Trace impurities have a long history of being tracked by EDANA members and are often subject to regulatory scrutiny, ongoing investigation by competent authorities, or general consumer concerns.
The core of the EDANA Stewardship Programme is the CODEX, which features:
Exposure-based risk assessment (EBRA) is the method of choice, as a scientifically sound approach using realistic exposure parameters. The guidance values do not affect the requirement to have the necessary safety assessments for individual products to comply with the General Product Safety Directive 2001/95/EC. The development of guidance values follows a tiered approach and may evolve over time if new scientific data and insights are available or regulatory limits are updated. A Scientific Review Panel provides expert advice on the EDANA Stewardship Programme CODEX. This Scientific Review Panel has also developed a compendium with key facts around AHPs, from supply to manufacture, safety evaluation, market surveillance, with focus on the CODEX guidance values and the analytical extraction methods.
The Stewardship Program allows companies to voluntarily go beyond current EU and national legislation and the participants are free to go beyond the established criteria of the Stewardship Program based on their specific quality assurance processes.