
PART 1
1 
These Regulations may be cited as the Food Safety (Information and Compositional Requirements) (Amendment) Regulations (Northern Ireland) 2020 and come into operation on 22nd February 2020.
2 
In these Regulations—
 “the 2016 Regulations” means the Food Safety (Information and Compositional Requirements) Regulations (Northern Ireland) 2016;
PART 2
3 
The 2016 Regulations are amended as follows.
4 

(1) In regulation 2 (Interpretation), for the definition of “the Delegated Regulation”, substitute—“
 “Delegated Regulation 127” means 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;
 Delegated Regulation 128” means Commission Delegated Regulation (EU) 2016/128 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 food for special medical purposes;”
(2) For the definition of “specified EU requirement” substitute—“
 “specified EU requirement” means any provision of the EU Regulation or Delegated Regulation 127 or Delegated Regulation 128 specified in column 1 of Schedule 1, as read with the provisions specified in the corresponding entry in column 2.”.
(3) In regulation 2 (interpretation)—
(a) For paragraph (4) substitute—“
(4) Any reference to a provision of Delegated Regulation 127 or Delegated Regulation 128 contained in the table in Schedule 1 is a reference to that provision as amended from time to time.”.
(b) For paragraph (5) substitute—“
(5) Any expression used in both these Regulations and in Delegated Regulation 127 or Delegated Regulation 128 has the same meaning it bears in Delegated Regulation 127 or Delegated Regulation 128, as the case may be.”.
5 
For regulation 8 (Transitional Arrangements) substitute—“
8. 

(1) Infant Formula and Follow on Formula that does not comply with any specified provision of Delegated Regulation 127 specified in Schedule 1 may continue to be marketed until stocks of such food are exhausted provided that—
(a) it complies with the provisions of the EU Regulation specified in Schedule 1;
(b) it was placed on the market or labelled—
(i) before 22nd February 2020; or
(ii) before 22nd February 2021 in the case of infant formula and follow-on formula manufactured from protein hydrolysates, and
(c) the requirements specified in the following provisions of the Infant Formula and Follow on Formula Regulations (Northern Ireland) 2007 are met —
(i) regulation 3(1) (prohibition on the marketing of infant formula unless certain conditions are met) in the case of infant formula; or
(ii) regulation 3(2) (prohibition on the marketing of follow-on formula unless certain conditions are met) in the case of follow on formula.
(2) Food for special medical purposes that does not comply with any specified provision of Delegated Regulation 128 specified in Schedule 1 may continue to be marketed until stocks of such food are exhausted provided that—
(a) it complies with the provisions of the EU Regulation specified in Schedule 1;
(b) it was placed on the market or labelled—
(i) before 22nd February 2019; or
(ii) before 22nd February 2020 in the case of food for special medical purposes developed to satisfy the nutritional requirements of infants, and
(c) the requirements specified in the following provisions of the Medical Food Regulations (Northern Ireland) 2000 are met-
(i) regulation 3(1) (restrictions on sale of a medical food);
(ii) regulation 3(2) (restrictions on sale of a medical food of a particular type).”.
6 
In Schedule 1 to the 2016 Regulations (specified EU Requirements), substitute Schedule 1 of these Regulations.
PART 3
7 

(1) The Regulations specified in column 1 of the table in Schedule 2 are revoked to the extent specified in column 3, subject to paragraph (2).
(2) The Regulations specified in column 1 of the table in Schedule 2 continue to have effect (so far as otherwise revoked to the extent specified in column 3 of that table)—
(a) until 21st February 2021 in respect of infant formula and follow-on formula manufactured from protein hydrolysates;
(b) for the purposes of regulation 8(1)(c) and regulation 8(2)(c) of the 2016 Regulations as substituted by regulation 5 of these Regulations.
Sealed with the official seal of the Department of Health on 27th January 2020.
Dr Naresh Chada
A senior officer of the Department of Health

SCHEDULE 1
Regulation 6
“
SCHEDULE 1
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) 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) ”
SCHEDULE 2
Regulation 7


Column 1 Column 2 Column 3
Instrument Reference Extent of revocation
The Medical Food Regulations (Northern Ireland) 2000 S.R. 200 No. 187 The whole Regulations
The Infant Formula and Follow-on Formula Regulations (Northern Ireland) 2007 S.R. 2007 No.506 The whole Regulations
The Infant Formula and Follow-on Formula Amendment Regulations (Northern Ireland) 2008 S.R 2008 No. 405 Regulation 3
The Infant Formula and Follow-on Formula Amendment Regulations (Northern Ireland) 2014 S.R. 2014 No. 11 The whole Regulations
The Food Safety (Information and Compositional Requirements) Regulations (Northern Ireland) 2016 S.R. 2016 No. 251 Schedule 3, paragraph 2
The Food Safety (Information and Compositional Requirements) (Amendment) Regulations (Northern Ireland) 2019 S.R. 2019 No. 9 Regulation 5