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)
Introductory Text
Article 1.Placing on the market
Article 2.Compositional requirements
Article 3.Suitability of ingredients
Article 4.Requirements on pesticides
Article 5.Name of the food
Article 6.Specific requirements on food information
Article 7.Specific requirements on the nutrition declaration
Article 8.Nutrition and health claims for infant formula
Article 9.Statements related to lactose and docosahexaenoic acid (DHA)
Article 10.Requirements for promotional and commercial practices for infant formula
Article 11.Requirements on information relating to infant and young child feeding
Article 12.Notification
Article 13.Directive 2006/141/EC
Article 14.Entry into force and application
Signature
ANNEX I
COMPOSITIONAL REQUIREMENTS REFERRED TO IN ARTICLE 2(1)
1. ENERGY
2. PROTEINS
2.1. Infant formula manufactured from cows' milk or goats' milk proteins...
2.2. Infant formula manufactured from soya protein isolates, alone or in...
2.3. Infant formula manufactured from protein hydrolysates
2.3.1. Protein source
2.3.2. Protein processing
2.3.3. Indispensable and conditionally indispensable amino acids and L-carnitine
2.4. In all cases, amino acids may be added to infant...
3. TAURINE
4. CHOLINE
5. LIPIDS
5.1. The use of the following substances shall be prohibited:
5.2. The trans fatty acid content shall not exceed 3 % of...
5.3. The erucic acid content shall not exceed 0,4 % of the...
5.4. Linoleic acid
5.5. Alpha-linolenic acid
5.6. Docosahexaenoic acid
5.7. Other long-chain (20 and 22 carbon atoms) polyunsaturated fatty acids...
6. PHOSPHOLIPIDS
7. INOSITOL
8. CARBOHYDRATES
8.1. Only the following carbohydrates may be used:
8.2. Lactose
8.3. Sucrose
8.4. Glucose
8.5. Glucose syrup or dried glucose syrup
8.6. Pre-cooked starch and/or gelatinised starch
9. FRUCTO-OLIGOSACCHARIDES AND GALACTO-OLIGOSACCHARIDES
10. MINERAL SUBSTANCES
10.1. Infant formula manufactured from cows' milk or goats' milk proteins...
10.2. Infant formula manufactured from soya protein isolates, alone or in...
11. VITAMINS
12. NUCLEOTIDES
ANNEX II
COMPOSITIONAL REQUIREMENTS REFERRED TO IN ARTICLE 2(2)
1. ENERGY
2. PROTEINS
2.1. Follow-on formula manufactured from cows' milk or goats' milk proteins...
2.2. Follow-on formula manufactured from soya protein isolates, alone or in...
2.3. Follow-on formula manufactured from protein hydrolysates
2.3.1. Protein source
2.3.2. Protein processing
2.3.3. Indispensable and conditionally indispensable amino acids
2.4. In all cases, amino acids may be added to follow-on...
3. TAURINE
4. LIPIDS
4.1. The use of the following substances shall be prohibited:
4.2. The trans fatty acid content shall not exceed 3 % of...
4.3. The erucic acid content shall not exceed 0,4 % of the...
4.4. Linoleic acid
4.5. Alpha-linolenic acid
4.6. Docosahexaenoic acid
4.7. Other long-chain (20 and 22 carbon atoms) polyunsaturated fatty acids...
5. PHOSPHOLIPIDS
6. CARBOHYDRATES
6.1. The use of ingredients containing gluten shall be prohibited.
6.2. Lactose
6.3. Sucrose, fructose, honey
6.4. Glucose
6.5. Glucose syrup or dried glucose syrup
7. FRUCTO-OLIGOSACCHARIDES AND GALACTO-OLIGOSACCHARIDES
8. MINERAL SUBSTANCES
8.1. Follow-on formula manufactured from cows' milk or goats' milk proteins...
8.2. Follow-on formula manufactured from soya protein isolates, alone or in...
9. VITAMINS
10. NUCLEOTIDES
ANNEX III
INDISPENSABLE AND CONDITIONALLY INDISPENSABLE AMINO ACIDS IN BREAST MILK
For the purposes of point 2 of Annexes I and...
A. Infant formula and follow-on formula manufactured from cows' milk or...
B. Infant formula and follow-on formula manufactured from protein hydrolysates
ANNEX IV
ACTIVE SUBSTANCES REFERRED TO IN ARTICLE 4(3)
Chemical name of the substance Maximum residue level(mg/kg) Cadusafos 0,006...
ANNEX V
ACTIVE SUBSTANCES REFERRED TO IN ARTICLE 4(4)
Chemical name of the substance (residue definition)
ANNEX VI
NAMES REFERRED TO IN ARTICLE 5
PART A Name referred to in Article 5(1)
PART B Name referred to in Article 5(2)
ANNEX VII
REFERENCE INTAKES REFERRED TO IN ARTICLE 7(7)
Nutrient Reference intake Vitamin A (μg) 400 Vitamin D (μg)...