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Regulation (EU) No 609/2013 of the European Parliament and of the CouncilShow full title

Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 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 (Text with EEA relevance)

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Changes over time for: Regulation (EU) No 609/2013 of the European Parliament and of the Council (without Annexes)

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CHAPTER IU.K.GENERAL PROVISIONS

Article 1U.K.Subject matter

1.This Regulation establishes compositional and information requirements for the following categories of food:

(a)infant formula and follow-on formula;

(b)processed cereal-based food and baby food;

(c)food for special medical purposes;

(d)total diet replacement for weight control.

2.This Regulation establishes a [F1Great Britain] list of substances that may be added to one or more of the categories of food referred to in paragraph 1 and lays down the rules applicable to the updating of that list.

Article 2U.K.Definitions

1.For the purposes of this Regulation, the following definitions shall apply:

(a)the definitions of ‘food’, ‘food business operator’, ‘retail’ and ‘placing on the market’ set out respectively in Article 2 and points (3), (7) and (8) of Article 3 of Regulation (EC) No 178/2002;

(b)the definitions of ‘prepacked food’, ‘labelling’ and ‘engineered nanomaterial’ set out respectively in points (e), (j) and (t) of Article 2(2) of Regulation (EU) No 1169/2011;

(c)the definitions of ‘nutrition claim’ and ‘health claim’ set out respectively in points (4) and (5) of Article 2(2) of Regulation (EC) No 1924/2006.

2.The following definitions shall also apply:

(a)‘infant’ means a child under the age of 12 months;

(b)‘young child’ means a child aged between one and three years;

(c)‘infant formula’ means food intended for use by infants during the first months of life and satisfying by itself the nutritional requirements of such infants until the introduction of appropriate complementary feeding;

(d)‘follow-on formula’ means food intended for use by infants when appropriate complementary feeding is introduced and which constitutes the principal liquid element in a progressively diversified diet of such infants;

(e)‘processed cereal-based food’ means food:

(i)

intended to fulfil the particular requirements of infants in good health while they are being weaned, and of young children in good health as a supplement to their diet and/or for their progressive adaptation, to ordinary food; and

(ii)

pertaining to one of the following categories:

  • simple cereals which are or have to be reconstituted with milk or other appropriate nutritious liquids,

  • cereals with an added high protein food which are or have to be reconstituted with water or other protein-free liquid,

  • pastas which are to be used after cooking in boiling water or other appropriate liquids,

  • rusks and biscuits which are to be used either directly or, after pulverisation, with the addition of water, milk or other suitable liquids;

(f)‘baby food’ means food intended to fulfil the particular requirements of infants in good health while they are being weaned, and of young children in good health as a supplement to their diet and/or for their progressive adaptation to ordinary food, excluding:

(i)

processed cereal-based food; and

(ii)

milk-based drinks and similar products intended for young children;

(g)‘food for special medical purposes’ means food specially processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone;

(h)‘total diet replacement for weight control’ means food specially formulated for use in energy restricted diets for weight reduction which, when used as instructed by the food business operator, replaces the whole daily diet;

[F2(i)‘Great Britain list’ means the list set out in the Annex.]

Article 3U.K.Interpretation decisions

[F3The appropriate authority may make regulations specifying:]

(a)

whether a given food falls within the scope of this Regulation;

(b)

to which specific category of food referred to in Article 1(1) a given food belongs.

F4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 4U.K.Placing on the market

1.Food referred to in Article 1(1) may only be placed on the market if it complies with this Regulation.

2.Food referred to in Article 1(1) shall only be allowed on the retail market in the form of prepacked food.

F53.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 5U.K.Precautionary principle

In order to ensure a high level of health protection in relation to the persons for whom the food referred to in Article 1(1) of this Regulation is intended, the precautionary principle as set out in Article 7 of Regulation (EC) No 178/2002 shall apply.

CHAPTER IIU.K.COMPOSITIONAL AND INFORMATION REQUIREMENTS

SECTION 1U.K.General requirements

Article 6U.K.General provisions

1.Food referred to in Article 1(1) shall comply with any requirement of [F6retained EU law] applicable to food.

2.The requirements laid down in this Regulation shall prevail over any conflicting requirement of [F6retained EU law] applicable to food.

F7Article 7U.K.Opinions of the Authority

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F8Article 8U.K.Access to documents

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Article 9U.K.General compositional and information requirements

1.The composition of food referred to in Article 1(1) shall be such that it is appropriate for satisfying the nutritional requirements of, and is suitable for, the persons for whom it is intended, in accordance with generally accepted scientific data.

2.Food referred to in Article 1(1) shall not contain any substance in such quantity as to endanger the health of the persons for whom it is intended.

For substances which are engineered nanomaterials, compliance with the requirement referred to in the first subparagraph shall be demonstrated on the basis of adequate test methods, where appropriate.

3.On the basis of generally accepted scientific data, substances added to food referred to in Article 1(1) for the purposes of the requirements under paragraph 1 of this Article shall be bio-available for use by the human body, have a nutritional or physiological effect and be suitable for the persons for whom the food is intended.

4.Without prejudice to Article 4(1) of this Regulation, food referred to in Article 1(1) of this Regulation may contain substances covered by [F9Regulation (EU) 2015/2283], provided that those substances fulfil the conditions under that Regulation for being placed on the market.

5.The labelling, presentation and advertising of food referred to in Article 1(1) shall provide information for the appropriate use of such food, and shall not mislead, or attribute to such food the property of preventing, treating or curing a human disease, or imply such properties.

6.Paragraph 5 shall not prevent the dissemination of any useful information or recommendations exclusively intended for persons having qualifications in medicine, nutrition, pharmacy, or for other healthcare professionals responsible for maternal care and childcare.

Article 10U.K.Additional requirements for infant formula and follow-on formula

1.The labelling, presentation and advertising of infant formula and follow-on formula shall be designed so as not to discourage breast-feeding.

2.The labelling, presentation and advertising of infant formula, and the labelling of follow-on formula shall not include pictures of infants, or other pictures or text which may idealise the use of such formulae.

Without prejudice to the first subparagraph, graphic representations for easy identification of infant formula and follow-on formula and for illustrating methods of preparation shall be permitted.

SECTION 2U.K.Specific requirements

Article 11U.K.Specific compositional and information requirements

1.F10... Taking into account relevant technical and scientific progress, [F11and having regard to such scientific opinion as an appropriate authority considers appropriate, the appropriate authority may make regulations], with respect to the following:

(a)the specific compositional requirements applicable to food referred to in Article 1(1), with the exception of requirements as set out in the Annex;

(b)the specific requirements on the use of pesticides in products intended for the production of food referred to in Article 1(1) and on pesticide residues in such food. F12...

(c)the specific requirements on labelling, presentation and advertising of food referred to in Article 1(1), including the authorisation of nutrition and health claims in relation thereto;

(d)the notification requirements for the placing on the market of food referred to in Article 1(1), in order to facilitate the efficient official monitoring of such food, F13...;

(e)the requirements concerning promotional and commercial practices relating to infant formula;

(f)the requirements concerning information to be provided in relation to infant and young child feeding in order to ensure adequate information on appropriate feeding practices;

(g)the specific requirements for food for special medical purposes developed to satisfy the nutritional requirements of infants, including compositional requirements and requirements on the use of pesticides in products intended for the production of such food, pesticide residues, labelling, presentation, advertising, and promotional and commercial practices, as appropriate.

F14...

F152.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F16Article 12U.K.Milk-based drinks and similar products intended for young children

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F17Article 13U.K.Food intended for sportspeople

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Article 14U.K.Technical guidelines

[F18The Secretary of State, the Scottish Ministers and the Welsh Ministers] may adopt technical guidelines to facilitate compliance by food business operators, in particular [F19small or medium sized enterprises as defined in the Annex to Commission Recommendation 2003/361/EC concerning the definition of micro, small and medium-sized enterprises], with this Chapter and Chapter III [F20, as it applies in their territory. For the purposes of this Article, the Annex to Commission Recommendation 2003/361/EC concerning the definition of micro, small and medium-sized enterprises is to be read as if—

(a)in Article 2—

(i)in paragraph 1, for “EUR 50 million, and/or an annual balance sheet total not exceeding EUR 43 million” there were substituted “£44,000,000, and/or an annual balance sheet total not exceeding £38,000,000”;

(ii)in paragraph 2, for “EUR 10 million” there were substituted “£8,800,000”;

(iii)in paragraph 3, for “EUR 2 million” there were substituted “£1,750,000”;

(b)in Article 3—

(i)in paragraph 2(a), for “EUR 1 250 000” there were substituted “£1,100,000”;

(ii)in paragraph 2(d), for “EUR 10 million” there were substituted “£8,800,000”;

(iii)in paragraph 5, for “by national or Community rules” there were substituted “under the law of Great Britain (or any part of it)”;

(c)in Article 5, in paragraph (b), for “national law” there were substituted “the law of Great Britain (or any part of it)”].

CHAPTER IIIU.K. [F21GREAT BRITAIN LIST]

Article 15U.K. [F22Great Britain list]

1.Substances belonging to the following categories of substances may be added to one or more of the categories of food referred to in Article 1(1), provided that these substances are included in the [F22Great Britain list] set out in the Annex and comply with the elements contained in the [F22Great Britain list] in accordance with paragraph 3 of this Article:

(a)vitamins;

(b)minerals;

(c)amino acids;

(d)carnitine and taurine;

(e)nucleotides;

(f)choline and inositol.

2.Substances that are included in the [F22Great Britain list] shall meet the general requirements set out in Articles 6 and 9 and, where applicable, the specific requirements established in accordance with Article 11.

3.The [F22Great Britain list] shall contain the following elements:

(a)the category of food referred to in Article 1(1) to which substances belonging to the categories of substances listed in paragraph 1 of this Article may be added;

(b)the name, the description of the substance and, where appropriate, the specification of its form;

(c)where appropriate, the conditions of use of the substance;

(d)where appropriate, the purity criteria applicable to the substance.

4.Purity criteria established by [F23retained EU law and any other legislation applying in any part of Great Britain] applicable to food, which apply to the substances included in the [F22Great Britain list] when they are used in the manufacture of food for purposes other than those covered by this Regulation, shall also apply to those substances when they are used for purposes covered by this Regulation unless otherwise specified in this Regulation.

5.For substances included in the [F22Great Britain list] for which purity criteria are not established by [F23retained EU law and any other legislation applying in any part of Great Britain] applicable to food, generally acceptable purity criteria recommended by international bodies shall apply until the establishment of such criteria.

F24...

6.In order to take into account technical progress, scientific developments or the protection of consumers’ health, [F25an appropriate authority may make regulations in relation to the categories of substances listed in paragraph 1 of this Article] with respect to the following:

(a)the removal of a category of substances;

(b)the addition of a category of substances that have a nutritional or physiological effect.

7.Substances belonging to categories not listed in paragraph 1 of this Article may be added to food referred to in Article 1(1), provided that they satisfy the general requirements set out in Articles 6 and 9 and, where applicable, the specific requirements established in accordance with Article 11.

Article 16U.K.Updating the [F26Great Britain list]

1.F27... In order to take into account technical progress, scientific developments or the protection of consumers’ health, [F28the appropriate authority may by regulations] amend the Annex, with respect to the following:

(a)the addition of a substance to the [F26Great Britain list];

(b)the removal of a substance from the [F26Great Britain list];

(c)the addition, removal or amendment of the elements referred to in Article 15(3).

F292.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

CHAPTER IVU.K.PROCEDURAL PROVISIONS

[F30Article 16AE+W+SRegulations

1.Any power to make regulations under this Regulation may be exercised by the Secretary of State for the whole or part of Great Britain if consent is given by—

(a)for regulations applying in relation to Scotland, the Scottish Ministers;

(b)for regulations applying in relation to Wales, the Welsh Ministers;

2.Regulations made under this Regulation may–

(a)contain consequential, incidental, supplementary, transitional or saving provision (including provision amending, repealing or revoking enactments);

(b)make different provision for different purposes.

3.In this Regulation–

  • appropriate authority” means:

    (a)

    for regulations applying in relation to England, the Secretary of State;

    (b)

    for regulations applying in relation to Scotland, the Scottish Ministers;

    (c)

    for regulations applying in relation to Wales, the Welsh Ministers;

  • enactment” includes any enactment of the types specified in the definition of ‘enactment’ in section 20(1) of the European Union (Withdrawal) Act 2018.

Article 16BE+W+SRegulations: Secretary of State

1.Any power of the Secretary of State to make regulations under this Regulation is exercisable by statutory instrument.

2.A statutory instrument containing regulations made under this Regulation is subject to annulment in pursuance of a resolution of either House of Parliament.

Article 16CE+W+SRegulations: The Scottish Ministers

1.For regulations made by the Scottish Ministers, see section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010.

2.Regulations made by the Scottish Ministers under this Regulation are subject to the negative procedure (see section 28 of the Interpretation and Legislative Reform (Scotland) Act 2010).

Article 16DE+W+SRegulations: The Welsh Ministers

1.Any power of the Welsh Ministers to make regulations under this Regulation is exercisable by statutory instrument.

2.A statutory instrument containing regulations made under this Regulation by the Welsh Ministers is subject to annulment in pursuance of a resolution of the National Assembly for Wales.]

F31Article 17U.K.Committee procedure

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F31Article 18U.K.Exercise of the delegation

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F31Article 19U.K.Urgency procedure

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CHAPTER VU.K.FINAL PROVISIONS

F31Article 20U.K.Repeal

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Article 21U.K.Transitional measures

1.Food referred to in Article 1(1) of this Regulation which does not comply with this Regulation but complies with Directive 2009/39/EC, and, as applicable, with Regulation (EC) No 953/2009 and Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, and which is placed on the market or labelled before 20 July 2016 may continue to be marketed after that date until stocks of such food are exhausted.

F32...

2.Food which is not referred to in Article 1(1) of this Regulation but which is placed on the market or labelled in accordance with Directive 2009/39/EC and Regulation (EC) No 953/2009, and, as applicable, with Directive 96/8/EC and Regulation (EC) No 41/2009 before 20 July 2016 may continue to be marketed after that date until stocks of such food are exhausted.

[F333.In this Article, any reference to compliance with a provision of the Directive is to be read as a reference to complying with that provision as would be required if the provision formed part of domestic law.]

F34Article 22U.K.Entry into force

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This Regulation shall be binding in its entirety and directly applicable in all Member States.

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