1. These Regulations may be cited as the Food for Specific Groups (Information and Compositional Requirements) (Amendment) (England) Regulations 2019 and they come into force on 22nd February 2019.
2. In these Regulations, “the 2016 Regulations” means the Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2016(1).
3.—(1) The 2016 Regulations are amended as follows.
(2) In regulation 2 (interpretation) —
(a)in paragraph (1) —
(i)after the definition of “the Act” 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;”(2);
(ii)after the definition of “food authority” insert —
““food for special medical purposes” has the same meaning in these Regulations as in the EU Regulation(3);
“infant” means a child under the age of 12 months;”;
(iii)in the definition of “specified EU requirement”, after “the EU Regulation” insert “or the Delegated Regulation”.
(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 7 (review) insert —
8. 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 (England) Regulations 2000 are met.”.
4. For the table in Schedule 1 to the 2016 Regulations substitute the following:
| Column 1 | Column 2 |
|---|---|
| Specified provision of the EU Regulation | 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)(c), 4(1) and the Annex insofar as it applies to food for special medical purposes |
| 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 second sub-paragraph of Article 2(3) (food to comply with 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 levels) insofar as it applies to young children rather than infants | Articles 1 and 3(1), (3) and (5) and Annex 2 |
| Article 3(4) (prohibition on the use of plant protection products) insofar as it applies to young children rather than infants | Articles 1 and 3(1) and (5) and Annex 3 |
| Article 4 (name of the food) | Article 1 and Annex 4 |
| Article 5(2) (specific requirements on food information) | Articles 1, and 5(1), and (3) |
| Article 6 (specific requirements on the nutrition declaration) | Article 1 and Part B of Annex 1 |
| Article 7 (nutrition and health claims) | Article 1 |
| Article 9 (notification requirement) | Article 1 |
5. In regulation 2 of the Medical Food (England) Regulations 2000 (interpretation)(4) for the definition of “medical food” substitute:
““medical food” means food coming within the classification of dietary foods for special medical purposes for which compositional and labelling requirements are laid down in the Directive and which has been developed to satisfy the nutritional requirements of infants; and”.
Signed by the authority of the Secretary of State for Health and Social Care.
Steve Brine
Parliamentary Under-Secretary of State,
Department of Health and Social Care
14th January 2019