The feasibility study is what Chemsafe proposes at the very first stage of almost every project. The feasibility study is a document that provides a preliminary analysis of your product/ingredient. It allows us to respond efficiently to your requests and provides you with an overall picture of time and cost (project planning and timeframe) to reach your goals. It is made through what we call “data gap analysis”. Over the years, costumers have proven to be satisfied with this kind of service because it is perceived as an open table for discussion. In our experience, a preliminary evaluation allows a better definition of the Regulatory Strategy to follow, preventing wasted time and money.
Where feasibility studies are key: defining the Novel Food status, registration of new ingredients and new food contact materials, preliminary evaluation of a GRAS status.
The data gap analysis is the best way for you and for us to understand whether you have all the necessary to reach your goals. More and more often customers are not sure whether what they have is sufficient and what exactly they need to comply with regulations. The data gap analysis is the key to understand what kind of tests/analysis might be missing or need to be implemented to be compliant with the regulations’ requirements.
Based on the information provided by the manufacturer, Chemsafe prepares your dossier and provides support in the follow-up stages after submission. Dossier can be revised, or some parts implemented by Chemsafe.
Based on the Three Rs principle (Replacement, Reduction and Refinement), for more ethical use of animals, every safety evaluation on substances or mixture (foodstuff) must start from an extensively bibliographic research. Chemsafe can provided its clients with this service.
The toxicological evaluation is an important part of all the foodstuff assessment. It can be asked by authorities after dossier submission or at circumstances. All our toxicological expert reports are verified and signed by our ERTs® (European Registered Toxicologist). Toxicological opinion can be released on specific matters upon a case-by-case evaluation.
The safety profile evaluation often requires some experimental studies. Guidance from the EFSA and Regulations released by the EU commission on foodstuff, despite supporting the Three R’s principle, often require experimental studies in order to protect public health from toxic substances. Chemsafe can assist you during the testing phase thanks to our vast and versatile laboratory network and partnerships. In our experience, the best pathway is marked by the integration of literature review with the experimental studies.
“In silico” is an expression meaning “performed on computer or via computer simulation” in the world of biological experiments. “In silico” models are used to virtually investigate molecular behaviour in order to accelerate and save in-vitro studies. The systems simulate human biology thanks to extensive database (e.i. quantitative SAR (QSAR) methods). Chemsafe provides “in silico” prediction for Toxicology (DEREK Nexus), Genotoxicity (SARAH Nexus), Metabolism (METEOR Nexus) and Degradation Products (ZENETH Nexus). Interpretation of results and Expert Report by our ERTs® (European Registered Toxicologist) can be included in this service.
The Code of Federal Regulations (CFR) in the United States declares that any substance intentionally added to food is a food additive and as such it requires a Pre-Market approval by FDA unless the substance is Generally Recognized as Safe (GRAS). Chemsafe, with its Panel of qualify experts, can give you support in the determination of the GRAS status for substances intended to be marketed in the USA as food ingredient.
Chemsafe support its clients in every steps. We care about your success.