Food enzyme dossier preparation

Scientific and regulatory consulting services for food enzyme approvals in Europe


Before new food enzymes can enter the EU market, they must be included in the European Community list of authorised food enzymes. For that purpose, their safety for use in foodstuffs for human consumption must be assessed. The European Commission (EC) assesses new food enzymes based on dossiers that must be professionally filed.

Dossier preparation

Applications for food enzyme approval by the EC must be submitted through the electronic submission system, the e-submission food chain platform. An application consists of the following parts: 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, data required for risk assessment by EFSA, and data required for risk management. It is a collection of documents on the food enzyme, including study reports to support the risk assessment by EFSA. In the case of microbial enzymes, Biosafe is able to provide most in vitro and in silico studies, and we have an even larger assortment of microbial tests via our partners. We can coordinate studies and find the right partners for ones that require specific know-how. The EU Transparency Regulation applies to most applications. We take it into account when dossiers are prepared and submitted.

The summary of the dossier should follow the structure of the technical dossier, and it should clearly provide conclusions and a statement that the product complies with the conditions of the Regulation (EC) No 1332/2008.

Scientific and regulatory consulting services for food enzyme approvals in Europe



Here are the relevant food enzyme
regulations in a nutshell:

  • Regulation (EC) 1331/2008 of the European Parliament and of the Council establishes a common authorization procedure for food enzymes, food additives and food flavourings. It was implemented with Commission Regulation (EU) 234/2011, which was amended by Commission implementing Regulation (EU) 2020/1823 to introduce changes following the adoption of the Transparency Regulation.

  • Regulation (EC) 1332/2008 lays down criteria and requirements concerning the assessment and authorisation of food enzymes. Commission implementing Regulation (EU) 562/2012 amended Regulation 234/2011 with regard to specific data required for risk assessment of food enzymes.


Challenges in food enzyme authorisation

The authorisation process of food enzymes is not always straightforward. Regulations and guidance documents provide overlapping information, and it is not always easy to know, which guidance to follow and how, and the level of details one should provide. EU legislation has shortcomings in terms of new genomic techniques, which can be applied in the development of food enzymes.

Biosafe is an expert in the molecular characterization of food enzyme production strains and in the analysis of viable cells and DNA in the product. Besides laboratory analyses, we provide extensive consultation on the topic, including dossier preparation and application submission stewardship.



Our Regulatory Services for food enzyme dossiers and applications

  • Providing expert advice on identification of relevant legislation and guidance; developing regulatory strategy
  • Gap-analyses on customer data
  • Extensive scientific literature searches
  • Expert advice on potential hazards, such as undesirable substances and antimicrobial resistance
  • Preparing and stewarding food enzyme applications and dossiers for the scientific risk assessment by the European Food Safety Authority (EFSA) and approval by the European Commission
  • Providing assistance with submission of methods of analyses to the European Union Reference Laboratory

Contact Prof. Sirpa Kärenlampi or PhD Anne Ukkonen for all your food enzyme studies and dossier preparations.

Request a quote or ask for more information!

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