Official Journal L 229 , 30/08/1980 p. 0001 - 0010
Greek special edition ....: Chapter 13 Volume 9 p. 132
Spanish special edition...: Chapter 13 Volume 11 p. 47
Portuguese special edition Chapter 13 Volume 11 p. 47
Finnish special edition....: Chapter 13 Volume 10 p. 226
Swedish special edition...: Chapter 13 Volume 10 p. 226
Amendments:
Amended by 185I
Amended by 385L0007
(OJ L 002 03.01.1985 p.22)
Incorporated by 294A0103(52)
(OJ L 001 03.01.1994 p.263)
Amended by 396L0070
(OJ L 299 23.11.1996 p.26)
Text:
COUNCIL DIRECTIVE of 15 July 1980 on the approximation
of the laws of the Member States relating to the exploitation and marketing
of natural mineral waters (80/777/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community, and
in particular Article 100 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas the laws of the Member States define natural mineral waters ; whereas
differing definitions are adopted in this connection within the Community ;
whereas these laws lay down the terms on which natural mineral waters are recognized
as such and govern the conditions for exploiting the springs ; whereas they
furthermore stipulate specific rules for marketing the waters in question;
Whereas the differences between these laws hinder the free movement of the natural
mineral waters, creating disparate competitive situations, and consequently
directly affect the establishing and functioning of the common market;
Whereas, in this particular case, the elimination of these barriers may be achieved
both by an obligation on each Member State to allow the marketing in its territory
of the natural mineral waters recognized as such by each of the other member
States and by laying down common rules concerning in particular the microbiological
requirements to be fulfilled and the conditions in which specific names must
be used for certain of the mineral waters;
Whereas, pending the conclusion of agreements on mutual recognition of natural
mineral waters between the Community and third countries, the terms should be
laid down on which, until implementation of the said agreements, similar products
imported from third countries may be allowed to enter the Community as natural
mineral waters,
Whereas care should be taken to ensure that natural mineral waters retain at
the marketing stage those characteristics which enabled them to be recognized
as such ; whereas, therefore, the containers used for packaging them should
have suitable closures;
Whereas, in respect of labelling, natural mineral waters are subject to the
general rules laid down by Council Directive 79/112/EEC of 18 December 1978
on the approximation of the laws of the Member States relating to the labelling,
presentation and advertising of (1)OJ No C 69, 11.6.1970, p. 14. (2)OJ No C
45, 10.5.1971, p. 5. (3)OJ No C 36, 19.4.1971, p. 14. foodstuffs for sale to
the ultimate consumer (1) ; whereas, accordingly, this Directive may be limited
to laying down the additions and derogations which should be made to those general
rules;
Whereas, in order to simplify and speed up the procedure, the Commission should
be entrusted with the task of adopting technical implementing measures, and
in particular defining the procedure for taking samples and the methods of analysis
necessary to check the composition of natural mineral waters;
Whereas, in all cases in which the Council entrusts the Commission with responsibility
for implementing rules laid down concerning foodstuffs intended for human consumption,
provision should be made for a procedure establishing close cooperation between
the Member States and the Commission within the Standing Committee for Foodstuffs,
set up by Decision 69/414/EEC (2),
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. This Directive concerns waters extracted from the ground of a Member State
and recognized by the responsible authority of that Member State as natural
mineral waters satisfying the provisions of Annex I, Section I.
2. This Directive also concerns waters extracted from the ground of a third
country, imported into the Community and recognized as natural mineral waters
by the responsible authority of a Member State.
The waters referred to in the first subparagraph may be so recognized only if
the responsible authority in the country of extraction has certified that they
satisfy Annex I, Section I, and that regular checks are made on the application
of the provisions of Annex II, paragraph 2.
The validity of the certification referred to in the second subparagraph may
not exceed a period of two years. It shall not be necessary to repeat the recognition
procedure referred to in the first subparagraph if the certification is renewed
before the end of the said period.
3. This Directive shall not apply: - to waters which are medicinal products
within the meaning of Directive 65/65/EEC (3),
- to natural mineral waters used at source for curative purposes in thermal
or hydromineral establishments.
4. The grounds for granting the recognition referred to in paragraphs 1 and
2, shall be stated in due form by the responsible authority of the Member State
and shall be officially published.
5. Each Member State shall inform the Commission of the cases where the recognition
referred to in paragraphs 1 and 2 has been granted or withdrawn. The list of
natural mineral waters so recognized shall be published in the Official Journal
of the European Communities.
Article 2
Member States shall take the measures necessary to ensure that only the waters
referred to in Article 1 which comply with the provisions of this Directive
may be marketed as natural mineral waters.
Article 3
Natural mineral water springs may be exploited and their waters bottled only
in accordance with Annex II.
Article 4
1. Natural mineral water, in its state at source, may not be the subject of
any treatment or addition 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 total or partial elimination of free carbon dioxide by exclusively physical
methods;
(c) the introduction or the reintroduction of carbon dioxide under the conditions
laid down in Annex I, Section III;
2. In particular any disinfection treatment by whatever means and, subject to
paragraph 1 (c), the addition of bacteriostatic elements or any other treatment
likely to change the viable colony count of the natural mineral water shall
be prohibited.
3. Paragraph 1 shall not constitute a bar to the utilization of natural mineral
water in the manufacture of soft drinks. (1)OJ No L 33, 8.2.1979, p. 1. (2)OJ
No L 291, 19.11.1969, p. 9. (3)OJ No 22, 9.2.1965, p. 369/65.
Article 5
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 Annex I, Section II, point
1.3.3.
After bottling, the total colony count at source may not exceed 100 per millilitre
at 20 to 22 șC in 72 hours on agar-agar or an agar-gelatine mixture and 20 per
millilitre at 37 șC 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 șC ± 1 șC during this 12-hour period.
At source, these values should not normally exceed 20 per millilitre at 20 to
22 șC in 72 hours and 5 per millilitre at 37 șC in 24 hours respectively, on
the understanding that they are to be considered as guide figures and not as
maximum permitted concentrations.
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.
3. Without prejudice to paragraphs 1 and 2 and the conditions of exploitation
laid down in Annex II, at the marketing stage: - 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,
- the natural mineral water may not contain any organoleptic defects.
Article 6
Any containers used for packaging natural mineral waters shall be fitted with
closures designed to avoid any possibility of adulteration or contamination.
Article 7
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
Annex I, Section III, as appropriate, "naturally carbonated natural mineral
water", "natural mineral water fortified with gas from the spring" or "carbonated
natural mineral water".
The sales description of natural mineral waters which have undergone any of
the treatments referred to in Article 4 (1) (b) shall have added to it as appropriate
the indication "fully de-carbonated" or "partially de-carbonated".
2. Labels on natural mineral waters shall also give the following mandatory
information: (a) - either the words : "composition in accordance with the results
of the officially recognized analysis of ... (date of analysis)",
- or a statement of the analytical composition giving its characteristic constituents;
(b) the place where the spring is exploited and the name of the spring.
3. Member States may also: (a) retain the provisions which require the country
of origin to be indicated, although this information cannot be demanded in the
case of natural mineral waters from a spring in the territory of the Community;
(b) introduce provisions which require information on any treatments referred
to in Article 4 (1) (a).
Article 8
1. 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.
2. It shall be forbidden to market natural mineral water from one and the same
spring under more than one trade description.
3. 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.
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.
Article 9
1. 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 of drinking water packaged in containers which does not satisfy the
provisions of Annex I, Section I, are liable to cause confusion with a natural
mineral water, in particular the description "mineral water".
2. (a) All indications attributing to a natural mineral water properties relating
to the prevention, treatment or cure of a human illness shall be prohibited.
(b) However, the indications listed in Annex III to this Directive shall be
authorized if they meet the relevant criteria laid down in that Annex 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 Annex I.
(c) Member States may authorize the indications "stimulates digestion", "may
facilitate the hepato-biliary functions" or similar indications. They may also
authorize the inclusion of other indications, provided that the latter do not
conflict with the principles stated in (a) and are compatible with those stated
in (b).
3. Member States may adopt special provisions regarding information - both on
packaging or labels and in advertising - concerning the suitability of a natural
mineral water for the feeding of infants. Such provisions may also concern the
properties of the water which determine the use of the said information.
Member States which intend taking such measures shall inform the other Member
States and the Commission of them beforehand.
4. Not later than three years after notification of this Directive, the Commission
shall submit to the Council a report and, where appropriate, suitable proposals
on the application of the provisions referred to in 1.2.12 of Annex I, Section
II.
Article 10
1. Member States shall adopt the measures necessary to ensure that trade in
natural mineral waters which comply with the definitions and rules laid down
in this Directive cannot be impeded by the application of non-harmonized national
provisions governing the properties, composition, conditions of exploitation,
packaging or labelling of natural mineral waters or foodstuffs in general.
2. Paragraph 1 shall not be applicable to non-harmonized national provisions
justified on grounds of: - protection of public health,
- prevention of fraud, unless such provisions are likely to impede the application
of the definitions and rules laid down by this Directive,
- protection of industrial and commercial property, indications of source, designations
of origin and the prevention of unfair competition.
Article 11
The sampling procedures and the methods of analysis necessary for checking the
microbiological characteristics referred to in Article 5 and the compositional
characteristics referred to in 1.2 of Annex I, Section II, shall be determined
in accordance with the procedure laid down in Article 12.
Article 12
1. Where the procedure laid down in this Article is to be followed, the matter
shall be referred to the Standing Committee on Foodstuffs, hereinafter called
"the Committee", by its Chairman, either on his own initiative or at the request
of the representative of a Member State.
2. The Commission representative shall submit a draft of the measures to be
taken to the Committee. The Committee shall deliver its opinion on that draft
within a time limit set by the chairman having regard to the urgency of the
matter. Opinions shall be arrived at by a majority of 41 votes, the votes of
the Member States being weighted in accordance with Article 148 (2) of the Treaty.
The chairman shall not vote.
3. (a) Where the measures envisaged are in accordance with the opinion of the
Committee the Commission shall adopt them;
(b) where the measures envisaged are not in accordance with the opinion of the
Committee, or if no opinion is delivered, the Commission shall forthwith submit
to the Council a proposal on the measures to be taken. The Council shall act
by a qualified majority;
(c) if within three months of the matter being brought before it the Council
has not acted, the measures proposed shall be adopted by the Commission.
Article 13
Article 12 shall apply for a period of 18 months from the date on which the
matter was first referred to the Committee under Article 12 (1).
Article 14
This Directive shall not apply to natural mineral waters intended for export
to third countries.
Article 15
Member States shall make such amendments to their laws as may be necessary to
comply with this Directive and shall forthwith inform the Commission thereof
; the laws thus amended shall be applied in such a way as to: - permit trade
in products complying with this Directive not later than two years after its
notification,
- prohibit trade in products not complying with this Directive four years after
its notification.
Article 16
This Directive shall also apply to the overseas departments of the French Republic.
Article 17
This Directive is addressed to the Member States.
Done at Brussels, 15 July 1980.
For the Council
The President
J. SANTER
ANNEX I
I. DEFINITION
1. "Natural mineral water" means microbiologically wholesome water, within the
meaning of Article 5, 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 elements
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, chemical 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 methods approved by the responsible authority.
The analyses referred to in (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 this Directive. 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 Article 5 (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 indication 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.
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 180 șC and 260 șC;
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;
>PIC FILE= "T0013777"> 1.2.12. the toxicity of certain constitutent 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 37 șC and 44 75 șC;
(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 22 șC in 72 hours on agar-agar or an agar-gelatine mixture,
(ii) at 37 șC 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
functions, 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
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.
ANNEX II CONDITIONS FOR THE EXPLOITATION AND MARKETING OF NATURAL MINERAL WATER
1. 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 point 1 of Annex I.
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, point (d) need not be applied to mineral waters exploited and marketed
in the territory of a Member State if, in that Member State at the time of notification
of this Directive, 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 polluted
and no longer presents the microbiological characteristics laid down in Article
5, 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 Article 5.
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 Annex I;
(b) the provisions of paragraphs 2 and 3 are being applied by the person exploiting
the spring.
ANNEX III INDICATIONS AND CRITERIA LAID DOWN IN ARTICLE 9 (2)
>PIC FILE= "T0013592">
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