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Commission Delegated Regulation (EU) 2016/127Show full title

Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding (Text with EEA relevance)

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  1. Introductory Text

  2. Article 1.Placing on the market

  3. Article 2.Compositional requirements

  4. Article 3.Suitability of ingredients

  5. Article 4.Requirements on pesticides

  6. Article 5.Name of the food

  7. Article 6.Specific requirements on food information

  8. Article 7.Specific requirements on the nutrition declaration

  9. Article 8.Nutrition and health claims for infant formula

  10. Article 9.Statements related to lactose and docosahexaenoic acid (DHA)

  11. Article 10.Requirements for promotional and commercial practices for infant formula

  12. Article 11.Requirements on information relating to infant and young child feeding

  13. Article 12.Notification

  14. Article 13.Directive 2006/141/EC

  15. Article 14.Entry into force and application

  16. Signature

    1. ANNEX I

      COMPOSITIONAL REQUIREMENTS REFERRED TO IN ARTICLE 2(1)

      1. 1. ENERGY

      2. 2. PROTEINS

        1. 2.1. Infant formula manufactured from cows' milk or goats' milk proteins...

        2. 2.2. Infant formula manufactured from soya protein isolates, alone or in...

        3. 2.3. Infant formula manufactured from protein hydrolysates

          1. 2.3.1. Protein source

          2. 2.3.2. Protein processing

          3. 2.3.3. Indispensable and conditionally indispensable amino acids and L-carnitine

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

      3. 3. TAURINE

      4. 4. CHOLINE

      5. 5. LIPIDS

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

        2. 5.2. The trans fatty acid content shall not exceed 3 % of...

        3. 5.3. The erucic acid content shall not exceed 0,4 % of the...

        4. 5.4. Linoleic acid

        5. 5.5. Alpha-linolenic acid

        6. 5.6. Docosahexaenoic acid

        7. 5.7. Other long-chain (20 and 22 carbon atoms) polyunsaturated fatty acids...

      6. 6. PHOSPHOLIPIDS

      7. 7. INOSITOL

      8. 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. Glucose syrup or dried glucose syrup

        6. 8.6. Pre-cooked starch and/or gelatinised starch

      9. 9. FRUCTO-OLIGOSACCHARIDES AND GALACTO-OLIGOSACCHARIDES

      10. 10. MINERAL SUBSTANCES

        1. 10.1. Infant formula manufactured from cows' milk or goats' milk proteins...

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

      11. 11. VITAMINS

      12. 12. NUCLEOTIDES

    2. ANNEX II

      COMPOSITIONAL REQUIREMENTS REFERRED TO IN ARTICLE 2(2)

      1. 1. ENERGY

      2. 2. PROTEINS

        1. 2.1. Follow-on formula manufactured from cows' milk or goats' milk proteins...

        2. 2.2. Follow-on formula manufactured from soya protein isolates, alone or in...

        3. 2.3. Follow-on formula manufactured from protein hydrolysates

          1. 2.3.1. Protein source

          2. 2.3.2. Protein processing

          3. 2.3.3. Indispensable and conditionally indispensable amino acids

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

      3. 3. TAURINE

      4. 4. LIPIDS

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

        2. 4.2. The trans fatty acid content shall not exceed 3 % of...

        3. 4.3. The erucic acid content shall not exceed 0,4 % of the...

        4. 4.4. Linoleic acid

        5. 4.5. Alpha-linolenic acid

        6. 4.6. Docosahexaenoic acid

        7. 4.7. Other long-chain (20 and 22 carbon atoms) polyunsaturated fatty acids...

      5. 5. PHOSPHOLIPIDS

      6. 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

        5. 6.5. Glucose syrup or dried glucose syrup

      7. 7. FRUCTO-OLIGOSACCHARIDES AND GALACTO-OLIGOSACCHARIDES

      8. 8. MINERAL SUBSTANCES

        1. 8.1. Follow-on formula manufactured from cows' milk or goats' milk proteins...

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

      9. 9. VITAMINS

      10. 10. NUCLEOTIDES

    3. ANNEX III

      INDISPENSABLE AND CONDITIONALLY INDISPENSABLE AMINO ACIDS IN BREAST MILK

      1. For the purposes of point 2 of Annexes I and...

      2. A. Infant formula and follow-on formula manufactured from cows' milk or...

      3. B. Infant formula and follow-on formula manufactured from protein hydrolysates

    4. ANNEX IV

      ACTIVE SUBSTANCES REFERRED TO IN ARTICLE 4(3)

      1. Chemical name of the substance Maximum residue level(mg/kg) Cadusafos 0,006...

    5. ANNEX V

      ACTIVE SUBSTANCES REFERRED TO IN ARTICLE 4(4)

      1. Chemical name of the substance (residue definition)

    6. ANNEX VI

      NAMES REFERRED TO IN ARTICLE 5

      1. PART A Name referred to in Article 5(1)

      2. PART B Name referred to in Article 5(2)

    7. ANNEX VII

      REFERENCE INTAKES REFERRED TO IN ARTICLE 7(7)

      1. Nutrient Reference intake Vitamin A (μg) 400 Vitamin D (μg)...

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