3 Amendment of the 2016 Regulations
1 The 2016 Regulations are amended as follows.
2 In regulation 2 (Interpretation)—
(a) in paragraph (1)—
(i) before the definition of “the EU regulation” insert—

““the Delegated Regulation” means Commission Delegated Regulation (EU) 2016/128 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.”

(ii) after the definition of “the EU regulation” insert —

““food for special medical purposes” has the same meaning in these Regulations as in the EU Regulation ;
“infant” means a child under the age of 12 months;”

;
Article 2(2)(g) of the EU Regulation states “ ‘food for special medical purposes’ means food specially 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.”
(iii) in the definition of “specified EU requirement”, after “the EU Regulation” insert “ or the Delegated Regulation ”.
(b) after paragraph (3) insert —

“4 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.
5 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.”

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3 After regulation 7 (Revocation) insert —

“8 Transitional Arrangements
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 Regulations (Northern Ireland) 2000 are met.”

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