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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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SECTION 1 General requirements

Article 6General provisions

1.Food referred to in Article 1(1) shall comply with any requirement of Union law applicable to food.

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

Article 7Opinions of the Authority

The Authority shall provide scientific opinions in accordance with Articles 22 and 23 of Regulation (EC) No 178/2002 for the purpose of the application of this Regulation. Those opinions shall serve as the scientific basis for any Union measure adopted pursuant to this Regulation which is likely to have an effect on public health.

Article 8Access to documents

The Commission shall apply Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents(1) to applications for access to any document covered by this Regulation.

Article 9General 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 Article 1 of Regulation (EC) No 258/97, 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 10Additional 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.

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