Voluntary Report - public distribution

**Date:** 8/7/2006

**GAIN Report Number:** E36113

E36000

**EU-25**

**Food and Agricultural Import Regulations and Standards**

**Package of proposals for new legislation on food additives, flavorings
and enzymes**

**2006**

**Approved by:**

![](media/image1.wmf)Stan Cohen

U.S. Mission to the EU

**Prepared by:**

Tania De Belder

**Report Highlights:**

A four-part package of legislative proposals concerning new legislation
on food additives, flavorings and enzymes has been published. Three of
the proposals are created in order to update the regulation on
additives, food enzymes and flavorings and the fourth one to lay down a
common approval procedure for these substances. It will take at least
another 18 months before these proposals will become EU law.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Brussels USEU \[BE2\]

\[E3\]

**Introduction**

The European Commission has adopted a package of four legislative
proposals updating existing regulations on food additives, food enzymes
and flavorings and an introduction of a simplified common approval
procedure for these substances. At the end of this report, details on
the scope of each individual legislation are given in the annex
containing the definitions of these substances.

**Additives**

The proposal on food additives would bring several current Directives
together into one single regulation. If adopted, it would replace the
framework additives Directive 89/107/EEC as well as the existing
Directives on colors (Directive 94/36/EC), sweeteners (Directive
94/35/EC) and additives other than colors and sweeteners (Directive
95/2/EC).

The new legislation replacing Directive 89/107/EEC would introduce a
simpler and faster food additive approval system. Under the current
system provided by Directive 89/107/EEC, the Commission must obtain the
consent of both the Council and the Parliament for the implementing
proposal recommending approval of an additive. (This procedure is known
as co-decision.)

Under the new legislation, the Commission would draft an implementing
proposal for the approval of an additive and submit it to the Standing
Committee on the Food Chain and Animal Health (SCFCAH). The SCFCAH is
made up of officials from Member State ministries. (This procedure is
known as comitology.)

Member State approval in the SCFCAH will be based on a safety evaluation
conducted by the European Food Safety Authority (EFSA). Thus all
applications for the approval of new food additives will be directed to
EFSA to carry out the safety evaluations. At the same time a
re-evaluation program will be introduced for food additives that are
currently on the EU market, also based on risk assessments by EFSA.

Another objective of the proposal is to require authorization of
additives that consist of, contain or are produced from genetically
modified organisms (GMO). These additives should be authorized under
Regulation (EC) No 1829/2003 on genetically modified food and feed prior
to their inclusion in the positive list under this Regulation. This rule
also applies to food enzymes and flavorings.

**Enzymes**

This proposal would introduce the regulation of food enzymes for the
first time at EU level.

Currently, only two food enzymes used as food additives are authorized
under the food additive legislation, while the remaining enzymes are not
regulated at all or are regulated as processing aids under Member
States' legislation (note: Processing aids fall outside the scope of the
EU food additives regulation and therefore did not require EU approval
until now). However, some Member States have specific regulations on
these products which will require harmonization across the EU-25.

Since a considerable number of food enzymes are already on the market, a
period of 24 months is provided for the submission of applications of
existing enzymes. An initial community list will be established after
evaluation by EFSA. The approval system and positive list will be
similar to those for additives. Requirements for the labeling of food
enzymes other than those used as processing aids are included in the
proposal as well.

**Flavorings**

The new proposal would update the current Directive 88/388/EEC on
flavorings to cope with technological and scientific developments. The
rules on maximum levels are clarified, as well as definitions of
flavorings. Stricter conditions are introduced for the use of the term
"natural" when describing flavorings.

**Common Authorization Procedure**

The key issue of these proposals is the introduction of a single common
procedure for the approval of food additives, flavorings and enzymes.
This last proposal backs up the first three proposed regulations since
it contains procedural rules, such as time limits for handling
applications and the format to be used for submission of the
applications.

The benefits of this common approach include simplified legislation and
more consistency in the procedures used to approve additives, flavorings
and enzymes. A great deal of importance will also be attached to the
safety evaluations that will be conducted by EFSA.

See also:
<http://ec.europa.eu/food/food/chemicalsafety/additives/prop_leg_en.htm>

**Visit our website:** our website
**[useu.usmission.gov/agri/usda.html]{.underline}** provides a broad
range of useful information on EU import rules and food laws and allows
easy access to USEU reports, trade information and other practical
information. More information on food additives can be found at
http://useu.usmission.gov/agri/additive.html. E-mail:
AgUSEUBrussels@usda.gov

**Related reports from USEU Brussels:**

  ------------------------------------------------------------ ------------------------------------ -------------------
  **Report Number**                                            **Title**                            **Date Released**

  E36111                                                       EU Decision-making: New Blocking     07/27/06
                                                               powers for the European Parliament   

  These reports can be accessed through our website                                                 
  [http://useu.usmission.gov/agri/]{.underline} or through the                                      
  FAS website                                                                                       
  <http://www.fas.usda.gov/scriptsw/attacherep/default.asp>.                                        
  ------------------------------------------------------------ ------------------------------------ -------------------

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###### ANNEX 

The following definitions on **food additives** shall apply:

\(a\) 'food additive' shall mean any substance not normally consumed as
a food in itself and not normally used as a characteristic ingredient of
food, whether or not it has nutritive value, the intentional addition of
which to food for a technological purpose in the manufacture,
processing, preparation, treatment, packaging, transport or storage of
such food results, or may be reasonably expected to result, in it or its
by-products becoming directly or indirectly a component of such foods;
however, the following are **not** considered to be food additives:

\(i\) foods containing monosaccharides, disaccharides or
oligosaccharides used for their sweetening properties;

\(ii\) foods, whether dried or in concentrated form, including
flavourings incorporated during the manufacturing of compound foods,
because of their aromatic, sapid or nutritive properties together with a
secondary colouring effect;

\(iii\) substances used in covering or coating materials, which do not
form part of foods and are not intended to be consumed together with
those foods;

\(iv\) products containing pectin and derived from dried apple pomace or
peel of citrus fruits, or from a mixture of both, by the action of
dilute acid followed by partial neutralisation with sodium or potassium
salts (\'liquid pectin\');

\(v\) chewing gum bases;

\(vi\) white or yellow dextrin, roasted or dextrinated starch, starch
modified by acid or alkali treatment, bleached starch, physically
modified starch and starch treated by amylolitic enzymes;

\(vii\) ammonium chloride;

\(viii\) blood plasma, edible gelatin, protein hydrolysates and their
salts, milk protein and gluten;

\(ix\) amino acids and their salts other than glutamic acid, glycine,
cysteine and cystine and their salts having no technological function;

\(x\) caseinates and casein;

\(xi\) inulin;

\(b\) 'processing aid' shall mean any substance which:

\(i\) is not consumed as a food by itself;

\(ii\) is intentionally used in the processing of raw materials, foods
or their ingredients, to fulfil a certain technological purpose during
treatment or processing; and

\(iii\) may result in the unintentional but technically unavoidable
presence in the final product of residues of the substance or its
derivatives provided they do not present any health risk and do not have
any technological effect on the final product;

\(c\) 'functional class' shall mean one of the categories set out in
Annex I based on the technological function a food additive exerts in
the foodstuff;

\(d\) 'unprocessed food' shall mean a food which has not undergone any
treatment resulting in a substantial change in the original state of the
food, for which purpose the following in particular are not regarded as
resulting in substantial change: dividing, parting, severing, boning,
mincing, skinning, paring, peeling, grinding, cutting, cleaning,
trimming, deep-freezing, freezing, chilling, milling, husking, packing
or unpacking;

\(e\) 'food with no added sugars' shall mean a food without the
following:

\(i\) any added monosaccharides, disaccharides or oligosaccharides; or

\(ii\) food containing monosaccharides, disaccharides or
oligosaccharides which is used for its sweetening properties;

\(f\) 'energy-reduced food' shall mean a food with an energy value
reduced by at least 30% compared with the original food or a similar
product;

\(g\) 'table-top sweeteners' shall mean preparations of permitted
sweeteners, which may contain other food additives and/or food
ingredients and which are intended for sale to the final consumer as a
substitute for sugar.

The following definition on **food enzymes** shall apply:

'food enzyme' means a product obtained by extraction from plants or
animals or by a

fermentation process using micro-organisms:

\(a\) containing one or more enzymes capable of catalyzing a specific
biochemical

reaction; and

\(b\) added to food to perform a technological function in the
manufacture, processing,

preparation, treatment, packaging, transport or storage of foods.

The following definitions on **flavorings** shall apply:

\(a\) \'flavorings\' shall mean products:

\(i\) not intended to be consumed as such, which are added to food in
order to

impart odour and/or taste;

\(ii\) made or consisting of the following categories: flavoring
substances,

flavoring preparations, thermal process flavorings, smoke flavorings,
flavor precursors or other flavorings or mixtures thereof;

\(b\) \'flavoring substance\' shall mean a chemically defined substance
with

flavoring properties;

\(c\) \'natural flavoring substance\' shall mean a flavoring substance
obtained by

appropriate physical, enzymatic or microbiological processes from
material of vegetable, animal or microbiological origin either in the
raw state or after processing for human consumption by one or more of
the traditional food preparation processes listed in Annex II;

\(d\) \'flavoring preparation' shall mean a product, other than a
flavoring substance, obtained from:

\(i\) food by appropriate physical, enzymatic or microbiological
processes either in the raw state of the material or after processing
for human consumption by one or more of the traditional food preparation
processes listed in Annex II and/or appropriate physical processes;

and/or

\(ii\) material of vegetable, animal or microbiological origin, other
than food, obtained by one or more of the traditional food preparation
processes listed in Annex II and/or appropriate physical, enzymatic or
microbiological processes;

\(e\) 'thermal process flavoring' shall mean a product obtained after
heat treatment

from a mixture of ingredients not necessarily having flavoring
properties themselves, of which at least one contains nitrogen (amino)
and another is a reducing sugar; the ingredients for the production of
thermal process flavorings may be:

\(i\) food; and/or (ii) source material other than food;

\(f\) 'smoke flavoring' shall mean a product obtained by fractionation
and purification of a condensed smoke yielding primary smoke
condensates, primary tar fractions and/or derived smoke flavorings as
defined in points (1), (2) and (4) of Article 3 of Regulation (EC) No
2065/2003;

\(g\) 'flavor precursor' shall mean a product, not necessarily having
flavoring properties itself, intentionally added to food for the sole
purpose of producing flavor by breaking down or reacting with other
components during food processing; it may be obtained from:

\(i\) food; and/or (ii) source material other than food;

\(h\) 'other flavoring' shall mean a flavoring added or intended to be
added to food in order to impart odour and/or taste and which does not
fall under the definitions (b) to (g);

\(i\) 'food ingredient with flavoring properties' shall mean a food
ingredient other than flavorings which may be added to food for the main
purpose of adding flavor to it or modifying its flavor;

\(j\) 'source material' shall mean material of vegetable, animal,
microbiological or mineral origin from which flavorings or food
ingredients with flavoring properties are produced; it may be: (i) food;
or (ii) source material other than food;

\(k\) 'appropriate physical process' shall mean a physical process which
does not

intentionally modify the chemical nature of the components of the
flavoring and does not involve the use of singlet oxygen, ozone,
inorganic catalysts, metal catalysts, organometallic reagents and/or UV
radiation.