23.5.86 Official Journal of the European Communities No C 124/7 
commercial documents referring to the 
foodstuffs where the latter are prepackaged and 
marketed at a stage prior to their sale to the 
ultimate consumer.' 
17. The following subparagraph is added to Article 11 
(3) (a): 
'It shall not apply to milk or milk products in bottles 
intended for re-use. Other derogations may be 
allowed in accordance with the procedure laid down 
in Article 17.' 
18. Article 11 (4) is replaced by the following: 
'4. In the case of the bottles referred to in the 
third subparagraph of paragraph 3 (a) and of 
packaging or containers whose largest face has an 
area of less than 10 square centimetres, only the 
particulars listed in points (1), (3) and (4) of Article 
3 (1) need be given.' 
19. Article 16, second paragraph, third indent, is 
replaced by the following: 
'In the latter event, and before the expiry of the 
abovementioned period, the Commission shall 
initiate the procedure provided for in Article 17 in 
order to determine whether the envisaged measures 
may be implemented subject, if necessary, to the 
appropriate modifications.' 
20. Article 17 is replaced by the following text: 
'Article 17 
Where the procedure laid down in this Article is 
invoked, the Commission shall decide after 
consulting the Standing Committee on Foodstuffs set 
up under Decision 69/414/EEC, hereinafter referred 
to as "the Commitee". The Committee shall discuss 
matters on which the Commission has requested an opinion. When seeking the opinion of the 
Committee, the Commission may set a time limit 
within which such opinion shall be given. No vote 
shall be taken. However, any member of the 
Committee may demand that his views be set down 
in the minutes.' 
21. Article 18 is deleted. 
22. Article 23 is deleted. 
23. The following is added to Annex I: 
'Definition 
All aromatizers. Designation 
Flavouring(s). 
This indication may be 
supplemented, if necess­
ary, by stating whether 
the aromatizers used are 
of vegetable or animal 
origin.' 
Article 2 
Member States shall amend their laws, regulations and 
administrative provisions, where necessary, in such a way 
as to: 
— permit trade in products complying with this 
Directive by ... at the latest (18 months after 
notification), 
— prohibit trade in products not complying with this 
Directive with effect from ... (three years after 
notification). 
They shall forthwith inform the Commission thereof. 
Article 3 
This Directive is addressed to the Member States. 
Proposal for a Council Directive on the approximation of the laws of the Member States 
relating to foodstuffs intended for particular nutritional uses 
COM(86) 91 final 
(Submitted by the Commission to the Council on 17 April 1986) 
(86/C 124/06) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 100 
thereof, 
Having regard to the proposal from the Commission, Having regard to the opinion of the Economic and 
Social Committee, 
Whereas on 21 December 1976 the Council adopted 
Directive 77/94/EEC on the approximation of the laws 
of the Member States relating to foodstuffs for particular 
nutritional uses ('); 
Having regard to the opinion of the European Par­
liament, O OJ No L 26, 31. 1. 1977, p. 55. 
No C 124/8 Official Journal of the European Communities 23.5.86 
Whereas the adoption of Directive 77/94/EEC was 
justified by the fact that the differences between national 
laws relating to foodstuffs for particular nutritional uses 
impeded their free movement, may have created unequal 
conditions of competition and thus had a direct impact 
on the establishment and functioning of the common 
market; 
Whereas the approximation of national laws pre­
supposed, in an initial stage, the preparation of a 
common definition, the determination of measures 
enabling the consumer to be protected against fraud 
concerning the nature of these products and the 
adoption of rules to be complied with in labelling the 
products in question; 
Whereas the products covered by this Directive are 
foodstuffs the composition and preparation of which 
must be specially designed to meet the particular 
nutritional requirements of the persons for whom they 
are mainly intended; whereas it may be necessary, 
therefore, to provide for derogations to the general or 
specific provisions applicable to foodstuffs in order to 
arrive at the specific nutritional objective; 
Whereas the basic principles of legislation and the list of 
groups of foodstuffs for particular nutritional uses to be 
dealt with by means of specific Directives are matters to 
be decided by the Council in accordance with the 
procedure laid down in Article 100 of the Treaty; 
Whereas the elaboration of specific Directives 
implementing the basic principles of legislation and 
amendments thereto are implementing measures of a 
technical nature: whereas their adoption should be 
entrusted to the Commission in order to simplify and 
expedite the procedure; 
Whereas in all cases where the Council empowers the 
Commission to implement rules relating to foodstuffs 
intended for human consumption, provision should be 
made for a procedure establishing close cooperation 
between the Member States and the Commission within 
the Standing Committee for Foodstuffs, set up by 
Council Decision 69/414/EEC (x), 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
1. This Directive shall apply to foodstuffs intended for 
particular nutritional uses. 
O OJ No L 291, 19. 11. 1969, p. 9. 2. (a) Foodstuffs for particular nutritional uses are 
foodstuffs which, owing to their special 
composition or manufacturing process, are clearly 
distinguishable from foodstuffs for normal 
consumption, which are suitable for their claimed 
nutritional purposes and which are marketed in 
such a way as to indicate such suitability. 
(b) A particular nutritional use must fulfil the 
particular nutritional requirements: 
(i) of certain categories of persons whose 
digestive processes or metabolism are 
disturbed; or 
(ii) of certain categories of persons who are in a 
special physiological condition and who are 
therefore able to obtain special benefit from a 
controlled consumption of certain substances 
in foodstuffs; or 
(iii) of infants or young children in good health. 
Article 2 
1. The products referred to in Article 1 (2) (b) (i) and 
(ii) may be characterized as 'dietetic' or 'dietary'. 
2. In the labelling, presentation and advertising of 
foodstuffs for normal consumption the following shall be 
prohibited: 
(a) the use of the adjectives 'dietetic' or 'dietary' either 
alone or in conjunction with other words, to 
designate these foodstuffs; 
(b) all other markings or any presentation likely to give 
the impression that one of the products referred to in 
Article 1 is involved. 
3. However in accordance with provisions which shall 
be adopted according to the procedure provided for in 
Article 9, it shall be possible, for foodstuffs for normal 
consumption which are suitable for a particular 
nutritional use, to indicate such suitability. 
The aforesaid provisions may lay down the arrangements 
for indicating this suitability. 
Article 3 
1. The nature or composition of the products referred 
to in Article 1 must be such that the products are appro­
priate for the particular nutritional use intended. 
2. The products referred to in Article 1 must also 
comply with any mandatory provisions applicable to 
foodstuffs for normal consumption, save as regards 
changes made to them to ensure their conformity with 
the definitions given in Article 1. 
23. 5. 86 Official Journal of the European Communities No C 124/9 
Article 4 
1. The specific provisions applicable to the groups of 
foods for particular nutritional uses appearing in the 
Annex shall be laid down by means of specific Directives. 
The specific Directives and amendments thereto shall 
be adopted according to the procedure laid down in 
Article 9. 
2. Such specific Directives may include in particular: 
(a) essential requirements as to the nature or 
composition of the products; 
(b) quality of raw materials; 
(c) hygienic requirements; 
(d) permitted changes within the meaning of Article 3 
(2); 
(e) list of substances with a specific nutritional purpose 
including purity criteria for those substances; 
(f) list of additives; 
(g) labelling, presentation and advertising; 
(h) conditions under which any reference may be made 
in labelling, presentation and advertising to a diet or 
to a category of persons for which a product 
referred to in Article 1 is intended; 
(i) sampling procedures and methods of analysis 
necessary for checking compliance with the 
requirements of the specific Directives. 
Article 5 
1. The labelling and methods used, the presentation, 
and advertising of the products referred to in Article 1 
must not attribute properties for the prevention, 
treatment or cure of human disease to such products or 
imply such properties. 
Derogations from the first subparagraph may be 
provided for in accordance with the procedure laid down 
in Article 9 in exceptional and clearly defined cases. 
2. Paragraph 1 shall not prevent the dissemination of 
any useful information or recommendations exclusively 
intended for persons having qualifications in medicine, 
nutrition or pharmacy. 
Article 6 
1. Council Directive 79/112/EEC O is hereby 
rendered applicable to products referred to in Article 1, 
under the conditions set out below. 
(') OJNoL33, 8. 2. 1979, p. 1. 2. The designation under which a product is sold shall 
be accompanied' by an indication of its particular 
nutritional characteristics; however, in the case of the 
products referred to in Article 1 (2) (b) (iii), this 
reference shall be replaced by a reference to the purpose 
for which they are intended. 
3. The labelling of products for which no specific 
Directive has been adopted in accordance which Article 
4 must also include: 
(a) the particular elements of the qualitative and 
quantitative composition or the special manufac­
turing process which give the product its particular 
nutritional characteristics; 
(b) the available energy value expressed in kj and kcal 
and the carbohydrate, protein and fat content per 
100 g or 100 ml of the product as marketed and, 
where appropriate, per specified quantity of the 
product as proposed for consumption. 
If, however, the energy value is less than 50 kj (12 
kcal) per 100 g or 100 ml of the product as 
marketed, these particulars may be replaced either by 
the words 'energy value less than 50 kj (12 kcal) per 
100 g' or by the words 'energy value less than 50 kj 
(12 kcal) per 100 ml'. 
4. The particular labelling requirements for those 
products for which a specific Directive has been adopted 
shall be laid down in that Directive. 
Article 7 
1. The products referred to in Article 1 shall only be 
allowed on the retail market in prepackaged form, and 
the packaging shall completely cover the products. 
2. Member States may, however, permit derogations 
from these provisions for purposes of the retail trade 
provided that the product is accompanied by the parti­
culars provided for in Article 6 at the time when it is put 
on sale. 
Article 8 
Member States shall not, for reasons related to their 
composition, manufacturing specifications, presentation 
or labelling, prohibit or restrict trade in products 
referred to in Article 1 which comply with this Directive 
and specific Directives where appropriate. 
Article 9 
Where the procedure laid down in this Article is 
followed, the Commission will take a decision after 
consulting the Standing Committee on Foodstuffs set up 
under Decision 69/414/EEC, hereinafter referred to as 
'the Committee'. The Committee shall discuss matters on 
No C 124/10 Official Journal of the European Communities 23.5.86 
which the Commission has requested an opinion. When 
seeking the opinion of the Committee, the Commission 
may set a time limit within which such opinion shall be 
given. No vote shall be taken. However, any member of 
the Committee may demand that his views be set down 
in the minutes. 
Article 10 
Directive 77/94/EEC is hereby repealed. 
Article 11 
1. Member States shall amend their laws, regulations -
and administrative provisions in such a way as: 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community and in particular Article 100 
thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European Par­
liament, 
Having regard to the opinion of the Economic and 
Social Committee, 
Whereas on 23 November 1976 the Council adopted 
Directive 76/893/EEC on the approximation of the laws 
of the Member States relating to materials and articles — to permit trade in products complying with this 
Directive by ... (18 months after the notification), 
— to prohibit trade in products not complying with this 
Directive with effect from ... (24 months after the 
notification). 
They shall forthwith inform the Commission thereof. 
2. Member States shall continue to put into effect the 
relevant provisions of Directive 77/94/EEC until the 
date on which the amendments are to be implemented. 
Article 12 
This Directive is addressed to the Member States. 
intended to come into contact with foodstuffs (*); 
whereas the number and nature of the changes that have 
had to be made to that Directive indicate the need for 
consolidation so as to maintain the clarity required of all 
legislation; 
Whereas Directive 76/893/EEC was adopted on the 
grounds that the differences that existed at that time 
between the national laws relating to the aforesaid 
materials and articles impeded the free movement 
thereof, could create unequal conditions of competition 
and could thereby directly affect the establishment or 
functioning of the common market; 
0) OJ No L 340, 9. 12. 1976, p. 19. ANNEX 
Groups of foods for particular nutritional uses for which specific provisions shall be laid down by specific 
Directives 
Infant formulae 
Follow-up milk and other follow-up foods 
Baby foods 
Low-energy and energy-reduced foods 
Proposal for a Council Directive on the approximation of the laws of the Member States 
relating to materials and articles intended to come into contact with foodstuffs 
COM(86) 90 final 
(Submitted by the Commission to the Council on 18 April 1986) 
(86/C 124/07)