The Foods for Specific Groups (Medical Foods for Infants) and Addition of Vitamins, Minerals and Other Substances (Scotland) Amendment Regulations 2020

Regulation 2

SCHEDULE 1 Amendment of the Foods for Specific Groups (Scotland) Regulations 2016

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—

“Transitional Provision

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)(1)—

(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(2) 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”.

Regulation 4

SCHEDULE 2 Revocations

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)

(1)

The table in schedule 1 was substituted by S.S.I. 2018/392.

(2)

Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (O.J. No. L 304, 22.11.2011, p.18).