Official Journal of the European Communities

L 179/129


of 18 June 1992

on infant formulae and follow-on formulae intended for export to third countries


Having regard to the Treaty establishing the European Economic Community, and in particular Article 113 thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Parliament (2),

Having regard to the opinion of the Economic and Social Committee (3),

Whereas Community rules concerning infant formulae and follow-on formulae are laid down by Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs for particular nutritional uses (4) in Commission Directive 91/321/EEC (5);

Whereas given the nature of the products in question it is desirable that Community rules or international standards relating to their composition are made applicable to such products intended for export to third countries;

Whereas in order to prevent inappropriate use of these products which could prejudice the health of infants it is also desirable to extend the application of the Community rules on labelling of infant formulae and follow-on formuale to those products intended for export to third countries;

Whereas the products complying with Directive 91/321/EEC may be marketed in the Community as from 1 December 1992; whereas no legislation prohibits the export of such products to third countries,


Article 1

This Directive concerns infant formuale and follow-on formulae, as defined by Article 1 (2) (c) and (d) of Directive 91/321/EEC, intended for export to third countries.

Article 2

Member States shall ensure that the products referred to in Article 1 may be exported from the Community only if they comply with this Directive.

Article 3

1.   No product other than infant formulae may be represented as suitable for satisfying by itself the nutritional requirements of normal healthy infants during the first four to six months of life.

2.   In addition the products referred to in Article 1 must comply:


with Articles 3, 4, 5 and 6 of Directive 91/321/EEC or with relevant applicable world standards established by Codex Alimentarius;


with Article 7 (2) to (6) of Directive 91/321/EEC;


with the provisions of Council Directive 89/396/EEC of 14 June 1989 on indications or marks identifying the lot to which a foodstuff belongs (6),

unless otherwise requested or stipulated by provisions established by the importing country.

3.   These products shall be labelled in an appropriate language and in such a way as to avoid any risk of confusion between infant formulae and follow-on formulae.

4.   The stipulations, prohibitions and restrictions laid down in Article 7 (2) to (6) of Directive 91/321/EEC shall also apply to the presentation of the products concerned and in particular their form, aspect or packaging and the packaging materials used.

Article 4

Member States shall take the necessary measures to comply with this Directive. They shall forthwith inform the Commission thereof. Those measures shall be applied in such a way as to prohibit exports of products which do not comply with this Directive, with effect from 1 June 1994.

When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The methods of making such a reference shall be laid down by the Member States.

Article 5

This Directive is addressed to the Member States.

Done at Luxembourg, 18 June 1992.

For the Council

The President


(1)  OJ No C 124, 16. 5. 1992, p. 14 and OJ No C 155, 20. 6. 1992, p. 18.

(2)  OJ No C 125, 18. 5. 1992.

(3)  OJ No C 106, 27. 4. 1992, p. 4.

(4)  OJ No L 186, 30. 6. 1989, p. 27.

(5)  OJ No L 175, 4. 7. 1991, p. 35.

(6)  OJ No L 186, 30. 6. 1989, p. 21. As last amended by Directive 91/238/EEC (OJ No L 107, 27. 4. 1991, p. 50).