Dossier preparation in the EU

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

Navigating the complex terrain of EU regulations and guidelines for food and feed product approvals can be daunting. The broad and occasionally conflicting information provided in regulations and guidance documents often raises questions about the appropriate level of detail and focus necessary for successful application submission.

At Biosafe, we specialize in offering expert consulting services for the preparation and submission of dossiers required for the approval of food enzymes, novel foods, feed additives, and GMO products within the European Union.

Applications for food and feed product approvals must be meticulously compiled and submitted via the e-submission food chain platform. A complete application includes:

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

The technical dossier integrates administrative and safety evaluation data required by EFSA, alongside risk management data demanded by the European Commission. It encompasses a comprehensive set of documents and study reports that underpin the safety evaluation of the product by EFSA.

For microbial products, Biosafe excels in conducting essential in vitro and in silico laboratory studies, extending our capabilities through a network of partners to offer a broader spectrum of tests. We can facilitate partner selection and study coordination, compiling the dossier in strict adherence to the EU Transparency Regulation to safeguard our clients' key assets.

Our service spectrum ranges from regulatory support and data review to full application submission, catering to food enzymes, additives, novel foods, and feed additives, including GMO strains and products.

Our services include:


  • Clarification of regulatory requirements and technical specifics, including liaison with EFSA, EC, or other authorities as necessary
  • Identification of data gaps
  • Notification of studies to EFSA
  • Comprehensive data and literature review
  • Compilation of files according to EC and EFSA standards
  • Dossier creation based on client-provided data or studies conducted/managed by Biosafe
  • Management of confidentiality claims in alignment with client agreements
  • Dossier submission to the EC under the Transparency Regulation framework
  • Continuous regulatory support throughout the application process
  • Flexible task distribution between the client and Biosafe to meet individual needs


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