Others – Safety Assessment of Food Products and Additives
Safety Assessment of Food Products and Additives
At CRONET Sagl, we provide scientific and regulatory consultancy services focused on the safety assessment of ingredients, additives, and other substances intended for food use. Leveraging our expertise in the evaluation of bioactive substances and a strong understanding of international regulatory frameworks, we support companies in bringing safe and compliant products to market.
Toxicological and Risk Assessment
We conduct comprehensive toxicological profiling of food ingredients and additives, evaluating parameters such as mutagenicity, carcinogenicity, and systemic toxicity. Our services include the critical review of preclinical studies to verify compliance with international standards (OECD, EFSA, FDA), as well as predictive risk assessments using advanced in silico tools like QSAR and read-across models.
Regulatory Support and Dossier Preparation
We assist in preparing and submitting regulatory dossiers for novel food substances, additives, flavourings, and enzymes, ensuring full alignment with EU regulations (e.g., Regulation EC 1333/2008), FDA guidelines, and other jurisdictional requirements. We also support clients in communicating effectively with regulatory authorities.
ADME and Bioavailability Evaluation
To understand the biological behavior of a substance, we evaluate its absorption, distribution, metabolism, and excretion (ADME). Our approach combines in vitro testing with in silico modeling to provide scientifically sound predictions of how substances behave within the body.
Impurity and Contaminant Assessment
We help identify and assess potential contaminants such as heavy metals, process residues, microplastics and natural toxins. Our risk assessment process evaluates the chemical safety implications of these impurities, supporting data-driven decisions and regulatory readiness.
Testing Strategy and Study Design
We guide companies in developing tailored testing strategies for safety evaluation. This includes support in selecting qualified GLP-certified laboratories and overseeing study execution to ensure data integrity and regulatory acceptance.
Labelling and Claims
Our consultants ensure that product labels comply with EU, US, and Swiss regulations. We also assist in the validation and submission of nutritional and health claims, supporting product positioning with scientifically sound and legally compliant messaging.
Why Choose CRONET?
Multidisciplinary Expertise
Experience in toxicology, food safety, and regulatory science.
Regulatory Know-How
Proven success with EFSA, FDA, and Swissmedic submissions.
Integrated Support
From early substance evaluation to final dossier submission.
Scientific Rigor
Every assessment is grounded in internationally recognized methodologies.