EFSA Technical Meeting – Latest Updates on Food Enzyme Applications

Posted 1 March, 2016

Based on recent experience of food enzyme dossiers received, EFSA is drafting a statement on exposure assessment for food enzymes, due to be published between June and September 2016. The objective of the technical meeting was to share and explain EFSA’s updated approach and to increase collaboration with applicants with the aim of achieving a more transparent evaluation process.

Food enzyme registration deadlines and timelines

There is no legal deadline to set up the EC register of food enzymes and the timing will completely depend on the quality of the submitted dossiers. The main constraints are currently related to the incompleteness of dossiers and accompanying  reports, non-harmonised terminology (food processes, food categories) and lack of analytical data (“empty statements”).

Guidance documents

The stakeholders gave a presentation on the existing scientific and administrative EFSA guidance documents together with explanatory notes on the assessment of food enzyme applications. This is a long-term ongoing project, essential for dietary exposure assessment, and will need the help of both applicants and manufacturers. An EFSA guidance document explaining in detail how to use the consumption database for the dietary exposure assessment database can be found here.

EFSA offered further clarification: in order to waive the exposure assessment, strains need to be properly characterized (identification, toxicity/pathogenicity, AMR) and have QPS status, which is granted by EFSA based on internal information reviewed twice a year.

Reasons for a new statement on exposure assessment of Food Enzymes

Based on experience acquired, the CEF Panel considered the case for evaluating exposure to enzymes using more realistic scenarios and applying a tiered approach. The CEF Panel has taken note of the difficulty of applying the ‘budget’ method to food enzymes in general as they are added during the processing of food and food ingredients. EFSA recognises that the assumptions underlying the ‘budget’ method have been examined for food additives but not for food enzymes.

Overall, EFSA’s challenges and objectives in order to increase transparency and collaboration with applicants and manufacturers are as follows:

  • Harmonisation of food processing terminology, food and substrate categories.
  • Use of more realistic conversion factors for dietary exposure calculations.
  • The need to develop a model for intake of food enzymes using FAIM (Food Additives Intake Model) as a model.
  • Developing a scientific statement for the refined exposure assessment of food enzymes.