Regulation 6
Regulation 2(1)
| Column 1 Specified provision of the EU Regulation | Column 2 Provisions to be read with the specified provision of the EU Regulation |
|---|---|
| Article 4(2) (requirement for relevant food to be pre-packed) | Articles 1(1) and 4(1) |
| Article 9(1) (requirement for the composition of food to be nutritionally appropriate and suitable) | Articles 1(1), 4(1) and 9(3) |
| Article 9(2) (prohibition on substances in dangerous quantities) | Articles 1(1) and 4(1) |
| Article 9(5) (requirements as to labelling, presentation and advertising of relevant food) | Articles 1(1), 4(1) and 9(6) |
| Article 10 (additional requirements for infant formula and follow-on formula) | Article 4(1) |
| Article 15(1) (Union list) | Articles 1(1) (a) and (c) and 4(1) and the Annex insofar as it applies to infant formula and follow-on formula and food for special medical purposes |
| Specified provision of Delegated Regulation (EU) 2016/127 | Provision of Delegated Regulation 127 to be read with the specified provision of Delegated Regulation 127 |
|---|---|
| Article 1(2) (placing on the market) | Article 1(1) |
| Article 2(1) (compositional requirements for infant formula) | Articles 1(1) and 2(3), Annex 1 and Annex 3 |
| Article 2(2) (compositional requirements for follow-on formula) | Articles 1(1) and 2(3), Annex 2 and Annex 3 |
| Article 2(3) (preparation of infant and follow-on formula) | Articles 1(1), 2(1) and (2) |
| Article 3(1) (suitability of ingredients for infant formula) | Articles 1(1) and 3(3) and point 2 of Annex 1 |
| Article 3(2) (suitability of ingredients for follow-on formula) | Articles 1(1) and 3(3) and point 2 of Annex 2 |
| Article 4(2) (active substance residue threshold) | Articles 1(1) and 4(1), (3) and (5) |
| Article 4(3) (derogation from active substance residue threshold) | Articles 1(1) and 4(1), (2) and (5) |
| Article 4(4) (requirements on pesticides) | Articles 1(1) and 4(1) and (5) |
| Article 5(1) (name of food not manufactured entirely from cows’ or goats’ milk protein) | Article 1(1) and Part A of Annex 6 |
| Article 5(2) (name of food manufactured entirely from cows’ or goats’ milk protein) | Article 1(1) and Part B of Annex 6 |
| Article 6 (specific requirements on food information) | Articles 1(1) and 7(1), (2), (3), (5), (6), (7) and (8) |
| Article 7(1) (specific requirements on the nutrition declaration) | Articles 1(1) and 7(4), Annex 1 and Annex 2 |
| Article 7(3) (repetition of information included in mandatory nutrition declaration) | Article 1(1) |
| Article 7(4) (nutrition declaration mandatory regardless of size of packaging or container) | Articles 1(1) and 7(1), Annex 1 and Annex 2 |
| Article 7(5) (application of Articles 31 to 35 of Regulation (EU) No. 1169/2011(1)) | Articles 1(1) and 7(6), (7) and (8) |
| Article 7(6) (expression of energy value and amounts of nutrients) | Articles 1(1) and 7(5) |
| The first sub-paragraph of Article 7(7) (prohibition on expressing energy value and amount of nutrients as a percentage of reference intake) | Articles 1(1) and 7(5) |
| Article 7(8) (presentation of particulars included in the nutrition declaration) | Article 1(1) |
| Article 8 (prohibition on making nutrition and health claims on infant formula) | Article 1(1) |
| Article 9(1) (“lactose only” statement) | Article 1(1) |
| The first sub-paragraph of Article 9(2) (“lactose free” statement) | Article 1(1) |
| The second sub-paragraph of Article 9(2), (statement that “lactose free” infant formula and follow-on formula is not suitable for infants with galactosaemia) | Article 1(1) |
| Article 9(3) (prohibition on references to docosahexaenoic acid where infant formula placed on the market on or after 22 February 2025) | Article 1(1) |
| Article 10(1) (restriction on advertising for infant formula) | Article 1(1) |
| Article 10(2) (prohibition of promotional devices to induce sales of infant formula) | Article 1(1) |
| Article 10(3) (prohibition of provision of free or low-priced products, samples or other promotional gifts to the general public, pregnant women, mothers or members of their families) | Article 1(1) |
| Article 10(4) (requirements for donations or low-priced sales of supplies of infant formula to institutions or organisations) | Article 1(1) |
| Article 11(2) (requirements on information relating to infant and young child feeding) | Article 1(1) |
| Article 11(3) (requirements on donations of informational or educational equipment or materials) | |
| Article 12 (notification requirements) | Article 1(1) |
| Article 10(2) (prohibition of promotional devices to induce sales of infant formula) | Article 1(1) |
| Article 10(3) (prohibition of provision of free or low-priced products, samples or other promotional gifts to the general public, pregnant women, mothers or members of their families) | Article 1(1) |
| Article 10(4) (requirements for donations or low-priced sales of supplies of infant formula to institutions or organisations) | Article 1(1) |
| Article 11(2) (requirements on information relating to infant and young child feeding) | |
| Article 11(3) (requirements on donations of informational or educational equipment or materials) | |
| Article 12 (notification requirements) | Article 1(1) |
| Specified provision of Delegated Regulation 128 | Provision of Delegated Regulation 128 to be read with the specified provision of the Delegated Regulation 128 |
|---|---|
| Article 2(2) (requirement for the formulation of food to be based on sound medical and nutritional principles) | Article 1 |
| The first sub-paragraph of article 2(3) (requirement for food for special medical purposes developed to satisfy the nutritional requirements of infants to comply with the compositional requirements in Part A of Annex I) | Articles 1 and 2(4) and Part A of Annex 1 |
| The second-sub paragraph of article 2(3) (requirement for food other than that developed to satisfy the nutritional requirements of infants to comply with the compositional requirements in Part B of Annex I) | Articles 1 and 2(4) and Part B of Annex 1 |
| Article 3(2) (requirement relating residue threshold for certain active substances where food for special medical purposes is developed to satisfy the nutritional requirements of infants and young children) | Articles 1 and 3(1), (3) and (5) and Annex 2 |
| Article 3(3) (maximum residue levels for substances listed in Annex II) | Articles 1 and 3(1) and (5) and Annex 2 |
| Article 3(4) (prohibition on the use of plant protection products) | Articles 1 and 3(1) and (5) and Annex 3 |
| Article 4 (name of the food) | Article 1 and Annex 4 |
| Article 5(1) (requirement for food for special medical purposes to comply with Regulation (EU) No. 1169/2011 unless otherwise specified) | Articles 1 and 5(2) |
| Article 5(2) (additional mandatory particulars relating to food information) | Articles 1 and 5(1) and (3) |
| Article 5(3) (application of articles 13(2) and (3) of Regulation (EU) No. 1169/2011 to additional mandatory particulars) | Articles 1 and 5(1) and (2) |
| Article 6 (specific requirements on the nutrition declaration) | Article 1 and Annex 1 |
| Article 7 (nutrition and health claims) | Article 1 |
| Article 8(1) (requirement for mandatory particulars to appear in a language easily understood by consumers) | Article 1 |
| The first sub-paragraph of article 8(2) (prohibition of pictures of infants or certain other pictures or text) | Article 1 |
| Article 8(3) (requirements relating to labelling, presentation and advertising) | Article 1 |
| The first sub-paragraph of article 8(4) (restriction on publication) | Article 1 and the third sub-paragraph of article 8(4) |
| Article 8(5) (prohibition on use of promotional devices to induce sales) | Article 1 |
| Article 8(6) (prohibition on providing free or low-priced products, samples or other promotional gifts) | Article 1 |
| Article 9 (notification) | Article 1 |
| Article 7(5) (application of articles 31 to 35 of Regulation (EU) No. 1169/2011) | Article 1(1), 7(6), (7) and (8) |
| Article 7(6) (expression of energy value and amounts of nutrients) | Article 1(1) and 7(5) |
| The first sub-paragraph of Article 7(7) (prohibition on expressing energy value and amount of nutrients as a percentage of reference intake) | Article 1(1) and 7(5) |
| Article 7(8) (presentation of particulars included in the nutrition declaration) | Article 1(1) |
| Article 8 (prohibition on making health claims on infant formula) | Article 1(1) |
| Article 9(1) (“lactose only” statement) | Article 1(1) |
| The first sub-paragraph of Article 9(2) (“lactose free” statement) | Article 1(1) |
| The second sub-paragraph of Article 9(2), (statement that lactose free infant formula and follow-on formula is not suitable for infants with galactosaemia) | Article 1(1) |
| Article 9(3) (prohibition on references to decosahexaenoic acid where infant formula placed on the market on or after 22 February 2025) | Article 1(1) |
| The first paragraph of article 10(1) (restriction on advertising for infant formula) | Article 1(1) |
| Article 10(2) (prohibition of promotional devices to induce sales of infant formula) | Article 1(1) |
| Article 10(3) (prohibition of provision of free or low-priced products, samples or other promotional gifts to the general public, pregnant women, mothers or members of their families) | Article 1(1) |
| Article 10(4) (requirements for donations or low-priced sales of supplies of infant formula to institutions or organisations) | Article 1(1) |
| Article 11(2) (requirements on information relating to infant and young child feeding) | |
| Article 11(3) (requirements on donations of informational or educational equipment or materials) | |
| Article 12 (notification requirements) | Article 1(1) ” |
Regulation (EU) No. 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, etc. (O.J. No. L 304, 22.11.2011, p.18)