2008/864/EC: Commission Decision of 30 July 2008 concerning a draft Decree from the Czech Republic laying down requirements for food supplements and the enrichment of foodstuffs (notified under document number C(2008) 3963) (Text with EEA relevance)
Date: 2008-07-30
Institutions: European Commission
Subjects: Czechia, EU Member State, animal health, animal nutrition, food hygiene, food supplement

L 307/4

EN

Official Journal of the European Union

18.11.2008

(Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory)

II

DECISIONS

COMMISSION

COMMISSION DECISION

of 30 July 2008

concerning a draft Decree from the Czech Republic laying down requirements for food
supplements and the enrichment of foodstuffs

(notified under document number C(2008) 3963)

(Only the Czech text is authentic)

(Text with EEA relevance)

(2008/864/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

supplements and the enrichment of foodstuffs, and in
particular Articles 2(3) and 4 as well as the Annexes 4
and 5 thereto.

Having regard to the Treaty
Community,

establishing the European

the
Having regard to Regulation (EC) No 1925/2006 of
European Parliament and of
the Council of 20 December
2006 on the addition of vitamins and minerals and of certain
other substances to foods (1), and in particular Articles 11(2)(b)
and 12 thereof,

Whereas:

(1)

(2)

Regulation (EC) No 1925/2006 on the addition of
vitamins and minerals and of certain other substances
in the absence of Community provision,
to foods,
provides for
the notification and the assessment of
national new provisions concerning, inter alia, the prohi­
bition or
certain other
substances in the manufacture of specified foods.

restriction on the use of

In accordance with the procedure provided for
in
Article 12 read in conjunction with Article 11(2)(b) of
Regulation (EC) No 1925/2006, the Czech authorities
notified the Commission on 30 November 2007 of a
food
draft Decree

laying down requirements

for

(1) OJ L 404, 30.12.2006, p. 26.

(3)

(4)

(5)

(6)

Article 2(3) of the draft Decree establishes by means of
Annex 4 thereto a list of other substances in the sense of
Article 2(2) of Regulation (EC) No 1925/2006, as well as
the respective conditions under which these substances
may be used in the manufacture of food supplements.

Articles 2(3) and 4 of the draft Decree establish by means
of Annex 5 thereto a list of plants and other substances
that
food
are prohibited in the manufacture of
supplements and foodstuffs in general.

In accordance with the provisions of Article 12(2) of
Regulation (EC) No 1925/2006,
the Commission
consulted the other Member States via the Standing
Committee on the Food Chain and Animal Health.

The draft Decree, as it currently stands, does not indicate
why the substances contained in Annex 4 have to
comply with the thresholds thereof based on public
health reasons.

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Official Journal of the European Union

L 307/5

(7)

(8)

(9)

(10)

(11)

In the absence of harmonised Community legislation,
Member States retain their competence to regulate the
production and marketing of goods in their territory
without prejudice to the Articles 28 and 30 of the EC
Treaty.

In particular, Article 2(3) of the draft Decree read in
conjunction with Annex 4 thereto appears to suggest
that substances other than those listed therein are not
permitted to be used in the manufacture of
food
supplements.

indicate how products,

Even if were demonstrated that Annex 4 is justified on
the basis of public health reasons, the draft decree does
not
lawfully produced and/or
marketed in other Member States that do not comply
with the requirements laid down in Articles 2(3) and 4
thereof will be treated.

(13)

(14)

(15)

international

scientific research,

their
results of
rules are necessary to give effective protection to the
interests referred to in that provision and, in particular,
that the marketing of the products in question poses a
real risk to public health.

that

The Czech authorities have not provided any evidence
that would justify the establishment of a list containing
prohibited substances to be used in the manufacture of
food supplements and foodstuffs in general.

Even if such evidence were provided, the draft Decree
contain any provision ensuring the free
does not
movement of
in
general
lawfully produced and/or marketed in other
Member States which contain substances not permitted
thereby.

food supplements

and foodstuffs

Therefore,
guarantees that
deriving from Articles 28 and 30 of the EC Treaty.

the draft Decree fails to provide adequate
the economic operators

the rights of

food supplements

free movement of

The draft Decree does not contain any provision ensuring
the
lawfully
produced and/or marketed in other Member States
which contain substances that are included in Annex 4
thereto but not in accordance with the conditions laid
down therein, or substances other than those included in
Annex 4 thereto either in the form of a mutual recog­
nition clause or in the form of an approval procedure
enabling economic operators to have such substances
included on the national list of authorised substances.

Pursuant to Articles 2(3) and 4 of the notified Decree
read in conjunction with Annex 5 thereto,
food
supplements and foodstuffs in general shall contain no
narcotic or psychotropic substances, nor precursors of
Category 1, nor any other substance demonstrated to
have a toxic, genotoxic,
teratogenic, hallucinogenic,
narcotic or other unfavourable effects on the human
body, nor any of the substances contained in Annex 5
thereto. The prohibition of certain other substances for
the manufacture of food supplements and foodstuffs in
general may be justified on grounds of the protection of
health and life of humans within the meaning of
Article 30 EC Treaty.

(16)

these observations,

In light of
the Commission has
delivered a negative opinion pursuant to Article 12(3)
of Regulation (EC) No 1925/2006.

(17)

The Czech authorities should accordingly be requested
not to adopt the draft Decree in question and modify
it in accordance with Articles 28 and 30 of the EC Treaty
taking into account the observations of the Commission
in its negative opinion.

(18)

The measures provided for in this Decision are in line
with the opinion of the Standing Committee on the Food
Chain and Animal Health,

HAS ADOPTED THIS DECISION:

Article 1

1.
The Czech Republic is required to refrain from adopting
its draft Decree laying down requirements for food supplements
and the enrichment of
is amended in
accordance with Paragraph 2.

foodstuffs, unless it

(12)

Since the latter article provides for an exception, to be
interpreted strictly,
free movement of
to the rule of
goods within the Community, it is for the national auth­
orities which invoke it to show in each case, in the light
of national nutritional habits and in the light of the

2.
The Czech Republic is required to amend the draft Decree
at issue in order to include a clear reference as to the treatment
of products which do not comply with the requirements of the
notified draft, but are lawfully produced and/or marketed in
other EU Member States, Turkey or EEA States.

L 307/6

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Official Journal of the European Union

18.11.2008

This Decision is addressed to the Czech Republic.

Article 2

Done at Brussels, 30 July 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission