The document states that industry should provide details of the physico-chemical characteristics of the food enzyme in question as well as data from toxicological tests.
EFSA will then address the safety of the source materials from which the food enzyme is produced, the manufacturing process and dietary exposure.
The need to provide this guidance arises from new EU legislation (Regulation No 1331/2008), which aims to set up a consistent process that food additives, food enzymes and food flavourings must fulfil in order to be approved. This will involve a safety evaluation by EFSA, followed by final approval by the Commission.
EFSA said that safety evaluation of food enzymes will start with those already on the market in the EU. After this, an EU list of authorised substances will be established by the European Commission. EFSA said it will then turn its attention to safety evaluations of new food enzymes.
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. As an example, food enzymes can be used 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.
Industry welcome
Commenting on the 1331/2008 guideline, the Association of Manufacturers and Formulators of Enzyme Products said earlier this year that it welcomed EFSA’s draft guidelines for assessing food enzyme safety, but it cautioned that regulation should be proportionate and clear.
Industry has largely come out in support of a unified approach to assessing enzyme safety, instead of having to undergo separate approval processes in France and Denmark.
To read EFSA’s guidance document, please click here.