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The Food Safety (Information and Compositional Requirements) Regulations (Northern Ireland) 2016

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Regulation 2(1)

[F1SCHEDULE 1N.I.Specified EU Requirements

Column 1 Specified provision of the EU RegulationColumn 2 Provisions to be read with the specified provision of the EU Regulation
Article 4(2) (requirement for relevant 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) and 9(3)
Article 9(2) (prohibition on substances in dangerous quantities)Articles 1(1) and 4(1)
Article 9(5) (requirements as to labelling, presentation and advertising of relevant food)Articles 1(1), 4(1) and 9(6)
Article 10 (additional requirements for infant formula and follow-on formula)Article 4(1)
Article 15(1) (Union list)Articles 1(1) (a) and (c) and 4(1) and the Annex insofar as it applies to infant formula and follow-on formula and food for special medical purposes
Specified provision of Delegated Regulation (EU) 2016/127Provision of Delegated Regulation 127 to be read with the specified provision of Delegated Regulation 127
Article 1(2) (placing on the market)Article 1(1)
Article 2(1) (compositional requirements for infant formula)Articles 1(1) and 2(3), Annex 1 and Annex 3
Article 2(2) (compositional requirements for follow-on formula)Articles 1(1) and 2(3), Annex 2 and Annex 3
Article 2(3) (preparation of infant and follow-on formula)Articles 1(1), 2(1) and (2)
Article 3(1) (suitability of ingredients for infant formula)Articles 1(1) and 3(3) and point 2 of Annex 1
Article 3(2) (suitability of ingredients for follow-on formula)Articles 1(1) and 3(3) and point 2 of Annex 2
Article 4(2) (active substance residue threshold)Articles 1(1) and 4(1), (3) and (5)
Article 4(3) (derogation from active substance residue threshold)Articles 1(1) and 4(1), (2) and (5)
Article 4(4) (requirements on pesticides)Articles 1(1) and 4(1) and (5)
Article 5(1) (name of food not manufactured entirely from cows’ or goats’ milk protein)Article 1(1) and Part A of Annex 6
Article 5(2) (name of food manufactured entirely from cows’ or goats’ milk protein)Article 1(1) and Part B of Annex 6
Article 6 (specific requirements on food information)Articles 1(1) and 7(1), (2), (3), (5), (6), (7) and (8)
Article 7(1) (specific requirements on the nutrition declaration)Articles 1(1) and 7(4), Annex 1 and Annex 2
Article 7(3) (repetition of information included in mandatory nutrition declaration)Article 1(1)
Article 7(4) (nutrition declaration mandatory regardless of size of packaging or container)Articles 1(1) and 7(1), Annex 1 and Annex 2
Article 7(5) (application of Articles 31 to 35 of Regulation (EU) No. 1169/2011)Articles 1(1) and 7(6), (7) and (8)
Article 7(6) (expression of energy value and amounts of nutrients)Articles 1(1) and 7(5)
The first sub-paragraph of Article 7(7) (prohibition on expressing energy value and amount of nutrients as a percentage of reference intake)Articles 1(1) and 7(5)
Article 7(8) (presentation of particulars included in the nutrition declaration)Article 1(1)
Article 8 (prohibition on making nutrition and health claims on infant formula)Article 1(1)
Article 9(1) (“lactose only” statement)Article 1(1)
The first sub-paragraph of Article 9(2) (“lactose free” statement)Article 1(1)
The second sub-paragraph of Article 9(2), (statement that “lactose free” infant formula and follow-on formula is not suitable for infants with galactosaemia)Article 1(1)
Article 9(3) (prohibition on references to docosahexaenoic acid where infant formula placed on the market on or after 22 February 2025)Article 1(1)
Article 10(1) (restriction on advertising for infant formula)Article 1(1)
Article 10(2) (prohibition of promotional devices to induce sales of infant formula)Article 1(1)
Article 10(3) (prohibition of provision of free or low-priced products, samples or other promotional gifts to the general public, pregnant women, mothers or members of their families)Article 1(1)
Article 10(4) (requirements for donations or low-priced sales of supplies of infant formula to institutions or organisations)Article 1(1)
Article 11(2) (requirements on information relating to infant and young child feeding)Article 1(1)
Article 11(3) (requirements on donations of informational or educational equipment or materials)
Article 12 (notification requirements)Article 1(1)
Article 10(2) (prohibition of promotional devices to induce sales of infant formula)Article 1(1)
Article 10(3) (prohibition of provision of free or low-priced products, samples or other promotional gifts to the general public, pregnant women, mothers or members of their families)Article 1(1)
Article 10(4) (requirements for donations or low-priced sales of supplies of infant formula to institutions or organisations)Article 1(1)
Article 11(2) (requirements on information relating to infant and young child feeding)
Article 11(3) (requirements on donations of informational or educational equipment or materials)
Article 12 (notification requirements)Article 1(1)
Specified provision of Delegated Regulation 128Provision of Delegated Regulation 128 to be read with the specified provision of the Delegated Regulation 128
Article 2(2) (requirement for the formulation of food 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 1
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 1
Article 3(2) (requirement relating 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) and Annex 2
Article 3(3) (maximum residue levels for substances listed in Annex II)Articles 1 and 3(1) and (5) and Annex 2
Article 3(4) (prohibition on the use of plant protection products)Articles 1 and 3(1) and (5) and Annex 3
Article 4 (name of the food)Article 1 and Annex 4
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 relating to food information)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 (specific requirements on the nutrition declaration)Article 1 and Annex 1
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
Article 7(5) (application of articles 31 to 35 of Regulation (EU) No. 1169/2011)Article 1(1), 7(6), (7) and (8)
Article 7(6) (expression of energy value and amounts of nutrients)Article 1(1) and 7(5)
The first sub-paragraph of Article 7(7) (prohibition on expressing energy value and amount of nutrients as a percentage of reference intake)Article 1(1) and 7(5)
Article 7(8) (presentation of particulars included in the nutrition declaration)Article 1(1)
Article 8 (prohibition on making health claims on infant formula)Article 1(1)
Article 9(1) (“lactose only” statement)Article 1(1)
The first sub-paragraph of Article 9(2) (“lactose free” statement)Article 1(1)
The second sub-paragraph of Article 9(2), (statement that lactose free infant formula and follow-on formula is not suitable for infants with galactosaemia)Article 1(1)
Article 9(3) (prohibition on references to decosahexaenoic acid where infant formula placed on the market on or after 22 February 2025)Article 1(1)
The first paragraph of article 10(1) (restriction on advertising for infant formula)Article 1(1)
Article 10(2) (prohibition of promotional devices to induce sales of infant formula)Article 1(1)
Article 10(3) (prohibition of provision of free or low-priced products, samples or other promotional gifts to the general public, pregnant women, mothers or members of their families)Article 1(1)
Article 10(4) (requirements for donations or low-priced sales of supplies of infant formula to institutions or organisations)Article 1(1)
Article 11(2) (requirements on information relating to infant and young child feeding)
Article 11(3) (requirements on donations of informational or educational equipment or materials)
Article 12 (notification requirements)Article 1(1) ]

Regulation 5

SCHEDULE 2N.I.Application and modification of provisions of the Order

PART 1 N.I.Modification of Articles 9(1), 33(1), 37 and 38

1.  For Article 9(1) of the Order (improvement notices) substitute—N.I.

(1) If an authorised officer has reasonable grounds for believing that a person is failing to comply with a provision specified in paragraph 1A, the authorised officer may, by a notice served on that person (in this Order referred to as an “improvement notice”)—

(a)state the officer's grounds for believing that the person is failing to comply with the relevant provision;

(b)specify the matters which constitute the person's failure to so comply;

(c)specify the measures which, in the officer's opinion, the person must take in order to secure compliance; and

(d)require the person to take those measures, or measures that are at least equivalent to them, within such period as may be specified in the notice.

(1A) Article 4(1) as read with Article 1(1) 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 953/2009 or a provision of that Regulation specified in Schedule 1 to the Food Safety (Information and Compositional Requirements) Regulations (Northern Ireland) 2016 .

2.  In Article 33(1) (powers of entry) for subparagraphs (a) to (c) substitute—N.I.

(a)to enter any premises within the council's district for the purpose of ascertaining whether there is or has been on the premises any contravention of a provision of Regulation (EU) No 609/2013 of the European Parliament and 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 specified in Schedule 1 to the Food Safety (Information and Compositional Requirements) Regulations (Northern Ireland) 2016; and

(b)to enter any business premises, whether within or outside of the council's district, for the purpose of ascertaining whether there is on the premises any evidence of any contravention within that district of any of those provisions.

3.  For Article 37(1) (appeals) substitute—N.I.

(1) Any person who is aggrieved by a decision of an authorised officer to serve an improvement notice under Article 9(1) as applied and modified by regulation 5(1) of, and Part 1 of Schedule 2 to, the Food Safety (Information and Compositional Requirements) Regulations (Northern Ireland) 2016, may appeal to a court of summary jurisdiction.

4.  In Article 37(2A)(b) for “(1)(a)” substitute “ (1) as applied and modified by regulation 5(1) of and Part 1 of Schedule 2 to, the Food Safety (Information and Compositional Requirements) Regulations (Northern Ireland) 2016, ”.N.I.

5.  In both Article 38(1) and (2) (appeals against improvement notices), after “improvement notice” insert “ under Article 9(1) as applied and modified by regulation 5(1) of, and Part 1 of Schedule 2, to the Food Safety (Information and Compositional Requirements) Regulations (Northern Ireland) 2016 ”.N.I.

PART 2 N.I.Application and modification of other provisions of the Order

Provision of the OrderModifications
Article 2(4) (extended meaning of “sale” etc.)

For “this Order” substitute “ the Food Safety (Information and Compositional Requirements) Regulations (Northern Ireland) 2016 ”.

Article 3 (application to food offered as prizes etc.

For “This Order” substitute “ The Food Safety (Information and Compositional Requirements) Regulations (Northern Ireland) 2016 ”.

Article 4 (presumptions that food intended for human consumption)

For “this Order” substitute “ the Food Safety (Information and Compositional Requirements) Regulations (Northern Ireland) 2016 ”.

Article 19 (offences due to fault of another person)

For “any of the preceding provisions of this Part” substitute “ Article 9(2) as applied by regulation 5(1) of the Food Safety (Information and Compositional Requirements) Regulations (Northern Ireland) 2016 or regulation 4 of those regulations ”.

Article 20 (defence of due diligence)

In paragraph (1), for “any of the preceding provisions of this Part” substitute “ Article 9(2) as applied by regulation 5(1) of the Food Safety (Information and Compositional Requirements) Regulations (Northern Ireland) 2016 or regulation 4 of those regulations, ”.

In paragraph (2) for “Article 13 and 14” substitute “ regulation 4 of the Food Safety (Information and Compositional Requirements) Regulations (Northern Ireland) 2016 ”.

Article 21(defence of publication in the course of business)

For “any of the preceding provisions of this part” substitute “ Article 9(2) as applied by regulation 5(1) of the Food Safety (Information and Compositional Requirements) Regulations (Northern Ireland) 2016 or regulation 4 of those regulations ”.

Article 29 (procurement of samples)

In paragraph (b)(ii), after “under Article 33”, insert “ as applied by regulation 5(2) and Part 1 of Schedule 2 to the Food Safety (Information and Compositional Requirements) Regulations (Northern Ireland) 2016 ”.

Article 30(8) (evidence of certificates given by a food analyst or examiner)

For “this Order” substitute “ the Food Safety (Information and Compositional Requirements) Regulations (Northern Ireland) 2016 ”.

Article 34 (obstruction etc. of officers)

In paragraph (1), for “this Order” (in each place occurring) substitute “ the Food Safety (Information and Compositional Requirements) Regulations (Northern Ireland) 2016 ”.

Article 36(1) and (2) (punishment of offences)

In paragraph (1), after “Article 34(1)”, insert “ , as applied and modified by regulation 5(4) and Part 2 of Schedule 2 to the Food Safety (Information and Compositional Requirements) Regulations (Northern Ireland) 2016, ”.

After paragraph (1), insert—

“(1A) A person guilty of an offence under Article 9(2), as applied by regulation 5(1) of the Food Safety (Information and Compositional Requirements) Regulations (Northern Ireland) 2016 shall be liable, on summary conviction, to a fine not exceeding level 5 on the standard scale.”.

In paragraph (2)—

(a)for “any other offence under this Order”, substitute “ an offence under Article 34(2), as applied by regulation 5(4) and Part 2 of Schedule 2 to the Food Safety (Information and Compositional Requirements) Regulations (Northern Ireland) 2016, ”; and

(b)in subparagraph (b), for “the relevant amount”, substitute “ the statutory maximum ”.

Regulation 6

SCHEDULE 3N.I.Amendments to statutory rules

The Food Intended for Use in Energy Restricted Diets for Weight Reduction Regulations (Northern Ireland) 1997N.I.

1.—(1) The Food Intended for Use in Energy Restricted Diets for Weight Reduction Regulations (Northern Ireland) 1997 M1 are amended in accordance with subparagraphs (2) to (7).

(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;.

(3) For regulation 2(1) substitute—

(1) A person shall not sell any relevant food under any name other than “total diet replacement for weight control” in the case of products intended as a replacement for the whole of the daily diet..

(4) In regulation 2(2) omit “or “meal replacement for weight control””.

(5) In regulation 3 for paragraphs (f) and (g) substitute—

(f)for products mentioned in regulation 2(1), a statement that the product provides adequate amounts of all essential nutrients for the day and a statement that the product should not be used for more than three weeks without medical advice..

(6) For regulation 5 substitute—

5.  A person shall not sell any relevant food being a product mentioned in regulation 2(1) unless all individual components making up the product are contained in the same package..

(7) Schedule 1 is amended in accordance with paragraphs (a) to (f)—

(a)for paragraph 1 (Energy) substitute—

Energy

1.  The energy provided by a product mentioned in regulation 2(1) shall not be less than 3360kJ (800 kcal) and shall not exceed 5040kJ (1200 kcal) for the total daily ratio

(b)for paragraph 2.1 substitute—

(2.1) The protein contained in products mentioned in regulation 2(1) shall provide not less than 25% and not more than 50% of the total energy of the product. In any case the amount of protein of products mentioned in regulation 2(1) shall not exceed 125g.;

(c)in paragraph 3.2 omit “(a)” after “2(1)”;

(d)omit paragraph 3.3;

(e)in paragraph 4 omit “(a)” after “2(1)”;

(f)for paragraph 5 “(vitamins and minerals)” substitute—

Vitamins and Minerals

5.  The products mentioned in regulation 2(1) shall provide for the whole of the daily diet at least 100% of the amounts of vitamins and minerals specified in the Table.

Marginal Citations

M1S.R. 1997 No.450, to which there are amendments not relevant to these Regulations

The Infant Formula and Follow-on Formula (Northern Ireland) Regulations 2007N.I.

F22.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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