(1) A product is an exempt product for the purposes of regulation 3(1) and this Schedule if it is a product for use for—
(a) special medical purposes, which meets the description in sub-paragraph (2)(a),
(b) infants or young children, which meets the description in sub-paragraph (2)(b), (c) or (d), or
(c) total diet replacement for weight control, which meets the description in sub-paragraph (2)(e).
(2) For the purposes of sub-paragraph (1), the descriptions referred to are—
(a) food for special medical purposes, as defined in Article 2(2)(g) of Regulation (EU) 609/2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control , which meet the requirements in Commission Delegated Regulation (EU) 2016/128 supplementing Regulation (EU) 609/2013 as regards the specific compositional and information requirements for food for special medical purposes ,
(b) foodstuffs intended for particular nutritional use by infants during the first months of life and satisfying by themselves the nutritional requirements of such infants until the introduction of appropriate complementary feeding, which complies with—
(i) Article 9 of Regulation (EU) 609/2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control, and
(ii) Articles 2(1) and (3), 3(1) and (3), 4 and 5 of Commission Delegated Regulation (EU) 2016/127 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 , as it forms part of domestic law (“Regulation (EU) 2016/127”),
(c) foodstuffs intended for particular nutritional use by infants when appropriate complementary feeding is introduced and constituting the principal liquid element in a progressively diversified diet of such infants, which complies with—
(i) Article 9 of Regulation (EU) 609/2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control, and
(ii) Articles 2(2) and (3), 3(2) and (3), 4 and 5 of Regulation (EU) 2016/127 ,
(d) baby foods and processed cereal-based foods, as defined in the Processed Cereal-based Foods and Baby Foods for Infants and Young Children (England) Regulations 2003 , which comply with the requirements of regulations 5 to 7 of those Regulations, and
(e) specially formulated foods intended for use in energy-restricted diets for weight reduction which—
(i) comply with the compositional requirements in Schedule 1 to the Foods Intended for Use in Energy Restricted Diets for Weight Reduction Regulations 1997 as it applies in England; and
(ii) when used as instructed by the manufacturer, replace the whole of the total daily diet.
(3) So far as this paragraph applies to Northern Ireland, references in sub-paragraph (2) to—
(a) Regulation (EU) 609/2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control;
(b) Commission Delegated Regulation (EU) 2016/128 supplementing Regulation (EU) 609/2013 as regards the specific compositional and information requirements for food for special medical purposes;
(c) Commission Delegated Regulation (EU) 2016/127 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,
are to be read as references to those instruments as they have effect in EU law and in Northern Ireland by virtue of the Windsor Framework.
(4) In paragraph (3), the “ Windsor Framework ” means the part of the EU withdrawal agreement known as the Windsor Framework by virtue of Joint Declaration No 1/2023 of 24th March 2023 made between the EU and the United Kingdom in the Joint Committee established by the EU withdrawal agreement .