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Commission Directive 2006/141/ECShow full title

Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC (Text with EEA relevance)

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  1. Introductory Text

  2. Article 1.This Directive is a ‘specific Directive’ within the meaning of...

  3. Article 2.For the purposes of this Directive, the definitions of ‘claim’,...

  4. Article 3.Infant formulae and follow-on formulae may be marketed within the...

  5. Article 4.Infant formulae and follow-on formulae shall not contain any substance...

  6. Article 5.Infant formulae shall be manufactured from protein sources defined in...

  7. Article 6.Follow-on formulae shall be manufactured from protein sources defined in...

  8. Article 7.(1.) Infant formulae shall comply with the compositional criteria set...

  9. Article 8.(1.) Only the substances listed in Annex III may be...

  10. Article 9.(1.) To facilitate the efficient official monitoring of infant formulae,...

  11. Article 10.(1.) Infant formulae and follow-on formulae shall not contain residues...

  12. Article 11.Except as provided for in Article 12, the name under...

  13. Article 12.The name under which infant formulae and follow-on formulae manufactured...

  14. Article 13.(1.) The labelling shall bear, in addition to those provided...

  15. Article 14.(1.) Advertising of infant formulae shall be restricted to publications...

  16. Article 15.(1.) Member States shall ensure that objective and consistent information...

  17. Article 16.In the Annex to Directive 1999/21/EC, the row relating to...

  18. Article 17.The new requirements set out in Article 7(1) and (2)...

  19. Article 18.(1.) Member States shall adopt and publish, by 31 December...

  20. Article 19.Directive 91/321/EEC, as amended by the Directives listed in Annex...

  21. Article 20.This Directive shall enter into force on the 20th day...

  22. Article 21.This Directive is addressed to the Member States.

    1. ANNEX I

      ESSENTIAL COMPOSITION OF INFANT FORMULAE WHEN RECONSTITUTED AS INSTRUCTED BY THE MANUFACTURER

      1. The values set out in this Annex refer to the...

      2. 1. ENERGY

      3. 2. PROTEINS

        1. 2.1. Infant formulae manufactured from cows’ milk or goats’ milk proteins...

        2. 2.2 Infant formulae manufactured from protein hydrolysates

        3. 2.3. Infant formulae manufactured from soya protein isolates, alone or in...

        4. 2.4 In all cases, amino acids may be added to infant...

      4. 3. TAURINE

      5. 4. CHOLINE

      6. 5. LIPIDS

        1. 5.1 The use of the following substances shall be prohibited:

        2. 5.2 Lauric acid and myristic acid

        3. 5.3 The trans fatty acid content shall not exceed 3 %...

        4. 5.4 The erucic acid content shall not exceed 1 % of...

        5. 5.5 Linoleic acid (in the form of glycerides = linoleates)

        6. 5.6 The alpha-linolenic acid content shall not be less than 12...

        7. 5.7 Long-chain (20 and 22 carbon atoms) polyunsaturated fatty acids (LCP)...

      7. 6. PHOSPHOLIPIDS

      8. 7. INOSITOL

      9. 8. CARBOHYDRATES

        1. 8.1 Only the following carbohydrates may be used:

        2. 8.2 Lactose

        3. 8.3 Sucrose

        4. 8.4 Glucose

        5. 8.5 Pre-cooked starch and/or gelatinised starch

      10. 9. FRUCTO-OLIGOSACCHARIDES AND GALACTO-OLIGOSACCHARIDES

      11. 10. MINERAL SUBSTANCES

        1. 10.1. Infant formulae manufactured from cows’ milk or goats’ milk proteins...

        2. 10.2. Infant formulae manufactured from soya protein isolates, alone or in...

      12. 11. VITAMINS

      13. 12. NUCLEOTIDES

    2. ANNEX II

      ESSENTIAL COMPOSITION OF FOLLOW-ON FORMULAE WHEN RECONSTITUTED AS INSTRUCTED BY THE MANUFACTURER

      1. The values set out in this Annex refer to the...

      2. 1. ENERGY

      3. 2. PROTEINS

        1. 2.1. Follow-on formulae manufactured from cows’ milk or goats’ milk proteins...

        2. 2.2 Follow-on formulae manufactured from protein hydrolysates

        3. 2.3. Follow-on formulae manufactured from soya protein isolates, alone or in...

        4. 2.4 In all cases, amino acids may be added to follow-on...

      4. 3. TAURINE

      5. 4. LIPIDS

        1. 4.1 The use of the following substances shall be prohibited:

        2. 4.2 Lauric acid and myristic acid

        3. 4.3. The trans fatty acid content shall not exceed 3 %...

        4. 4.4 The erucic acid content shall not exceed 1 % of...

        5. 4.5 Linoleic acid (in the form of glycerides = linoleates)

        6. 4.6 The alpha-linolenic acid content shall not be less than 12...

        7. 4.7 Long-chain (20 and 22 carbon atoms) polyunsaturated fatty acids (LCP)...

      6. 5. PHOSPHOLIPIDS

      7. 6. CARBOHYDRATES

        1. 6.1 The use of ingredients containing gluten shall be prohibited.

        2. 6.2 Lactose

        3. 6.3 Sucrose, fructose, honey

        4. 6.4 Glucose

      8. 7. FRUCTO-OLIGOSACCHARIDES AND GALACTO-OLIGOSACCHARIDES

      9. 8. MINERAL SUBSTANCES

        1. 8.1. Follow-on formulae manufactured from cows’ milk or goats’ milk proteins...

        2. 8.2. Follow-on formulae manufactured from soya protein isolates, alone or in...

      10. 9. VITAMINS

      11. 10. NUCLEOTIDES

    3. ANNEX III

      NUTRITIONAL SUBSTANCES

      1. 1. Vitamins

      2. 2. Mineral substances

      3. 3. Amino acids and other nitrogen compounds

      4. 4. Other nutritional substances

    4. ANNEX IV

    5. ANNEX V

      INDISPENSABLE AND CONDITIONALLY INDISPENSABLE AMINO ACIDS IN BREAST MILK

      1. For the purpose of this Directive, the indispensable and conditionally...

      2. 1 kJ = 0,239 kcal. Per 100 kJ Per 100...

    6. ANNEX VI

      Specification for the protein content and source and the processing of protein used in the manufacture of infant formulae and follow-on formulae with a protein content less than 0,56 g/100 kJ (2,25 g/100 kcal) manufactured from hydrolysates of whey proteins derived from cows’ milk protein

      1. 1. Protein content

      2. 2. Protein source

      3. 3. Protein processing

      4. 4. Protein quality

    7. ANNEX VII

    8. ANNEX VIII

      PESTICIDES WHICH SHALL NOT BE USED IN AGRICULTURAL PRODUCTION INTENDED FOR THE PRODUCTION OF INFANT FORMULAE AND FOLLOW ON FORMULAE

      1. Table 1 Chemical name of the substance (residue definition)

      2. Table 2 Chemical name of the substance

    9. ANNEX IX

    10. ANNEX X

      1. PART A Repealed Directive, with list of its successive amendments

      2. PART B List of time limits for transposition into national law

    11. ANNEX XI

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