2016 No. 190
The Foods for Specific Groups (Scotland) Regulations 2016
Made
Laid before the Scottish Parliament
Coming into force
The Scottish Ministers make the following Regulations in exercise of the powers conferred by sections 6(4), 16(1), 17(1), 26(1) and (3), 31(1) and 48(1) of the Food Safety Act 19901, section 2(2) and paragraph 1A of schedule 2 of the European Communities Act 19722 and all other powers enabling them to do so.
These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears to the Scottish Ministers that it is expedient for any reference to specified provisions of Regulation (EU) No 609/2013 of the European Parliament and of the Council on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/20093 to be construed as a reference to those provisions as amended from time to time.
So far as these Regulations are made in exercise of powers under the Food Safety Act 1990, the Scottish Ministers have had regard to relevant advice given by Food Standards Scotland4 in accordance with section 48(4A) of that Act5.
There has been consultation, as required by Article 9 of Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety6.
Citation, commencement and extentI41
1
These Regulations may be cited as the Foods for Specific Groups (Scotland) Regulations 2016 and come into force on 20th July 2016.
2
These Regulations extend to Scotland only.
InterpretationI72
1
In these Regulations—
“the Act” means the Food Safety Act 1990;
F3“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
“food authority” means a council constituted under section 2 of the Local Government etc. (Scotland) Act 19947;
“the EU Regulation” means Regulation (EU) No 609/2013 of the European Parliament and of the Council, on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009; and
“specified EU requirement” means any provision of the EU RegulationF2or the Delegated Regulation specified in column 1 of schedule 1 as read with the provisions specified in the corresponding entry in column 2.
2
Unless the context otherwise requires any reference in these Regulations to an Article is a reference to an Article of the EU RegulationF4or the Delegated Regulation, as the case may be.
F53
Expressions defined in Article 2 of the EU Regulation have the same meaning in these Regulations as they have in that Regulation.
EnforcementI93
Each food authority must execute and enforce these Regulations within its area.
Offences and penaltiesI84
1
F13Subject to regulation 4A, a person is guilty of an offence if they fail to comply with any specified EU requirement.
2
A person guilty of an offence under this regulation is liable on summary conviction to a fine not exceeding level 5 on the standard scale.
F8Transitional Provision4A
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.
Application of provisions of the ActI65
The provisions of the Act specified in column 1 of the table in schedule 2 apply, with the modifications specified in column 2 of that table, for the purposes of these Regulations.
Amendment of the Foods Intended for Use in Energy Restricted Diets for Weight Reduction Regulations 1997I36
1
The Foods Intended for Use in Energy Restricted Diets for Weight Reduction Regulations 19978 are amended in accordance with paragraph (2).
2
For the definition of “relevant food” in regulation 1(2) substitute—
“relevant food” means specially formulated food intended for use in energy-restricted diets for weight reduction, being food which complies with the compositional requirements in schedule 1 and which, when used as instructed by the manufacturer, replaces the whole of the total daily diet.
RevocationsI57
1
Regulations 26 and 27 of the Infant Formula and Follow-on Formula (Scotland) Regulations 20079 are revoked.
2
The Notification of Marketing of Food for Particular Nutritional Uses (Scotland) Regulations 200710 are revoked.
I2SCHEDULE 1Specified EU requirements
Sch. 1 Table substituted (22.2.2019) by The Foods for Specific Groups (Medical Foods) (Miscellaneous Amendments) (Scotland) Regulations 2018 (S.S.I. 2018/392), regs. 1(1), 4(3)
Words in sch. 1 omitted (22.2.2020) by virtue of The Foods for Specific Groups (Medical Foods for Infants) and Addition of Vitamins, Minerals and Other Substances (Scotland) Amendment Regulations 2020 (S.S.I. 2020/7), reg. 1, sch. 1 para. 1(4)(a)(i)
Words in sch. 1 omitted (22.2.2020) by virtue of The Foods for Specific Groups (Medical Foods for Infants) and Addition of Vitamins, Minerals and Other Substances (Scotland) Amendment Regulations 2020 (S.S.I. 2020/7), reg. 1, sch. 1 para. 1(4)(a)(ii)
F1Column 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 |
F9. . . | F9. . . |
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) |
F10. . . | F10. . . |
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) |
F11Article 15(1) (Union list) | F11Article 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 |
F12Specified 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 |
I1SCHEDULE 2Modification of provisions of the Act
Provision of the Act | Modifications |
|---|---|
Section 3 (presumptions that food intended for human consumption) | In subsection (1), for “this Act” substitute “the Foods for Specific Groups (Scotland) Regulations 2016”. |
Section 20 (offences due to fault of another person) | For “any of the preceding provisions of this Part” substitute “the Foods for Specific Groups (Scotland) Regulations 2016”. |
Section 2111 (defence of due diligence) | In subsection (1), for “any of the preceding provisions of this Part” substitute “the Foods for Specific Groups (Scotland) Regulations 2016”. |
Section 22 (defence of publication in the course of business) | In subsection (1), for “any of the preceding provisions of this Part” substitute “any provision of the Foods for Specific Groups (Scotland) Regulations 2016”. |
Section 29 (procurement of samples) | In paragraph (b)(ii), after “under section 32 below” insert “including under section 32 as applied and modified by regulation 5 and schedule 2 of the Foods for Specific Groups (Scotland) Regulations 2016”. |
Section 30(8) (evidence of certificates given by a food analyst or examiner) | For “this Act” substitute “the Foods for Specific Groups (Scotland) Regulations 2016”. |
Section 32 (powers of entry) | In subsection (1), for paragraphs (a) to (c) substitute “(a) to enter any premises within the authority’s area for the purpose of ascertaining whether there has been any contravention of a specified EU requirement (as defined in regulation 2 of the Foods for Specific Groups (Scotland) Regulations 2016); (b) to enter any business premises, whether within or outside the authority’s area, for the purpose of ascertaining whether there is on the premises any evidence of any contravention of such a requirement; and (c) when exercising a power of entry under this section, to exercise the associated powers in sub-sections (5) and (6) relating to records.”. |
Section 33 (obstruction etc. of officers) | In subsection (1), for “this Act” (in each place where it occurs) substitute “the Foods for Specific Groups (Scotland) Regulations 2016”. |
Section 35(1) (punishment of offences) | After “section 33(1) above” insert “as applied and modified by regulation 5 and schedule 2 of the Foods for Specific Groups (Scotland) Regulations 2016,”. |
Section 36 (offences by bodies corporate) | In subsection (1), for “this Act” substitute “the Foods for Specific Groups (Scotland) Regulations 2016”. |
Section 36A12 (offences by Scottish partnerships) | For “this Act” substitute “the Foods for Specific Groups (Scotland) Regulations 2016”. |
Section 44 (protection of officers acting in good faith) | For “this Act”— (a) where it first appears substitute “the Foods for Specific Groups (Scotland) Regulations 2016 (“the 2016 Regulations”)”; and (b) on each other occasion it appears substitute “the 2016 Regulations”. |
(This note is not part of the Regulations)
Sch. 1 in force at 20.7.2016, see reg. 1(1)