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
- In force
- CELEX number: 32013R0609
- Official Journal: JOL_2013_181_R_0035_01
- Form: Regulation
- Procedure number: 2011/0156(COD), 2011/0156/COD
- Languages:
- bg
- cs
- da
- de
- el
- en
- et
- fi
- fr
- ga
- hr
- hu
- it
- lv
- lt
- mt
- nl
- pl
- pt
- ro
- sk
- sl
- es
- sv
Dates
Date of document: - June 12, 2013
- June 29, 2013
- January 1, 1001
- Application - Partial application See Art 22
- July 19, 2013
- Application - Partial application See Art 22
- Entry into force - Date pub. +20 See Art 22
- July 20, 2016
- Application - See Art 22
Modified by
Modified by:
- Commission Delegated Regulation (EU) 2021/571 of 20 January 2021 amending the Annex to Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the list of substances that may be added to infant and follow-on formula, baby food and processed cereal-based food (Text with EEA relevance) - detail
- Commission Delegated Regulation (EU) 2017/1091 of 10 April 2017 amending the Annex to Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the list of substances that may be added to processed cereal-based food and baby food and to food for special medical purposes (Text with EEA relevance. ) - detail
- Commission Delegated Regulation (EU) 2023/439 of 16 December 2022 amending the Annex to Regulation (EU) No 609/2013 of the European Parliament and of the Council to allow the use of nicotinamide riboside chloride as a source of niacin in food for special medical purposes and total diet replacement for weight control (Text with EEA relevance) - detail
Completed by:
- Commission Delegated Regulation (EU) 2017/1798 of 2 June 2017 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for total diet replacement for weight control (Text with EEA relevance. )
- Commission Delegated Regulation (EU) 2017/1522 of 2 June 2017 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for total diet replacement for weight control (Text with EEA relevance. )
- Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding (Text with EEA relevance)
All documents based on this document:
- Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding (Text with EEA relevance)
- Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes (Text with EEA relevance)
- Commission Delegated Regulation (EU) 2017/1091 of 10 April 2017 amending the Annex to Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the list of substances that may be added to processed cereal-based food and baby food and to food for special medical purposes (Text with EEA relevance. )
- Commission Delegated Regulation (EU) 2017/1522 of 2 June 2017 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for total diet replacement for weight control (Text with EEA relevance. )
- Commission Delegated Regulation (EU) 2017/1798 of 2 June 2017 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for total diet replacement for weight control (Text with EEA relevance. )
- Commission Delegated Regulation (EU) 2018/561 of 29 January 2018 amending Delegated Regulation (EU) 2016/127 with regard to protein requirements for follow-on formula (Text with EEA relevance. )
- Commission Delegated Regulation (EU) 2019/828 of 14 March 2019 amending Delegated Regulation (EU) 2016/127 with regard to vitamin D requirements for infant formula and erucic acid requirements for infant formula and follow-on formula (Text with EEA relevance.)
- Commission Delegated Regulation (EU) 2020/566 of 17 February 2020 correcting certain language versions of Delegated Regulation (EU) 2016/128 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes (Text with EEA relevance)
- Commission Delegated Regulation (EU) 2021/571 of 20 January 2021 amending the Annex to Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the list of substances that may be added to infant and follow-on formula, baby food and processed cereal-based food (Text with EEA relevance)
- Commission Delegated Regulation (EU) 2021/572 of 20 January 2021 amending Delegated Regulation (EU) 2016/127 as regards the date of application of certain of its provisions (Text with EEA relevance)
- Commission Delegated Regulation (EU) 2021/1040 of 16 April 2021 amending Delegated Regulation (EU) 2016/128 as regards the requirements on pesticides in food for special medical purposes developed to satisfy the nutritional requirements of infants and young children (Text with EEA relevance)
- Commission Delegated Regulation (EU) 2021/1041 of 16 April 2021 amending Delegated Regulation (EU) 2016/127 as regards the requirements on pesticides in infant formula and follow-on formula (Text with EEA relevance)
- Commission Delegated Regulation (EU) 2022/519 of 14 January 2022 amending Delegated Regulation (EU) 2016/127 as regards the protein requirements for infant and follow-on formula manufactured from protein hydrolysates (Text with EEA relevance)
- Commission Delegated Regulation (EU) 2022/2182 of 30 August 2022 amending Delegated Regulation (EU) 2017/1798 as regards the lipid and magnesium requirements for total diet replacement for weight control (Text with EEA relevance)
- Commission Delegated Regulation (EU) 2023/439 of 16 December 2022 amending the Annex to Regulation (EU) No 609/2013 of the European Parliament and of the Council to allow the use of nicotinamide riboside chloride as a source of niacin in food for special medical purposes and total diet replacement for weight control (Text with EEA relevance)
- Commission Delegated Regulation (EU) 2023/589 of 10 January 2023 amending Delegated Regulation (EU) 2016/127 as regards the protein requirements for infant and follow-on formula manufactured from protein hydrolysates (Text with EEA relevance)
Modifies
Modifies:
- Commission Regulation (EU) No 1161/2011 of 14 November 2011 amending Directive 2002/46/EC of the European Parliament and of the Council, Regulation (EC) No 1925/2006 of the European Parliament and of the Council and Commission Regulation (EC) No 953/2009 as regards the lists of mineral substances that can be added to foods Text with EEA relevance
- undefined
- Commission Directive 2006/82/EC of 23 October 2006 adapting Directive 91/321/EEC on infant formulae and follow-on formulae and Directive 1999/21/EC on dietary foods for special medical purposes, by reason of the accession of Bulgaria and Romania
- Commission Directive 2013/26/EU of 8 February 2013 adapting certain directives in the field of food safety, veterinary and phytosanitary policy, by reason of the accession of Croatia
Repeal:
- Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC Text with EEA relevance
- Commission Regulation (EC) No 953/2009 of 13 October 2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses (Text with EEA relevance)
- Commission Directive 2007/29/EC of 30 May 2007 amending Directive 96/8/EC as regards labelling, advertising or presenting foods intended for use in energy-restricted diets for weight reduction (Text with EEA relevance)
- Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses (recast) (Text with EEA relevance)
- Council Directive 92/52/EEC of 18 June 1992 on infant formulae and follow-on formulae intended for export to third countries
- Commission Regulation (EC) No 41/2009 of 20 January 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten (Text with EEA relevance)
- Commission Regulation (EC) No 1243/2008 of 12 December 2008 amending Annexes III and VI to Directive 2006/141/EC as regards compositional requirements for certain infant formulae (Text with EEA relevance)
Affected by case
- Judgment of the Court (Second Chamber) of 2 March 2023. Kwizda Pharma GmbH v Landeshauptmann von Wien. Request for a preliminary ruling from the Verwaltungsgericht Wien. Reference for a preliminary ruling – Food safety – Food – Regulation (EU) No 609/2013 – Article 2(2)(g) – Concept of ‘food for special medical purposes’ – Other particular nutritional requirements – Dietary management – Modification of the diet – Nutrients – Use under medical supervision – Ingredients not absorbed or metabolised in the alimentary canal – Distinction in relation to medicinal products – Distinction in relation to food supplements. Case C-760/21.
- A02P2LG
- Judgment of the Court (Second Chamber) of 27 October 2022. Orthomol pharmazeutische Vertriebs GmbH v Verband Sozialer Wettbewerb eV. Request for a preliminary ruling from the Oberlandesgericht Düsseldorf. Reference for a preliminary ruling – Food safety – Food – Regulation (EU) No 609/2013 – Article 2(2)(g) – Delegated Regulation (EU) 2016/128 – Food for special medical purposes – Other particular nutritional requirements – Food providing a general benefit for the patient – Distinction in relation to medicinal products. Case C-418/21.
- A02P2LG
- Case C-760/21: Request for a preliminary ruling from the Verwaltungsgericht Wien (Austria) lodged on 10 December 2021 — Kwizda Pharma GmbH
- article 2 paragraph 2 point (g)
- Case C-418/21: Request for a preliminary ruling from the Oberlandesgericht Düsseldorf (Germany) lodged on 9 July 2021 — Orthomol pharmazeutische Vertriebs GmbH v Verband Sozialer Wettbewerb e.V.
- article 2 paragraph 2 point (g)
Legal basis
- Consolidated version of the Treaty on the Functioning of the European Union PART THREE - UNION POLICIES AND INTERNAL ACTIONS TITLE VII - COMMON RULES ON COMPETITION, TAXATION AND APPROXIMATION OF LAWS Chapter 3 - Approximation of laws Article 114 (ex Article 95 TEC)
- Consolidated version of the Treaty on the Functioning of the European Union PART SIX - INSTITUTIONAL AND FINANCIAL PROVISIONS TITLE I - INSTITUTIONAL PROVISIONS Chapter 2 - Legal acts of the Union, adoption procedures and other provisions Section 2 - Procedures for the adoption of acts and other provisions Article 294 (ex Article 251 TEC)
EuroVoc Vocabulary
- Labelling
- Foodstuffs
- Food – ingredients, traces, residues, marketing standards
- Consumer information, education and representation
- Foodstuffs
- Marketing standard
- Baby food
- Consumer information
- Dietary product
- Food safety