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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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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 Union list set out in the Annex and comply with the elements contained in the Union 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 Union 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 Union 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 Union law applicable to food, which apply to the substances included in the Union 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 Union list for which purity criteria are not established by Union law applicable to food, generally acceptable purity criteria recommended by international bodies shall apply until the establishment of such criteria.
Member States may maintain national rules setting stricter purity criteria.
6.In order to take into account technical progress, scientific developments or the protection of consumers’ health, the Commission shall be empowered to adopt, in relation to the categories of substances listed in paragraph 1 of this Article, delegated acts in accordance with Article 18 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.
1.Subject to the general requirements set out in Articles 6 and 9 and, where applicable, the specific requirements established in accordance with Article 11, and in order to take into account technical progress, scientific developments or the protection of consumers’ health, the Commission shall be empowered to adopt delegated acts in accordance with Article 18, to amend the Annex, with respect to the following:
(a)the addition of a substance to the Union list;
(b)the removal of a substance from the Union list;
(c)the addition, removal or amendment of the elements referred to in Article 15(3).
2.Where, in the case of emerging health risks, imperative grounds of urgency so require, the procedure provided for in Article 19 shall apply to delegated acts adopted pursuant to this Article.
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