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Food for special consumer groups and the previous diet law


In the course of the amendment of the regulations for foods for special nutritional purposes, the concept of "dietetic foods" was abandoned and replaced by European regulations for "foods for special consumer groups" (more information and detailed explanations can be found under the heading 'Info', DIÄT- NEWS 091/2016 ').
Food for special consumer groups is intended to meet the special nutritional requirements of certain population groups, e.g. during illness or in infancy and toddlerhood.
Regulation (EU) No. 609/2013 on food for infants and young children, food for special medical purposes and total diet replacement for weight control has been in effect since July 20, 2016 and replaces the "Diet Framework Directive" (Directive 2009/39 / EC) on food intended for a particular diet. It is also known as the “Regulation on food for special consumer groups” or, using the English terminology, the FSG regulation (Foods for Specific Groups - FSG).

Regulation (EU) No. 609/2013 now only contains regulations for certain food categories. According to Art. 1 Paragraph 1 of Regulation (EU) No. 609/2013, this includes:

• Infant formula and follow-on formula
• Processed cereal foods and other complementary foods
• Food for special medical purposes (balanced diets)
• Total rations for a weight control diet

Food that was subject to the diet law applicable up until July 20, 2016, but is no longer covered by the scope of Regulation (EU) No. 609/2013, such as: B. Food for pregnant and breastfeeding women or athletes or meal replacements are to be regarded as "food for general consumption" from this point in time and are therefore subject to the general food law provisions.

An exception applies to food for infants and young children, which are not conclusively regulated at EU level. This applies, for example, to milk-based drinks intended for healthy toddlers (1 to 3 years of age) (so-called "toddler milk"). These foods can continue to be marketed as foods for special consumer groups, provided they comply with the provisions of the DietV. This is to ensure that these particularly sensitive consumer groups are only offered foods that are also suitable for them.

Art. 15 of Regulation (EU) No. 609/2013 stipulates that only those substances of one of the above The categories of foods listed in the annex in the "Union list" may be added. Substances that do not belong to any of the categories listed in the Union list may only be added to foods in accordance with Article 1 (1) if they meet the requirements of Article 9 (3) (see Article 15 (7)). The substances must therefore be in a bioavailable form, have a nutritional or physiological effect and be suitable for the people for whom they are intended.
In addition, the composition must be such that the food complies with the generally recognized scientific data on the nutritional requirements of the persons for whom it is intended and is suitable for these persons.
In order to regulate the further special requirements for the composition of the food for special consumer groups, the European Commission published delegated legal acts according to Article 18 of Regulation (EU) No. 609/2013 on 02.02.2016 in the Official Journal of the European Union:

• Delegated legal act for infant formula and follow-on formula (Regulation (EU) No. 2016/127)
• Delegated act for food for special medical purposes (Regulation (EU) No. 2016/128)
• Delegated act for total rations for weight control diet (VO (EU) 2017/1798)

The Delegated Regulation for Infant Formula and Follow-On Formula (Regulation (EU) No. 2016/127) has been in effect since February 22, 2020, with the exception of infant formula and follow-on formula made from protein hydrolyzates, for which it will apply from February 22, 2021.

The Delegated Regulation on Food for Special Medical Purposes has been in force since February 22, 2019, with the exception of food for special medical purposes developed to meet the nutritional requirements of infants, for which it has been in force since February 22, 2020.

Until the delegated legal acts (Regulation (EU) 2016/127, Regulation (EU) 2016/128 and Regulation (EU) 2017/1798) came into force, the provisions of the DietV applied to the above-mentioned food categories, possibly supplemented by the provisions of the Regulation (EU) No. 609/2013.

There is an obligation to notify:

• Food for infants and young children for which there are no final regulations at EU level. This applies to milk-based drinks or similar products intended for healthy toddlers (1 to 3 years of age) (so-called "toddler milk");
• Food for special medical purposes within the meaning of Art. 2 Paragraph 2 Letter g of Regulation (EU) No. 609/2013;
• Infant formula within the meaning of Article 2 Paragraph 2 Letter c of Regulation (EU) No. 609/2013;

The name under which a food is placed on the market for special consumer groups must include an indication of the specific nutritional purposes for which it is suitable and for which specific population group it is intended.

The suitability for the specified nutritional purpose must be proven by generally recognized scientific data. If there are no published data on identical products, i. H. available in the same composition to appropriate groups of people, the beneficial use and effectiveness must be proven by appropriate studies.

In addition to the provisions of Regulation (EU) No. 609/2013 and the DietV, horizontal food law regulations also apply to food, such as the Food Information Regulation (EU) No. 1169/2011. Other special product specifications in laws and regulations remain unaffected, unless food for special consumer groups is explicitly excluded.
.

National regulations:
Diet Ordinance (Status: 05.07.2017) Food, Commodities and Feed Code (Food and Feed Code - LFGB; Status: 20.11.2019) Ordinance on the limitation of contaminants in food (Contaminants Ordinance - KmV; Status: 19.03.2010)
European regulations:
REGULATION (EU) No. 1169/2011 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2011 on consumer information about food and amending Regulations (EC) No. 1924/2006 and (EC) No. 1925/2006 of European Parliament and of the Council and repealing Directive 87/250 / EEC of the Commission, Directive 90/496 / EEC of the Council, Directive 1999/10 / EC of the Commission, Directive 2000/13 / EC of the European Parliament and of the Council, Directives 2002/67 / EC and 2008/5 / EC of the Commission and Regulation (EC) No. 608/2004 of the Commission REGULATION (EU) No. 609/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 12 June 2013 on food for infants and young children, food for special medical purposes and total diet replacement for weight control and repealing Council Directive 92/52 / EEC, Directive 96/8 / EC, 1999/21 / EC, 2006 / 125 / EC and 2006/141 / EC of the Commission, Directive 2009/39 / EC of the European Parliament and of the Council and Regulations (EC) No. 41/2009 and (EC) No. 953/2009 of the Council and the COMMISSION DELEGATED REGULATION (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No. 609/2013 of the European Parliament and of the Council with regard to the specific composition and information requirements for infant formula and follow-on formula and with regard to information which are to be provided regarding the nutrition of infants and young children COMMISSION DELEGATED REGULATION (EU) 2016/128 of 25 September 2015
to supplement Regulation (EU) No. 609/2013 of the European Parliament and of the Council with regard to the special composition and information requirements for foods for special medical purposes Regulation (EU) No. 609/2013 of the European Parliament and of the Council with regard to the special composition and information requirements for total rations for weight control nutrition DIRECTIVE 2006/125 / EC OF THE COMMISSION of December 5, 2006 on processed cereal-based foods and baby foods for infants and young children (codified Version) IMPLEMENTING REGULATION (EU) No. 828/2014 OF THE COMMISSION of 30 July 2014
on the requirements for the provision of information to consumers about the absence or reduced presence of gluten in foods REGULATION (EC) NO. 1924/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of December 20, 2006 on nutrition and health claims made on foodstuffs REGULATION (EC) NO. 1925/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of December 20, 2006 on the addition of vitamins and minerals as well as certain other substances to food REGULATION (EC) No. 1881/2006 OF THE COMMISSION of December 19, 2006 to fix the maximum levels for certain contaminants in food (EC) No. 2073/2005 OF THE COMMISSION of November 15, 2005 on microbiological criteria for foodstuffs REGULATION (EC) No. 396/2005 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 23 February 2005 on maximum levels of pesticide residues in or on food and feed of plant and animal origin and amending Directive 91/414 / EEC of the Council REGULATION (EC) No. 1107/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 21 October 2009 on the placing of plant protection products on the market and repealing Council Directives 79/117 / EEC and 91/414 / EEC


(Updated on: 04/14/2020)

Association guideline "Balanced diets" (2019)

Directive of the DIÄTVERBAND on the interpretation of the delegated Regulation (EU) 2016/128 as well as relevant texts and regulations from national and European law


The law on foods for special medical purposes, which are also referred to as balanced diets for short, was revised in 2016 as part of the revision of European dietary law. The legal basis is on the one hand the new regulation (EU) No. 609/2013 on food for special consumer groups, which sets the regulatory framework, and on the other hand the delegated regulation (EU) 2016/128 on food for special medical purposes with more specific, product-specific regulations . The latter regulation has been in force since February 22nd, 2016. However, it has only been effective since February 22nd, 2019. In addition, transitional provisions apply to products that were placed on the market before the effective date.

Published in June 2019 in the publication series of the DIÄTVERBAND "Dietetic foods in practice and science", issue 100/2019

Association Directive "Balanced Diets" (2019) Directive of the DIÄTVERBAND on the interpretation of the delegated Regulation (EU) 2016/128 as well as relevant texts and regulations from national and European law


Order: "Food for a special diet" and "Food for special consumer groups"


Laws, ordinances and guidelines from national and European law

Compilation of relevant legal texts on the occasion of the revision of the European diet law

published in June 2016 in the publication series of the DIÄTVERBAND "Dietetic foods in practice and science", issue 99/2016, ISSN 0930-5637-99 / 2016


If you are interested in this brochure, please send an email to [email protected]

Order: "From old and new times"


Compendium of publications by Thomas Mettke with critical analyzes of food law

published in June 2014 in the publication series of the DIÄTVERBAND "Dietetic foods in practice and science", issue 98/2014, ISSN 0930-5637-98 / 2014
on the occasion of Thomas Mettke's 75th birthday

If you are interested in this brochure, please send an email to [email protected]

Order: "Food for a special diet"


Laws, ordinances and guidelines from national and European law

published in June 2008 in the publication series of the DIÄTVERBAND "Dietetic foods in practice and science", issue 95/2008, ISSN 0930.5637-95 / 2008

€ 15.00 including VAT (2.39), free shipping
Order form "Food for a special diet"

Order: Association guideline "Supplementary balanced diets"


Directive of the DIÄTVERBAND and relevant texts as well as laws, ordinances and guidelines from national and European law

published in May 2007 in the publication series of the DIÄTVERBAND "Dietetic foods in practice and science", issue 94/2007, ISSN 0930-5637-94 / 2007

€ 15.00 including VAT (€ 2.39), free shipping
Order form "Association guideline: Supplementary balanced diets"