SCHEDULE 4Amendment of the Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2016
InterpretationI11
In this Schedule, “the 2016 Regulations” means the Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2016 M1.
Amendment of regulation 2 of the 2016 RegulationsI22
In regulation 2 of the 2016 Regulations (interpretation), omit paragraph (6).
Amendment of regulation 8 of the 2016 RegulationsI33
For regulation 8 of the 2016 Regulations (transitional arrangements) substitute—
Transitional arrangements8
Food for special medical purposes that does not comply with any specified provision of the Delegated Regulation 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 regulation 3(1) and (2) of the Medical Food (England) Regulations 2000 M2 (restrictions on sale) are met.
Amendment of Schedule 1 to the 2016 RegulationsI44
In Schedule 1 to the 2016 Regulations M3 (specified EU Requirements)—
a
in the part of the table relating to the EU Regulation, in the entry relating to “Article 15(1) (Union list)”, in column 2, for “Articles 1(1)(c), 4(1) and the Annex insofar as it applies to food for special medical purposes” substitute “
Articles 1(1)(a) and (c) and 4(1) and the Annex insofar as it applies to infant formula, follow-on formula and food for special medical purposes
”
;
b
for the part of the table relating to the Delegated Regulation substitute—
Specified provision of the Delegated Regulation
Provisions to be read with the specified provision of the Delegated Regulation
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 1)
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 1)
Articles 1 and 2(4) and Part B of Annex 1
Article 3(2) (requirement relating to 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 2)
Articles 1 and 3(1), (2) 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