EU REACH Regulation

Experien Health Sciences staff, along with the staff of our EU partner Experien Chemical Services (Ireland) Limited based in Cork Ireland, have been involved with the registration of chemical substances in EU member countries from the very beginning of the EU’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation, but also long before that under what was known as the Notification of New Substances (NONS) process which formed the basis for REACH. Unlike the U.S. and many other countries, there is no free pass for so-called “existing” chemicals. With few exceptions, such as R&D and volumes less than 1 metric tonne per year, every molecule of every chemical placed on the EU market, either on its own or in a formulated mixture, must be covered by a unique registration held by each EU-manufacturer, each EU-importer, or by an “Only Representative” who has been [voluntarily] appointed by each non-EU manufacturer or formulator exporting to the EU. To secure registration, EU REACH requires specific data to be submitted depending on the volume being placed on the market. This data must be reliable, must be submitted to the European Chemicals Agency (ECHA) through the REACH-IT system, and the submitter must have a legal right to use the data in their submission. Fortunately, there are several ways to fulfill ECHA’s data requirements and we can help you find the most economical path forward.

We have technically qualified personnel on both sides of the Atlantic with many years of experience who can:

  • Help you understand how EU REACH impacts you and help you devise a compliance strategy that maximizes the benefits to your business.
  • Help you understand the cost and timing of filing a REACH registration for your substances, and help you identify any cost-saving data waivers that can be applied.
  • Serve as your Only Representative or Third-Party Representative.
  • Help secure access to the physical-chemical, toxicological, eco-toxicological, and environmental fate data that may be required to support your registration, whether by sponsoring your own testing using qualified laboratories, by identifying analog or read-across data to include in your submission, or by purchasing access to the data you need from other manufacturers of the same substance through the Substance Information Exchange Forum (SIEF).
  • Complete any required exposure assessments and risk characterisations and prepare the Chemical Safety Report (CSR).
  • Prepare your registrations dossiers, as Lead Registrant or Joint Registrant, and submit them to ECHA.
  • Help you maintain compliance by updating the dossiers as required and by responding to ECHA if your substance is chosen for evaluation, restriction, or authorisation.
  • Help you to properly communicate your REACH registration status to customers and explain the duties they retain under the regulation.