NATURAL MINERAL WATERS REGULATIONS

SUBSIDIARY LEGISLATION 449.44

NATURAL MINERAL WATERS REGULATIONS

1st July, 2004

LEGAL NOTICE 343 of 2004.

The title of these regulations is the Natural Mineral Waters

Regulations.

I.

DEFINITION

1. ‘Natural mineral water’ means microbiologically wholesome water, within

the meaning of regulation 9, originating in an underground water table or deposit and

emerging from a spring tapped at one or more natural or bore exits.

Natural mineral water can be clearly distinguished from ordinary drinking water

(a) by its nature, which is characterized by its mineral content, trace

elernents or other constituents and, where appropriate, by certain

effects;

(b) by its original state,

both characteristics having been preserved intact because of the underground origin

of such water, which has been protected from all risk of pollution.

2. These characteristics, which may give natural mineral water properties

favourable to health, must have been assessed

(a) from the following points of view

1. geological and hydrological,

2. physical, chernical and physico-chemical,

3. microbiological,

4. if necessary, pharmacological, physiological and clinical;

(b) according to the criteria listed in Section II;

(c) according to scientific rnethods approved by the responsible authority.

The analyses referred to in sub-paragraph (a)(4) may be optional where the water

presents the compositional characteristics on the strength of which it was considered

a natural mineral water in the Member State of origin prior to the entry into force of

Directive 80/777/EEC. This is the case in particular when the water in question

contains, per kg, both at source and after bottling, a minimum of 1 000 mg of total

solids in solution or a minimum of 250 mg of free carbon dioxide.

3. The composition, temperature and other essential characteristics of natural

mineral water must remain stable within the limits of natural fluctuation; in

particular, they must not be affected by possible variations in the rate of flow.

Within the meaning of regulation 9.1, the normal viable colony count of natural

mineral water means the reasonably constant total colony count at source before any

treatment, whose qualitative and quantitative composition taken into account in the

recognition of that water is checked by periodic analysis.

II.

REQUIREMENTS AND CRITERIA FOR APPLYING THE DEFINITION

1.1

Requirements for geological and hydrological surveys

There must be a requirement to supply the following particulars

1.1.1. the exact site of the catchment with indicalion of its altitude, on a map

with a scale of not more than 1:1 000;

1.1.2.

a detailed geological report on the origin and nature of the terrain;

1.1.3.

the stratigraphy of the hydrogeological layer;

1.1.4.

a description of the catchment operations;

1.1.5. the demarcation of the area or details of other measures protecting the

spring against pollution.

NATURAL MINERAL WATERS

1.2. Requirements for physical, chemical and physico-chemical surveys

These surveys shall establish

1.2.1. the rate of flow of the spring;

1.2.2. the temperature of the water at source and the ambient temperature;

1.2.3. the relationship between the nature of the terrain and the nature and type of

minerals in the water;

1.2.4. the dry residues at 180ºC and 260ºC;

1.2.5. the electrical conductivity or resistivity, with the measurement temperature

having to be specified;

1.2.6. the hydrogen ion concentration (pH);

1.2.7. the anions and cations;

1.2.8. the non-ionized elements;

1.2.9. the trace elements;

1.2.10. the radio-actinological properties at source;

1.2.11. where appropriate, the relative isotope levels of the constituent elements

of water, oxygen (160 - 180) and hydrogen (protium, deuterium, tritium);

1.2.12. the toxicity of certain constituent elements of the water, taking account of

the limits laid down for each of them.

1.3. Criteria for microbiological analyses at source

These analyses must include

1.3.1. demonstration of the absence of parasites and pathogenic micro-organisms;

1.3.2. quantitative determination of the revivable colony count indicative of

faecal contamination

(a) absence of Escherichia coli and other coliforms in 250 ml at 37ºC and

(1) Products which comply with these regulations may be

marketed prior 1st July, 2004.

(2) Products packaged and labelled prior to the 1 st July, 2004

may be sold until stocks are exhausted.

CONDITIONS FOR THE EXPLOITATION AND MARKETING

OF NATURAL MINERAL WATER

Exploitation of a natural mineral water spring shall be subject to permission

from the responsible authority of the country where the water has been extracted,

after it has been established that the water in question complies with the provisions

laid down in paragraph 1 of the First Schedule.

2. Equipment for exploiting the water must be so installed as to avoid any

possibility of contamination and to preserve the properties, corresponding to those

ascribed to it, which the water possesses at source.

To this end, in particular

(a) the spring or outlet must be protected against the risks of pollution;

(b) the catchment, pipes and reservoirs must be of materials suitable for

water and so built as to prevent any chemical, physico-chemical or

microbiological alteration of the water;

(c) the conditions of exploitation, particularly the washing and bottling

plant, must meet hygiene requirements. In particular, the containers

must be so treated or manufactured as to avoid adverse effects on the

microbiological and chemical characteristics of the natural mineral

water;

(d) the transport of natural mineral water in containers other than those

authorized for distribution to the ultimate consumer is prohibited.

However, sub-paragraph (d) need not be applied to mineral waters exploited and

marketed in the terntory of a Member State if, in that Member State at the time of

notification of Council Directive 80/777/EEC, transport of the natural mineral water

in tanks from the spring to the bottling plant was authorized.

3. Where it is found during exploitation that the natural mineral water is

NATURAL MINERAL WATERS

polluted and no longer presents the microbiological characteristics laid down in

regulation 9, the person exploiting the spring must forthwith suspend all operations,

particularly the bottling process, until the cause of pollution is eradicated and the

water complies with the provisions of regulation 9.

4. The responsible authority in the country of origin shall carry out periodic

checks to see whether

(a) the natural mineral water in respect of which exploitation of the spring

has been authorized complies with Section I of the First Schedule;

(b)

the provisions of paragraphs 2 and 3 are being applied by the person

exploiting the spring.

These regulations implement the provisions of Council

Directive 80/777/EEC on the exploitation and marketing of natural

mineral waters, as amended by Council Directive 80/1276/EEC,

Council Directive 85/7/EEC, Directive 96/70/EC of the European

Parliament and of the Council, Regulation (EC) No 1882/2003 of

the European Parliament and of the Council, and Commission

Directive 2003/40/EC.

Indications and Criteria laid down in regulation 11.7

Indications

Criteria

Low mineral content

Mineral salt content, calculated as a fixed

residue, not greater than 500 mg/l

Very low mineral content

Mineral salt content, calculated as a fixed

residue, not greater than 50 mg/l

Rich in mineral salts

Mineral salt content, calculated as a fixed

residue, greater than 1500 mg/l

Contains bicarbonate

Bicarbonate content greater than 600 mg/l

Contains sulphate

Sulphate content greater than 200 mg/l

Contains chloride

Chloride content greater than 200 mg/l

Contains calcium

Calcium content greater than 150 mg/l

Contains magnesium

Magnesium content greater than 50 mg/l

Contains fluoride

Fluoride content greater than 1 mg/l

Contains iron

Bivalent iron content greater than 1 mg/l

Acidic

Free carbon dioxide content greater than 250

mg/l

Contains sodium

Sodium content greater than 200 mg/l

Suitable for the preparation of infant -

food

Suitable for a low-sodium diet

Sodium content less than 20 mg/l

May be laxative

-

May be diuretic

-

NATURAL MINERAL WATERS

1. These regulations concern waters extracted from the

gr ound of a Member State o f th e Eur opean Com mun ity an d

recognized by the responsible authority of that Member State as

natural mineral waters satisfying the provisions of Section I of the

First Schedule.

4.2 These regulations also concern waters extracted from the

ground of a third country, imported into the European Community

and recognized as natural mineral waters by the responsible

authority of a Member State.

4.3

These regulations shall not apply to

(a) to waters which are medicinal products, as defined in

the Medicines Act,

(b) to natural mineral waters used at source for curative

purposes in thermal or hydromineral establishments;

and

(c) to natural mineral waters intended for export to third

countries.

Constituents naturally present in natural rnineral waters and maximum limits

which, if exceeded, may pose a risk to human health

Constituents

Maximum limits (mg/l)

Antimony

0.0050

Arsenic

0.010 (as total)

Barium

1.0

Cadmium

0.003

Chromium

0.050

Copper

1.0

Cyanide

0.070

Fluorides

5.0

Lead

0.010

Manganese

0.50

Mercury

0.0010

Nickel

0.020

Nitrates

Nitrites

0.1

Selenium

0.010

NATURAL MINERAL WATERS

1. The waters referred to in regulation 4.2 may be so

recognized only if the responsible authority in the country of

extraction has certified that they satisfy Section I of the First

Schedule, and that regular checks are made on the application of

the provisions of paragraph 2 of the Second Schedule.

5.2 The validity of the certification referred to in regulation

5.1 shall be for a period of five years. It shall not be necessary to

repeat the recognition procedure referred to in regulation 4.2 if the

certification is renewed before the end of the said period.

5.3

The grounds for granting the recognition referred to in

r e g u la t io n s 4 .1 an d 4 .2 s h a l l b e s t at e d i n d u e f o r m b y t h e

responsible authority and shall be officially published in the

Gazette.

5.4 The responsible authority shall inform the European

Commission of the cases where the recognition referred to in

regulations 4.1 and 4.2 had been granted or withdrawn.

Performance characteristics * for analysing the constituents in the First Schedule

Constituents

Accuracy of

Precision of

Detection

Notes

parametric

parametric

Limit in % of

value in %

value (Note 2)

parametric

(Note 1)

value (Note 3)

Antimony

Arsenic

Barium

Cadmium

Chromium

Copper

Cyanides

Note 4

Fluorides

Lead

Manganese

Mercury

Nickel

Nitrates

Nitrites

Selenium

Only waters referred to in regulations 4.1 and 4.2 may be

marketed as natural mineral waters.

Maximum limits for residues from treatment of natural rnineral waters

and spring waters by ozone-enriched air

Maximum limit ( # ) (µ g/l)

Treatment residue

Dissolved ozone

Bromates

Bromoforms

# Compliance with the maximum limits is monitored by the competent authorities at the time of

bottling or other form of packaging intended for the final consumer.

*Analytical methods for measuring concentrations of the constituents listed in the First Schedule 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 the First

Schedule.

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

repeated measurernents 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.

Natural mineral water springs may be exploited and their

waters bottled only in accordance with the Second Schedule.

1. Natural mineral water, in its state at source, may not be the

subject of any treatment other than

(a) the separation of its unstable elements, such as iron

and sulphur compounds, by filtration or decanting,

possibly preceded by oxygenation, in so far as this

treatment does not alter the composition of the water

as regards the essential constituents which give it its

properties;

(b) the separation of iron, manganese and sulphur

compounds and arsenic from certain natural mineral

waters by treatment with ozone-enriched air in so far

as such treatment does not alter the composition of the

water as regards the essential constituents which give

it its properties, and provided that

(i)

the treatment complies with any conditions for

use which may be laid down in accordance with

the procedure laid down in Article 12 of Council

Directive 80/777/EEC,

(ii) the treatment is notified to, and specifically

controlled by, the competent authorities;

(c) the separation of undesirable constituents other than

those specified in paragraphs (a) or (b), in so far as

this treatment does not alter the composition of the

water as regards the essential constituents which give

it its properties, and provided that

(i)

the treatment complies with the conditions for

use to be laid down in accordance with the

procedure laid down in Article 12 of Council

Directive 80/777/EEC,

(ii) the treatment is notified to, and specifically

controlled by, the competent authorities;

(d) the total or partial elimination of free carbon dioxide

by exclusively physical methods.

8.2 Natural mineral water, in its state at source, may not be the

subject of any addition other than the introduction or the re-

introduction of carbon dioxide under the conditions laid down in

Section III of the First Schedule.

8.3

In particular, any disinfection treatment by whatever means

and, subject to regulation 8.2, the addition of bacteriostatic

elements or any other treatment likely to change the viable colony

count of the natural mineral water shall be prohibited.

8.4 Regulation 8.1 shall not constitute a bar to the utilization

of natural mineral waters and spring waters in the manufacture of

soft drinks.

1. The revivable total colony count of a natural mineral water

at source shall conform to its normal viable colony count and give

satisfactory evidence of the protection of the source against all

contamination. This total colony count shall be determined under

the conditions laid down in Section II of the First Schedule, point

1.3.3.

9.1.1 After bottling, the total colony count at source may

not exceed 100 per millilitre at 20 to 22ºC in 72 hours

on agaragar or an agar-gelatine mixture and 20 per

millilitre at 37ºC in 24 hours on agar-agar. The total

colony count shall be measured within the 12 hours

following bottling, the water being maintained at 4ºC

± 1ºC during this 12-hour period.

9.1.2 At source, these values should not normally exceed 20

per millilitre at 20 to 22ºC in 72 hours and 5 per

millilitre at 37ºC in 24 hours respectively, on the

understanding that they are to be considered as guide

figures and not as maximum permitted concentrations.

9.2 At source and during its marketing, a natural mineral water

shall be free from

(a) parasites and pathogenic micro-organisms;

(b) Escherichia coli and other coliforms and faecal

streptococci in any 250 ml sample examined;

(c) sporulated sulphite-reducing anaerobes in any 50 ml

sample examined;

(d) Pseudomonas aeruginosa in any 250 ml sample

examined.

9.3 Without prejudice to regulations 9.1 and 9.2 and the

conditions of exploitation laid down in the Second Schedule, at the

marketing stage

(a) the revivable total colony count of a natural mineral

water may only be that resulting from the normal

increase in the bacteria content which it had at source,

(b) the natural mineral water may not contain any

organoleptic defects.

Any container used for packaging natural mineral waters

shall be fitted with closures designed to avoid any possibility of

adulteration or contamination.

1. The sales description of natural mineral waters shall be

‘natural mineral water’ or, in the case of an effervescent natural

mineral water as defined in Section III of the First Schedule, as

appropriate, ‘naturally carbonated natural mineral water’, ‘natural

mineral water fortified with gas from the spring’ or ‘carbonated

natural mineral water’.

11.1.1 The sales description of natural mineral waters

which have undergone any of the treatments referred

to in regulation 8.1(d) shall have added to it as

appropriate the indication ‘fully decarbonated’ or

‘partially decarbonated’.

11.2 Labels on natural mineral waters shall also give the

following mandatory information

(a) a statement of the analytical composition, giving its

characteristic constituents;

(b) the place where the spring is exploited and the name of

the spring;

(c) information on any treatments referred to in regulation

8.1(b) and (c).

11.3 The name of a locality, hamlet or place may occur in the

wording of a trade description provided that it refers to a natural

mineral water the spring of which is exploited at the place indicated

by that description and provided that it is not misleading as regards

the place of exploitation of the spring.

11.4 It shall be forbidden to market natural mineral water from

one and the same spring under more than one trade description.

11.5 When the labels or inscriptions on the containers in which

the natural mineral waters are offered for sale include a trade

description different from the name of the spring or the place of its

exploitation, this place or the name of the spring shall be indicated

in letters at least one and a half times the height and width of the

largest of the letters used for that trade description.

11.5.1 The first subparagraph shall apply, mutatis mutandis

and with the same intention as regards the importance

attributed to the name of the spring or the place of its

exploitation, with regard to the trade description used

in advertising, in whatsoever form, relating to natural

mineral waters.

11.6 It shall be forbidden, both on packaging or labels and in

advertising in whatsoever form, to use designations, proprietary

names, trade marks, brand names, illustrations or other signs,

whether emblematic or not, which

(a) in the case of a natural mineral water, suggest a

characteristic which the water does not possess, in

particular as regards its origin, the date of the

authorization to exploit it, the results of analyses or

any similar references to guarantees of authenticity;

(b) in the case of drinking water packaged in containers

which does not satisfy the provisions of Section I of

the First Schedule, are liable to cause confusion with a

natural mineral water, in particular the description

‘mineral water’.

11.7 All indications attributing to natural mineral water

properties relating to the prevention, treatment or cure of a human

illness shall be prohibited.

11.7.1 However, the indications listed in the Third Schedule

shall be authorized if they meet the relevant criteria

laid down in that Schedule or, in the absence thereof,

criteria laid down in national provisions and provided

that they have been drawn up on the basis of physico-

chemical

analyses

and,

where

necessary,

pharmacological,

physiological

and

clinical

examinations carried out according to recognized

scientific methods, in accordance with Section I,

paragraph 2 of the First Schedule.

11.7.2 The indications ‘stimulates digestion’, ‘may

facilitate the hepato-biliary functions’ or similar

indications are authorized. The Food Safety

Commission may also authorize the inclusion of other

indications, provided that the latter do not conflict

with the principles stated in regulation 11.7 and are

compatible with those stated in subregulation 11.7.1.

11.8 The term ‘spring water’ shall be reserved for a water which

is intended for human consumption in its natural state, and bottled

at source, which

(a) satisfies the conditions of exploitation laid down in the

Second Schedule, paragraphs 2 and 3, which shall be

fully applicable to spring waters,

(b) satisfies the microbiological requirements laid down in

regulation 9,

(c) satisfies the labelling requirements of regulation

11.2(b) and (c) and regulations 11.3 to 11.5,

(d) has not undergone any treatment other than those

referred to in regulation 8.

In addition, spring waters shall comply with other

provisions relating to the quality of water intended for human

consumption.

1. Where the Food Safety Commission has detailed grounds

for considering that a natural mineral water does not comply with

the provisions laid down in these regulations, or endangers public

health, albeit freely circulating in one or more Member States, it

may temporarily restrict or suspend trade in that product within

Malta. It shall immediately inform the European Commission and

the other Member States thereof and give reasons for its decision.

12.2 At the request of any Member State or the European

Commission, the Food Safety Com mission shall provide all

relevant information concerning recognition of the water, together

with the results of the regular checks.

1. By the 1 st January, 2006 at the latest, natural mineral waters

s hall , at th e tim e o f pack ag ing , co mp ly wit h t he m ax im um

co ncen tr atio n lim its s et o ut in the Fou r th Sch edu le f o r t he

constituents listed in that Schedule.

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

referred to above is extended until the 1 st January, 2008.

For the purposes of official controls, the specifications

listed in the Fifth Schedule for analysing the constituents listed in

the Fourth Schedule shall apply.

1. Natural mineral waters with a fluoride concentration

exceeding 1.5 mgcl shall bear on the label the words ‘contains more

than 1.5 mg/l of fluoride: not suitable for regular consumption by

infants and children under 7 years of age’.

15.2 The label information laid down in regulation 15.1 shall be

placed in immediate proximity to the trade name and in clearly

visible characters.

15.3 Natural mineral waters which, under the terms of

regulation 15.1, 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 regulation 11.2.

1. Without prejudice to the provisions of regulation 8.1(b),

application of the treatment of natural mineral waters with ozone-

enriched air must be n otif ied in ad van ce to the responsible

authority, which shall ensure that

(a) use of such treatment is justified by the composition of

the water in terms of compounds of iron, manganese,

sulphur and arsenic;

(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 responsible authority.

16.2 Ozone-enriched air treatment of natural mineral waters

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 modified by the treatment;

(b) the natural mineral water before treatment must

comply with the microbiological criteria laid down in

regulations 9.1 and 9.2;

(c) the treatment shall not lead to the formation of

residues with a concentration exceeding the maximum

limits laid down in the Sixth Schedule or residues

which could pose a risk to public health.

16.3 Pursuant to regulation 11.2(c), the labelling of natural

mineral waters which have been treated with ozone-enriched air

s h a l l b e a r, i n p r o x i m i t y t o t h e a n a l y t i c a l c o m p o s i t i o n o f

characteristic constituents, the words ‘water subjected to an

authorised ozone-enriched air oxidation technique’.

16.4 The provisions of this regulation shall apply to spring

waters.

The Directorate responsible for foodstuffs within the Malta

Standards Authority is designated as the responsible authority for

the recognition of natural mineral waters.

NATURAL MINERAL WATERS

5ºC;

(b) absence of faecal streptococci in 250 ml;

(c)

absence of sporulated sulphite-reducing anaerobes in 50 ml;

(d) absence of Pseudomonas aeruginosa in 250 ml.

1.3.3. determination of the revivable total colony count per ml of water

(i)

at 20 to 22ºC in 72 hours on agar-agar or an agar-gelatine mixture,

(ii)

at 37ºC in 24 hours on agar-agar.

1.4. Requirements for clinical and pharmacological analyses

1.4.1. The analyses, which must be carried out in accordance with scientifically

recognized methods, should be suited to the particular characteristics of the natural

mineral water and its effects on the human organism, such as diuresis, gastric and

intestinal fimctions, compensation for mineral deficiencies.

1.4.2. The establishment of the consistency and concordance of a substantial

number of clinical observations may, if appropriate, take the place of the analyses

referred to in 1 .4.1. Clinical analyses may, in appropriate cases, take the place of the

analyses referred to in 1 .4.1 provided that the consistency and concordance of a

substantial number of observations enable the same results to be obtained.

III.

SUPPLEMENTARY QUALIFICATIONS RELATING TO EFFERVESCENT

NATURAL MINERAL WATERS

NATURAL MINERAL WATERS

At source or after bottling, effervescent natural mineral waters give off carbon

dioxide spontaneously and in a clearly visible manner under normal conditions of

temperature and pressure. They fall into three categories to which the following

descriptions respectively shall apply

(a) ‘naturally carbonated natural mineral water’ means water whose content

of carbon dioxide from the spring after decanting, if any, and bottling is

the same as at source, taking into account where appropriate the

reintroduction of a quantity of carbon dioxide from the same water table

or deposit equivalent to that released in the course of those operations

and subject to the usual technical tolerances;

(b) ‘natural mineral water fortified with gas from the spring’ means water

whose content of carbon dioxide from the water table or deposit after

decanting, if any, and bottling is greater than that established at source;

(c) ‘carbonated natural mineral water’ means water to which has been

added carbon dioxide of an origin other than the water table or deposit

from which the water comes.