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HORIZONTAL and VERTICAL
LEGISLATION ON PARNUTS
ON PARNUTS
Vasilis Gkantzios
Veterinarian MSc
GREEK FOOD AUTHORITY
Belgrade 24 Nov 2011
Main topics of presentation…

Definitions – common language

General Rules and Production
Standards

Sections of specific legislation
Definition PARNUTS
Foodstuffs,
•
clearly distinguishable from normal
foodstuffs owing to their special
composition or manufacturing process
•
suitable for their claimed nutritional
purposes
•
marketed as suitable for particular
nutritional purposes
1. Infant formulae
2. Follow up milk and other follow up foods and
baby foods
3. Low/reduced energy foods for weight control
4. Dietary foods for special medical purposes
5. Low-sodium foods (including dietary salts)
6. Gluten-free foods
7. Foods intended especially for sportsmen
8. Foods for persons suffering from
carbohydrate-metabolism disorders
(diabetes)
General legislation
Regulation (EC) No.
178/2002
Article 3
 General objectives
 Food law shall pursue one or more of the
general objectives of a high level of
protection of human life and health and
the protection of consumers' interests,
including fair practices in food trade, taking
account of, where appropriate, the protection
of animal health and welfare, plant health
and the environment.
Medical claims on all foods
Foods with medical claims are considered medicines,
food law does not apply
The labelling and methods used must not attribute to
any foodstuff the property of preventing, treating or
curing a human disease, or refer to such properties
These prohibitions also apply to:
a)
the presentation of foodstuffs (shape, appearance
or packaging), the way in which they are arranged
and the setting in which they are displayed
b)
advertising
Rules on labelling, presentation
and advertising
Foodstuffs intended for particular nutritional
uses which have not been regulated by a
specific directive shall comply with the of
foodstuffs for general consumption:
 Labelling Directive 2000/13/EC,
 Nutrition Labelling Directive 90/496/EC
 Addition of Vitamins and Minerals to
foodstuffs 1925/2006/EC.
Compulsory labelling
TOP 10
1.
2.
3.
4.
5.
6.
Name under which product is sold*
List of ingredients
Name or Business name and address of
manufacturer or packager, or of seller in the EU
Net quantity*
Date of minimum durability*
Actual alcoholic strength of beverages >1.2%
alcohol by volume*
*Must appear in the same field of vision
Compulsory Labelling
TOP 10
7.
8.
9.
10.
Special storage instructions/conditions of
use
Origin – if absence misleads the consumer
Instructions for use where necessary
Quantity of certain ingredients (QUID)
Dir 2000/13 on labelling

The labelling and methods used must not
mislead the purchaser:



(i) as to the characteristics of the foodstuff and,
in particular, as to its nature, identity, properties,
composition, quantity, durability, origin or
provenance, method of manufacture or
production;
(ii) by attributing to the foodstuff effects or
properties which it does not possess;
(iii) by suggesting that the foodstuff possesses
special characteristics
Dir 2000/13
No medicinal claims on food

contain medicinal products in significant
quantities


however food and medicine may contain same
ingredients like glucose, guar gum
be claimed to prevent, treat or cure diseases

referrals to the relief of symptoms is not allowed
either
Horizontal provisions
Directive 2009/39/EC on Foodstuffs
Intended for Particular Nutritional Uses
Approximation of National laws through:
 Common definitions
 Defined product composition
 Standards on products nature
 Common notification procedures
 Labelling rules
User groups of PARNUTS
Products should meet requirements of:
1. Persons whose digestive processes or
metabolism are disturbed
2. Persons in a special physiological condition
especially benefiting from controlled
consumption of certain substances in foodstuffs
3. Infants or young children in good health
only i and ii may be called ‘dietetic’ or ‘dietary’
products
In the labelling of foodstuffs for
normal consumption is prohibited:


the use of the adjectives ‘dietetic’ or
‘dietary’ either alone or in conjunction
with other words, to designate those
foodstuffs
other markings or any presentation
likely to give the impression that it a
product for particular nutritional use
Specific requirements for
Parnuts

essential requirements as to the nature or
composition of the products

provisions regarding the quality of raw materials

list of specific additives

provision on labelling, presentation and advertising
Labelling requirements





Only pre-packaged products
Nutritional characteristics must
accompany the designation of products
Detailed nutritional composition
Particular elements or special
manufacture process must be labeled
Specific labelling requirements for
products under specific directives
Notification


Detailed provisions in specific legislation
For products that do not belong to Annex I



Notification of model of label when marketed for
first time (even if marketed in another MS)
Qualitative or quantitative information
Scientific substantiation of nutritional
characteristics
Rules to come…

list of substances to be added to Parnuts and the
purity criteria applicable to them

conditions of use

provisions for foodstuffs for normal consumption
that are suitable for a particular nutritional use

special provisions for foods for persons with
diabetes

use of terms concerning the reduction or absence
of sodium or salt content or the absence of gluten
Category specific
legislation
Annex I of Directive 2009/39/EC


In addition to the framework directive, which
established the basic rules for the dietetic
foods, for certain dietetic foods categories
have been established detailed specific
directives.
These additional provisions mainly relate to
the nature or the composition of these
products and to the labeling requirements
These so-called vertical directives cover
the following categories of foods (1):

Infant Formulae and Follow-on Formulae covered
by Commission Directive 2006/141/EC

Processed Cereal-based foods and baby foods for
infants and young children is covered by
Commission Directive 2006/125/EC

Foods intended for weight reduction is covered by
Commission Directive 96/8/EC

Dietary Foods for Special Medical Purposes is
covered by Commission Directive 1999/21/EC.
These so-called vertical directives cover
the following categories of foods (2):

foods intended to meet the
expenditure of intense muscular effort,
especially for sportsmen

Foods for persons suffering from
carbohydrate metabolism disorders
(diabetes).
Infant formula and follow-on
formula
‘infant formulae’ means foodstuffs intended for
particular nutritional use by infants during
the first months of life and satisfying by
themselves the nutritional requirements of
such infants until the introduction of
appropriate complementary feeding
‘follow-on formulae’ means foodstuffs intended
for particular nutritional use by infants when
appropriate complementary feeding is
introduced and constituting the principal
liquid element in a progressively diversified
diet of such infants
Gluten – free category of foods


The ‘gluten-free’ and ‘very low gluten’ foods
category are covered by the stand alone
Regulation 41/2009/EC concerning the
composition and labelling of foodstuffs
suitable for people intolerant to gluten.
This Regulation was drafted in order to help
meet the needs of the people with coeliac
disease who are a specific group of
population suffering from a permanent
intolerance to gluten.
Foods for persons suffering from
diabetes

Commission has not yet given any
specific directive for foods for persons
suffering from diabetes

There is only Report from the
Commission to the European Parliament
and the Council from the year 2008
Conclusions in the report

There are no scientific grounds for specific
compositional criteria for foods for particular nutritional uses in people with diabetes

People with diabetes should be able to
meet their diatary needs from normal foods
Foods for sportsmen

Commission has not yet given any specific
directive for foods for sportsmen

There is only Report of the Scientific
Committee for food from the year 2001 on
composition and specifications

In this report four food categories for sportsmen
have been identified
Carbohydrate rich energy
products

Carbohydrate intake is essential in all types of
exercise lasting longer than one hour

High glyacemic index carbohydrates foods are
recommended and they should provide 10 g
per kg during 24-h recovery

The refuelling should begin immediatelly after
the exercise
Carbohydrate-electrolyte drinks

During prolonged exercise drinks containing
carbohydrate and electrolytes improve the
performance

The only electrolyte added to drinks that is
known to give benefit is sodium (460-1150
mg/l)

The optimum carbohydrate concentration in the
drink is 80-350 kcal/1000 ml
Protein rich products

Atheletes continue to believe, that extra protein
intake is essential for maximal
performance.There is not much evidence to
support this.

The protein requirement for strength athletes,
who have trained for years, is not higher than 1,0
– 1,2 g/per kgbw per day
Supplemented foods



There is no scientific evidence, that additional
supplementation of minerals and vitamins is
needed
Only for caffeine and creatine there is scientific
data to show they have some effect.
Caffeine levels of 3-8 mg/kgbw and creatine
levels of 2-3 g per day improve short-term
performance
Addition of nutrients to
PARNUTs


A number of nutritional substances such as
vitamins, minerals, amino acids and others may be
added to foods for particular nutritional uses in
order to ensure that the particular nutritional
requirements of the persons for whom those foods
are intended are fulfilled and/ or in order to satisfy
the legal requirements laid down in specific
directives adopted pursuant to Article 4(1) of
Directive 2009/39/EC.
These nutritional substances are regulated by the
Commission Regulation (EC) No 953/2009 of 13
October 2009 on substances that may be added
for specific nutritional purposes in foods for
particular nutritional uses
Products which have
similarities with PARNUTS
Functional or fortified foods
 Food supplements
 Novel foods
 Medical devices
 Medicinal products incl. herbal medicines

THANK YOU!!