14 Safety controls over food enzymes
| (27749)
12179/06
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
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| Legal base | Article 95EC; co-decision; QMV
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| Document originated | 28 July 2006
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| Deposited in Parliament | 22 August 2006
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| Department | Food Standards Agency
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| Basis of consideration | EM of 29 August 2006
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| Previous Committee Report | None
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| To be discussed in Council | No date set
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| Committee's assessment | Politically important
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| Committee's decision | Not cleared; further information awaited
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Background
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.
Conclusion
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
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