Division of Food Sciences - University of Nottingham

Food flavour course

Flavour Legislation

Joy Hardinge
 Part of the Food Improvement Agent
Package of Legislation
 Majority of the Legislation came into force
Jan 2011
 Union List -Published 2nd October 2012,
 The Regulation provides for;

◦ A Community list of Flavourings and source

materials
◦ Conditions of use
◦ Rules on Labeling
 The scope covers “ Certain food Ingredients
with Flavouring Properties”
 These are defined as
◦ Food ingredients, other than flavourings, which
may be added to food for the main purpose of
adding flavour to it or modifying its flavour and
which contribute significantly to the presence in
food of certain naturally occurring undesirable
substances
 The Regulation shall NOT apply to:
◦ Exclusively sweet, sour or salty materials
◦ Raw foods
◦ Non compounded foods such as, but not
exclusively, fresh, dried or frozen spices and/or
herbs, mixtures of tea and mixtures for infusion as
such as long as they have not been used as food
ingredients
 Flavourings impart or modify odour and/or
taste
 Divided into
◦ flavouring substances, flavouring preparations,
thermal process flavourings, smoke flavourings,
flavour precursors, or other flavourings
 A defined Chemical substance with
flavouring properties
 Similar to old definition
 HOWEVER they are not subdivided into
Nature Identical and Artificial
 There is a definition of Natural Flavouring
substance
 Obtained by appropriate physical,
enzymatic, or microbial 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.
Natural flavouring substances correspond to
substances that are naturally present and
have been identified in nature
 Eg Limonene obtained from oranges
 Chopping  steeping
 Heating, cooking, baking,  Coating
frying (240C) pressure  Cooling
cooking (120C)
 Distillation/rectification
 Cutting
 Emulsification
 Drying
 Extraction including solvent
 Evaporation
 Filtration
 Fermentation
 Maceration
 Grinding
 Mixing
 Infusion
 Percolation
 Microbiological processes
 Refrigeration/freezing
 Peeling
 squeezing
 Pressing,
 Roasting/grilling
 Appropriate physical processes
◦ Doesn’t intentionally modify the chemical nature
without prejudice to the list of traditional processes
◦ Doesn’t involve singlet oxygen, ozone, inorganic
catalysts, metal catalysts, organometalllic reagents,
and/or UV radiation
 Art 3 2 (d) Flavouring preparations – a
product other than a flavouring substance
obtained 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
 It can be from food or non food

Eg Orange Oil
Examples of Flavouring Preparations
 Single strength Essential Oils
 Concentrated & terpeneless Essential Oils
 Essential Oil Terpenes
 Isolates of Essential Oils
 Oleo-resins, resinoids & absolutes
 Extracts of Natural Source Materials
 Distillates of Natural Source Materials
 Tinctures of Natural Source Materials
 Fruit Juices used for their Flavouring Properties

These are all natural even if they contain

solvent or carrier
 – A product obtained after heat
treatment from a mixture of ingredients
not necessarily having flavouring
properties themselves of which at least
one contains nitrogen (amino) and
another is a reducing sugar; the
ingredients may be food or none food
 The process conditions are placed in a
separate annex.
 – definition taken from smoke regulation
 A product obtained by fractionation and
purification of a condensed smoke yielding
primary smoke condensates, primary tar
fractions and/or derived smoke flavourings
as defined in the EU Smoke Regulation
(2065/2003)

◦ Flavour Precursor – product, not necessarily with
flavouring properties intentionally added to food for
the sole purpose of producing flavour by breaking
down or reacting with other components during
food processing
◦ May be derived from food or non food
 Other Flavouring – Anything that is added for
odour and /or taste and doesn’t fit in a
previous category!
 Flavourings may contain permitted food
additives and or food ingredients

General Conditions – Art 4

 Must be safe
 Must not mislead the consumer
 Flavouring preparations and flavour
precursors from food
 Thermal process flavourings from food and
made within prescribed guidelines
 Food ingredients with flavouring properties
 All Flavouring substances
 Flavouring preparations, flavour precursors
and source materials from non food
 Thermal process flavourings not made
within the guidelines and/or from non food
 Other flavourings
 Article 3.3
◦ Source materials for which there is significant
evidence of use to produce flavourings are
considered as food.
◦ Examples quoted in whereas clause 16 are rose
wood and strawberry leaves
 Flavourings and Source materials which
require evaluation have to be placed on the
Community List.
 The entry shall specify the identity and
where necessary conditions of use
 The word flavouring – or a more specific name
 For food or a more specific reference
 Storage/use instructions
 Batch or lot number
 A list in descending order of all the flavouring categories
present and the names or e numbers of each of the other
substances in the product
 Contact details of manufacturer packer or seller
 Maximum quantity of materials subject to quantitative
limits
 Net quantity
 Minimum durability/use by date
 Allergen labelling
 The ingredients break down and maximum
level information may be given in trade
document provided prior to delivery –
provided that the words “not for retail sale”
are used.
 For tanker deliveries all the information may
be in trade documents
 As before,the flavouring part must be
composed of natural flavouring substances
and/or flavouring preparations only – a
range of categories is given

◦ Natural Flavouring Substances – flavouring

component must be exclusively natural
flavouring substances
 – flavouring component must be at least 95%
from ‘x”
 Balance of flavouring part has to be natural
 The non flavouring part does not have to be
natural
 - the flavour component is partially
derived from “x” and can be recognised
 flavouring component is from different
source materials and a reference to them
would not reflect the flavour
 Open to Interpretation eg.
◦ Is it hierarchical ?
◦ How much is partially?
◦ When can you use “natural flavouring”?

Flavour Industry has produced guidance Document

Food Industry has also produced guidance
Commission currently working on Guidance
 Flavourings - or a more specific name
 Smoke flavouring unless it doesn’t impart a
smokey flavour
 The term “natural”may only be used if it
meets the requirements set out in the B2B
requirements
 NATURAL FLAVOURING

FLAVOURING COMPONENTS MUST BE EXCLUSIVELY

FLAVOURINGS PREPARATIONS AND/OR NATURAL
FLAVOURING SUBSTANCES

PROCESSED FLAVOURINGS AND SMOKE FLAVOURINGS

CAN NEVER BE NATURAL
 Part:
◦ A. Union List of Flavouring Substances
◦ B. Flavouring Preparations
◦ C. Thermal Process Flavourings
◦ D. Flavour Precursors
◦ E. Other Flavourings
◦ F. Source Materials
 Only Part A is in place currently – covering
Flavouring Substances
 Virtually all the requested substances are
included
Art.1 – Definitions – Flavouring substances are
defined as either
 Evaluated flavouring substances – those for which
the evaluations and approval is complete or
 Flavouring substances under evaluation – those for
which the risk assessment has not as yet been fully
completed; these have been assigned footnotes
setting dates by which the additional date has to be
submitted
Art.4 – Flavourings substances under
evaluation may still be placed on the market
and used in the same way as evaluated
substances

36
 Purity of the
named Rest
Co Foo
FL Example
Chemical of Union List entry (FL-no: 01.061
CAS No.
JECF E
substance at
least 95%
ricti
ons
t Refe
No. Name A No. No not rence
– 01.077) .
unless
otherwise
of
Use
e
specified
At least 94%
(sum of
cis/trans
isomers);
01.0 Undeca-1,3,5- 16356-
1341 secondary 4 EFSA
61 triene 11-9
component
2,4,6-
undecatriene
(Z,Z,E)
Submitted by
4 – additional
shall be 31/12/13
scientific data
37
 Camphor  Ammonium
 Quinine Chloride
hydrochloride  Glycyrrhizic acid
 Caffeine  Quinine
 Theobromine
 Reb A
 Glycyrrhizic acid
(ammoniated)  Quinine sulphate
 NHDC
Out of 2523 original entries only 11 had conditions of use
Ammonium, sodium, potassium and calcium
salts as well as chlorides, carbonates and
sulphates are covered by the generic substances,
providing that they have flavouring properties.

A racemate entry covers both the R and S forms

but an entry for the R form on its own does not
cover the S form (and vice versa).

Where levels are set they apply to foods as

marketed apart from those which require
reconstitution where the dilution has to be taken
into account

Carry over and reverse carry over apply.

39
Approval of New Flavouring Substances

New flavouring substances – Evaluated and added to the

List Prior to Use: i.e. « Pre-Market Approval »
Common Autorisation Procedure: Regulation (EC) No
1331/2008 and Implementing Regulation (EU) No
234/2011 have to be followed.

40
 Chopping  steeping
 Heating, cooking, baking,  Coating
frying (240C) pressure
cooking (120C)  Cooling
 Cutting  Distillation/rectification
 Drying  Emulsification
 Evaporation  Extraction including solvent
 Fermentation  Filtration
 Grinding  Maceration
 Infusion  Mixing
 Microbiological processes
 Percolation
 Peeling
 Refrigeration/freezing
 Pressing,
 Roasting/grilling  squeezing
 Agaric acid  Hydrocyanic acid
 Aloin  Menthofuran
 Capsaicin  Methyl eugenol
 Coumarin  Pulegone
 Hypericine  Quassin
 Beta asarone  Safrole
 estragole  Teucrin A
 Thujone
 Only the main sources in the diet are
limited
 There isn’t a maximum limit in all food.
Name Compound food in Maximum level in
which the level is mg/kg
restricted

Estragole Dairy products 50

Processed 50
fruits,vegetables
Fish products 50
Non-alcoholic
Beverages 10
 The levels for Methyl eugenol, Estragole
and safrole don’t apply when the food
doesn’t contain flavourings
 This only apply if the flavouring contains
them
 Part A – Source materials not allowed
 Part B - those with conditions of use
◦ Eg Quassia which is only allowed in flavourings
for bakery wares and beverages
Maximum Temperature – 180 C
Maximum Time - 15mins
A doubling of the heating time is allowed for
each decrease of temperature by 10 °C, up to a
maximum of 12 hours.
Max PH - 8
4,8-DiMeIQx 50 microg/kg

PhIP 50 microg/kg
 Flavour industry guidance - The European Flavour
Industry has produced a number of guidance
documents and also a set of Q & A’s

 http://www.effa.eu/library/guidance-documents

 The Food Industry has also produced guidance

 http://www.fooddrinkeurope.eu/publication/foodd
rinkeurope-guidelines-on-flavourings/

 Both these document packages have been shared

with the Commission
 Framework Regulation agreed in 2003
 Brand Specific Approval Process.
 17 materials originally submitted for Evaluation.
Number decreased substantially as evaluation has
proceeded
 Positive list of primary smoke products published
in December 2013
 The list of permitted primary smoke products
was finally published in December 2013 –
Regulation 1321/2013
 It contains 10 products and for each
◦ Conditions of use
◦ Specifications
◦ Unique code and identification details of
authorisation holder
 1.7. Cheese and cheese products 0.50 g/kg
 12.2. Herbs, spices, seasonings 3.0 g/kg
 12.6. Sauces 1.0 g/kg
 15. Ready-to-eat savouries and snacks 3.0 g/kg

 This is not an exhaustive list .

 When combinations of smoke flavourings are
used in or on foodstuffs the individual levels
shall be reduced proportionally

 Guidance has been produced by the flavour

Industry on how to do this
 OFTEN QUOTED AS A POSITIVE LIST SYSTEM

 FDA LISTED MATERIALS

 FEMA GRAS MATERIALS
 OTHER GRAS MATERIALS
 USA GRAS list system
(“Generally Regarded as Safe”)
• Currently contains over 3000 entries
• Regularly Update and published

• Mixture of natural extracts, chemical substances and

other flavouring components

• Additional entries are by clearance through FEXPAN

(the Flavouring and Extract Manufacturers’ Association
of the United States expert panel and made up of non-
industry independent experts, mainly toxicologists)
 USA SYSTEM
• REGULATES NATURAL AND
ARTIFICIAL
• NATURE INDENTICAL = ARTIFICIAL
• PROCESSED FLAVOURINGS and SMOKE
FLAVOURINGS CAN BE NATURAL
 TOTALLY DIFFERENT SYSTEM
 GRAS CONCEPT NOT FOLLOWED
 SIMILAR TO UK PRIOR TO EU LEGISLATION
 TOTALLY DIFFERENT SYSTEM
 Positive list combined with 18 more generic
categories based on chemical structure

 POSITIVE LIST BUT CONTAINS GENERICS

EXAMPLE OF JAPANESE LIST

ISO EUGENOL
ISO THIOCYANATES (EXCEPT HARMFUL
SUBSTANCES)

KETONES
LACTONES (EXCEPT HARMFUL SUBSTANCES)
LINALOOL
LINALYL ACETATE
MALTOL
 IN THE PAST THERE HAVE BEEN CONSIDERABLE
PROBLEMS WITH IMPORTED FOODS NOT
CONFORMING TO THE JAPANESE REGULATIONS

 INDUSTRY WORKING WITH JAPANESE AUTHORITIES

TO TRY TO OBTAIN GREATER HARMONY WITH
OTHER COUNTRIES

 JAPANESE AUTHORITIES CURRENTLY EVALUATING

FLAVOURING MATERIALS – SOME NEW MATERIALS
NOW ALLOWED
?
 This is the currently the closest to Global
Legislation
◦ JECFA has evaluated flavouring substances for many
years – covered a large number of FEMA GRAS
materials
◦ CCFA has a guideline on flavourings

Still many many years away!!!

THANK YOU FOR YOUR ATTENTION