REACH and TSCA Regulatory Testing Services

REACH and TSCA Regulatory Testing Services

Smithers provides a comprehensive range of testing for the EU Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), and the US Lautenberg Chemical Safety Act amended Toxic Substances Control Act (TSCA), including analytical support, risk assessment, and registration solutions.

Smithers has decades of experience in study designs for new chemical notifications, including support of REACH registrations from the inception of Regulation (EC) 1907/2006. Our team has worked with a range of substances traditionally seen as difficult-to-test, developing congruent approaches in test and dosing design considerations across regulatory study types.

Our approach to constructing study data sets is to enable the production of complete, reliable, and compliant information that supports correct decision-making in associated regulatory studies. Smithers has developed strategies to appropriately conduct test designs and analysis with test items and their degradation products that exhibit one or a mixture of the following properties:
  • Low solubility
  • Volatile
  • Surface-active
  • Ionisable
  • Unstable
    • Photolysis, hydrolysis or oxidation
  • Persistent
  • Multiconstituent or UVCB (unknown or variable composition, complex reaction products and biological)
    • Development of analytical methodologies to appropriately characterize and follow test substance behavior in test systems
Smithers can conduct non-labelled analysis for several tests that would traditionally be performed with a radiolabel.

Contact us to learn more about our expertise with regulatory studies, or to discuss your testing needs.

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