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(1);
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);”
(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(3) 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(4) 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(5) to the 2016 Regulations (specified EU Requirements), substitute Schedule 1 of these Regulations.
O.J. No. L 25, 2.2.2016, p.1, as last amended by Commission Delegated Regulation (EU) 2019/828 (O.J. No. L 137, 23.5.2019, p.12)
OJ No. L 25, 2.2.2016, p. 30–43
S.R. 2007 No. 506, as amended by S.R. 2008 No. 405 and S.R. 2014 No. 11
The table in Schedule 1 was substituted by regulation 4 of the Food Safety (Information and Compositional Requirements) (Amendment) Regulations (Northern Ireland) 2019. S.R. 2019 No. 9