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Regulating Food Enzymes in the EU

EU legislation on Food Enzymes

Historically, enzymes have been considered to be non-toxic and not of safety concern for consumers since they are naturally present in ingredients used to make food. As such, until 2008, food enzymes other than those used as food additives (e.g. E1103 Invertase and E1105 Lysozyme) were either not regulated at EU level or regulated under individual Member States’ national legislation. Only France and Denmark required safety assessments for food enzymes before they could be used in food production. Ireland does not have specific national legislation in relation to food enzymes.

In 2008, Regulation (EC) No 1332/2008 was introduced to lay down rules on food enzymes used in foods, including enzymes used as processing aids, with a view to harmonising national provisions relating to the use of enzymes in foods. 

  • Regulation (EC) No 1332/2008 (OJ L 354, p7, 31.12.2008) of the European Parliament and of the Council of 16 December 2008 on food enzymes.

Regulation (EC) No 1332/2008 only covers enzymes that are added to food to perform a technological function in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food, including enzymes used as processing aids. It also covers ‘food enzyme preparations’, which are defined as a formulation consisting of one or more food enzymes in which substances such as food additives and/or other food ingredients are incorporated to facilitate their storage, sale, standardisation, dilution or dissolution.

Regulation (EC) No 1332/2008 does not cover:

  • Enzymes that are intended for human consumption, such as enzymes for nutritional or digestive purposes.
  • Food enzymes used exclusively in the production of food additives falling within the scope of Regulation (EC) No 1333/2008 on food additives. 
  • Food enzymes used exclusively in the production of processing aids.
  • Microbial cultures traditionally used in the production of food such as cheese and wine, and which may incidentally produce enzymes but are not specifically used to produce them.

Food enzymes which fall within the scope of Regulation (EC) No 1829/2003 on genetically modified food and feed must be authorised in accordance with that Regulation, as well as under Regulation (EC) No 1332/2008.