
1 

(1) These Regulations may be cited as the Foods for Specific Groups (Medical Foods) (Miscellaneous Amendments) (Scotland) Regulations 2018 and come into force on 22 February 2019.
(2) These Regulations extend to Scotland only.
2 

(1) The Foods Intended for Use in Energy Restricted Diets for Weight Reduction Regulations 1997  are amended in accordance with paragraphs (2) to (4).
(2) In regulation 2 (name of the food and compositional requirements)—
(a) for paragraph (1) substitute—“
(1) No person shall sell any relevant food under any name other than  “total diet replacement for weight control”.”, and
(b) in paragraph (2) omit  “or  “meal replacement for weight control””.
(3) In regulation 3 (labelling requirements)—
(a) at the end of paragraph (e) insert “
                    and
                  ”,
(b) in paragraph (f), for  “regulation 2(1)(a)” substitute “
                    regulation 2(1)
                  ”,
(c) at the end of paragraph (f) omit  “and”, and
(d) omit paragraph (g).
(4) In schedule 1 (essential composition of relevant food)—
(a) in each of paragraphs 1.1, 2.1, 3.2, 4 and 5.1, for  “regulation 2(1)(a)” substitute “
                    regulation 2(1)
                  ”,
(b) in paragraph 2.1 omit  “and (b)”, and
(c) omit paragraphs 1.2, 3.3 and 5.2.
3 

(1) The Foods for Special Medical Purposes (Scotland) Regulations 2000  are amended as follows.
(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4 

(1) The Foods for Specific Groups (Scotland) Regulations 2016  are amended in accordance with paragraphs (2) and (3).
(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) 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes
                      ”
                      , and
(ii) in the definition of  “specified EU requirement” after  “the EU Regulation” insert “
                        or the Delegated Regulation
                      ”,
(b) in paragraph (2) after  “EU Regulation” insert “
                    or the Delegated Regulation, as the case may be
                  ”,
(c) for paragraph (3) substitute—“
(3) Expressions defined in Article 2 of the EU Regulation have the same meaning in these Regulations as they have in that Regulation.”, and
(d) in paragraph (4)—
(i) after  “Article 2” insert “
                        of the EU Regulation
                      ”, and
(ii) after  “EU Regulation” in the second place it appears insert “
                        or the Delegated Regulation, as the case may be
                      ”.
(3) In schedule 1 (specified EU requirements) replace the table with the following.“
Column 1 Column 2
Specified provision of the EU Regulation Provisions of the EU Regulation to be read with the specified provision of the EU Regulation
Article 4(1) (requirement for placing food on the market) Article 1 (1)
Article 4(2) (requirement for 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), 9(3) and (4)
Article 9(2) (prohibition on substances in dangerous quantities) Articles 1(1) and 4(1)
Article 9(3) (requirement for substances added to food) Article 1 (1)
Article 9(5) (requirements as to labelling, presentation and advertising of food) Articles 1(1), 4(1) and 9(6)
Article 10 (additional requirements for infant formula and follow-on formula) Article 4(1)
Specified provision of the Delegated Regulation Provisions of the Delegated Regulation 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) (requirement for food to comply with Part B of Annex I) Articles 1 and 2(4), and Part B of Annex I
Article 3(2) (requirement on pesticides in food for special medical purposes developed to satisfy the nutritional requirements of infants and young children) Article 3(5)
Article 3(4) (maximum residue levels) Article 3(5)
Article 4 (name of the food) Annex IV
Article 5(2) (specific requirements on food information) Articles 1, and 5(1) (3)
Article 6 (specific requirements on the nutrition declaration) Article 1
Article 7 (nutrition and health claims) Article 1
Article 9 (notification) Article 1”
JOE FITZPATRICK

Authorised to sign by the Scottish Ministers

St Andrew's House,

Edinburgh
