COMMISSION DIRECTIVE 96/5/EC of 16 February 1996 on processed cereal-based foods and baby foods for infants and young children (Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (1), and in particular Article 4 thereof,
Whereas the Community measures envisaged by this Directive do not exceed what is necessary for the attainment of the objectives already provided for by Directive 89/398/EEC;
Whereas processed cereal-based foods and baby foods for infants and young children are used as part of a diversified diet and do not constitute the sole source of nourishment of infants and young children;
Whereas there is a great variety of the products in question reflecting the widely varied diet of infants being weaned and young children owing to social and cultural circumstances existing in the Community;
Whereas the essential composition of the products in question must be appropriate for the nutritional requirements of infants and young children in good health as established by generally accepted scientific data, account being taken of the abovementioned factors;
Whereas the essential nutritional requirements for the composition of the two broad categories of these products, namely processed cereal-based foods and baby foods should be laid down;
Whereas although, because of the nature of such products, a number of mandatory requirements and other restrictions as to the level of vitamins, minerals and other nutrients should be imposed, such nutrients may be added voluntarily by manufacturers provided that they use exclusively the substances listed in Annex IV to this Directive;
Whereas the use of the products to which such nutrients have been voluntarily added at levels currently observed in the Community do not appear to result in excessive intakes of those nutrients by infants and young children; whereas attention will be paid to any future developments of the situation, and if necessary, appropriate measures will be taken;
Whereas the provisions relating to the use of additives in the manufacture of processed cereal-based foods and baby foods will be laid down in a Council Directive;
Whereas the use of novel food ingredients will be dealt with horizontally for all foodstuffs in a separate measure;
Whereas this Directive reflects current knowledge about these products; whereas any amendment, to allow for innovation based on scientific and technical progress, will be decided by the procedure laid down in Article 13 of Directive 89/398/EEC;
Whereas, in view of the persons for whom the products are intended, the necessary microbiological criteria and maximum levels for contaminants should be laid down without delay;
Whereas pursuant to Article 7 of Directive 89/398/EEC the products covered by this Directive are subject to the general rules laid down by Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (2), as last amended by Commission Directive 93/102/EC (3);
Whereas in this Directive the additions and exceptions to those general rules are adopted and expanded upon, where appropriate;
Whereas, in particular, the nature and destination of the products covered by this Directive require nutritional labelling showing the energy value and principal nutrients they contain; whereas, on the other hand, the method of use should be specified in accordance with point 8 of Article 3 (1) and Article 10 of Directive 79/112/EEC, in order to prevent inappropriate uses liable to harm the health of infants;
Whereas, whilst claims not specifically prohibited may generally be made for the products in question in conformity with the rules applicable for all foodstuffs, such claims should, where appropriate, take into account the compositional criteria specified in this Directive;
Whereas the Scientific Committee for Food has, in accordance with Article 4 of Directive 89/398/EEC, been consulted on the provisions liable to affect public health;
Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. This Directive is a 'specific Directive` within the meaning of Article 4 of Directive 89/398/EEC.
2. This Directive covers foodstuffs for particular nutritional use fulfilling the particular requirements of infants and young children in good health in the Community and are intended for use by infants while they are being weaned, and by young children as a supplement to their diet and/or for their progressive adaptation to ordinary food. They comprise:
(a) 'Processed cereal-based foods` which are divided into the following four categories:
(i) simple cereals which are or have to be reconstituted with milk or other appropriate nutritious liquids;
(ii) cereals with an added high protein food which are or have to be reconstituted with water or other protein-free liquid;
(iii) pastas which are to be used after cooking in boiling water or other appropriate liquids;
(iv) rusks and biscuits which are to be used either directly or, after pulverization, with the addition of water, milk or other suitable liquids.
(b) 'Baby foods` other than processed cereal-based foods.
3. This Directive does not apply to milks intended for young children.
4. For the purpose of this Directive:
- 'infants` shall mean children under the age of twelve months,
- 'young children` shall mean children aged between 1 and 3 years.
Article 2
Member States shall ensure that the products referred to in Article 1 are marketed within the Community only if they conform to the rules laid down in this Directive.
Article 3
Processed cereal-based foods and baby foods shall be manufactured from ingredients whose suitability for particular nutritional use by infants and young children has been established by generally accepted scientific data.
Article 4
1. Processed cereal-based foods shall comply with the compositional criteria specified in Annex I.
2. Baby foods which are described in Annex II shall comply with the compositional criteria specified therein.
Article 5
Only the nutritional substances listed in Annex IV may be added in the manufacture of processed cereal-based foods and baby foods. Within 12 months of the entry into force of this Directive maximum levels, in addition to those already stipulated, shall be laid down where necessary.
The purity criteria for those substances shall be laid down at a later stage.
Article 6
Processed cereal-based foods and baby foods shall not contain any substance in such quantity as to endanger the health of infants and young children. Necessary maximum levels shall be established without delay.
Microbiological criteria shall also be established as necessary.
Article 7
1. The labelling of the products concerned shall bear in addition to the particulars provided for in Article 3 of Directive 79/112/EEC, the following mandatory particulars:
(a) A statement as to the appropriate age from which the product may be used, regard being had to its composition, texture or other particular properties. The stated age shall not be less than four months for any product. Products recommended for use from the age of four months may indicate that they are suitable from that age unless independent persons having qualifications in medicine, nutrition or pharmacy, or other professionals responsible for maternal and child care, advise otherwise.
(b) Information as to the presence or absence of gluten if the indicated age from which the product may be used is below six months.
(c) The available energy value expressed in kJ and kcal, and the protein, carbohydrate and lipid content, expressed in numerical form, per 100 g or 100 ml of the product as sold and, where appropriate, per specified quantity of the product as proposed for consumption;
(d) The average quantity of each mineral substance and of each vitamin governed by a specific level in Annex I and Annex II respectively, expressed in numerical form, per 100 g or 100 ml of the product as sold and, where appropriate, per specified quantity of the product as proposed for consumption;
(e) Instructions for appropriate preparation, when necessary, and a statement as to the importance of following those instructions.
2. The labelling may bear:
(a) the average quantity of the nutrients set out in Annex IV when such declaration is not covered by the provisions of point (d) of paragraph 1, expressed in numerical form, per 100 g or 100 ml of the product as sold and, where appropriate, per specified quantity of the product as proposed for consumption;
(b) in addition to numerical information, information on vitamins and minerals shown in Annex V, expressed as a percentage of the reference values given therein, per 100 g or 100 ml of the product as sold, and where appropriate, per specified quantity of the product as proposed for consumption, provided that the quantities present are at least equal to 15 % of the reference values.
Article 8
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 September 1997. They shall forthwith inform the Commission thereof.
Those laws, regulations and administrative provisions shall be applied in such a way as to:
- permit trade in products complying with this Directive, by 1 October 1997,
- prohibit trade in products which do not comply with this Directive, with effect from 31 March 1999.
When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
Article 9
This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Communities.
Article 10
This Directive is addressed to the Member States.
Done at Brussels, 16 February 1996.