COMMISSION OF THE EUROPEAN COMMUNITIES 
C0M(94) 475 final 
Brussels,07.11.1994 
Report from the Commission 
to 
the Council and to the European Parliament 
Implementation of Article 9 of 
Council Directive 89/398/EEC 
on the approximation of the laws of the Member States 
relating to foodstuffs intended for particular nutritional uses 
Report from the Commission 
to 
the Council and to the European Parliament 
Implementation of Article 9 of 
Council Directive 89/398/EEC 
on the approximation of the laws of the Member States 
relating to foodstuffs intended for particular nutritional uses 
1. Council Directive 89/398/EEC was adopted on 3 May 1989 and notified to Member States 
on 16 May 1989. 
2. The directive sets out the definition for these products as well as provisions concerning 
their labelling, presentation and advertising. It further provides for the adoption of specific 
provisions for a number of groups of such products as listed in its Annex I, by means of 
specific Commission Directives. 
3. Foods for particular nutritional uses (dietetic foods) not belonging to the groups listed in 
Annex I can be marketed in the Community provided they fulfill the requirements set out in 
the directive. Given however the nature of the products, it was important to provide a 
mechanism which would permit their efficient official monitoring. 
4. This mechanism is set out in Article 9 of the directive. For reasons of clarity the relevant 
text is reproduced below: 
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" 1. When a product as reffered to above (i.e. non-Annex I) is placed on the market for the first 
time the manufacturera or, where a product is manufactured in a third State, the importer, 
shall notify the competent authority of the Member State where the product is being marketed 
by forwarding it a model of the label used for the product. 
2. Where the same product is subsequently placed on the market in another Member State the 
manufacturer or, where appropriate, the importer, shall provide the competent authority of that 
Member State with the same information, together with an indication of the recipient of the 
first notification. 
3. Where necessary, the competent authority shall be empowered to require the manufacturer 
or, where appropriate, the importer, to produce the scientific work and the data establishing 
the product's compliance with Article 1 (2) together with the information provided for in 
Article 7 (3) (a). If such work is contained in a readily available publication, a mere reference 
to this publication shall suffice." 
Article 9 also provided that Member States communicate to the Commission the identity of 
the competent authorities where the notifications were to be sent. 
The Commission in accordance with the requirements of the directive published the list of the 
competent authorities in the Official Journal of the European Communities1. 
The Commission has gathered information on the implementation of this article. This 
information was provided by Member States and other interested parties. The information 
received was dated during a period ranging from June 1993 to January 1994 ( with 
clarifications received up to April 1994). 
lOlC imofWMA993,p. 6 
an(*0JC273ofm*0J993,ix 10 
The following table summarizes the situation: 
Member State B DK GR DE ES F IE IT L N P UK 
Notifications 0 0 0 0 1006 34 0 680 0 4 11 -
(Total) 
Some comments are necessary to clarify the above figures. It was felt best to provide more 
information where available per Member State. 
Spain 
333 products have been classified by the authorities as products complying with directive 
89/398/EEC but not included in the products listed in its Annex I. These products are not 
further characterised. 673 of the products are classified as not being in conformity with 
directive 89/398/EEC. In their vast majority they comprise products containing mainly 
vitamins, minerals, trace elements, amino-acids and extracts of medicinal plants alone or in 
combination which in Spain are considered as pharmaceutical specialities and have to appear 
on a special register. 
Italy 
253 products of those notified are table-top sweeteners or products containing artificial 
sweeteners. The vast majority of the remainder are diet integrators containing vitamins, 
minerals, amino-acids, essential fatty acids, proteins and dietary fibre, alone or in 
combination. 
Portugal 
Products notified included non-alcoholic drinks, chewing gum and foofstuffs without addition 
of sugars and a table-top sweetener. 
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France 
Notifications concerned products intended for low birthweight infants, pregnant and 
breastfeeding women, growing children, milk based products for young children, specialized 
fibre products and product containing medium chain triglycerides. 
The Netherlands 
All products notified were low lactose products. 
United Kingdom 
Due to a decentralised system of notification figures for this Member State were not available. 
From the above it is obvious that the majority of the products notified were either products 
containing artificial sweeteners or diet integrators/food supplements containing vitamins, 
minerals, trace elements, amino-acids, etc. Forthcoming Community legislation on 
sweeteners will take care of the former products while the vast majority of the latter are not 
usually intended for the particular nutritional needs of specific categories of persons and 
therefore should not be considered as being included in the field of application of Directive 
89/398/EEC. 
The remaining products which were notified were few in number and indeed in many Member 
States no products were notified at all. This is mainly attributed to the fact that nearly all 
dietetic products on the market belong to one of the groups of products listed in Annex I of 
directive 89/398/EEC and as such are not subject to the notification procedure prescribed by 
Article 9 of the directive. 
The Commission is to this date not aware of any problems with the notification procedures 
itself. Indeed the comments received by Industry are positive. Therefore the Commission has 
no reason whatsoever to propose any changes to it. 
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BSN 0254-1475 
COM(94) 475 final 
DOCUMENTS 
EN 
Catalogue number : CB-CO-94-500-EN-C 
ISBN 92-77-81578-7 
Office for Officiai Publications of the European Communities 
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