COMMISSION OF THE EUROPEAN COMMUNITIES 
Brussels, 29.11.1995 
COM(95) 588 final 
94/0076 (COD) 
Amended proposal for a 
EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE 
amending Directive 89/398/EEC on the approximation of the laws of Member States relating to 
foodstuffs intended for particular nutritional uses 
(presented by the Commission pursuant to Article 189 a (2) 
of the EC-Treaty) 

Explanatory memorandum 
In response to the opinion of the European Parliament1 delivered on 11 October 1995 on the 
proposal for a European Parliament and Council Directive amending Directive 89/398/EEC on 
the approximation of the laws of Member States relating to foodstuffs intended for particular 
nutritional uses2 which aimed to modify the list of groups of foods for particular nutritional uses 
for which specific directives shall be adopted, and in accordance with article 189A of the EC 
Treaty, the Commission has decided to amend the above mentioned proposal. 
The Commission has accepted the amendments relating to : 
- the introduction of a new recital referring to the agreement on a "modus vivendi" between the 
European Parliament, the Council and the Commission (amendment 1). 
- the inclusion of foods for persons suffering from carbohydrate metabolism disorders 
(diabetes) in the groups of foods listed in Annex I for which specific provisions will be laid 
down by specific directives (amendment 18 in part, amendment 16 in part). 
- defining the conditions for the use of the terms low-sodium, reduced-sodium and sodium-free 
and gluten-free for dietetic foods where the scientific basis for doing so is available (the 
principle of amendment 17). 
- recalling in the recitals that it remains possible to harmonise other rules for other groups of 
foods for particular nutritional uses (amendment 4) 
The Commission did not accept the amendments concerning : 
- the inclusion of low-sodium foods and gluten-free foods in the groups of foods listed in 
Annex I for which specific directives shall be adopted (amendments 18 in part, amendment 
without number on a separate vote, amendment 16 in part). The Commission maintains that 
such specific directives are not necessary for the reasons it has explained in its original 
proposal and because in addition now it has accepted to define the conditions under which the 
terms relating to sodium and gluten content can be used. 
- the pesticide levels and residues in infant formulae and baby foods because this is not the 
appropriate directive for such references to be made (amendments 9 and, 10 and 16). 
- the addition of a new paragraph in article 4 stating that new groups of foods for particular 
nutritional uses may be added in Annex I (amendment 5). This is the case now and would be 
superfluous to have it in the articles. An amendment (n° 4) for a recital on this point has been 
accepted. 
1 O.J 
2 O.J. N° C108 16.04.1994, p. 17 
I 
creation of a new Annex la comprising allowed claims for dietetic foods (amendment 6). 
There are no suggestion for any specific claims to appear in that Annex, therefore the 
Commission considers it unnecessary. 
3 
In response to the opinion of the European Parliament3 delivered on 11 October 1995 on the 
proposal for a European Parliament and Council Directive amending Directive 89/398/EEC on 
the approximation of the laws of the Member States relating to foodstuffs intended for particular 
nutritional uses4 and in accordance with Article 189A of the EC Treaty, the Commission has 
decided to amend the above proposal as follows : 
Original proposal Amended proposal 
1. The following new recital is added after the 
first recital : 
Whereas an agreement on a 'modus vivendi' 
between the European Parliament, the Council 
and the Commission concerning the 
implementing measures for acts adopted in 
accordance with the procedure laid down in 
Article 189b of the EC Treaty was reached on 
20 December 1994 
2. The second recital is amended as follows : 
Whereas to date such a Directive relating to Whereas to date such a Directive relating to 
infant formulae and follow-on formulae has infant formulae and follow-on formulae has 
been adopted; been adopted; 
whereas there are reasons relating to public whereas there are reasons relating to public 
health for adopting specific provisions, in health for adopting specific provisions, in 
accordance with Article 4 of Directive accordance with Article 4 of Directive 
89/398/EEC, for cereal based foods and baby 89/398/EEC, for cereal based foods and baby 
foods intended for infants and young children, foods intended for infants and young children, 
foods for weight control diets and foods for foods for weight control diets, foods for 
special medical purposes foreseen in Annex I special medical purposes and foods for 
to the said Directive; persons suffering from carbohydrate 
metabolism disorders (diabetes"! foreseen in 
Annex I to the said Directive. 
3 O.J 
4 O.J. N°C108 16.04.1994, p. 17 
Whereas the same imperative reasons for 
adopting specific provisions for the other 
groups listed in Annex I to Directive 
89/398/EEC namely low-sodium foods, 
including low-sodium or sodium-free dietary 
salts, gluten-free foods, foods intended to 
meet the expenditure of intense muscular 
effort, especially for sportsmen and foods for 
persons suffering from carbohydrate 
metabolism disorders (diabetes) cannot be put 
forward; whereas such products can be 
adequately marketed and be efficiently 
monitored officially under the general 
provisions of Directive 89/398/EEC. 3. The third recital is amended as follows : 
Whereas the same imperative reasons for 
adopting specific provisions for the other 
groups listed in Annex I to Directive 
89/398/EEC namely low-sodium foods, 
including low-sodium or sodium-free dietary 
salts, gluten-free foods, and foods intended to 
meet the expenditure of intense muscular 
effort, especially for sportsmen cannot be put 
forward; whereas such products can be 
adequately marketed and be efficiently 
monitored officially under the general 
provisions of Directive 89/398/EEC provided 
that the conditions for the use of certain terms 
used to indicate the particular nutritional 
property of products arc defined-
4. The following new recital is added after 
the last recital 
Whereas it remains possible tô harmonise at 
Community level rules for other groups of 
foods for particular nutritional uses, as 
necessary, in the interest of consumer 
protection and free movement of such 
foodstuffs, 
Article \ 
Directive 89/398/EEC is amended as follows : 
1. The following article 4a is inserted in 
directive S9/398/EEC 
"Article 4a 
The conditions under which the terms 
concerning 
- reduction or absence of sodium (salt) 
content 
- absence of gluten (gluten free) 
may be used to describe the products 
referred to in Article 1 shall be adopted in 
accordance with the procedure laid down 
in Article 13" 
Annex I to directive 89/398/EEC_ojUhe_ 2. Annex I to directive 89/398/EEC is hereby 
approximation of the laws of the Member replaced by the following : 
States relating to foodstuffs intended for 
particular nutritional uses is hereby 
replaced by the following : 
"ANNEX 1 
Groups of foods for particular nutritional 
uses for which specific provisions will be 
laid down by specific directives1 "ANNEX 1 
Groups of foods for particular nutritional 
uses for which specific provisions will be 
laid down by specific directives1 
1. Infant formulae and follow-on formulae 
2. Cereal based foods and baby foods 
3. Food intended for weight control diets 
4. Dietary foods for special medical 
purposes 1. Infant formulae and follow-on formulae 
2. Cereal based foods and baby foods 
3. Food intended for weight control diets 
4. Dietary foods for special medical 
purposes 
5. Foods for persons suffering from 
carbohydrate metabolism disorders 
(diabetes) 
It is understood that products already on the market when 
the Directive is adopted will not be affected by it" 1 It is understood that products already on the market 
when the Directive is adopted will not be affected by 
C 
ISSN 0254-1475 
COM(95) 588 final 
DOCUMENTS 
EN 06 10 
Catalogue number : CB-CO-95-621-EN-C 
ISBN 92-77-96412-X 
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