Food

The feasibility study is a document that provides a preliminary analysis of your product/ingredient and draws the path to meet regulatory and scientific requirements to reach client goals. It allows us to respond efficiently to your requests and provides you with an overall picture of time and cost (project planning and timeframe). It is made through what we call "data gap analysis". Feasibility studies are vital in defining the novel food status and registration of new ingredients and new food contact materials.

The data gap analysis is the best way for Chemsafe and the Clients to understand whether the available information is enough to respond to a specific regulatory or scientific challenge. Customers are unsure whether what they have is sufficient and what exactly they need to comply with regulations. The data gap analysis is the key to understanding what tests/analyses might be missing or need to be implemented to comply with the regulations' requirements.

Based on the Three Rs principle (Replace, Reduce, Refine), for more ethical use of animals, every safety evaluation on substances or mixtures (foodstuff) must start from extensive bibliographic research. Chemsafe can provide its clients with this service.

The Novel Food activities can be divided into
- Complete Novel Food procedure (Regulation (EU) 2015/2283)
- Nove Food status determination (Consultation process - Regulation (EU) 2018/456)
- Traditional food from third countries (Regulation (EU) 2015/2283)
- Modification of an already authorized novel food (e.g., an extension of use: new categories)
A gap analysis is carried out as the project's first step. Additional information may be needed to meet the admissibility criteria of the Novel Food application. The resulting missing information and suggestions are shared in a Feasibility Study with the client.
The Novel Food dossier is built and submitted to the European Commission (EC) platform. The dossier narrative includes an extensive literature review, the toxicological risk assessment and the estimated intake scenario.
If the EC and the European Food Safety Authority (EFSA) require extra information, post-submission activities and support will follow.

Regulation (EC) No 1332/2008 on food enzymes
Regulation (EC) No 1333/2008 on food additives
Regulation (EC) No 1334/2008 on food flavouring
Regulation (EC) No 1331/2008 establishing a common authorization procedure
A gap analysis is carried out as the project's first step. Additional information may be needed to meet the admissibility criteria of the specific food ingredient application. The resulting missing information and suggestions are shared in a Feasibility Study with the client.
The dossier is built and submitted to the European Commission (EC) submission platform. The dossier narrative includes an extensive literature review, the toxicological risk assessment and the estimated intake scenario.
If the EC and/or the European Food Safety Authority (EFSA) require extra information, post-submission activities and support will follow.

The toxicological evaluation is essential to all foodstuffs. It can be the case of internal needs, for example, for using processing aids or assessing contaminants or Non-intentionally added substances (NIAS). Likewise, authorities can request an extra toxicological evaluation post-submission or under certain circumstances. At Chemsafe, our ERTs® (European Registered Toxicologists) verify and sign all our toxicological reports.

Experimental studies (in-vitro, in vivo) are frequently necessary to assess substances' potential toxicity and help the assessor perform a risk assessment. Chemsafe can assist you during the testing phase thanks to their toxicological and scientific background and the vast laboratory network and partnerships.

"In silico" methods are routinely used to assess the mutagenic potential of chemicals under several regulatory regimes. These models investigate molecular behavior to accelerate, save or replace in-vitro studies. The systems simulate human biology thanks to extensive databases (e.i. quantitative SAR (QSAR) methods). Prediction for Toxicology (DEREK Nexus), Genotoxicity (SARAH Nexus), Metabolism (METEOR Nexus) and Degradation Products (ZENETH Nexus) are available at Chemsafe. Interpretation of results and Expert Reports 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. As such, it requires Pre-Market approval by the FDA unless the substance is Generally Recognized as Safe (GRAS). Chemsafe can support you in determining the GRAS status for substances intended to be marketed in the USA as food ingredients.

Chemsafe supports its clients in every step. We care about your success.