
1 
These Regulations may be cited as the Foods for Specific Groups (Medical Foods for Infants) and Addition of Vitamins, Minerals and Other Substances (Scotland) Amendment Regulations 2020 and come into force on 22February 2020.
2 
Schedule 1 has effect.
3 

(1) The Addition of Vitamins, Minerals and Other Substances (Scotland) Regulations 2007 are amended as follows.
(2) In regulation 2(1) (interpretation), in the definition of “the EC Regulation”, for “I or II”, substitute “I, II or III”.
(3) In regulation 4(2) (offences and penalties)—
(a) at the end of sub-paragraph (d), omit “and”,
(b) after sub-paragraph (e), insert—“
(f) Article 8(2)(a)(i) (prohibition of the addition of a substance listed in Annex III, Part A to foods or its use in the manufacture of foods), and
(g) Article (8)(2)(a)(ii) (prohibition of the addition of a substance listed in Annex III, Part B to foods or its use in the manufacture of foods, unless that substance is added or used in accordance with the conditions specified in that Part).”.
4 

(1) The instruments specified in column 1 of the table in schedule 2 are revoked to the extent specified in column 3 of that table, subject to paragraph 2.
(2) The instruments specified in column 1 of the table in schedule 2 continue to have effect (so far as otherwise revoked to the extent specified in column 3 of that table) for the purposes of regulation 4A of the Foods for Specific Groups (Scotland) Regulations 2016.
JOE FITZPATRICK
Authorised to sign by the Scottish Minsters
St Andrew’s House,
Edinburgh
14th January 2020
SCHEDULE 1
Regulation 2
1 

(1) The Foods for Specific Groups (Scotland) Regulations 2016 are amended as follows.
(2) In regulation 4(1) (offences and penalties), for “A person” substitute “Subject to regulation 4A, a person”.
(3) After regulation 4, insert—“
4A. 
A person is not guilty of an offence under regulation 4(1) if they continue to market food for special medical purposes which does not comply with a provision of the Delegated Regulation specified in schedule 1, provided that—
(a) it complies with the requirements of the EU Regulation specified in schedule 1,
(b) it was placed on the market or labelled—
(i) before 22 February 2019, or
(ii) before 22 February 2020 in the case of food for special medical purposes developed to satisfy the nutritional requirements of infants, and
(c) the requirements specified in regulation 3 of the Foods for Special Medical Purposes (Scotland) Regulations 2000 are met.”.
(4) In schedule 1 (specified EU requirements)—
(a) in the part of the table relating to the EU Regulation—
(i) omit the entry relating to Article 4(1) (requirement for placing food on the market),
(ii) omit the entry relating to Article 9(3) (requirement for substances added to food), and
(iii) insert, at the end—“
Article 15(1) (Union list) Article 1(1)(a) and (c) and Articles 4(1) and 15(3) and the Annex, insofar as they apply to infant formula and follow-on formula and food for special medical purposes”.
(b) for the part of the table relating to the Delegated Regulation substitute—“

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 for special medical purposes to be based on sound medical and nutritional principles) Article 1
The first sub-paragraph of Article 2(3) (requirement for food for special medical purposes developed to satisfy the nutritional requirements of infants to comply with the compositional requirements in Part A of Annex I) Articles 1 and 2(4) and Part A of Annex I
The second sub-paragraph of Article 2(3) (requirement for food other than that developed to satisfy the nutritional requirements of infants to comply with the compositional requirements in Part B of Annex I) Articles 1 and 2(4) and Part B of Annex I
Article 3(2) (residue threshold for certain active substances where food for special medical purposes is developed to satisfy the nutritional requirements of infants and young children) Articles 1 and 3(1), (3) and (5)
Article 3(3) (maximum residue levels for substances listed in Annex II) Articles 1 and 3(1) and (5) and Annex II
Article 3(4) (requirements on plant protection products) Articles 1 and 3(1), (5) and Annex III
Article 4 (name of the food) Article 1 and Annex IV
Article 5(1) (requirement for food for special medical purposes to comply with Regulation (EU) No 1169/2011 unless otherwise specified) Articles 1 and 5(2)
Article 5(2) (additional mandatory particulars) Articles 1 and 5(1) and (3)
Article 5(3) (application of articles 13(2) and (3) of Regulation (EU) No 1169/2011 to additional mandatory particulars) Articles 1 and 5(1) and (2)
Article 6(1) (mandatory nutrition declaration) Articles 1 and 6(3)
Article 6(2) (prohibition of repetition of information) Article 1
Article 6(4) (application of articles 31 to 35 of Regulation (EU) No 1169/2011) Articles 1 and 6(3) and (5)
Article 6(5) (energy value and amount of nutrients of food for special medical purposes) Articles 1 and 6(4)
Article 6(6) (prohibition of expressing energy value and amount of nutrients as a percentage of reference intakes) Articles 1 and 6(4)
The first sub-paragraph of Article 6(7) (presentation of nutrition declaration particulars) Articles 1 and 6(4)
The second sub-paragraph of Article 6(7) (placement of nutrition declaration particulars) Articles 1 and 6(4)
The third sub-paragraph of Article 6(7) (indication of amount of sodium) Articles 1 and 6(4)
Article 7 (nutrition and health claims) Article 1
Article 8(1) (requirement for mandatory particulars to appear in a language easily understood by consumers) Article 1
The first sub-paragraph of Article 8(2) (prohibition of pictures of infants or certain other pictures or text) Article 1
Article 8(3) (requirements relating to labelling, presentation and advertising) Article 1
The first sub-paragraph of Article 8(4) (restriction on publication) Article 1 and the third sub-paragraph of Article 8(4)
Article 8(5) (prohibition on use of promotional devices to induce sales) Article 1
Article 8(6) (prohibition on providing free or low-priced products, samples or other promotional gifts) Article 1
Article 9 (notification) Article 1”.
SCHEDULE 2
Regulation 4


Column 1 Column 2 Column 3
Instrument Reference Extent of revocation
The Foods for Special Medical Purposes (Scotland) Regulations 2000 S.S.I. 2000/130 The whole Regulations
The Infant Formula and Follow-on Formula (Scotland) Regulations 2007 S.S.I. 2007/549 Regulation 30
The Infant Formula and Follow-on Formula (Scotland) Amendment Regulations 2008 S.S.I. 2008/322 Regulation 3
The Food (Scotland) Act 2015 (Consequential and Transitional Provisions) Order 2015 S.S.I. 2015/100 Paragraph 7 of the schedule
The Foods for Specific Groups (Medical Foods) (Miscellaneous Amendments) (Scotland) Regulations 2018 S.S.I. 2018/392 Regulation 3(2)