Amendment of the 2016 RegulationsE+W
3.—(1) The 2016 Regulations are amended as follows.
(2) In regulation 2 (interpretation)—
(a)in paragraph (1)—
(i)at the appropriate place insert—
““the Delegated Regulation” (“y Rheoliad Dirprwyedig”) means Commission Delegated Regulation (EU) 2016/128 as amended from time to time 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 M1;”;
““food for special medical purposes” (“bwyd at ddibenion meddygol arbennig”) has the same meaning in these Regulations as in the EU Regulation M2;”;
““infant” (“baban”) means a child under the age of 12 months;”; and
(ii)in the definition of “specified EU requirement”, after “the EU Regulation” insert “ or the Delegated Regulation ”; and
(b)after paragraph (4) insert—
“(5) Any reference to a provision of the Delegated Regulation contained in the table in Schedule 1 is a reference to that provision as amended from time to time.
(6) Any reference to the Delegated Regulation is a reference to the Delegated Regulation only insofar as it applies to food for special medical purposes other than that developed to satisfy the nutritional requirements of infants.”
(3) After regulation 6 (amendments to statutory instruments) insert—
“Transitional arrangements
7. Food for special medical purposes, other than that developed to satisfy the nutritional requirements of infants, that does not comply with the specified provisions of the Delegated Regulation may continue to be marketed until stocks of such food are exhausted provided—
(a)it complies with the specified provisions of the EU Regulation;
(b)it was placed on the market or labelled before 22 February 2019; and
(c)the requirements of regulation 3(1) and (2) of the Medical Food (Wales) Regulations 2000 are met.”
Commencement Information
Marginal Citations
M1OJ No. L 25, 2.2.2016, p. 30.
M2Article 2(2)(g) of the EU Regulation states “ ‘food for special medical purposes’ means food specifically processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone.”