Dossier preparation

Scientific and regulatory consulting services for food and feed product approvals in the European Union

Regulations and guidance documents often provide rather general and sometimes also contradictory information. It is not always clear, which guidance to follow and what is the level of details required. Where should you direct your focus?

Biosafe provides consulting on dossier preparation and application submission stewardship for products such as food enzymes, novel foods, feed additives and GMO products.

Applications for the most food and feed product approvals by the EC must be submitted through the electronic submission system, the e-submission food chain platform. An application consists of:

  • an accompanying letter;
  • a technical dossier;
  • a detailed summary of the dossier,
  • and a public, non-confidential summary of the dossier.

The technical dossier consists of the administrative data, the data required for safety evaluation by EFSA, and the data required for risk management by the European Commission. It is a collection of documents on the product, including study reports to support the safety evaluation by EFSA. In the case of microbial products, Biosafe provides most in vitro and in silico laboratory studies, and we can provide an even larger selection of tests via our network of partners. We can find the right partners for you and coordinate the details of the studies. The dossier is compiled in accordance with the EU Transparency Regulation to protect the key assets of our customers.

We have services available according to your needs: starting from the review of data and regulatory support to the full application submission service. The service is available for food enzymes and additives, novel foods, and feed additives, including genetically modified strains and products.

Our services include:


  • Clarification of requirements or technical details (also with EFSA, EC or other authorities if needed)
  • Identifying data gaps
  • Notification of studies to EFSA
  • Data review
  • Literature reviews
  • Compiling the files in the form required by the EC and EFSA
  • Writing the dossier based on the data provided by the customer or obtained in the studies conducted or coordinated by Biosafe
  • Confidentiality claims as agreed with the customer
  • Submission of the application (including the dossier) to the EC, considering the Transparency Regulation
  • Regulatory support to the customer during the application process
  • Flexible allocation of tasks between the customer and Biosafe


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