Transcript Directive 96-8-EC on Foods for use

Directive 2009/39/EC on
PARNUTS
Directive 96/8/EC on
Foods for use in energyrestricted diets for weight
reduction
Martijn Martena, PhD
Netherlands Food and
Consumer Product Safety
Authority
Utrecht, the Netherlands
Belgrade 19-20 March 2012
Topics
 2009/39/EC: Foodstuffs intended for particular
nutritional uses
 96/8/EC: Food intended for use in energy-restricted diets
for weight reduction
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Workshop on PARNUTS - Belgrade, 19-20 March 2012
PARNUTS
Directive 2009/39/EC of the European Parliament and of the
Council of 6 May 2009 on foodstuffs intended for particular
nutritional uses
Directive 2009/39/EC is a recast of
•Council Directive 89/398/EEC of 3 May 1989 on the
approximation of the laws of the Member States relating to
foodstuffs intended for particular nutritional uses
•because of many amendments
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Workshop on PARNUTS - Belgrade, 19-20 March 2012
Definition PARNUTS
•Foodstuffs intended for particular nutritional uses (PARNUTS)
are foodstuffs which, owing to their special composition or
manufacturing process, are:
•clearly distinguishable from foodstuffs for normal
consumption
•suitable for their claimed nutritional purposes
•marketed as suitable for particular nutritional purposes
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Workshop on PARNUTS - Belgrade, 19-20 March 2012
User groups of PARNUTS
PARNUTS should meet requirements of:
i
Persons whose digestive processes or metabolism are disturbed
ii Persons in a special physiological condition who benefit
especially from controlled consumption of certain substances in
foodstuffs
iii Infants or young children in good health
only i and ii may be called ‘dietetic’ or ‘dietary’ products
•
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normal foods cannot be presented as PARNUTS through the use
of the words ‘dietetic’ or ‘dietary’ or in any other way
Workshop on PARNUTS - Belgrade, 19-20 March 2012
Groups of PARNUTS
Existing Directives:
1. Infant formulae and follow-on formulae (Directive
2006/141/EC)
2. Processed cereal-based foods and baby foods for infants
and young children (Directive 2006/125/EC)
3. Food intended for use in energy-restricted diets for
weight reduction (Directive 96/8/EC)
4. Dietary foods for special medical purposes (Directive
1999/21/EC)
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Workshop on PARNUTS - Belgrade, 19-20 March 2012
Groups of PARNUTS
Directives not yet introduced:
• 1. Foods intended to meet the expenditure of intense
muscular effort, especially for sportsmen;
• 2. Foods for persons suffering from carbohydratemetabolism disorders (diabetes)
(article 3 and annex I)
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Labelling PARNUTS (1)
•Conditions for claims concerning the absence of gluten or
absence/ reduction of sodium are to be defined by the
Commission
•(article 5)
•Regulation (EC) No 41/2009 of 20 January concerning the
composition and labelling of foodstuffs suitable for people
intolerant to gluten
•applies since 1 January 2012
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Workshop on PARNUTS - Belgrade, 19-20 March 2012
Labelling PARNUTS (2)
•In labelling, presentation or advertising of PARNUTS no
properties for the prevention, treatment or cure of human
disease may be used or suggested
•derogation for information to persons with qualifications in
medicine, nutrition or pharmacy!
•(article 8)
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Workshop on PARNUTS - Belgrade, 19-20 March 2012
Labelling PARNUTS (3)
Labelling must include
• Indication of its particular nutritional characteristics
• very important: this indication is mandatory and is therefore not
covered by Regulation No. 1924/2006
Products for which no specific Directive has been adopted:
• composition particulars or special manufacturing process that
provides it with its particular nutritional characteristics
• energy in kJ and kcal, carbohydrates, fat, protein per 100g or ml
• if energy <50kJ words may be used:energy value less than 50 kJ
(article 9)
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Packaging
• Products only allowed on retail market in pre-packaged form
• Package shall completely cover products
• Member States may permit derogations, provided that product is
accompanied by obligatory labelling conditions
(article 10)
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Notification
For PARNUTS which do not fit one of existing categories:
When placed on the market for the first time the competent
authority in that Member State must be notified by sending the label
At each subsequent placing on the market in other Member States
the same information including the initial notification has to be sent
to the competent authority
The producer must present scientific data proving the suitability for
the intended goal and the beneficial effects of the product
(article 11)
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Workshop on PARNUTS - Belgrade, 19-20 March 2012
Composition
Addition of nutritional substances to PARNUTS is controlled by:
• positive lists included in the specific directives
• Directive Regulation (EC) No 953/2009 (applies since 1 January
2010)
• contains lists of permitted minerals, vitamins, amino acids,
carnitine and taurine, nucleotides, choline and inositol
The addition must meet the special requirements of the users and is
based on scientific data (to be presented when desired)
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Workshop on PARNUTS - Belgrade, 19-20 March 2012
Topics
 2009/39/EC: Foodstuffs intended for particular nutritional
uses
 96/8/EC: Food intended for use in energy-restricted
diets for weight reduction
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Workshop on PARNUTS - Belgrade, 19-20 March 2012
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Workshop on PARNUTS - Belgrade, 19-20 March 2012
Foods for use in energy-restricted diets
for weight reduction (96/8/EC)
Divided in:
•products presented as a replacement for the whole of the
daily diet
• =>labelling: “total diet replacement for weight control”
•products presented as a replacement for one or more meals
of the daily diet
• => labelling: “meal replacement for weight control”
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meal replacement for weight control?
Green Coffee
1000: instant coffee
with botanicals
“1000 years history
with Asian wisdom
for healthy weight
loss”
Products are not covered by Directive 96/8/EC but by the food
supplements directive 2002/ 46/EC
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Composition
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(annex 1)
Replacement
whole diet
Replacement of
1 or more meals
Energy
800 » product « 1200
kcal/d
200 »product « 400
kcal/d
Protein
25% » product « 50%
of energy + « 125g
25% » product « 50%
of energy
Fat
« 30% of energy +
linoleic acid » 4.5 g
« 30% of energy +
linoleic acid » 1 g
Dietary fibre
10 g » product « 30g
Vitamins and
minerals
100% of amounts of
table 1
30% of amounts of
table 1 + K » 500 mg
per meal
Workshop on PARNUTS - Belgrade, 19-20 March 2012
Labelling(1)
In addition to art 3 of labelling Directive 2000/13/EC (current
labelling directive which replaced Directive 79/112/EEC):
•energy in kcal and kJ, protein, carbohydrates, fat,
expressed per quantity for consumption
•minerals and vitamins as stipulated per quantity for
consumption; for meal replacement also as % of RDA
(Directive 90/496/EEC, nutrition labelling)
•Directives 2000/13/EC and 90/496/EEC will be replaced by
Regulation No. 1169/2011, which will apply starting 13
December 2014
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Workshop on PARNUTS - Belgrade, 19-20 March 2012
Labelling(2)
•instructions for appropriate preparation + statement of
importance of following these instructions
•statement of laxative effect if polyols > 20 g/day
•statement of importance of maintaining adequate daily fluid
intake
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Labelling(3)
Compulsory statements
for total diet replacement products:
• that it provides adequate amounts of nutrients/ d
• that it should not be used for more than 3 weeks without medical
advice
for meal replacement products:
• use only as part of energy-restricted diet that includes other
foodstuffs
No references to rate or amount of weight loss
Claims regarding reduction of hunger or increase of satiety are
allowed by Regulation No. 1924/2006 on nutrition and health claims
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Workshop on PARNUTS - Belgrade, 19-20 March 2012
Claims on foods intended for use in energy-restricted
diets for weight reduction (96/8/EC) in relation to
Regulation No. 1924/2006
For foods intended for use in energy-restricted diets for
weight reduction, no specific provisions on the use of nutrition
and health claims are laid down in Directive 96/8/EC.
Thus, nutrition and health claims made on foods intended for
use in energy-restricted diets for weight reduction are
governed by Regulation No. 1924/2006 on nutrition and
health claims.
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Workshop on PARNUTS - Belgrade, 19-20 March 2012