Gradient

Global Regulatory Compliance

REACH

Overview
Example Projects
Experts

Overview

Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) is a ground-breaking European Union (EU) legislation that imposes stringent chemical registration and notification requirements on companies manufacturing or marketing products in the EU.  With strengths in chemical exposure, toxicity assessment, and information management, as well as our in-depth chemistry knowledge, Gradient supports clients comply with this evolving and complex legislation.  We can also assure confidentiality while managing your product and chemical information in communications with suppliers up and down the supply chain.

Example Projects

REACH Pre-registration Support

Full Description

For a US manufacturer completing preregistration in the EU, Gradient determined if certain substances were exempt from REACH based on whether they were "intended for release." We also evaluated the notification requirements for substances of very high concern (SVHCs) contained in our client's products.

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.

Cancer Classification of PHMB

Full Description

Gradient evaluated data from cancer and genotoxicity bioassays to determine whether the biocide polyhexamethylene biguanide (PHMB) has a linear or nonlinear mode of action (MOA) for carcinogenesis. We made a recommendation on how PHMB should be classified with respect to carcinogenicity according to EU criteria.

Environmental Safety Review of Personal Care Product Ingredients

Full Description

Gradient prepared a standardized screening procedure for evaluating the ecological risks of ingredients in products such as skin lotions and cleansers. Using QSAR models and toxicological and physical-chemical information from databases such as ESIS/IUCLID, we developed derived no effect levels (DNELs) to assess the environmental safety of the product's ingredients.

Data Mining of Exposure Scenarios for EIS-ChemRisks

Full Description

Gradient assisted the European Commission by mining data from US EPA-sponsored exposure assessments for entry into the EIS-ChemRisks databases used for REACH. The information included consumer product-related exposure scenarios along with other factors necessary for exposure and risk calculations.

REACH Training for Foreign Manufacturers

Full Description

For a consumer products company, Gradient developed strategies and training materials to educate its Chinese manufacturers on how to comply with REACH. We incorporated industry-relevant examples to clarify REACH requirements. The client used our training materials to advise foreign suppliers of its REACH compliance obligations, which were necessary for the client to fulfill so they could continue exporting products to the EU.

REACH Compliance Plan

Full Description

Gradient designed a REACH compliance strategy for a major consumer products company, which included communicating with suppliers, developing of submission timelines, completing and submitting of required forms, implementing of systems to maintain confidentiality and protect intellectual property, and establishing of help desk support for Safety Data Sheets.

Experts

Eric M. Dube Read Bio

Tom A. Lewandowski Read Bio

Ari S. Lewis Read Bio

Lorenz R. Rhomberg Read Bio

Manu Sharma Read Bio

Tim Verslycke Read Bio