Transcript Directive 2009-39

Directive 2009/39/EC on
PARNUTS
Directive 1999/21/EC on
dietary foods for special
medical purposes (FSMPs)
Martijn Martena, PhD
Netherlands Food and Consumer
Product Safety Authority
Utrecht, the Netherlands
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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Directives 1999/21/EC: Foods for special medical purposes
(FSMPs)
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Dietary foods for special medical purposes
1999/21/EC
Category of PARNUTS, specially processed for
dietary management of patients and to be used
under medical supervision intended for the
exclusive or partial feeding of patients with:
limited, impaired or disturbed capacity to take, digest,
absorb, metabolise or excrete ordinary foodstuffs,
nutrients or metabolites or other medically-determined
nutrient requirements
whose dietary management cannot be achieved by
modification of diet or with other PARNUTS
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FSMP categories
a) nutritionally complete foods with standard nutrient formulation
as sole source of nourishment and may also be used as partial
replacement or supplement
b) nutritionally complete foods with nutrient-adapted formulation
specific for a disease, disorder, or medical condition and may
also be used as sole nourishment, partial replacement or
supplement
c) nutritionally incomplete foods with standard or nutrientadapted formulation specific for a disease, disorder, or medical
condition, not suitable as sole source of nourishment
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Dietary foods for special medical purposes
• Mandatory elements in the labelling
• Composition (a.o. energy, carbohydrate, protein fat, vitamins,
minerals)
• Instructions for use
• the content of components the declaration of which would be
necessary for the appropriate use
• statement “For the dietary management of…….” (disease,
disorder or medical condition)
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Dietary foods for special medical purposes
• Mandatory elements in the labelling (continued)
• description of the properties and/or characteristics that make
the product useful, relating to nutrients which have been
increased, reduced etc.
 Example: a FSMP for patients with constipation

high fiber (making the product useful for the patient): not a nutrition
claim, outside the scope of Directive 1924/2006
high protein (not directly related to the usefulness of the food for
special medical purposes, valid for a healthy individual): nutrition claim
under the scope of 1924/2006.
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Trade name FSMPs
The products can only be sold under the name
“dietary foods for special medical purposes”
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Labelling FSMPs
Preceded by the words “important notice”
• that product must be used under medical supervision
• whether product is suitable as sole source of nourishment
• intended for specific age group, as appropriate
• that product poses a health hazard when consumed by persons for
which the product is not intended
These indications are sometimes omitted
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Labelling FSMPs
• statement “For the dietary management of…….” (disease, disorder
or medical condition) ! not to treat, cure or prevent !
• where appropriate a statement concerning precautions or contraindications
• description of the properties and/or characteristics that make the
product useful, relating to nutrients which have been increased,
reduced etc.
• where appropriate that product is not for parenteral use
• instructions for appropriate preparation, use and storage
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Official monitoring FSMPs
• notification of the competent authority of the MS prior to market
introduction by forwarding to it a model of the label used for the
product
• Member States may choose not to impose this obligation
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Practical problems FSMPs
Fish oil capsules for the dietetic treatment of ADHD
Sugar cane extract tablets for the dietetic treatment of high
cholesterol
Cinnamon capsules for the dietetic treatment of diabetes
Vitamin tablets for the dietetic support of diabetes patients
Probiotic mixture to ‘fortify’ breast milk as a dietetic means to
prevent allergy in infants
FSMP for infants similar to infant formulae specially for cramps
(disease?)
Are these products FSMPs?
Possible solution: assess the scientific validity
This requires specialist knowledge however
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borderline problems
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Products which have similarities with PARNUTS
Functional or fortified foods
Food supplements including botanicals
Novel foods
Medical devices
Medicinal products incl. herbal medicines
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Fortified foods
Many foods are fortified with with ‘functional’ ingredients
such as vitamins, minerals including trace elements, amino
acids, essential fatty acids, fibre, various plants and herbal
extracts.
This fortification is often aimed at maintaining optimal health
and well-being
Fortified foods covered by Regulation (EC) No 1925/2006 of
the European Parliament and of the Council of 20 December
2006 on the addition of vitamins and minerals and of certain
other substances to foods
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