Commission Directive 2006/125/ECShow full title

Article 1

1. This Directive is a ‘specific Directive’ within the meaning of Article 4(1) 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 pulverisation, 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.

Article 2

For the purpose of this Directive, the following definitions shall apply:

(a)

‘infants’ means children under the age of 12 months;

(b)

‘young children’ means children aged between one and three years;

(c)

‘pesticide residue’ means the residue in processed cereal-based foods and baby foods of a plant protection product, as defined in point 1 of Article 2 of Directive 91/414/EEC, including its metabolites and products resulting from its degradation or reaction.

Article 3

Member States shall ensure that the products referred to in Article 1(2) are marketed within the Community only if they conform to the rules laid down in this Directive.

Article 4

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 5

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 6

Only the nutritional substances listed in Annex IV may be added in the manufacture of processed cereal-based foods and baby foods.

The purity criteria for those substances shall be laid down at a later stage.

Article 7

1. 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 for substances other than those referred to in paragraphs 2 and 3 shall be established.

2. Processed cereal-based foods and baby foods shall not contain residues of individual pesticides at levels exceeding 0,01 mg/kg, except for those substances for which specific levels have been set in Annex VI, in which case these specific levels shall apply.

Analytical methods for determining the levels of pesticide residues shall be generally acceptable standardised methods.

3. The pesticides listed in Annex VII shall not be used in agricultural products intended for the production of processed cereal-based foods and baby foods.

However, for the purpose of control:

(a) pesticides listed in Table 1 of Annex VII are considered not to have been used if their residues do not exceed a level of 0,003 mg/kg. This level, which is considered to be the limit of quantification of the analytical methods, shall be kept under regular review in the light of technical progress;

(b) pesticides listed in Table 2 of Annex VII are considered not to have been used if their residues do not exceed a level of 0,003 mg/kg. This level shall be kept under regular review in the light of data on environmental contamination.

4. The levels referred to in paragraphs 2 and 3 shall apply to the products as proposed ready for consumption or as reconstituted according to the instructions of the manufacturers.

5. For pesticides listed in Annex VI, where a decision concerning the non-inclusion of an active substance in Annex I to Directive 91/414/EEC is taken, Annex VI and Annex VII to this Directive shall be amended accordingly.

6. Microbiological criteria shall be established as necessary.

Article 8

1. The labelling of the products concerned shall bear in addition to the particulars provided for in Article 3 of Directive 2000/13/EC, 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 as specified 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 paragraph 1(d), 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 9

Directive 96/5/EC, as amended by the Directives listed in Annex VIII, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex VIII, Part B.

References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex IX.

Article 10

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Article 11

This Directive is addressed to the Member States.

Done at Brussels, 5 December 2006.

For the Commission

The President

José Manuel Barroso