Directive 90 496 Cee Pdf File

Council Directive 90/496/EEC on Nutrition Labelling of Foodstuffs provides for the possibility of amending. 2 http://ec.europa.eu/food/fs/sc/scf/out171_en.pdf.

Directive 90/496/EEC on Nutrition
Paper on Revision of Technical Issues
Page 3
Labelling for Foodstuffs:
Technical Issues
Directorate E - Safety of the food chain
Page 4
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Council Directive 90/496/EEC on Nutrition Labelling of Foodstuffs providesfor the possibility of
amending specific aspects of the legislation via the Standing Committeeprocedure. Whilst the Com-
mission continues to reflect on some of the more fundamental issuesrelated to the revision of this
Directive, it has been decided that it would be timely to make useof this procedure to address some
of these aspects (which can be considered under the broad heading of‘technical issues’). This paper
identifies the technical issues to be considered, summarises the commentsreceived from the 2003
consultation on revision of the Nutrition Labelling Directive, andhighlights other work which might be
relevant to discussions on how the legislation might be amended.
The Health and Consumer Protection Directorate General is keen to obtainthe views of stakehol-
ders on how these technical issues might be addressed and is issuingthis discussion paper as part of
the consultation process. Responses should reach the dedicated e-mailbox SANCO-TECHNICAL-
ISSUES@ec.europa.eu by 14 July 2006. They may include general commentsbut should otherwise be
structured to match the sections in this text and the specific questionson which the Commission seeks
Page 5
Introduction ............................................................................................................................1
Reference Values for Vitamins and Minerals ......................................................................2
Background ....................................................................................................................2
Current legislation.....................................................................................................2
Responses to the 2003 Consultation ..........................................................................2
Proposal on the Addition of Vitamins and Minerals and of Certain
Other Substances to foods..........................................................................................2
Scientific Committee on Food....................................................................................2
Codex .........................................................................................................................3
European Food SafetyAuthority ............................................................................... 3
Questions on which the Commission seeks comments................................................4
Nutrient Definitions................................................................................................................5
Background ....................................................................................................................5
Current legislation ....................................................................................................5
Responses to the 2003 Consultation ..........................................................................5
Codex .........................................................................................................................5
Questions on which the Commission seeks comments................................................6
Energy Conversion Factors....................................................................................................7
Background ....................................................................................................................7
Current legislation.....................................................................................................7
Responses to the 2003 Consultation ..........................................................................7
Codex and FAO/WHO ...............................................................................................7
Questions on which the Commission seeks comments................................................8
Tolerances for nutrient declaration ......................................................................................9
Background ....................................................................................................................9
Current legislation.....................................................................................................9
Responses to the 2003 Consultation ..........................................................................9
Codex .........................................................................................................................9
Member States' Approaches.....................................................................................10
Canadian Approach.................................................................................................10
Questions on which the Commission seeks comments..............................................10
Annex 1: Comparison of Reference Labelling Values...........................................................11
Annex 2: Definitions of dietary fibre ....................................................................................12
Annex 3: Examples of Member States' Guidance on Tolerances forNutrition
Declarations ............................................................................................................................13
Annex 4: Sampling Plan and Tolerances from Canadian Food Inspection
Agency- Nutrition Labelling Compliance Test.......................................................................15
1
1.
Council Directive 90/496/EEC on Nutrition Labelling of Foodstuffs provides
for the possibility of amending specific aspects of the legislationvia the Standing
Committee procedure. Whilst the Commission continues to reflect onsome of the
more fundamental issues related to the revision of this Directive,it has been decided
that it would be timely to make use of this procedure to address someof these aspects
(which can be considered under the broad heading of ‘technical issues’);particularly
as they may be an important and necessary support for otherrelated Community
legislation in force or proposed, such as the directives onfood supplements and
dietetic foods and the regulatory proposals currently underdiscussion regarding
nutrition and health claims made on foods and the additionof vitamins and minerals
2.
This paper identifies the technical issues to be considered, summarisesthe
comments received from the 2003 consultation on revision of the NutritionLabelling
1
and highlights other work which might be relevant to discussions onhow
3.
It should be emphasised that only those issues which the Directiveprovides
for can be amended via the Standing Committee procedure and, therefore,can be dealt
4.
The Health and Consumer Protection Directorate-General is keen to obtainthe
views of stakeholders on how these technical issues might be addressedand is issuing
this discussion paper as part of the consultation process. Responsesshould reach the
dedicated e-mail box SANCO-TECHNICAL-ISSUES@ec.europa.euby 14 July 2006.
They may include general comments but should otherwise be structuredto match the
sections in this text and the specific questions on whichthe Commission seeks
1
http://ec.europa.eu/food/food/labellingnutrition/nutritionlabel/index_en.htm
2
Background
5.
The Annex to the Nutrition Labelling Directive (90/496/EEC) lists vitamins
and minerals which may be declared on the nutrition label, their recommendeddaily
allowances (RDAs), and specifies what is a ‘significant amount’ (15%of the RDA per
100g or 100ml). Article 1, paragraph 4(a) of the Directive allows forchanges to the
list of vitamins, minerals and their recommended daily allowancesto be adopted
Responses to the 2003 Consultation
Relevant comments are:
• General agreement on the need to bring the annex up to date and totake account
of the lists of vitamins and minerals in Directive 2001/15/EEC (onsubstances that
may be added for specific nutritional purposes in foods for particularnutritional
use) and Directive 2002/46/EEC (on the approximation of thelaws of the Member
• Some comments that 10% would be more appropriate than 15% as a ‘significant
amount’, or that it should be brought into line with CODEX(5% of the
• A number of requests for ‘significant amount’ to be reduced for productswith
• A number of comments about the need to have consistency/harmonisationin the
way that vitamins are named on the nutrition label.
• Some requests to have RDAs for different populations - especiallychildren.
Proposal on the Addition of Vitamins and Minerals and of CertainOther Substances
7.
It should be noted that a proposal for the addition of vitaminsand minerals
and certain other substances to foods is currently underconsideration by the
European Parliament and the Council. The lists of vitamins and mineralscontained
within this proposal include many more nutrients than the ones listedin the Annex of
Scientific Committee on Food
The Scientific Committee for Food(SCF) published an opinion on the
Revision of Reference Values for Nutrition Labelling on the5 March 2003
. This sets
3
2
3
The term “Reference Labelling Value (RLV)” was proposed by the SCFin its 1992 report on Nutrient
and Energy Intakes for the European Community; the purposebeing to highlight that the RLV was
derived specifically for use with nutrition labelling.
3
4 years. The SCF report covers all of the vitamins and minerals listedin Directive
2001/15/EEC (foods for particular nutritional use), Directive2002/46/EEC (food
supplements), and in the draft proposal on the addition of vitaminsand minerals.
Annex 1 provides a comparison between the figures proposed by theSCF and those in
the current Annex to the Nutrition Labelling Directive.
For adults, a comparison of the values recommended by the SCF againstthose
• Increases in values for 6 vitamins and minerals – folates; vitaminsB
, C, E;
• Decreases in values for 7 vitamins and minerals – niacin; biotin;vitamins B
, B
,
6
• Values for 5 vitamins and minerals remain the same – vitamins A,D; pantothenic
• Values set for 10 new vitamins and minerals – vitamin K; potassium;sodium;
chloride; copper; selenium; manganese; chromium; molybdenum; fluoride.
10.
The Codex Guidelines on Nutrition Labelling (CAC/GL 2-1985(Rev.1 –
1993)) provide Nutrient Reference Values (NRVs) for 14 vitamins andminerals to be
used for labelling purposes. These NRVs are the same as the RDAs inthe current
11.
A discussion paper on The Proposals for Addition of RevisedNutrient
Reference Values for Labelling Purposes was presented at the27
Session of the
Directive 90 496 Cee Pdf File
Codex Committee on Nutrition and Foods for Special Dietary Purposes(CCNFSDU)
in Bonn, Germany in November 2005. The Committee agreed tocontinue
European Food SafetyAuthority
In January 2005, the Commission asked the European FoodSafety Authority
(EFSA) to review advice on dietary intakes, highlighting that thescientific advice on
recommended nutrient intakes is important as the basis of Communityaction in the
field of nutrition. For vitamins and minerals, EFSA was asked to reviewthe SCF
recommendations on micronutrients in the light of new scientific evidenceand advise
on the population reference intakes. EFSA has indicated that thistask will take some
time, with a potential completion date of post 2010 being estimated.
4
• Are the values in the SCF opinion on the Revision ofReference Values for
Nutrition Labelling an acceptable basis for updating the Annexto the Nutrition
• Are there concerns about any of the values in the SCF opinion?
• Is there a need to have values for different population groups inthe Annex?
• Is there a need for consistency/harmonisation in the naming of vitaminson the
nutrition label? Are there any examples where this has caused a problem?
• Is there a need to change the figure for what constitutes a significantamount?
• In view of the fact that other terms are being used forlabelling purposes
(guideline daily amounts, reference labelling values), is the term‘recommended
4
Whilst this issue can be discussed in relation to revision of thetechnical issues, it is not certain that it
will be possible to make changes via the Standing Committee procedure.
5
Background
13.
Article 1, paragraph 4 of the Nutrition Labelling Directive providesdefinitions
for a number of nutrients that are used in nutrition labelling. Inparagraph 4(j), it is
noted that ‘fibre’ means the material to be defined accordingto Standing
Committee procedure and measured by the method of analysis to bedetermined in
Responses to the 2003 Consultation
Relevant comments are:
• General agreement that a definition for fibre, along with a definedmethod, was
• Some comments that in changing the definition for fibre there wouldbe a need to
• Some requests for work on further definitions around fats/fattyacids and
vitamins/minerals. Also the need for harmonisation of definitionsacross the
5
15.
th
session the CCNFSDU made further progress on moving towards an
agreed definition for fibre (considering this within the discussionson the Guidelines
for the Use of Nutrition Claims: Draft Table of Conditions forNutrient Contents
).
The latest definition, which was returned to Step 6 for furthercomment and
discussions at the next session of the Committee, states that:
“Dietary fibre means carbohydrate polymers with a degree of polymerisation(DP)
not lower than 3 which are neither digested nor absorbed in thesmall intestine. A
degree of polymerisation not lower than 3 is intended to exclude mono- and
disaccharides. It is not intended to reflect the average DP ofa mixture. Dietary fibre
• Edible carbohydrate polymers naturally occurring in thefood as
• carbohydrate polymers, which have been obtained from food raw
material by physical, enzymatic or chemical means,.
5
The Standing Committee procedure set out in the Directive only allowsfor a definition to be set for
fibre. Discussions on definitions of other nutrients will need towait for the more fundamental revision
6
http://www.codexalimentarius.net/web/archives.jsp?lang=en - Alinorm 06/29/26 Report of the 27
Session of the Codex Committee on Nutrition and Foods for SpecialDietary Purposes, paragraphs 14-
Page 12
16.
It should be noted that in the draft Codex guidelines the definitionis linked to
text on the properties of dietary fibre and to a footnote providingfurther information
on dietary fibre derived from plant origin. The full text is givenin Annex 2.
• Are the current Codex discussions a suitable basis for setting downa definition of
• Are there any concerns about this definition and how it might beincorporated into
the Directive? For example, how should the issue of the footnote bedealt with?
7
Background
17.
Article 5, paragraph 1 of the Nutrition Labelling Directive providesenergy
conversion factors for a range of nutrients (carbohydrates,polyols, protein, fat,
alcohol and organic acids). Paragraph 2 notes that amendments tothese conversion
factors can be made via the Standing Committee procedure, ascan additions for
substances which belong to or are components of one ofthe categories of
nutrients listed in paragraph 1; the purpose being to moreprecisely calculate the
18.
The Standing Committee procedure was used in 2003 to introducea
conversion factor for salatrims (Directive 2003/120/EEC).
19.
• A number of requests to introduce an energy conversion factor forfibre.
• Comment that there were problems/inconsistencies with conversionfactors used
in the Nutrition Labelling Directive and those for a numberof PARNUTS
• Reference made to an FAO/WHO workshop and how this could provideguidance
for future development of energy conversion factors.
20.
Conversion factors in the current CODEX Guidelines on NutritionLabelling
(CAC/GL 2-1985 (Rev.1 – 1993)) are in line with those in the NutritionLabelling
Directive, although the latter also includes values for polyols andsalatrims. Whilst
there have been discussions within the CCNFSDU over recent years,there is no clear
timetable for when further work on energy conversion factors willbe taken forward.
The FAO/WHO workshop on FoodEnergy – methods of analysis and
conversion factors was held in Rome, 3-6 December 2002
. The report, published in
2003, highlighted that there is a major need to rationalise and harmonisemethods of
food analysis and energy conversionfactors. The outcome of the workshop was a list
of recommended methods of foodanalysis, from the most desirable based on current
science to those approaches considered acceptable given current realities.For food
energy conversion factors, the preferred factors are integratedinto the
recommendations, based on the analytical methods used.
http://www.fao.org/documents/show_cdr.asp?url_file=/docrep/006/y5022e/y5022e00.htm
8
• Is there any need to amend the current energy conversion factorsin the Nutrition
• Is there any need to add to the current energy conversion factorsin the Nutrition
Labelling Directive? For example, is a conversion factor for fibrerequired or for
8
8
Page 15
Tolerances for nutrient declaration
Current Legislation
The Nutrition Labelling Directive stipulates that the definitionof tolerable
margins between values declared on labelling and those obtainedby official
controls should be determined following the Standing Committeeprocedure.
The task of setting tolerable margins for the declaration of nutrientcontent for food
supplements was also identified as a priority during the discussionsthat led to the
adoption of Directive 2002/46/EC on foodsupplements.
23.
• General agreement that tolerances should be defined at Communitylevel in order
to avoid trade barriers and ensure consumer protection.
• Highlighted that some Member States already have guidelines in placesetting
• Some comments that it may be necessary to discuss samplingand analytical
methods and whether these need to be specified in legislation.
• Comments that tolerances should be set for different foodstuffsto take into
account factors such as raw material variation, foodmatrix, processing and
storage. Tolerances may also need to be defined for specific nutrientsin order to

90/496/cee

reflect issues of stability (especially for some vitamins).
• Important that the existence of tolerances should not lead to therequirement for
individual laboratory testing to derive nutritional values for labellingpurposes.
Current legislation allows the use of foodcomposition tables to derive such
CODEX
The Codex Guidelines on Nutrition Labelling (CAC/GL 2-1985(Rev.1 –
1993)) state in the section 3.5 Tolerances and Compliancethat;
• Tolerance limits should be set in relation to public health concerns,shelf-life,
accuracy of analysis, processing variability and inherent labilityand variability
of the nutrient in the product, and, according to whether the nutrienthas been
• The values used in nutrient declaration should be weightedaverage values
derived from data specifically obtained from analyses ofproducts which are
• In those cases where a product is subject to a Codex standard,requirements for
tolerances for nutrient declaration established by the standardshould take
Page 16
Member States' Approaches
Some Member States have provided guidance on tolerances fornutrient
declarations, (examples from Denmark and the UK are set outin Annex 3). For
macronutrients, both examples follow a similar general approach, withthe acceptable
level of tolerance decreasing as the level of the macronutrient ina product increases.
The actual guideline figures are different, but not dissimilar.For example, for a
product that declares 25% fat, the Danish tolerance will be ±15% andthe UK ±20%.
For added vitamins and minerals, the Danish guidance allows 80-150%of the
declared value (to take into account the loss of nutrient over time).It also notes the
importance of the actual nutrient content being within tolerancelimits during the
whole shelf life period, and that if there are minimum and maximumlimits prescribed
in legislation then the analysed amount must not exceed these.The UK takes a
different approach, providing tolerances for water soluble vitamins and minerals
(+100% or -50% of the declared value) and oil soluble vitamins (±30%).
27.
It is interesting to contrast the Danish and UK guidance with thatprovided by
9
legislation passed in 2003 that will require most prepackaged foodsin Canada to bear
a Nutrition Facts table. Whilst the acceptable tolerance is basicallysimilar, i.e. ±20%,
the actual guidance is much more prescriptive, being based on asound statistical
framework. The purpose being to ensure the industry has a high probabilityof a label
declaration being within the tolerance, whilst the consumer wouldhave an equally
high probability that that the label declaration accurately reflectsthe nutrient content
of the food. This statistical approachtakes into account nutrient variability in foods as
well as method variability. Annex 4 summarises the Canadiansystem, which in
addition to setting tolerances also provides rounding rules for nutrientdeclarations
Questions on which the Commission seeks comments
• What are the important factors to take into account insetting tolerances for
• Is a ‘simple’ (e.g. UK/Danish approach) or ‘complex’ (e.g.Canadian) system
preferred? What are the benefits and disadvantages of each?
• Should different tolerances be set for different product categories?In particular,
how should the issue of adding overages for some vitamins to takeaccount of
• How should products with inherent variability or seasonal variation,such as fresh
9
http://www.inspection.gc.ca/english/fssa/labeti/nutricon/nutricone.pdf
11
Comparison of Reference Labelling Values
Labelling
SCF Report 2003
SCF Report 2003
(6 months to 4
Vitamins
1
1.4
0.5
2
1.6
0.7
18
7
6
2
0.7
200
125
12
1
0.8
60
45
equivalents)
800
D (µg)
5
E (mg)
12
K (µg)
75
Pantothenic acid (mg)
6
Biotin (µg)
50
Minerals
800
550
800
550
-
1000
-
400
-
500
14
8
15
5
-
0.5
150
80
-
20
300
80
-
1.2
-
20
-
25
-
0.7
12
Definition and properties of dietary fibre
th
'Definition:
1
lower than 3 which are neither digested nor absorbed in the smallintestine. A degree
of polymerisation not lower than 3 is intended to exclude mono- anddisaccharides. It
is not intended to reflect the average DP of a mixture. Dietary fibreconsists of one or
• Edible carbohydrate polymers naturally occurring in the food as
• carbohydrate polymers, which have been obtained from food raw
material by physical, enzymatic or chemical means,.
Properties:
• Decrease intestinal transit time and increase stools bulk
• Reduce blood total and/or LDL cholesterol levels
• Reduce post-prandial blood glucose and /or insulin levels.
With the exception of non-digestible edible carbohydrate polymersnaturally
occurring in foods as consumed where a declaration or claim is madewith respect to
dietary fibre, a physiological effect should be scientifically demonstratedby clinical
studies and other studies as appropriate. The establishmentof criteria to quantify
physiological effects is left to national authorities.
1
When derived from a plant origin, dietary fibre may include fractionsof lignin and/or other
compounds when associated with polysaccharides in the plant cell wallsand if these compounds are
quantified by the AOAC gravimetric analytical method for dietary fibreanalysis : Fractions of lignin
and the other compounds (proteic fractions, phenolic compounds,waxes, saponins, phytates, cutin,
phytosterols, etc.) intimately 'associated' with plantpolysaccharides are often extracted with the
polysaccharides in the AOAC 991.43 method. These substances are includedin the definition of fibre
insofar as they are actually associated with the poly- or oligo-saccharidicfraction of fibre. However,
when extracted or even re-introduced into a foodcontaining non digestible polysaccharides, they
cannot be defined as dietary fibre. When combined with polysaccharides,these associated substances
Page 19
ANNEX 3
Examples of Member States' Guidance on Tolerances for Nutrition
10
The following limits, including analytical uncertainty, regardingmacronutrients are at
Nutrient
Tolerance
Carbohydrate
Sugars
Dietary fibres
≤ 10 g per 100 g
≥ 40 g per 100 g
+/- 15 %
Fatty acids (sum of
monounsaturated
0,5 – 3,5 g per 100 g
+/- 0,5 g
Na
+/- 15 %
in general
For naturally occurring vitamins and minerals a tolerance of+/- 25%, exclusive
analytical uncertainty, calculated at a 99% confidential level.
For added vitamins and minerals we have experienced from many yearsof analytical
control of food supplements andfoods for special dietary purposes, a necessity to
accept asymmetrical margins of tolerance. In dialogue with manufacturers and
analytical experts, we have accepted a tolerance of 80 – 150 % foradded vitamins and
minerals, exclusive analytical uncertainty calculated at a 95% confidencelevel. The
loss of nutrient over time is one of the arguments for acceptingasymmetrical
tolerance limits. It is important that the actual nutrient contentis within tolerance
limits during the whole shelf life period. More narrow limitscould be discussed
concerning minerals. If legislation prescribes minimum and maximum values for
addition of nutrients, the analysed amount must not exceed these limits.
provided as part of Member States' comments to the Commission’s 2003consultation on revision of
Page 20
United Kingdom
For Major Parameters: Protein, Fat, Carbohydrates (including sugars)
Declared Values
More than 2% and less than 5%
Recommended Tolerance
+/- 30% of the declared value
individual circumstances
Note 1 : For Fibre note the figure is for the AOAC method.
Note 2 : For values above 5% seasonal/natural variability should beconsidered for meat, for example,
Note 3 : For wholemeal cereal products and saturated fats higher tolerancesmay apply
For Vitamins and Minerals (note these tolerances apply only tonon-liquid
Type of Nutrient
Water Soluble Vitamins, i.e. B Vitamins Group
and minerals declared value
+/- 30% of the declared value
Note 1 : For certain heat treated products, e.g. confectionery, vitaminlosses are compensated for by
Page 21
Sampling Plan and Tolerances Fro
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