Studies may be needed to evaluate whether food or feed ingredients could have negative effects on the health of animals, humans or the environment. Deciding whether a study is necessary for safety reasons or can be waived requires a scientific approach to regulatory affairs.
We offer detailed gap analyses to identify regulatory data requirements and assess the completeness and suitability of existing data. This includes a thorough review of available documentation for compliance with current EU and international regulatory standards. Based on the findings, we define missing information and develop tailored study plans to ensure the successful completion of food and feed additive, enzyme, flavouring, or health claim applications. Our approach ensures efficiency, scientific rigor, and alignment with regulatory expectations from the outset.
We provide end-to-end support in the design and execution of safety and efficacy studies for target animal species, consumers, and users, ensuring full compliance with regulatory requirements. Our services include defining study objectives, drafting scientifically sound protocols, sourcing competitive offers from reputable and GLP-compliant study facilities, and overseeing the study process. We monitor study progress, assess data quality, and interpret results to ensure that the final outputs meet the expectations of regulatory authorities and support a successful application.
We provide expert support in the design, monitoring, and evaluation of in vitro and in vivo toxicity studies to demonstrate the safety of food and feed substances in compliance with international regulatory standards. Our expertise includes a full range of genotoxicity testing, covering both in vitro and in vivo methods such as the Ames test, micronucleus assays (including liver and bone marrow), Comet assay, and the transgenic rodent (TGR) gene mutation assay. In addition to genotoxicity, we assist in the planning and interpretation of acute, sub-chronic, chronic, and reproductive toxicity studies. Each study is designed to meet the specific requirements of the substance and the regulatory framework, ensuring a scientifically robust and defensible safety assessment. We collaborate closely with contract research organizations (CROs) and maintain oversight throughout the study lifecycle to ensure data quality and regulatory alignment.
We conduct scientific assessments of the environmental fate of substances, including absorption, distribution, metabolism, degradation, and excretion (ADME) pathways. Our services cover the evaluation of potential environmental risks associated with the use of food and feed additives, including the design and monitoring of required ecotoxicological and environmental fate studies. We also perform environmental exposure calculations in line with current EFSA and OECD guidance, ensuring that all assessments meet regulatory requirements and support a robust safety evaluation.
If you would like some support to evaluate whether studies are required or would like assistance in selecting a testing facility and planning a compliant trial, please feel free to contact us.
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