Natural Mineral Waters Regulations, 2004

L.N. 343 of 2004

FOOD SAFETY ACT

(CAP. 449)

Natural Mineral Waters Regulations, 2004

IN exercise of the powers conferred by article 10 of the Food Safety

Act, the Minister of Health, the Elderly and Community Care has made

the following regulations:-

The title of these regulations is the Natural Mineral Waters Citation and

commencement

Regulations, 2004.

These regulations shall enter into force on the 1 st July, 2004,

provided that

(a) products which comply with these regulations may be

marketed prior to that date;

(b) products packaged and labelled prior to the 1 st July, 2004

may be sold until stocks are exhausted.

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.

1 These regulations concern waters extracted from the ground Scope and

applicability

of a Member State of the European Community and 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.

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

regulations 4.1 and 4.2 shall be stated in due form by the 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.

Only waters referred to in regulations 4.1 and 4.2 may be

marketed as natural mineral waters.

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 (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 reintroduction

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 Microbiological

parameters.

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 22 ∫C in 72 hours on agar-

agar or an agar-gelatine mixture and 20 per millilitre at 37 ∫C in 24

hours on agar-agar. The total colony count shall be measured within

the 12 hours following bottling, the water being maintained at 4

∫C ± 1 ∫C during this 12-hour period.

9.1.2 At source, these values should not normally exceed

20 per millilitre at 20 to 22 ∫C in 72 hours and 5 per millilitre at 37

∫C 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 de-

carbonated’ 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

to these regulations 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 Temporary

restrictions on

for considering that a natural mineral water does not comply with the marketing.

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 Commission 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 Maximum

concentration limits.

shall, at the time of packaging, comply with the maximum concentration

limits set out in the Fourth Schedule for the 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 Specifications for

official controls.

in the Fifth Schedule for analysing the constituents listed in the Fourth

Schedule shall apply.

1 Natural mineral waters with a fluoride concentration Waters containing

fluoride.

exceeding 1.5 mg/l 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), Treatment with

ozone-enriched air.

application of the treatment of natural mineral waters with ozone-

enriched air must be notified in advance 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 shall

bear, in proximity to the analytical composition of 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.

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Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press