Select Committee on European Scrutiny Thirty-Seventh Report

14 Safety controls over food enzymes



COM(06) 425

+ ADDS 1-2

Draft Regulation on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, and Council Directive 2001/112/EC

Legal baseArticle 95EC; co-decision; QMV
Document originated28 July 2006
Deposited in Parliament22 August 2006
DepartmentFood Standards Agency
Basis of considerationEM of 29 August 2006
Previous Committee ReportNone
To be discussed in CouncilNo date set
Committee's assessmentPolitically important
Committee's decisionNot cleared; further information awaited


14.1 According to the Commission, the use of enzymes by the food industry has increased steadily over the past 25 years, and has extended from traditional areas, such as bread, cheese, beer and wine, into many other applications. However, Community legislation governing their safety, currently set out in Directive 89/107/EEC, applies only to those used as food additives:[32] other enzymes used in food processing are either not regulated at all, or are dealt with under national legislation covering processing aids, which differs significantly between Member States. The Commission points out that, whilst historically enzymes were considered to be non-toxic, the efforts of the food industry to develop new products has resulted in more complex enzymes, which could in turn give rise to a number of potential hazards (for example, allergenicity, residual microbiological activity and chemical toxicity). It therefore takes the view that, in order to ensure consumer safety, all food enzymes — including those produced by genetically modified micro-organisms — should be subject to safety evaluation and authorisation, and that this should be carried out at Community level, in order to remove potential trade barriers and provide a harmonised level of consumer protection. This approach was also foreshadowed in the Commission's White Paper on Food Safety in 1999.[33]

The current proposal

14.2 This proposal would require all enzymes, apart from those use exclusively as processing aids in the production of food additives, flavourings or novel foods (for which corresponding Regulations exist), to be subject to an evaluation carried out by the European Food Safety Authority (EFSA) to assess safety, technological need, and benefit to the consumer. Subject to the necessary level of approval from Member States within the Standing Committee on the Food Chain and Animal Health, those enzymes which meet the necessary criteria would be included by the Commission on a Community list, which would also provide details of their purity and origin, and only those enzymes on the list could be used in foodstuffs. In addition, the proposal would introduce labelling requirements for food enzymes sold to manufacturers or directly to the consumer. Special provisions would apply to enzymes which consist of, contain or are produced from a genetically modified organism (GMO), in that these would first have to be evaluated under the Regulation on genetically modified food and feed.[34]

The Government's view

14.3 In her Explanatory Memorandum of 29 August 2006, the Minister of State for Public Health at the Department of Health (Caroline Flint) merely observes that the proposal is welcome in that the introduction of Community procedures for the safety assessment and authorisation of enzymes would enable consumers throughout the Community to benefit from an increased level of protection. She also says that such procedures would provide a harmonised basis for businesses to market and use enzymes throughout the Community.

14.4 The Minister's Explanatory Memorandum is accompanied by a partial Regulatory Impact Assessment, which also forms the basis of the consultation exercise being undertaken by the Government. This points out that the proposal may have an effect on manufacturers' costs, depending on whether the chosen level of assessment — which has yet to be agreed — is manufacturer/blend specific or enzyme specific.[35] The Assessment also highlights the implications this could have for smaller manufacturers who may not have the necessary laboratory or human resources if a manufacturer/blend specific approach is adopted, and says that this issue will be addressed during the consultations exercise.


14.5 In principle, the steps proposed here appear sensible, and to fill a gap in the existing controls. That said, we note the concerns which have arisen over the potential cost, particularly if a manufacturer/blend specific approach were to be adopted, and, for that reason, we think it would be sensible to await the outcome of the Government's consultation on this and other aspects of the proposal, before taking a final view. In the meantime, therefore, we are not clearing the document.

32   To date, only two such enzymes have been approved. Back

33   (20875) 5761/00; see HC 23-x (1999-2000), para 2 (1 March 2000). Back

34   Regulation (EC) No 1829/2003. OJ No. L268, 18.10.03, p.1. Back

35   The estimated cost per enzyme is put at €500,000. Back

previous page contents next page

House of Commons home page Parliament home page House of Lords home page search page enquiries index

© Parliamentary copyright 2006
Prepared 26 October 2006