EFSA has completed the first safety assessment of a food enzyme as part of a plan by European Union decision-makers to set up an authorised list of these substances. This scientific opinion marks the start of an important new chapter in the Authority’s risk assessment work, with hundreds of assessments of food enzymes set to follow over the next few years. Given that enzymes have long been used in food production, why is it only now that EFSA has been tasked with evaluating these substances in a systematic way? Dr Fidel Toldra, an expert member of EFSA’s Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), explains.
Dr Fidel Toldra
Expert member of EFSA’s Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)
What are enzymes?
F.T.: Enzymes are protein molecules that are present in all living things, including the human body. They play an essential role in food processing by speeding up and targeting chemical reactions.
Where do food enzymes come from?
F.T.: Food enzymes are obtained from plants and animals or by fermentation from micro-organisms. They are used to perform technological functions in food production, such as converting starch into sugar during beer production or contributing to curd formation in the production of cheese.
Why is EFSA only now beginning a systematic evaluation of food enzymes?
F.T.: New legislation came into force in 2009 to harmonise the use of food enzymes across the EU. Before then, food enzymes, other than those used as food additives, were not regulated at EU level. France and Denmark were the exception and the only Member States that required the evaluation of enzymes used as processing aids prior to their use in the manufacture of food. The EU law introduced a common approval procedure for food enzymes, food flavourings and additives.
What type of food enzymes does the regulation cover?
F.T.: The law applies to enzymes that perform any technological function in the manufacture, processing, preparation, treatment, packaging, transport and storage of food. It includes food enzymes used as processing aids. But it does not include food enzymes intended for human consumption, such as those added for nutritional purposes.
What will this regulation mean in practical terms?
F.T.: This legislation aims to establish a future EU list of food enzymes. As a first step, producers need to submit applications for the authorisation of new and existing enzymes used in foods – including those previously assessed by authorities in France and Denmark. The European Commission has set a deadline of 11 March 2015 to receive these applications. EFSA will carry out safety evaluations of the food enzyme dossiers before they can be considered for inclusion on the list of approved food enzymes by EU decision-makers.
How many food enzyme applications will EFSA be asked to assess?
F.T.: Following discussions with industry and the Commission, we estimate that EFSA’s CEF Panel will carry out safety assessments on around 300 food enzyme applications in the coming years.
What type of information do applicants need to provide to allow EFSA to carry out a risk assessment of a food enzyme?
F.T.: EFSA has developed a guidance document and accompanying explanatory notes that specify the type of data and studies that industry should provide for the safety assessment of a food enzyme application. This includes the description of chemical composition, properties, uses and use levels, as well as toxicological tests.
- Guidance of the Scientific Panel of Food Contact Material, Enzymes, Flavourings and Processing Aids (CEF) on the Submission of a Dossier on Food Enzymes for Safety Evaluation 
- Explanatory Note for the Guidance of the Scientific Panel of Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) on the Submission of a Dossier on Food Enzymes
Can food enzymes producers continue to put their existing products on the market while this assessment and authorisation process is ongoing?
F.T.: Yes, until a full EU list is established the current national rules on the use and marketing of food enzymes will apply. The establishment of this list by the European Commission will take place in a single step after EFSA has delivered opinions on all food enzyme applications received by the 2015 deadline.
Tell us about the food enzyme assessment published by EFSA.
F.T.: The application relates to a type of food enzyme known as a xylanase. This xylanase is used in starch processing, the distillation of alcoholic drinks and baking processes. It is produced through the fermentation of a strain of Aspergillus oryzae which has a long history of safe use. However, Aspergillus is also known to produce undesirable compounds called mycotoxins as secondary metabolites. The Aspergillus used to produce this food enzyme has been genetically modified to prevent or reduce the formation of these unwanted products. EFSA has conducted a full risk assessment – including an evaluation of toxicity and allergenicity - and found no safety concerns at the proposed uses and use levels.
- Scientific Opinion on Xylanase from a Genetically Modified Strain of Aspergillus oryzae (strain NZYM-FB)
Can stakeholders find out more about EFSA’s work on food enzymes?
F.T.: Yes, EFSA will be holding a full day information session on this topic at its headquarters in Parma, Italy, on 27 May, 2014. Stakeholders will have the opportunity to discuss the scientific, regulatory and procedural requirements related to food enzymes applications with the Authority’s scientists. While registration for the meeting is now closed, presentations delivered on the day will be posted on EFSA’s website shortly after the event.