Our work

Regulatory support

For the introduction of a new food or ingredient, it is essential to consider the regulatory environment applicable to its target markets at an early stage of product development. The European Union has established a whole set of new Regulations, Directives and Notes. Extensive expertise in legislation, enables TNO to fully assist clients in key matters concerning international regulatory procedures for newly developed food and feed products.

TNO has clear insight into the elements necessary for gaining approval for new products, new production processes, or new applications in food supply. Furthermore, TNO is able to advice on the possible consequences of changes in current legislation for existing products. We have a sound record of successful involvement in European regulatory procedures. These include the following regulatory frame-works:

  • Functional Foods and Ingredients
  • Novel Foods and Ingredients
  • Genetically Modified Foods, Feeds and Ingredients
  • Food Supplements
  • Foods for Particular Nutritional Uses (FPNU, Dietary Products, Sports Nutrition and Clinical Nutrition)
  • Nutrition Claims and Health Claims

Also, fruitful co-operations have been built up with external parties, who can be called upon when appropriate assistance is sought from reputed regional business partners for tasks outside the EU, like US GRAS notifications. In this matter regional differences are taken into account to develop an optimal, truly international regulatory strategy.

Integrated regulatory support

TNO’s value as a partner in regulatory support is strongly enhanced by offering safety and/or efficacy testing, scientific evaluation and dossier preparation in an integrated fashion and by covering regulatory aspects from the earliest stages of product development. Up-to-date research services are available including chemical, microbiological, technological, nutritional, and toxicological testing and assessment. We closely cooperate with our clients in managing projects in which technological, scientific and regulatory issues are dealt with in a flexible manner.

Services

Regulatory consultancy at all stages of product development:

  • Advice on regulatory feasibility, strategy and consequences of changes in legislation (authorization or notification)
  • Preparation of regulatory dossiers for pre-market approval, post-market inspection or marketing support
  • Preparation of product specifications and labelling information
  • Preparation of expert opinions and position papers on positive health effects
  • Product safety evaluations: evaluation of scientific literature, safety studies and dossiers, production processes, product specifications
  • Peer review of statements and dossiers, second opinions
  • Contacts with authorities and other relevant bodies
  • Overall (multidisciplinary and/or multinational) project management and strategy

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