The new explanatory note is in addition to existing guidance notes for applicants submitting a technical dossier for the safety evaluation of a food enzyme, prior to its authorisation and subsequent inclusion in the relevant EU legislation.
However, it is a step that seems to suggest the original guidance did not go far enough to explain what exactly is expected of applications.
Referring to the explanatory note, EFSA states: “The purpose is to give examples of scientific data needed for risk assessment established in the CEF (Food Contact Material, Enzymes, Flavourings and Processing Aids) Panel Guidance on the submission of a Dossier on Food Enzymes.
“It should be stressed that the explanatory note is not replacing but complementing the CEF Panel Guidance.”
An enzyme is defined as a protein that accelerates or promotes a biochemical reaction. Enzymes may be added to food to perform a technological function in manufacturing, processing, preparation, treatment, packaging, transport or storage.
Food enzymes can be used, for example, in certain cases as alternatives to food additives in order to improve the texture, appearance or nutritional value of food, as well as helping in certain food production processes, such as cheese making and beer brewing.
All food enzymes currently on the EU market, as well as new food enzymes, are subject to safety evaluation by the European Food Safety Authority (EFSA) and approval via a Union list.
The explanatory note published by EFSA says that a complete technical dossier is requested for each food enzyme regardless of the source material.
It adds: “This holds especially true for food enzymes produced by genetically modified micro-organisms (GMM).
“Generally, grouping of dossiers on the basis of production organisms and/or food enzyme is not acceptable.
“Data need to be specific for the food enzyme under evaluation, especially compositional data (including impurities), TOS (Total Organic Solids), specific activity (enzyme activity per amount of TOS), production method (including characterisation of the strain and down-stream processes).”
It also highlights that food enzymes tested in toxicological studies must be demonstrated to be representative of the commercial product and that evidence of the representativeness should be provided in the dossier.
The note then includes a long list with, on one side, the requirements from the CEF panel guidance while the column opposite contains explanations, examples and comments on this.
In December 2008 the regulations on food enzymes and on a common authorisation procedure for food additives, food enzymes and food flavourings of the European Parliament and the Council were adopted. Both Regulations entered into force on 20 January 2009.