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What does the new guidance cover?
- Problem formulation and target substance characterisation
- Identification and evaluation of source substances
- Application of New Approach Methodologies (NAMs) to fill data gaps
- Conducting detailed uncertainty analysis
- Transparent reporting, conclusions and documentation
Key features:
- Incorporating modern tools such as NAMs (e.g. in silico and in vitro methods) to strengthen assessments
- Emphasis on reducing uncertainties and ensuring clarity
- Promoting systematic and well-documented read-across evaluations
While the microorganisms’ working context is being currently revised, the industry still emphasises the need for further improvements, highlighting:
- The need to improve the Biological Properties document
- The necessity to update validation rules and
- The importance of having a clear and consistent data entry format, including a clear distinction between how to manage “legacy dossiers” and newly submitted ones.
We’re committed to innovation in regulatory science and will be applying EFSA’s new guidance to enhance our costumers’ chemical safety assessments, reducing unnecessary testing while ensuring strong protection for consumers and the environment. Please do not hesitate to contact us for discussing how we can support you with tailored solutions in line with the latest regulatory requirements.
Click on the link to discover more about EFSA’s approach.
