Time and money

Second-tier safety tests are relatively expensive and time-consuming. For instance, a sub-chronic oral toxicity study is likely to take 12 months, including reporting. While first-tier tests are rather predictive, second-tier tests should give a more definitive answer.

Basis for risk assessment

Taken together with data on consumer intake, second-tier testing should provide a basis for risk assessment. In some cases, for risk assessment, extension of the second-tier testing phase with further studies may be needed.

Services

Services provided for second-tier testing may include, for instance, one or more of the following:

• selection of testing laboratories (based on experience with over 2,000 contract studies in toxicology, analytical chemistry, nutrition, pharmacology and microbiology, from 1990 onwards)
• monitoring of contract studies (for instance: repeated-dose toxicity, stability testing)
• consulting with authorities
• consulting with external experts in order to address specific issues (for instance: consumer intake assessment, necessity to further assess digestibility, absorption and fate of a compound in the body, necessity to assess effects on fertility, on fetal development or on the immune, nervous or endocrine system, necessity to perform any other further testing)
• further defining and building elements of a dossier for registration
• adapting the tentative time schedule towards market introduction, if necessary
• estimating overall feasibility and chance of success
• providing a basis for further decisions