EFSA takes first steps towards list of authorised food enzymes

Posted by AFN Staff Writers on 21st May 2014
EFSA to assess and regulate food enzymes used in processes like alcohol distillation

The European Food Safety Authority (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.

EFSA said this scientific opinion marked 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.

Enzymes have long been used in food production, but it is only recently 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), said that new legislation came into force in 2009 to harmonise the use of food enzymes across the EU and before that time, food enzymes, other than those used as food additives, had not been 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,” Dr Toldra said. “The EU law introduced a common approval procedure for food enzymes, food flavourings and additives,” he said.

What are food enzymes?

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.

“Food enzymes are obtained from plants and animals or by fermentation from micro-organisms,” Dr Toldra said. “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,” he said.

Details about the new EU regulation

Dr Toldra said the EU law applied to enzymes that performed any technological function in the manufacture, processing, preparation, treatment, packaging, transport and storage of food. This includes food enzymes used as processing aids, but not include food enzymes intended for human consumption, such as those added for nutritional purposes.

“This legislation aims to establish a future EU list of food enzymes,” Dr Toldra said. “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,” he said.

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.

Dr Toldra said that following discussions with industry and the Commission, EFSA estimated that its CEF Panel would carry out safety assessments on around 300 food enzyme applications in the coming years. 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.

Current food enzyme producers

Dr Toldra said that until a full EU list was 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,” Dr Toldra said.

The first food enzyme assessment published by EFSA

The first safety safety assessment of a food enzyme related to an application for a type of food enzyme known as a xylanase.

“This xylanase is used in starch processing, the distillation of alcoholic drinks and baking processes,” Dr Toldra said. “It is produced through the fermentation of a strain of Aspergillus oryzae which has a long history of safe use,” he said.

“However, Aspergillus is also known to produce undesirable compounds called mycotoxins as secondary metabolites,” Dr Toldra said. “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,” he said.

Australian regulation of food enzyme substances

Food enzymes have been regulated in Australia since 1996. There are specific permissions for enzymes used in the manufacture of food in Standard 1.3.3 — Processing Aids, in the Australia New Zealand Food Standards Code (the Code). The permitted enzymes can be sourced from animals, plants or microorganisms. The Code and Standard 1.3.3 can be found from Food Standards Australia New Zealand’s (FSANZ) website Food Standards Code.

In Australia, enzymes permitted for the manufacture of food are specified by their internationally determined and recognised enzyme name, their Enzyme Commission (EC) number and the unique source from which the enzyme is produced. The enzyme name and EC number are unique identifiers for each enzyme and are determined by the International Union of Biochemistry and Molecular Biology (IUBMB).

The Code regulates permissions for enzymes to be used in the manufacture of food. FSANZ has not approved any enzyme which is added to a food for a specific nutritional effect, rather than for a technological function. However, the Code requires approval for nutritive substances and for novel foods and also has specific compositional standards for some special purpose foods (e.g. foods for special medical purposes).

The process for enzyme approval in Australia

Enzymes which are considered processing aids require a pre-market assessment before they are permitted to be used.  An Application requesting a permission to use the enzyme in the manufacture of food is required to be submitted to FSANZ. FSANZ has detailed information on the information which is required in an enzyme Application and the process of assessing an Application on FSANZ’s website: http://www.foodstandards.gov.au/code/changes/applying/pages/default.aspx.

If an enzyme was considered to perform the function as a food additive (Standard 1.3.1) and not a processing aid, FSANZ said an application for a new food additive would be required. Currently there are no approved enzymes as food additives in the Code, unlike Europe where there may be a small number.