Almost every region of the world has a legal framework and a statutory body that regulates the manufacture, importation or marketing of chemicals.
Many regulatory endpoints are based on harmonized testing methodologies, although their application can be subtly different across regulators. In addition, the interpretation and usage of the resulting data can vary. A good example of this is the comparison between the regulatory approaches of the EU/ECHA and the US/EPA. EU-REACH is a hazard-based system, while the TSCA is a risk-based system. Therefore, in these jurisdictions, the data and regulatory arguments supporting the same chemical require different tactics.
Navigating your chemical onto the global market can be challenging. You need a broad and deep understanding of different regulations and strategic insight to help you leverage your data in the most efficient and cost-effective manner. You also need to ensure that your chemical’s regulatory journey to approval is as rapid and smooth as possible. This means anticipating regulatory hurdles and having clear mitigation plans from the start.