Food enzymes

The European Parliament adopted a resolution drafted by Avril DOYLE (EPP, IE), and made some amendments to the proposal, stipulating stricter conditions of use by introducing the precautionary principle as a rule of conduct. The main amendments were as follows:

- legal base: whereas the Commission’s proposal cited two legal bases Articles 37 and 95, Parliament stated that Article 95 should be the sole legal base;

- scope: this Regulation will not apply to: (a) microbial cultures that are used in the production of food and which may incidentally produce enzymes but which are not specifically used to produce them; (b) enzymes intended for direct human consumption, such as enzymes for nutritional purposes or enzymes used as digestive aids. A new clause states that no person shall place on the market a food enzyme or any food in which such a food enzyme is present if the use of the food enzyme does not comply with the Regulation;

- precautionary principle: a food enzyme may be included in the Community list only if it meets the following conditions: it does not, on the basis of the scientific evidence available and the precautionary principle , pose a safety concern to the health of the consumer at the level of use proposed; there is a reasonable technological need; its use does not mislead the consumer; misleading the consumer includes, but is not limited to, issues related to the nature, freshness and quality of ingredients used, the naturalness of a product or of the production process, the nutritional quality of the product or the fruit and vegetable content; its use has a clear benefit for the consumer;

- EFSA: the opinions of the Authority should be published as soon as the scientific assessment is completed, before the Community list is drawn up. A fresh scientific evaluation and classification should be performed at least every 10 years. The Authority shall be allowed to decide on a "fast track" authorisation procedure for food enzymes which are currently on the market if the Authority is satisfied that they have undergone an adequate safety assessment at national or Community level within the EU so that such enzymes could be directly transposed to the Community list of food enzymes; any appropriate transitional measures may be adopted in accordance with the regulatory procedure with scrutiny;

- comitology: it may be decided in accordance with the regulatory procedure with scrutiny whether or not a given substance falls within the scope of this Regulation. Parliament also stipulated that various implementing rules must be made in accordance with the regulatory procedure with scrutiny;

- definitions: Parliament inserted definitions for “enzyme”, “food enzyme preparation”, "produced by GMOs" and “quantum satis”; it amended the definition for “food enzyme”. It stated, in addition, that the most accurate enzyme name should be used, including its common or recommended name, systematic name and synonyms, if possible according to the nomenclature of the International Union of Biochemistry and Molecular Biology and, in the case of complex enzymes, selected on the basis of the enzyme activity that determines the enzyme's function;

- Parliament clarified that a food enzyme falling within the scope of Regulation (EC) No 1829/2003 and not already included in the Community list may be included in that list in accordance with this Regulation only if it is covered by an authorisation in accordance with Regulation (EC) No 1829/2003;

- labelling: Parliament provided that food enzymes and food enzyme preparations not intended for sale to the final consumer, whether sold singly or mixed with each other, may be marketed only if the packaging or containers provide certain prescribed information. Enzymes or foods containing food enzymes intended for sale to the final consumer may be marketed only if their packaging contains certain information, inter alia, the name under which the food enzyme is sold or both that name and the technological function in the food; and where applicable, an indication that the product contains genetically modified organisms or substances produced from them. In addition, information about all enzymes used in the production process should be made available to consumers, if not on the label then at least through other information channels, with priority assigned to those at the point of sale. Moreover, provision should also be made for consumers to access this information from home, for example over the Internet or by means of telephone hotlines;

Lastly, enzymes present in the food product must be designated by the name of one of the categories of ingredients listed in Annex II, followed by their specific name and an indication of whether they are still active in the final product or not; for enzymes produced from GMOs the indication "produced from GMOs" shall be given on the label.