As the leader in flexible containment and disposable cGMP systems, ILC Dover, with the assistance of an independent third party consultant, has reviewed the products they offer to the pharmaceutical industry with regard to the REACH (Registration, Evaluation and Authorisation of Chemicals) regulation. It has been determined that the products offered are classified as articles by this regulation. As defined by REACH, an article is a finished product that functions to a greater degree than its chemical composition.
Since no substances or preparations used in DoverPac™ articles are imported into the EU that would be over the 1t limit per year, no registration requirements exist. Additionally, no substances of very high concern (SVHC) are used in their products. As such, ILC Dover is REACH compliant and committed to continue to monitor the REACH regulation with regards to existing and future products.