU manufacturers, importers and users of chemical substances, as well as EU producers, importers and suppliers of articles such as finished goods, parts and components.
Article 33 of REACH requires us to provide information about certain “substances of very high concern” (“SVHCs”) if any SVHCs are present in a concentration of more than 0.1% of the weight of an article that we supply in the EU.
Based on information currently available to us, no substances from the SVHC candidate list are present in our products as described by Article 33, except as follows.
In general, it is known within the industry that cables of electric and electronic equipment may contain phthalates (DEHP, bis(2-ethyl(hexyl)phthalate), CAS nr.: 117-81-7; EC nr. 204-211-0). In addition, Varian Brachytherapy business has identified the following applicators and accessory products, ordered either in sets or individually through our parts catalog that may contain DEHP.
Set # GM11008880: Esophagus Bougie set; individual parts numbers are:
- GM 11007410
- GM 11007420
- GM 11007430
- GM 11007440
Set# GM11008890/11009010 Centering Intraluminal Applicator; individual part number:
Set # GM 11004690, Nasopharynx Applicator set; individual part numbers are:
- GM 11003310
- GM 11003320
We are closely monitoring these issues and will continue to adapt this information as applicable.
THIS DISCLOSURE IS FOR INFORMATIONAL PURPOSES ONLY, DOES NOT CONSTITUTE A LEGAL REPRESENTATION AND DOES NOT CREATE OR CONFIRM THE EXISTENCE OF ANY RIGHTS, LIABILITIES OR OBLIGATIONS OF VARIAN, ITS AFFILIATES, ANY OF THEIR RESPECTIVE CUSTOMERS OR ANY OTHER PERSON. THE SALE OF VARIAN PRODUCTS SHALL BE GOVERNED EXCLUSIVELY BY THE TERMS AND CONDITIONS SET FORTH IN THE APPLICABLE VARIAN SALE AGREEMENT.
Varian's assessments contained in this disclosure are solely Varian's opinion. The information contained herein is based on information Varian has obtained as of the date indicated. Any Varian customer or other person needing information or guidance about REACH should seek advice of legal counsel.
Posted on September 28, 2009.