Gradient

Global Chemical Registration & Notifications

Overview
Example Projects
Experts

Overview

Gradient has the chemistry, exposure, and toxicology expertise to help companies navigate and fulfill registration requirements around the world. Through well-designed data compilation, management, and analysis, we can minimize the time, testing, and resources needed to bring a new chemical to market in multiple jurisdictions. Gradient's activities in this area include overseeing physiochemical and toxicological testing, conducting hazard assessments in accordance with the Globally Harmonized System (GHS) of Classification and Labeling (accounting for country-specific requirements), and characterizing potential human health and ecological risks under various chemical use scenarios.

Gradient has teamed up with The REACH Centre to provide a comprehensive suite of sustainable solutions for chemical compliance and product stewardship. For more information on our joint international experiences, see listed countries below.

Gradient chemical registration and notification experience with partners, including The REACH Centre: Australia, Canada, China, European Union, Norway, Japan, South Korea, Malaysia, Taiwan, Thailand, United States, Angola, Brazil, New Zealand, Algeria, Argentina, Belgium, Chile, Columbia, Egypt, India, Israel, Kuwait, Mexico, Russia, Switzerland, Tunisia, Turkey.

Example Publications:

Zhang, J. March 28, 2017. "Cross-jurisdictional Considerations for Avoiding Animal Testing When Evaluating Chemical Toxicity." Presented at the Society of Chemical Hazard Communication Spring 2017 Meeting, New Orleans, LA.

Meijer, S; Gioia, R; Zhang, J. October 8, 2015. "REACH Overview with Special Considerations for REACH 2018." Presented at Gradient's Reach 2018 Webinar.

Kneeland, J; Sharma, M; Lewis, A. October 2014. "Global Chemical Registration Strategies for Oilfield Chemicals." Presented at the 21st International Petroleum Environmental Conference, Houston, TX. 30p.

Kneeland, JM; Mehler, WT; Lewis, A; Sharma, M. 2013. "Strategies for Registering Polymers of Low Concern in Multiple International Markets." Presented at the Society of Environmental Toxicology and Chemistry (SETAC) 34th Annual Meeting, Nashville, TN, November 22-23.

 

Example Projects

REACH Registration of a Complex UVCB Substance

Full Description

Gradient prepared a REACH registration dossier for an Annex IX tonnage level, complex UVCB substance. We devised and managed a cost effective testing plan that met all characterization, physical/chemical, human health and ecotoxicity testing requirements. We re-evaluated the hazard classification of the substance based on new testing data, completed an exposure assessment and produced the Chemical Safety Assessment and Report.

Chemical Registration in Asia-Pacific Countries

Full Description

Gradient coordinated the preparation and notification of technical dossiers for several chemicals under various regulatory guidelines in a number of Asia-Pacific countries, including Japan, China, Thailand, Australia, and New Zealand. The effort involved input on physiochemical properties, chemical hazard profiles, and expected exposures to workers, the public, and the environment.

US TSCA Chemical Registration and Reporting

Full Description

Gradient provided technical expertise to fulfill regulatory requirements under the Toxic Substances Control Act (TSCA). We developed questionnaire templates to document exemptions and gather necessary data for premanufacture notices (PMNs), and prepared exemption and PMN documentation. We utilized a database of product and chemical toxicity studies to prepare a list of studies that may be subject to TSCA Section 8(e) reporting requirements. Our expertise in read-across and complex chemistries, thorough analysis of exemptions, and careful documentation helped the client avoid unnecessary PMNs and create sustainable compliance strategies.

Toxicology Support for a Significant New Use Notification under TSCA

Full Description

Gradient evaluated a US EPA Significant New Use Rule (SNUR) for a chemical of interest. We reviewed toxicity data for the chemical, developed criteria for the selection of chemical surrogates to inform the toxicity assessment, and used modeling-based approaches to characterize chemical bioavailability. The collective toxicity dataset and in silico models were used to evaluate the need for SNUR toxicity tests.

Review of Lead Toxicity and Epidemiology Studies for IUCLID Submission

Full Description

Gradient conducted a comprehensive assessment of lead toxicity for children and adults, summarizing epidemiology, reproductive toxicology, and pharmacokinetic studies and entered our findings into IUCLID 5 as part of the necessary dossier for lead registration under REACH.

Experts

Jessie M. Kneeland Read Bio

Ari S. Lewis Read Bio

Manu Sharma Read Bio

Caroline B. Tuit Read Bio

Jiaru Zhang Read Bio