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2.4 Enzymes derived by recombinant technology

Applications of gene technology for the production of processing aids are mainly focused on the use of recombinantly expressed enzymes (Braunschweiger and Conzelmann, 1997). The regulations on enzymes, including those produced by genetic engineering, are not standardised in Europe. The EC directive 90/220/EEC applies only to the release of GMOs, or to products containing GMOs, and therefore does not concern enzymes deriving from recombinant technology. Nor it is likely that the planned novel food legislation of the EC will include enzymes. The Netherlands is one of the few countries providing a complete list of enzymes (or other processing aids and food additives) used in the food industry (Approved 'Novel Food Products' in the Netherlands). In Switzerland and the UK, several enzymes have also been listed (Genetically engineered products approved for food use in the United Kingdom and Approved genetically engineered food products in Switzerland), whereas no such lists were available from most of the other countries. Regulations on enzymes, if present at all, vary greatly among different countries.

In Germany, the use of enzymes (and microorganisms) in food does not generally require specific approval according to the LMBG ('Lebensmittel- und Bedarfsgegenständegesetz'). For certain applications of enzymes, such as in cheese production, specific registrations may be required; the German regulation for the manufacture of cheese discriminates between natural rennet and its substitutes (e.g. chymosin), requiring approval for the latter.

For the reasons given above, data on the approval of enzymes or other processing aids or food additives derived by genetically modified microorganisms has not been systematically summarised here. Approved enzymes are listed only for the Netherlands, Switzerland and the United Kingdom. The use of chymosin, expressed either in Kluyveromyces lactis, E. coli K12 or Aspergillus niger ssp. awamori, reportedly has been approved until 1993 in at least 17 countries, including Belgium, Chile, Denmark, Finland, Hungary, Ireland, Israel, New Zealand, Norway, Poland, Portugal, South Africa, Sweden, Switzerland, the United Kingdom, the United States, and in the former Yugoslavia (Teuber, 1993).

In contrast to the regulatory situation, the picture of commercial availability of recombinantly expressed enzymes is much clearer. At least 19 different enzymes, most of which can be applied in the food industry, have been produced by heterologous expression in various genetically modified microorganisms (Commercially available enzymes derived from recombinant technology). In addition, some food additives are also produced by means of genetically engineered microorganisms. Vitamin B12 manufactured from Rhône-Poulenc has been recently approved for food use in Switzerland (Approved genetically engineered food products in Switzerland), apparently using genetically modified Agrobacterium radiobacter (Braunschweiger and Conzelmann, 1997). Efforts to produce Vitamin B2 (riboflavin) using a recombinant Bacillus subtilis strain have also been reported (van Loon et al., 1996). Very recently (on 17 February, 1997), riboflavin from Hoffmann-La Roche has been granted food approval by the British Ministry of Agriculture, Fisheries and Food (Genetically engineered products approved for food use in the United Kingdom).