Foods for specific groups

SUMMARY OF:

Regulation (EU) No 609/2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control

WHAT IS THE AIM OF THE REGULATION?

The regulation:

seeks to ensure better consumer protection in relation to the content and marketing of:
- foods for infants, young children and special medical purposes,
- total diet replacement for weight control;
seeks to provide greater legal certainty for businesses operating in the sector and for national authorities applying the rules;
replaces a plethora of rules that had built up over 3 decades and become both complex and fragmented.

KEY POINTS

Regulation (EU) No 609/2013 strengthens rules on foods for vulnerable population groups that need particular protection, such as infants and children up to 3 years old, overweight or obese people and people with specific medical conditions (e.g. people with metabolism disorders).

The regulation’s annex contains a single list of substances (including minerals and vitamins) that can be added to these foods, replacing the 3 lists that existed under the previous legislation.

Labelling

The regulation also vests the European Commission with the responsibility of adopting, by means of delegated acts, specific compositional and labelling rules for the following categories of foods:

infant and follow-on formulae;
processed cereal-based foods and other baby foods;
foods for special medical purposes; and
total diet replacement for weight control.

Since the regulation’s entry into force on 20 July 2016, gluten-free and very-low-gluten foods have been governed by Regulation (EU) No 1169/2011 on the labelling of foodstuffs (see summary). A Commission implementing act, Implementing Regulation (EU) No 828/2014, ensured the transfer of rules on these products to that regulation. In contrast to the previous legislation, these rules also apply to non pre-packed foods such as those served in restaurants.

Delegated acts

The Commission has adopted the following delegated acts supplementing Regulation (EU) No 609/2013:

Delegated Regulation (EU) 2016/127 on 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, amended by Delegated Regulations (EU) 2018/561, (EU) 2019/828, (EU) 2021/572 and (EU) 2021/1041;
Delegated Regulation (EU) 2016/128 on the specific compositional and information requirements for food for special medical purposes, amended by Delegated Regulations (EU) 2020/566 and (EU) 2021/1040;
Delegated Regulation (EU) 2017/1798 on the specific requirements with regard to total diet replacement for weight control products.

Reports on milk-based products for children and food intended for sportspeople

Regulation (EU) No 609/2013 also required the Commission, having consulted the European Food Safety Authority (see summary), to present to the European Parliament and the Council:

a report on milk-based drinks (‘growing-up milks’) and similar products intended for young children, analysing the need to draw up special compositional and labelling rules for this kind of product;
a report on food intended for sportspeople, analysing the need to draw up special compositional and labelling rules.

The 2 reports concluded that there was no need for specific rules for these products and they are therefore covered by general food legislation, namely Regulation (EC) No 1924/2006 on nutrition and health claims (see summary).

Amendments to Regulation (EU) No 609/2013

By means of 2 delegated regulations, the Commission has amended the annex to Regulation (EU) No 609/2013.

Delegated Regulation (EU) 2017/1091 concerns the substances that may be added to processed cereal-based food and baby food and to food for special medical purposes; and
Delegated Regulation (EU) 2021/571 concerns the substances that may be added to infant and follow-on formula, baby food and processed cereal-based food.

Repeal

Regulation (EU) No 609/2013 repeals Directives 92/52/EEC, 96/8/EC, 1999/21/EC, 2006/125/EC, 2006/141/EC, 2009/39/EC and Regulations (EC) No 41/2009 and (EC) No 953/2009.

FROM WHEN DOES THE REGULATION APPLY?

It has applied since 20 July 2016, except for Article 11 (compositional and information requirements), Article 16 (updating the EU list), Article 18 (delegated acts) and Article 19 (urgency procedure), all of which have applied since 19 July 2013.

BACKGROUND

For more information, see:

Foods for specific groups (European Commission)
Foods for infants and other groups (European Food Safety Authority).

MAIN DOCUMENT

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 (OJ L 181, 29.6.2013, pp. 35-56)

Successive amendments to Regulation (EU) No 609/2013 have been incorporated into the original text. This consolidated version is of documentary value only.

RELATED DOCUMENTS

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 (OJ L 259, 7.10.2017, pp. 2-10)

See consolidated version.

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 (OJ L 25, 2.2.2016, pp. 1-29)

See consolidated version.

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 (OJ L 25, 2.2.2016, pp. 30-43)

See consolidated version.

Commission Implementing Regulation (EU) No 828/2014 of 30 July 2014 on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food (OJ L 228, 31.7.2014, pp. 5-8)

Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, pp. 18-63)

See consolidated version.

Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (OJ L 404, 30.12.2006, pp. 9-25)

See consolidated version.

last update 21.03.2023