Commission Directive 2003/40/EC of 16 May 2003 establishing the list, concentration limits and labelling requirements for the constituents of natural mineral waters and the conditions for using ozone-enriched air for the treatment of natural mineral waters and spring waters
Date: 2003-05-16
Institutions: European Commission
Subjects: consumer protection, freshwater, labelling, marketing, mineral water, public health, water treatment

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Official Journal of the European Union

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COMMISSION DIRECTIVE 2003/40/EC

of 16 May 2003

establishing the list, concentration limits and labelling requirements for the constituents of natural
mineral waters and the conditions for using ozone-enriched air for the treatment of natural
mineral waters and spring waters

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 80/777/EEC (1), of 15 July
1980 on the approximation of the laws of the Member States
relating to the exploitation and marketing of natural mineral
waters, as last amended by Directive 96/70/EC of the European
the Council (2), and in particular Article
Parliament and of
11(1) thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

Constituents may be present
in the natural state in
certain natural mineral waters because of their hydrogeo-
logical origin and may present a risk to public health
above a certain concentration.
It is therefore deemed
necessary to establish concentration limits for these
constituents in natural mineral waters.

Article 11 of Directive 80/777/EEC makes provision for
adopting harmonised concentration limits for the consti-
tuents of natural mineral waters after consulting the
Scientific Committee for Food, and for labelling require-
the presence of
ments to indicate, where applicable,
certain constituents at high concentrations.

The Scientific Committee for Food issued an opinion (3),
on arsenic, barium, fluoride, boron and manganese and,
for other constituents of natural mineral waters, vali-
dated the limits recommended by the WHO for drinking
water.

revised Codex standard for

The
‘natural mineral
waters’ (4), gives, for health purposes, a list of constitu-
ents and maximum limits for these constituents. It was
adopted on the basis of the most recent international
scientific data and affords sufficient public health protec-
tion.

It is generally acknowledged that a low-level fluoride
intake can have a beneficial effect on teeth. By contrast,
excessive fluoride intake across the board can have
harmful effects on public health. Thus, it is necessary to
lay down a harmonised maximum limit for fluoride in
natural mineral waters affording sufficient protection for
the population as a whole.

The World Health Organisation recommended a guide
value of 1,5 mg/l for fluoride for drinking water, which
was validated for natural mineral waters by the Scientific
Committee for Food in the abovementioned opinion. In
order to protect infants and young children, who are the

(1) OJ L 229, 30.8.1980, p. 1.
(2) OJ L 299, 23.11.1996, p. 26.
(3) Opinion of 13 December 1996 on arsenic, barium, fluoride, boron

and manganese in natural mineral waters.

(4) Codex standard 108-1981, Rev 1-1997, revised during the 7th

session of the CCNMW (October 2000).

(7)

(8)

(9)

most sensitive to the risk of fluorosis, where the fluoride
content of a natural mineral water exceeds this guide
value, a reference to this fact, which can be seen easily
by the consumer, also needs to be made on the label.

recommendations of 1996. However,

The Scientific Committee for Food indicated a guide
value for boron in natural mineral waters based on the
WHO (5),
the
WHO and other
internationally recognised scientific
organisations have since then made new appraisals of
boron's effect on public health and have recommended
higher values. The European Food Safety Authority
should therefore be consulted about boron in natural
mineral waters so that the new scientific appraisals avail-
able can be taken into account and a maximum limit for
boron should not be set at this stage.

The Scientific Committee for Food also indicated in the
above opinion the acceptable level for barium, manga-
nese and arsenic in natural mineral waters. For the other
undesirable constituents of natural mineral waters which
may have a harmful effect on public health, the revised
Codex standard lays down maximum limits that afford
sufficient protection for public health. However,
the
limit for nitrates is deemed to be too low in the light of
the available data and should be brought into line with
that for drinking water (6).

The maximum limit for nitrates laid down in the Codex
standard affords sufficient protection for public health
and should serve as a reference for Community and
international trade in natural mineral waters. However,
during the procedure for official recognition of natural
mineral water sources referred to in Article 1 of the
aforementioned Directive, the Member States' competent
authorities must be able to take a lower guide value for
nitrates in natural mineral waters collected within their
territory.

(10) Natural mineral waters whose content in certain consti-
tuents exceeds the maximum limits for these constitu-
ents shall, for public health purposes, be subjected to the
separation treatments for these constituents. In order to
enable the operators concerned to make the necessary
investment to comply with these new standards, suffi-
cient periods should be allowed before the maximum
concentration limits for such constituents come into
force, in particular with regard to fluoride and nickel for
which no separation treatment has yet been assessed or
authorised at Community level.

(5) WHO (1996): guidelines on the quality of drinking water, second

edition, volume 2.

(6) Council Directive 98/83/EC (OJ L 330 of 5.12.1998, p. 32).

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(11)

For the purposes of official checks on these constituents,
a fluctuation margin around the maximum concentra-
tion limits is required corresponding to measurement
uncertainties.

It also defines the conditions for using ozone-enriched air for
separating compounds of iron, manganese, sulphur and arsenic
from natural mineral waters or spring waters, and the labelling
requirements for waters which have undergone such treatment.

(12) Article 4(1)(b) of Directive 80/777/EEC (as amended)
provides for the separation of iron, manganese, sulphur
and arsenic from certain natural mineral waters, using
ozone-enriched air treatment, subject to an assessment
of this treatment by the Scientific Committee for Food
and adoption of the conditions for use of this treatment
by the Standing Committee on the Food Chain and
Animal Health.

(13)

treatment which provides

The Scientific Committee for Food issued an opinion (1),
on this
for both given
methods and results. However, it is deemed appropriate
to stipulate only given results, in order to take account
of developments in ozone-enriched air treatment techni-
ques
and treatment variability depending on the
physico-chemical composition of the water to be treated.

(14) Moreover, treatment with ozone-enriched air should not
modify the composition in terms of characteristic consti-
tuents within the meaning of Article 7(2)(a) of Directive
80/777/EEC, or have a disinfectant action within the
meaning of Article 4(3) or generate the formation of
treatment residues which may have a harmful effect on
public health.

(15)

(16)

Pursuant to Article 7(2)(c) of the above Directive, natural
mineral waters treated with ozone-enriched air must
bear a reference on the label giving customers sufficient
information about the treatment carried out.

In accordance with the provisions of Article 9(4)(a)
fourth indent of Directive 80/777/EEC, the provisions
concerning the treatments provided for in Article 4 of
the Directive, and in particular treatment with ozone-
enriched air, are applicable to spring waters.

(17)

The measures laid down in this Directive are in accor-
dance with the opinion of the Scientific Committee on
the Food Chain and Animal Health,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Article 2

By 1 January 2006 at the latest, natural mineral waters
1.
shall, at the time of packaging, comply with the maximum
concentration limits set out in Annex I for the constituents
listed in that Annex.

However, in the case of fluorides and nickel, the deadline

2.
referred to above is extended until 1 January 2008.

By way of derogation from paragraph 1, during the
3.
procedure for official recognition of natural mineral waters
collected within their territory, the competent authorities of the
Member States may take a lower reference value for nitrates
and nitrites, provided that the same reference value is applied
to all applications made to them.

Article 3

For the purposes of official controls, the Member States shall
comply with the specifications listed in Annex II for analysing
the constituents listed in Annex I.

Article 4

1.
Natural mineral waters with a fluoride concentration
exceeding 1,5 mg/l shall bear on the label the words ‘contains
more than 1,5 mg/l of
regular
consumption by infants and children under 7 years of age’.

fluoride: not suitable for

2.
The label information laid down in paragraph 1 of this
Article shall be placed in immediate proximity to the trade
name and in clearly visible characters.

3.
Natural mineral waters which, under the terms of para-
graph 1 of this Article, bear label information, shall indicate
the actual fluoride content in relation to the physico-chemical
composition in terms of essential constituents, as laid down in
Article 7(2)(a) of Directive 80/777/EEC.

This Directive establishes the list of constituents of natural
mineral waters which may present a risk to public health, the
limits for admissible levels of these constituents, the deadlines
for application of these limits and the labelling requirements
for certain constituents. These constituents must be present in
the water naturally and may not result from contamination at
source.

Article 5

1. Without prejudice to the provisions of Article 4(1)(b) of
Directive 80/777/EEC, application of the treatment of natural
mineral waters with ozone-enriched air must be notified in
advance to the competent authorities, who shall ensure that:

(1) Opinion of the Scientific Committee for Food of 7 June 1996 on
the use of ozone for separating unstable elements such as iron,
manganese and arsenic from natural mineral waters.

(a) use of such treatment is justified by the composition of the
water in terms of compounds of iron, manganese, sulphur
and arsenic;

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(b) the operator takes all measures necessary to guarantee that
the treatment is effective and safe and to allow it to be
checked by the competent authorities.

Ozone-enriched air treatment of natural mineral waters

2.
must comply with all the following conditions:

(a) the physico-chemical composition of the natural mineral
waters in terms of essential constituents shall not be modi-
fied by the treatment;

(b) the natural mineral water before treatment must comply
with the microbiological criteria laid down in Article 5(1)
and (2) of Directive 80/777/EEC;

(c) the treatment shall not lead to the formation of residues
with a concentration exceeding the maximum limits laid
down in Annex III or residues which could pose a risk to
public health.

Article 6

Pursuant to Article 7(2)(c) of Directive 80/777/EEC, the label-
ling of natural mineral waters which have been treated with
ozone-enriched air shall bear,
in proximity to the analytical
composition of characteristic constituents, the words ‘water
subjected to an authorised ozone-enriched air oxidation tech-
nique’.

Article 7

Without prejudice to the provisions of Article 9(4)(b) of Direc-
tive 80/777/EEC, the provisions of Articles 5 and 6 of this
Directive shall apply to spring waters.

Article 8

1.
The Member States shall take the necessary measures to
permit the marketing of products complying with the present
Directive by 1 January 2004 at the latest.

2. Without prejudice to the deadlines set out in Article 2(1)
and (2), the Member States shall prohibit the marketing of
products not complying with the present Directive from 1 July
2004. However, products packaged and labelled prior to 1 July
2004 may be sold until stocks are exhausted.

Article 9

The Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 31 December 2003 at the latest. They shall forth-
with inform the Commission thereof.

The provisions adopted pursuant
to this paragraph shall
contain a reference to this Directive or shall be accompanied
by such reference at
their official publication.
Member States shall determine how such reference is to be
made.

the time of

Article 10

This Directive shall enter into force on the 20th day following
that of its publication in the Official Journal of the European
Union.

Article 11

This Directive is addressed to the Member States.

Done at Brussels, 16 May 2003.

For the Commission

David BYRNE

Member of the Commission

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Constituents naturally present in natural mineral waters and maximum limits which, if exceeded, may pose a
risk to public health

ANNEX I

Constituents

Antimony

Arsenic

Barium

Boron

Cadmium

Chromium

Copper

Cyanide

Fluorides

Lead

Manganese

Mercury

Nickel

Nitrates

Nitrites

Selenium

Maximum limits
(mg/l)

0,0050

0,010 (as total)

1,0

For the record (*)

0,003

0,050

1,0

0,070

5,0

0,010

0,50

0,0010

0,020

50

0,1

0,010

(*) The maximum limit for boron will be fixed, where necessary, following an
opinion of the European Food Safety Authority and on a proposal from the
Commission by 1 January 2006.

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ANNEX II

Performance characteristics (*) for analysing the constituents in Annex I

Constituents

Accuracy of para-
metric value in %
(Note 1)

Precision of para-
metric value
(Note 2)

Detection limit in % of
parametric value
(Note 3)

Notes

Antimony

Arsenic

Barium

Boron

Cadmium

Chromium

Copper

Cyanides

Fluorides

Lead

Manganese

Mercury

Nickel

Nitrates

Nitrites

Selenium

25

10

25

10

10

10

10

10

10

10

20

10

10

10

10

25

10

25

10

10

10

10

10

10

10

10

10

10

10

10

See Annex I

Note 4

25

10

25

10

10

10

10

10

10

10

20

10

10

10

10

(*) Analytical methods for measuring concentrations of the constituents listed in Annex I must be able to measure, as a minimum,
concentrations equal to the parametric value with a specified accuracy, precision and detection limit. Whatever the sensitivity of the
method of analysis used, the result will be expressed using at least the same number of decimal places as for the maximum limit laid
down in Annex I.

Note 1: accuracy is the systematic error and is the difference between the average value of a large number of repeated measurements

and the exact value.

Note 2: precision is the random error and is expressed in general as the standard deviation (within a batch and between batches) of a

sample of results from the average. Acceptable precision is equal to twice the relative standard deviation.

Note 3:

the detection limit is:
— either three times the relative standard deviation within a batch of a natural sample containing a low concentration of

the parameter,

— or five times the relative standard deviation within a batch of a virgin sample.

Note 4:

the method should make it possible to determine total cyanide in all its forms.

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Maximum limits for residues from treatment of natural mineral waters and spring waters by ozone-enriched
air

ANNEX III

Treatment residue

Maximum limit (*)
(µg/l)

Dissolved ozone

Bromates

Bromoforms

50

3

1

(*) Compliance with the maximum limits is monitored by the competent authori-
ties in the Member States at the time of bottling or other form of packaging
intended for the final consumer.