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9.6.2012 Official
Journal
of
the
European
Union L
150/71
COMMISSION IMPLEMENTING REGULATION (EU) No 489/2012
of 8 June 2012
establishing implementing rules for the application of Article 16 of Regulation (EC) No 1925/2006
of the European Parliament and of the Council on the addition of vitamins and minerals and of
certain other substances to foods
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(6) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
Having regard to the Treaty on the Functioning of the European
Committee on the Food Chain and Animal Health,
Union,
Having regard to Regulation (EC) No 1925/2006 of the
HAS ADOPTED THIS REGULATION:
European Parliament and of the Council of 20 December
2006 on the addition of vitamins and minerals and of certain
Article 1
other substances to foods ( 1 ), and in particular Article 16
thereof,
Subject matter
This Regulation establishes implementing rules for the appli
Whereas:
cation of Article 16 of Regulation (EC) No 1925/2006 and in
particular on the provision of the necessary relevant
(1) Article
16
of
Regulation
(EC)
No
1925/2006
establishes information by the Member States to the Commission for the
that the Commission shall submit, by 1 July 2013, a
purpose of evaluating the effects of implementation of the
report to the European Parliament and the Council on
Regulation (EC) No 1925/2006.
the effects of implementing that Regulation. With regard
to this, the Member States shall provide the necessary
relevant information to the Commission.
Article 2
Relevant information
(2) The
necessary
relevant
information
to
be
provided
by
the
Member States should relate to the evolution of the
1. Member
States
shall
by
1
July
2012
provide
to
the
market in foods to which vitamins and minerals have
Commission the necessary relevant information in particular
been added, including data demonstrating trends in the
concerning the following:
market since harmonisation at Union level of the
addition of vitamins and minerals to foods.
(a) evolution of the national market in foods to which vitamins
and minerals have been added since the date of application
(3) Such
information
should
include
consumption
patterns
of Regulation (EC) No 1925/2006;
of foods to which vitamins and minerals have been
added and information on intake of vitamins and
minerals by the population and by specific population
(b) consumption patterns of foods to which vitamins and
groups if appropriate. This should include information
minerals have been added;
that demonstrates changes in dietary habits since
harmonisation of the addition of vitamins and minerals
(c) intake levels of vitamins and minerals by the population;
to foods.
(4) The
relevant
information
to
be
provided
by
the
Member (d) the addition of substances other than vitamins or minerals
States should also relate to the addition of substances
to foods, including food supplements as defined in point (a)
other than vitamins or minerals to foods, including
of Article 2 of Directive 2002/46/EC and the information
food supplements, as defined by Directive 2002/46/EC
on the consumption patterns of such foods as well as the
of the European Parliament and of the Council of
amounts of these substances added to foods and food
10 June 2002 on the approximation of the laws of the
supplements.
Member States relating to food supplements ( 2 ). Such
information should include information on the
2. The
necessary
relevant
information
to
be
provided
by
the
consumption of such foods and the amounts of the
Member States to the Commission referred to in paragraph 1
substances added, and on any national measures
shall include at least the information specified in Annex I to this
whether legislative or not, that have been taken so as
Regulation.
to restrict or prohibit the use of certain other substances
in foods.
The necessary relevant information and details thereof shall be
(5) It
is
necessary
by
way
of
these
implementing
rules
to submitted to the Commission in the format laid down in Annex
establish a list of the relevant information that Member
II to this Regulation.
States should collect and provide to the Commission, and
to set a common format for presenting this information.
3. A
Member
State
shall
inform
the
Commission
if
any
of
the information specified in Annex I is not available or cannot
( 1 ) OJ L 404, 30.12.2006, p. 26.
for any other reason be provided to the Commission by 1 July
( 2 ) OJ L 183, 12.7.2002, p. 51.
2012.

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L 150/72
EN
Official Journal of the European Union
9.6.2012
Article 3
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 June 2012.
For the Commission
The President
José Manuel BARROSO

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EN
9.6.2012 Official
Journal
of
the
European
Union L
150/73
ANNEX I
Necessary relevant information to be provided by the Member States for the purpose of evaluating the effects of
implementation of Regulation (EC) No 1925/2006
A. Information concerning the evolution of the national market in foods to which vitamins and minerals have been
added shall include the following:
1. general information on the national market including the market share of specific foods or food categories;
2. information on trends in the evolution of the national market.
The information referred to in points 1 and 2 shall include the information for the foods which contain the most
commonly added vitamins and minerals and information on the amounts of vitamins and minerals added to foods.
Such information may be obtained from commercially available market reports, national monitoring measures and
other relevant and defined sources.
B. Information on consumption patterns of foods to which vitamins and minerals have been added shall include the
following:
1. information on the consumption patterns of specific foods or food categories to which vitamins and minerals have
been added for the population and if appropriate, for specific population groups, including such information for
the foods which contain the most commonly added vitamins and minerals and information on the amounts of
vitamins and minerals added to foods;
2. information obtained from nationally representative dietary consumption surveys, data from academic studies and
other relevant and defined sources, including the information on the dietary survey methodology, such as the
dietary assessment methodology, and the population subgroups and age groups assessed;
3. information on any observed changes in overall dietary habits and trends in the consumption of foods to which
vitamins and minerals have been added, in particular those changes that may be associated with the date of
application of the Regulation (EC) No 1925/2006. Member States shall provide the details for the basis of these
observed changes, including details on the base-line data used to compare past and current consumption of foods
to which vitamins and minerals have been added.
C. Information on the intake levels of vitamins and minerals shall include the following:
1. information on the intake levels for vitamins and minerals for the population and, if appropriate, for specific
population groups. This information shall be obtained from the data sources referred to in point B.2 of this Annex;
2. information on any observed changes in intake levels for vitamins and minerals including trends in the levels of
intake that may be associated with the date of application of Regulation (EC) No 1925/2006. Member States shall
provide the details for the basis of these observed changes, including details on the base-line data used to compare
intake levels of vitamins and minerals prior to and after the date of application of Regulation (EC) No 1925/2006.
D. Information on the addition of substances other than vitamins or minerals to foods shall include the following:
1. information on the national market in foods to which certain other substances have been added, including the
market share of specific foods or food categories;
2. information on the national market in food supplements, as defined by point (a) of Article 2 of Directive
2002/46/EC;
3. information on the most commonly added substances to foods based on information from commercially available
market reports, national monitoring measures and other relevant and defined sources and shall include information
on the levels of addition of other substances to specific foods or food categories;
4. information on national measures including legislative and non-legislative measures that aim to restrict or prohibit
the use of other substances in the manufacture of foods, including food supplements.

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L 150/74
EN
Official Journal of the European Union
9.6.2012
ANNEX II
Format for the presentation of the information provided by the Member States
Evolution of the market in foods to which vitamins and minerals have been added
Type of information to be provided Source
of
data
National market share of different food products to which vitamins and minerals have
been added by food category, as defined by the 20 main food categories of the food
classification system FoodEx ( 1 ), excluding foods for particular nutritional uses and food
supplements.
Trends in the market size for foods to which vitamins and minerals have been added,
and in particular information on the market prior to and after the date of application of
Regulation (EC) No 1925/2006.
( 1 ) European Food Safety Authority; The food classification and description system FoodEx 2 (draft- revision 1). Supporting Publications
2011:215. [438 pp.]. Available online: www.efsa.europa.eu
Consumption patterns of foods to which vitamins and minerals have been added
Type of information to be provided Source
of
data
Average consumption levels by the population of foods to which vitamins and minerals
have been added.
Average consumption levels of foods to which vitamins and minerals have been added
according to the following population groups:
— adults (18 years and above);
— children (under 18 years); and if appropriate, by specific age groups; and
— by food category as defined by the 20 main food categories of the food classification
system FoodEx, excluding foods for particular nutritional uses and food supplements.
Amounts of vitamins and minerals added to the foods, according to the 20 main food
categories of the food classification system FoodEx. This shall be provided as amounts or
ranges of amounts added.
Observed changes in consumption patterns of foods to which vitamins and minerals
have been added including data on base-line data used to compare consumption prior to
and after the date of application of Regulation (EC) No 1925/2006.
Intake levels of vitamins and minerals
Type of information to be provided Source
of
data
Average intake levels for vitamins and minerals for the population.
Average intake levels for vitamins and minerals according to the following population
groups:
— adults (18 years and above);
— children (under 18 years); and if appropriate, by specific age groups.
Dietary survey methodology (mainly methods for dietary assessment, age groups, popu
lation subgroups).
Observed changes in intake levels for vitamins and minerals including data on base-line
data used to compare intake levels prior to and after the date of application of Regu
lation (EC) No 1925/2006.

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EN
9.6.2012 Official
Journal
of
the
European
Union L
150/75
Addition of substances other than vitamins or minerals
Type of information to be provided Source
of
data
National market share of food products, including food supplements, to which other
substances have been added, according to the following categories of substances used:
1. Amino-acids
2. Enzymes
3. Prebiotics and probiotics
4. Essential fatty acids and other special fatty acids
5. Botanicals and botanical extracts
6. Other substances.
Trends in the market size and in particular information on the market prior to and after
the date of application of Regulation (EC) No 1925/2006.
National measures that concern the restriction or prohibition of the use of other
substances in the manufacture of foods, including food supplements.

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