Overview

Handling Chemicals in a way to minimize the risk to human beings and the environment is not an isolated local task. Companies marketing chemicals internationally, will have to adhere to specific regional regulations for the safe use of the products in their target markets. Certain factors need to be considered and frameworks like GHS, and numerous country specific approaches play a key role for the risk management of chemicals Regulatory compliance.

Freyr with its in-house Regulatory team and global network of affiliates keeps track of the Regulatory developments concerning global chemicals notification/registration and supports its clients with the most suitable strategy for chemicals Regulatory compliance in the targeted markets.

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Freyr Expertise

  • Supply-Chain Regulatory Compliance, Formulation Review and INCI List Generation
    • Retrieval of Raw Materials (RM) Source Documents (RM questionnaire, MSDS, Product specification, CoA etc.) and Compliance Assessment, Regulatory Formulation Review, INCI list Generation
    • Set up process (Document Management System) for periodic update and compliance management 
  • Regulatory Pathway And Market Access Approvals
    • Regulatory guidance to build a crucial framework supporting product development phase to launch while determining the fastest and/or greatest value path to register/notify product
    • Chemical Notifications for compliance (CLP, Poison Center, Biocides, Detergents, Home Care Products etc.)
  • Chemical Toxicological Assessment
    • Toxicological profiling of chemicals/ botanicals as per current scientific standards and alternate assessment approach (Read across, QSAR Predictions, High-Throughput Study, benchmark dose etc)
    • Exposure assessment (human health and environment), Derivation of Permitted daily exposure (PDE) and occupational exposure limits (OELs)
    • Establishing occupational exposure bands (OEBs)
  • Scientific Assessment Reports and Position Paper
    • Endocrine Disruption Assessment in line with OECD conceptual framework, EFSA/ECHA Guidance on identifying endocrine disruptors
    • Claim substantiation for food and cosmetics, Development of Product Data Sheet, Writing scientific reports to defend / support changes in product hazard identification/classification/risk assessment
  • Data Scouting Services and Regulatory Intelligence
    • The data scouting team support significant product value chain from Ideation, Regulatory strategy to product life cycle management for wide range of consumer products including Cosmetics, Biocides / Pesticide, Food, OTC drugs etc.
  • EU REACH and EU CLP Registration/ Dossier Update
  • Hazard communication (Safety Data Sheet / Label) Development/ Review/ Updates
  • Raw Materials Document Management System (RM-DMS)
  • End-to-end Chemicals Regulatory Compliance
  • Chemical Safety Consulting

Freyr Advantages

  • Cost-effective package on Regulatory guidance for drafting product wise Regulatory pathway/ framework for market access
  • Qualified team of experts with hands-on experience across all categories of chemicals notification/registration
  • Support for region-specific Regulatory complexities
  • Extensive partner network across the globe
  • Strong relationships with different Regulatory Authorities
  • Structured approach to ensure quick market access

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About Chemicals Regulatory Services

csra.freyrsolutions.com