Other Global Chemical Regulations
Most countries regulate the chemicals they manufacture, import and use, to protect the environment and the health of animals and people. The specific regulatory frameworks vary with jurisdiction with many based on EU REACH.
Wherever there is a chemical control legislation, Covance has been active in supporting clients and navigating their chemical through it.
- Global network of in-country regulatory scientists
- Experience in a vast array of regulatory application submissions to chemical regulators across the globe
- Joined-up regulatory thinking that maximizes the use and value of your core data dossier through strategic tailoring for each regulator
Understanding the unique needs of each global regulation
Most global chemical regulations have similar endpoint and data requirements, but there are specific and nuanced differences. For example, not all jurisdictions accept QSARs in place of in vitro data. Some jurisdictions, like China, insist on having environmental studies conducted locally on local organisms. It can therefore be challenging to work out how to replicate a chemical registration from one jurisdiction to others.
You also need to consider the chemical and regulatory approach. For example: is it pre-supply, is the focus based on hazard or risk assessment, what is the scope of substances included in the regulations (e.g. polymers versus monomers)?
Supporting global regulatory submissions strategically
With insight from across the globe, our regulator scientists can support your chemical submissions strategically. A strategic approach minimizes the number of repeat studies, maximizes use of core data and reduced time to market.
A track record of cost-effective and timely submission to global chemical regulators
A network of regulatory scientists on the ground, fluent in local languages and with in-depth regulatory knowledge, ensures a targeted approach. From global notification or regional submissions, we have worked in many jurisdictions worldwide including:
- Canada (Canadian Environmental Protection Act - CEPA)- including Ontario
- China (MEP Order 7)
- Japan (Chemical Substance Control Law)
- South Korea (K-REACH)
- New Zealand