Assessment and authorization of food and feed products

Regulatory research beyond standard toxicology

© artursfoto/Adobe Stock
At Fraunhofer ITEM, we support our clients in all scientific and regulatory issues. This includes the evaluation of all data available and preparation of dossiers.
© vaitekune/Adobe Stock

The safety of food and feed products is top priority to sustain and improve human health and animal well-being.

In collaboration with the European Commission, the European Food Safety Authority (EFSA) assesses these products before they can be authorized for the European market. The following product categories are distinguished: food ingredients, feed additives, food contact materials, genetically modified organisms (GMOs), nutrition, and biological hazards.

Authorizations in the context of food and feed require dossiers to be submitted to the competent authority. Comprehensive data is required for the preparation of substance and product dossiers and their assessment in accordance with the relevant regulation is complex. Based on our interdisciplinary, in-depth expertise and many years of experience, we support you in all scientific and regulatory issues. In addition to evaluating the available data, we cooperate with you to develop a tailor-made regulatory strategy, assess potential residues and metabolites of concern, prepare dossiers including risk assessments and expert statements, and submit and defend dossiers.

Our aim is to identify risks to health and the environment and to reduce these.

Our services

We support you in the authorization of food and feed ingredients and products.

Scientific and regulatory advice

 

  • Evaluation and assessment of available data and data requirements
  • Development of regulatory strategies and support in the implementation of regulatory requirements
  • Development of testing strategies and commissioning and monitoring of required experimental studies
  • Toxicological and ecotoxicological assessment based on experimental data, quantitative structure-activity relationships ((Q)SAR) and read-across of the substances including GMOs, production processes, and all by-products and residues
  • Exposure assessment and risk assessment with regard to consumers
  • Dossier preparation and submission
  • Communication with the authorities

Additional specific services in the different product categories

Food ingredients

Our service: 

  • study monitoring (e.g. analyses in the food product, storage stability)

 

in the categories:

  • food additives
  • food enzymes
  • flavorings
  • smoke flavorings
  • vitamin and mineral resources added to food products

 

Nutrition

Our services: 

  • Research of the history of a food/distinction of a novel food
  • Scientific evidence of nutrition and health claims
  • Evaluation of the production process including all by-products and residues

 

In the categories: 

  • nutrition and health claims
  • novel foods
  • baby foods
  • food allergies

Additives in animal feed

  • Exposure assessment and risk assessment with respect to animal health

Food contact material

  •  
  • Assessment of migrating substances

Biological hazards

Our services: 

  • Scientific evidence of sufficient efficacy
  • Assessment of potential development of resistance
  • Risk assessment of animal by-product processing

 

In the categories: 

  • processing of animal by-products
  • decontaminators for animal products

Miscellaneous services

  • Training courses
  • Development of models for exposure and emission evaluation
  • Assistance with strategic decisions and product development
  • In-house exposure measurements and analytics

Processing aids

  •  
  • Identification of processing aids and differentiation from food additives

Your contact for the assessment and authorization of food and feed products

Ariane Zwintscher

Contact Press / Media

Ariane Zwintscher

Head of Department of Regulatory Issues

Phone +49 511 5350-312