FEDERAL PUBLIC SERVICE FOR PUBLIC HEALTH, SAFETY OF THE
FOOD CHAIN AND THE ENVIRONMENT
Royal Decree amending the Royal Decrees of 30 May 2021 on the
placing on the market of nutrients and foodstuffs to which nutrients
have been added, of 29 August 2021 on the manufacture of and trade
in food supplements containing substances other than nutrients and
plants or plant preparations, and of 31 August 2021 on the
manufacture of and trade in foodstuffs consisting of or containing
plants or plant preparations
FEDERAL PUBLIC SERVICE FOR PUBLIC HEALTH, SAFETY OF THE FOOD CHAIN AND
THE ENVIRONMENT
15 DECEMBER 2024. - Royal Decree amending the Royal Decrees of 30 May 2021
on the placing on the market of nutrients and foodstuffs to which nutrients have
been added, of 29 August 2021 on the manufacture of and trade in food
supplements containing substances other than nutrients and plants or plant
preparations, and of 31 August 2021 on the manufacture of and trade in
foodstuffs consisting of or containing plants or plant preparations
PHILIPPE, King of the Belgians,
To all those present and to come, Greetings.
Having regard to of the Law of 24 January 1977 on the protection of the
health of consumers with regard to foodstuffs and other products, Articles 1,
2, 6 and 10 amended by the Law of 22 March 1989;
Having regard to the Royal Decree of 30 May 2021 on the placing on the
market of nutrients and foodstuffs to which nutrients have been added,
Articles 2(6) and (7) and 5;
Having regard to the Royal Decree of 29 August 2021 on the manufacture of
and trade in food supplements containing substances other than nutrients and
plants or plant preparations, Articles 2(3) and (6) and 5;
Having regard to the Royal Decree of 31 August 2021 on the manufacture of
and trade in foodstuffs consisting of or containing plants or plant
preparations, Articles 2(8) and (10) and 3, as amended by the Royal Decree of
12 December 2023;
Having regard to Regulation (EC) No 178/2002 of the European Parliament
and of the Council of 28 January 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Authority
and laying down procedures in matters of food safety;
Having regard to Regulation (EC) No 1925/2006 of the European
Parliament and of the Council of 20 December 2006 on the addition of
vitamins and minerals and of certain other substances to foods;
Having regard to 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;
Having regard to the communication to the European Commission of (date
of transmission), pursuant to Article 5(1) of Directive (EU) 2015/1535 of the
European Parliament and of the Council of 9 September 2015 laying down a

procedure for the provision of information in the field of technical regulations
and of rules on Information Society services;
Having regard to the opinion of the High Council for Health issued on xxx;
Having regard to the opinion of the Inspector of Finance, issued on 7 May
2024;
Having regard to the opinion xxx of the Council of State, issued on (date),
pursuant to Article 84(1), subparagraph 1(2), of the laws on the Council of
Having regard to of the Law of 24 January 1977 on the protection of the health of
consumers with regard to foodstuffs and other products, Articles 2(1–3) and
10(1), replaced by the Law of 9 February 1994;
Having regard to the Royal Decree of 30 May 2021 on the placing on the market
of nutrients and foodstuffs to which nutrients have been added, Articles 2(6) and
(7) and 5;
Having regard to the Royal Decree of 29 August 2021 on the manufacture of and
trade in food supplements containing substances other than nutrients and plants
or plant preparations, Articles 2(3) and (6) and 5;
Having regard to the Royal Decree of 31 August 2021 on the manufacture of and
trade in foodstuffs consisting of or containing plants or plant preparations,
Articles 2(8) and (10) and 3, as amended by the Royal Decree of 12 December
2023;
Having regard to Regulation (EC) No 178/2002 of the European Parliament and of
the Council of 28 January 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Authority and
laying down procedures in matters of food safety;
Having regard to Regulation (EC) No 1925/2006 of the European Parliament and
of the Council of 20 December 2006 on the addition of vitamins and minerals and
of certain other substances to foods;
Having regard to 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;
Having regard to Directive 2002/46/EC of the European Parliament and of the
Council of 10 June 2002 on the approximation of the laws of the Member States
relating to food supplements;
Having regard to the communication to the European Commission of 30 May
2024, pursuant to Article 5(1) of Directive (EU) 2015/1535 of the European
Parliament and of the Council of 9 September 2015 laying down a procedure for
the provision of information in the field of technical regulations and of rules on
Information Society services;
Having regard to the opinion of the High Council for Health issued on

9 September 2024;
Having regard to the opinion of the Inspector of Finance, issued on 7 May 2024;
Having regard to Opinion 77.119/3 of the Council of State, issued on
18 November 2024, pursuant to Article 84(1)(1)(2) of the Laws on the Council of
State, consolidated on 12 January 1973;
Following the proposal of the Minister for Agriculture and the Minister for
Public Health, and the opinion of the Ministers who deliberated thereon in the
Council,
WE HAVE DECREED AND HEREBY DECREE:
CHAPTER 1: Amendments to the Royal Decree of 30 May 2021 on the
placing on the market of nutrients and foodstuffs to which nutrients
have been added
Following the proposal of the Minister for Agriculture and the Minister for Public
Health,
We have decreed and hereby decree:
CHAPTER 1. - Amendments to the Royal Decree of 30 May 2021 on the placing on
the market of nutrients and foodstuffs to which nutrients have been added
Article 1. In the Royal Decree of 30 May 2021 on the placing on the market of
nutrients and foodstuffs to which nutrients have been added, an Article 1a is
inserted, worded as follows:
‘Article 1a. This Decree shall apply to foodstuffs intended for human
consumption as defined in Article 2 of Regulation (EC) No 178/2002 of the
European Parliament and of the Council of 28 January 2002 laying down the
general principles and requirements of food law, establishing the European
Food Safety Authority and laying down procedures in matters of food safety.’.
general principles and requirements of food law, establishing the European Food
Safety Authority and laying down procedures in matters of food safety.’.
Article 2. Article 2(6) of the same Decree is replaced by the following:
‘6° food supplements: foodstuffs whose purpose is to supplement the normal
diet and which consist of one or more nutrients, plants, plant preparations or
other substances with a nutritional or physiological effect, alone or in
combination, marketed in measured doses, namely in forms of presentation
such as capsules, lozenges, tablets, pills and other similar forms, as well as
sachets of powder, ampoules of liquids, drop bottles and other similar forms of
liquid or powder preparations intended to be taken in small measured units;’.
‘6° food supplements: foodstuffs whose purpose is to supplement the normal diet
and which consist of one or more nutrients, plants, plant preparations or other
substances with a nutritional or physiological effect, alone or in combination,
marketed in measured doses, namely in forms of presentation such as capsules,
lozenges, tablets, pills and other similar forms, as well as sachets of powder,
ampoules of liquids, drop bottles and other similar forms of liquid or powder
preparations intended to be taken in small measured units;’.
Article 3. Article 2 of the same Decree is supplemented by point 7 worded as
follows:
‘7° foodstuff: any substance or product that is processed, partially processed
or unprocessed, intended to be or reasonably expected to be ingested by
humans, other than:
1° animal feed;
2° live animals unless they are prepared for human consumption;
3° plants before harvesting;

4° medicinal products;
5° cosmetics;
6° tobacco and tobacco products;
7° narcotic drugs and psychotropic substances;
8° residues and contaminants.’.
‘7° foodstuff: foodstuffs intended for human consumption as defined in Article 2
of Regulation (EC) No 178/2002 of the European Parliament and of the Council of
28 January 2002 laying down the general principles and requirements of food
law, establishing the European Food Safety Authority and laying down
procedures in matters of food safety. “
Article 4. Article 5 of the same Decree is replaced by the following:
‘Article 5. § 1. It shall be prohibited to place on the market food supplements
consisting of or containing one or more nutrients if prior notification to the
Service has not been made in accordance with the following provisions.
.
A notification file must be submitted in one copy or via the FOODSUP
application on the website of the FPS Health, Safety of the Food Chain and the
Environment (www.santé.belgique.be).
‘Article 5. § 1. It shall be prohibited to place on the market foodstuffs consisting
of or containing one or more nutrients if prior notification to the Service has not
been made in accordance with the following provisions.
A notification file must be submitted in one copy or via the FOODSUP application
on the website of the FPS Health, Safety of the Food Chain and the Environment.
The notification file must contain the following data:
1° the nature of the foodstuff;
2° the list of ingredients of the product (qualitative and quantitative);
3° the list of nutrients added per recommended portion of the foodstuff to be
consumed daily on the labelling or per quantity of the foodstuff equal to the

average daily intake of that foodstuff provided for in Annex 2 for the foodstuffs
referred to in Article 4;
4° if applicable, the nutritional analysis of the product;
7° the commitment to carry out frequent analyses at different times of the
product and to make the results available to the Service.
Payment of a fee per notified product in pre-dosed form to the account of the
Budget Fund for Raw Materials and Products in accordance with Article 10(1)
of the Royal Decree of 13 November 2011 laying down the fees and
contributions due to the Budget Fund for Raw Materials and Products and
meeting the conditions set out in the request to pay is necessary for the
submission of the notification file.
Products shall be marketed in accordance with Article 17(1) of Regulation
(EC) No 178/2002 of the European Parliament and of the Council of 28
January 2002 laying down the general principles and requirements of food
law, establishing the European Food Safety Authority and laying down
procedures in matters of food safety.
Budget Fund for Raw Materials and Products in accordance with Article 10(1) of
the Royal Decree of 13 November 2011 laying down the fees and contributions
due to the Budget Fund for Raw Materials and Products and meeting the
conditions set out in the request to pay is necessary for the submission of the
notification file.
Products shall be marketed in accordance with Article 17(1) of Regulation (EC) No
178/2002 of the European Parliament and of the Council of 28 January 2002
laying down the general principles and requirements of food law, establishing the