CELEX: 51980FC0777
Language: en
Date: 2007-02-16
Title: Proposal for a Directive …/…/EC of the European Parliament and of the Council of […] relating to the exploitation and marketing of natural mineral waters (Codified version)

EN

|[pic]                     |COMMISSION OF THE EUROPEAN COMMUNITIES                                                                           |

                                        Brussels,
                                        COM

                                                                  Proposal for a

                                          DIRECTIVE …/…/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

                                                                      of […]

                                       relating to the exploitation and marketing of natural mineral waters

                                                                (Codified version)

                                                              EXPLANATORY MEMORANDUM

1.    In the context of a people’s Europe, the Commission attaches great importance to simplifying and clarifying Community law so as to make  it
       clearer and more accessible to the ordinary citizen, thus giving him new opportunities and the chance to make use of the  specific  rights
       it gives him.

       This aim cannot be achieved so long as numerous provisions that have  been  amended  several  times,  often  quite  substantially,  remain
       scattered, so that they must be sought partly in the original instrument and partly in later amending ones.  Considerable  research  work,
       comparing many different instruments, is thus needed to identify the current rules.

       For this reason a codification of rules that have frequently been amended  is  also  essential  if  Community  law  is  to  be  clear  and
       transparent.

2.    On 1 April 1987 the Commission therefore decided[1] to instruct its staff that all legislative acts should be codified after no  more  than
       ten amendments, stressing that this is a minimum requirement and that departments should endeavour to codify at even shorter intervals the
       texts for which they are responsible, to ensure that the Community rules are clear and readily understandable.

3.    The Conclusions of the Presidency of the Edinburgh  European  Council  (December 1992)  confirmed  this[2],  stressing  the  importance  of
       codification as it offers certainty as to the law applicable to a given matter at a given time.

       Codification must be undertaken in full compliance with the normal Community legislative procedure.

       Given that no changes of substance may be made to the instruments affected by codification, the European Parliament, the Council  and  the
       Commission have agreed, by an interinstitutional agreement dated 20 December 1994, that an accelerated procedure may be used for the fast-
       track adoption of codification instruments.

4.    The purpose of this proposal is to undertake a codification of Council Directive 80/777/EEC of 15 July 1980 on  the  approximation  of  the
       laws of the Member States relating to the exploitation and marketing of natural mineral waters[3]. The new Directive  will  supersede  the
       various acts incorporated in it[4]; this proposal fully preserves the content of the acts being codified and hence does no more than bring
       them together with only such formal amendments as are required by the codification exercise itself.

       5.   The codification proposal was drawn up on the basis  of  a  preliminary  consolidation,  in  all  official  languages,  of  Directive
       80/777/EEC and the instruments amending it, carried out by the Office for Official Publications of the European Communities, by means of a
       data-processing system. Where the Articles have been given new numbers, the correlation between the old and the new numbers is shown in  a
       table contained in Annex V to the codified Directive.

                                            ê 80/777/EEC (adapted)

                                                                  Proposal for a

                                          DIRECTIVE …/…/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

                                                                      of […]

                                       relating to the exploitation and marketing of natural mineral waters

                                                            (Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article Ö 95 Õ thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee[5],

Acting in accordance with procedure laid down in Article 251 of the Treaty[6],

Whereas:

                                            ê .

   1) Council Directive 80/777/EEC of 15 July 1980 on the approximation of the laws of  the  Member  States  relating  to  the  exploitation  and
      marketing of natural mineral waters[7] has been substantially amended several times[8]. In the interests of  clarity  and  rationality  the
      said Directive should be codified.

                                            ê 80/777/EEC recital 1

   2) The laws of the Member States define natural mineral waters. Differing definitions are adopted in this  connection  within  the  Community.
      These laws lay down the terms on which natural mineral waters are recognized as such and govern the conditions for exploiting the  springs.
      They furthermore stipulate specific rules for marketing the waters in question.

                                            ê 80/777/EEC recital 2 (adapted)

   3) The differences between these laws hinder the free movement of the natural mineral waters, creating disparate competitive  situations,  and
      consequently directly affect the functioning of the Ö internal Õ market.

                                            ê 80/777/EEC recital 3

   4) 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.

                                            ê 96/70/EC recital 2

   5) The primary purposes of any rules on natural mineral waters should be to protect the health of consumers, to prevent consumers  from  being
      misled and to ensure fair trading.

                                            ê 80/777/EEC recital 4

   6) 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.

                                            ê 80/777/EEC recital 5

   7) 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. Therefore, the containers used for packaging them should have suitable closures.

                                            ê 80/777/EEC recital 6

   8) In respect of labelling, natural mineral waters are subject to the general  rules  laid  down  by  Directive  2000/13/EC  of  the  European
      Parliament and of the Council of 20March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation
      and advertising of foodstuffs [9]. Accordingly, this Directive may be limited to laying down the additions and derogations which should  be
      made to those general rules.

                                            ê 96/70/EC recital 6 (adapted)

   9) The inclusion of the statement of the analytical composition of a natural mineral water should  be  compulsory  in  order  to  ensure  that
      consumers are informed.

                                            ê .

  10) The measures necessary for the implementation of this Directive should be adopted in accordance with Council  Decision  1999/468/EC  of  28
      June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission[10].

  11) This Directive should be without prejudice to the obligations of the Member States relating  to  the  time-limits  for  transposition  into
      national law of the acts set out in Annex IV, Part C,

                                            ê 80/777/EEC

HAVE 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, point 2.

                                            ê 96/70/EC Art. 1 pt. 1

The validity of the certification referred to in the second subparagraph may not exceed a period of five 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.

                                            ê 80/777/EEC

3. This Directive shall not apply:

(a)   to waters which are medicinal products within the meaning of Directive 2001/83/EC of the European Parliament and of the Council[11];

(b)   to natural mineral waters used at source for curative purposes in thermal or hydromineral establishments.

                                            ê 80/777/EEC

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 Union.

                                                                    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.

                                            ê 96/70/EC Art. 1 pt. 2

                                                                    Article 4

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 the conditions for use to be laid down in accordance with the procedure referred to in Article 14(2)  and
           following consultation of the European Food Safety Authority;

       (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 referred to in Article 14(2)  and
           following consultation of the European Food Safety Authority;

       (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.

                                            ê 96/70/EC Art. 1 pt. 2 (adapted)

Ö The first subparagraph Õ shall not constitute a bar to the utilization of natural mineral waters and spring waters in the manufacture  of  soft
drinks.

                                            ê 96/70/EC Art. 1 pt. 2

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 Annex I, Section III.

                                            ê 96/70/EC Art. 1 pt. 2 (adapted)

3. Any disinfection treatment by whatever means and, subject to paragraph 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.

                                            ê 80/777/EEC

                                                                    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 point 1.3.3 of Section II of Annex I.

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.

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.

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:

(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.

                                                                    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».

                                            ê 80/777/EEC (adapted)

The sales description of natural mineral waters which have undergone any of the treatments referred to in Ö point (d) of the  first  subparagraph
of Article 4(1), Õ shall have added to it as appropriate the indication «fully de-carbonated» or «partially de-carbonated».

                                            ê 96/70/EC Art. 1 pt. 3

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 points (b) and (c) of the first subparagraph of Article 4(1).

                                            ê 96/70/EC Art. 1 pt. 3 (adapted)

3. In the absence of Community provisions on information on any treatments referred to in point (c) of paragraph 2, Member  States  may  maintain
Ö their Õ national Ö provisions Õ.

                                            ê 80/777/EEC

                                                                    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.

                                            ê 80/777/EEC (adapted)

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 Ö of exploitation Õ  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.

                                            ê 80/777/EEC

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 case 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. All indications attributing to a natural mineral water properties relating to the prevention, treatment or cure of a human  illness  shall  be
prohibited.

                                            ê 80/777/EEC (adapted)

However, the indications listed in Annex III 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 point 2 of Section I of Annex I.

                                            ê 80/777/EEC

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  the  first
subparagraph and are compatible with those stated in the second subparagraph.

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.

                                            ê 96/70/EC Art. 1 pt. 5

4. 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 Annex II, points 2 and 3, which shall be fully applicable to spring waters;

(b)   satisfies the microbiological requirements laid down in Article 5;

(c)   satisfies the labelling requirements of Article 7(2)(b) and (c) and Article 8;

(d)   has not undergone any treatment other than those referred to in Article 4. Other treatments  may  be  authorized  in  accordance  with  the
       procedure referred to in Article 14(2).

In addition, spring waters shall comply with the provisions of Council Directive98/83/EC[12].

                                            ê 96/70/EC Art. 1 pt. 5 (adapted)

5. In the absence of Community provisions on the treatment for spring waters referred to in point (d) of the first subparagraph of  Article  9(4)
Member States may maintain Ö their Õ national provisions on the treatments.

                                            ê 80/777/EEC

                                                                    Article 10

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.

                                            ê 96/70/EC Art. 1 pt. 7

                                                                    Article 11

1. Where a Member State has detailed grounds for considering that a natural mineral water does not comply with the provisions laid down  in  this
Directive, or endangers public health, albeit freely circulating in one or more Member States, that Member  State  may  temporarily  restrict  or
suspend trade in that product within its territory. It shall immediately inform the Commission and the  other  Member  States  thereof  and  give
reasons for its decision.

2. At the request of any Member State or the Commission, the Member State which has recognized the water shall provide all  relevant  information
concerning recognition of the water, together with the results of the regular checks.

3. The Commission shall examine as soon as possible the grounds adduced by the Member State referred  to  in  paragraph  1  within  the  Standing
Committee referred to in Article 14(1), and shall then deliver its opinion forthwith and take appropriate measures.

4. If the Commission considers that amendments to this Directive are necessary in order to ensure the  protection  of  public  health,  it  shall
initiate the procedure referred to in Article 14(2), with a view to adopting those amendments. The  Member  State  which  has  adopted  safeguard
measures may, in that event, retain them until the amendments have been adopted.

                                            ê 96/70/EC Art. 1 pt. 8

                                                                    Article 12

1. The following shall be adopted in accordance with the procedure referred to in Article 14(2):

(a)   limits for the levels of constituents of natural mineral waters;

(b)   any necessary provisions for the indication on the labelling of high levels of certain constituents;

(c)   the conditions of use of ozone-enriched air referred to in point (b) of the first subparagraph of Article 4(1);

(d)   the information on the treatments referred to in point (c) of Article 7(2)

2. The following may be adopted in accordance with the procedure referred to in Article 14(2):

(a)   methods of analysis, including limits of detection, to determine the absence of pollution of natural mineral waters;

(b)   the sampling procedures and the methods of analysis necessary for checking the microbiological characteristics of natural mineral waters.

                                            ê 96/70/EC Art. 1 pt. 9

                                                                    Article 13

Any decision likely to have an effect on public health shall be adopted by the Commission following consultation  of  the  European  Food  Safety
Authority.

                                            ê 1882/2003 Art. 3 and Annex III pt. 4

                                                                    Article 14

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health, set up by Article 58  of  Regulation  (EC)  No
178/2002 of the European Parliament and of the Council[13], hereinafter referred to as “the Committee”.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article  8
thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. The Committee shall adopt its rules of procedure.

                                            ê 80/777/EEC

                                                                    Article 15

This Directive shall not apply to natural mineral waters intended for export to third countries.

                                            ê .

                                                                    Article 16

Directive 80/777/EEC, as amended by the acts listed in Annex IV, is repealed, without prejudice to the obligations of the Member States  relating
to the time-limits for transposition into national law of the acts set out in Annex IV, Part C.

References to the repealed Directive shall be construed as references to this Directive and shall be read  in  accordance  with  the  correlation
table in Annex V

                                                                    Article 17

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

                                            ê 80/777/EEC

                                                                    Article 18

This Directive is addressed to the Member States.

Done at Brussels, […]

For the European Parliament  For the Council
The President    The President
[…]   […]

                                            ê 80/777/EEC

                                                                     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.

                                            ê 80/777/EEC (adapted)

2.    Ö The Õ characteristics Ö referred to in point 1 Õ, which may give natural mineral water properties favourable to health, shall  have  been
       assessed:

       (a)  from the following points of view:

           i)    geological and hydrological;

           ii)   physical, chemical and physico-chemical;

           iii)  microbiological;

           iv)   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.

                                            ê 80/777/EEC

      The analyses referred to in point (a)(iv)  of  the  first  subparagraph  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 shall remain stable within the limits of  natural
       fluctuation; in particular, they shall 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 shall 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 °C and 260 °C;

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 shall 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 °C and 44·5 °C;

       (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:

       (a)  at 20 to 22 °C in 72 hours on agar-agar or an agar-gelatine mixture,

       (b)  at 37 °C in 24 hours on agar-agar.

1.4.  Requirements for clinical and pharmacological analyses

1.4.1.      The analyses, which shall 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.

                                                                     ________

                                            ê 80/777/EEC (adapted)

                                                                     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 Ö Section I Õ
       of Annex I.

                                            ê 80/777/EEC

2.    Equipment for exploiting the water shall 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.

                                            ê 80/777/EEC

      To this end, in particular:

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

       (b)  the catchment, pipes and reservoirs shall 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, shall meet  hygiene  requirements.  In  particular,  the
           containers shall 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 shall 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.

                                            ê 80/777/EEC (adapted)

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 Ö points Õ 2 and 3 are being applied by the person exploiting the spring.

                                                                     ________

                                            ê 80/777/EEC

                                                                    ANNEX III

                                                INDICATIONS AND CRITERIA LAID DOWN IN ARTICLE 9(2)

|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       |
|                                                                |1 500 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                                                 |—                                                                       |

                                                                     ________

                                            é

                                                                     ANNEX IV

                                                                      Part A

                                                Repealed Directive with its successive amendments
                                                           (referred to in Article 16)

|Council Directive 80/777/EEC                                                  |                                                     |
|(OJ L 229, 30.8.1980, p. 1)                                                   |                                                     |
|Council Directive 80/1276/EEC                                                  |Article 1, third indent only                         |
|(OJ L 375, 31.12.1980, p. 77)                                                  |                                                     |
|Council Directive 85/7/EEC                                                     |Article 1, point 10 only                             |
|(OJ L 2, 3.1.1985, p. 22)                                                      |                                                     |
|Directive 96/70/EC of the European Parliament and of the Council               |                                                     |
|(OJ L 299, 23.11.1996, p. 26)                                                  |                                                     |
|Regulation (EC) No 1882/2003 of the European Parliament and of the Council     |Annex III, point 4 only                              |
|(OJ L 284, 31.10.2003, p. 1)                                                   |                                                     |

                                                                      Part B

                                                              Non-repealed amendment

                                                           (referred to in Article 16)

|1985 Act of Accession                                                                                                                    |

                                                                      Part C

                                             List of time-limits for transposition into national law
                                                           (referred to in Article 16)

|Directive                 |Time-limit for          |Permission of trade in products       |Prohibition of trade in products not    |
|                          |transposition           |complying with this Directive         |complying with this Directive           |
|80/777/EEC                |-                       |18 July 1982                          |18 July 1984                            |
|80/1276/EEC               |-                       |-                                     |-                                       |
|85/7/EEC                  |-                       |-                                     |-                                       |
|96/70/EC                  |-                       |28 October 1997                       |28 October 1998[14]                     |
|1882/2003                 |-                       |-                                     |-                                       |

                                                                  _____________

                                                                     ANNEX V

                                                                Correlation Table

|Directive 80/777/EEC                                                 |This Directive                                                       |
|Article 1(1)                                                         |Article 1(1)                                                         |
|Article 1(2)                                                         |Article 1(2)                                                         |
|Article 1(3), first and second indents                               |Article 1(3)(a) and (b)                                              |
|Article 1(4)                                                         |Article 1(4)                                                         |
|Article 1(5)                                                         |Article 1(5)                                                         |
|Article 2                                                            |Article 2                                                            |
|Article 3                                                            |Article 3                                                            |
|Article 4(1)(a)                                                      |Article 4(1)(a)                                                      |
|Article 4(1)(b), first and second indents                            |Article 4(1), first subparagraph, (b)(i) and (ii)                    |
|Article 4(1)(c), first and second indents                            |Article 4(1), first subparagraph, (c)(i) and (ii)                    |
|Article 4(1)(d)                                                      |Article 4(1), first subparagraph, (d)                                |
|Article 4(2)                                                         |Article 4(2)                                                         |
|Article 4(3)                                                         |Article 4(3)                                                         |
|Article 4(4)                                                         |Article 4(1), second subparagraph                                    |
|Article 5(1)                                                         |Article 5(1)                                                         |
|Article 5(2)                                                         |Article 5(2)                                                         |
|Article 5(3), first and second indents                               |Article 5(3)(a) and (b)                                              |
|Article 6                                                            |Article 6                                                            |
|Article 7(1)                                                         |Article 7(1)                                                         |
|Article 7(2)                                                         |Article 7(2)                                                         |
|Article 7(2a)                                                        |Article 7(3)                                                         |
|Article 8                                                            |Article 8                                                            |
|Article 9(1)                                                         |Article 9(1)                                                         |
|Article 9(2)(a), (b) and (c)                                         |Article 9(2), first, second and third subparagraphs                  |
|Article 9(3)                                                         |Article 9(3)                                                         |
|Article 9(4)                                                         |________                                                             |
|Article 9(4a), first subparagraph, first to fourth indents           |Article 9(4), first subparagraph, (a) to (d)                         |
|Article 9(4a), second subparagraph                                   |Article 9(4), second subparagraph                                    |
|Article 9(4b)                                                        |Article 9(5)                                                         |
|Article 10(1)                                                        |Article 10                                                           |
|Article 10a                                                          |Article 11                                                           |
|Article 11(1), first to fourth indents                               |Article 12(1)(a) to (d)                                              |
|Article 11(2), first and second indents                              |Article 12(2)(a) and (b)                                             |
|Article 11a                                                          |Article 13                                                           |
|Article 12                                                           |Article 14                                                           |
|Article 13                                                           |________                                                             |
|Article 14                                                           |15                                                                   |
|Article 15                                                           |________                                                             |
|Article 16                                                           |________                                                             |
|________                                                             |Article 16                                                           |
|________                                                             |Article 17                                                           |
|Article 17                                                           |Article 18                                                           |
|Annex I(I)(1)                                                        |Annex I(I)(1)                                                        |
|Annex I(I)(2), first subparagraph, (a)(1) to (4)                     |Annex I(I)(2), first subparagraph, (a)(i) to(iv)                     |
|Annex I(I)(2), first subparagraph, (b)                               |Annex I(I)(2), first subparagraph, (b)                               |
|Annex I(I)(2), first subparagraph, (c)                               |Annex I(I)(2), first subparagraph, (c)                               |
|Annex I(I)(2), second subparagraph                                   |Annex I(I)(2), second subparagraph                                   |
|Annex I(I)(3)                                                        |Annex I(I)(3)                                                        |
|Annex I(II), 1.1                                                     |Annex I(II), 1.1                                                     |
|Annex I(II), 1.2                                                     |Annex I(II), 1.2                                                     |
|Annex I(II), 1.3                                                     |Annex I(II), 1.3                                                     |
|Annex I(II), 1.3.1                                                   |Annex I(II), 1.3.1                                                   |
|Annex I(II), 1.3.2                                                   |Annex I(II), 1.3.2                                                   |
|Annex I(II), 1.3.3, (i) and (ii)                                     |Annex I(II), 1.3.3, (a) and (b)                                      |
|Annex I(II), 1.4                                                     |Annex I(II), 1.4                                                     |
|Annex I(III)                                                         |Annex I(III)                                                         |
|Annex II                                                             |Annex II                                                             |
|Annex III                                                            |Annex III                                                            |
|________                                                             |Annex IV                                                             |
|________                                                             |Annex V                                                              |

                                                                   ____________

                                                             -----------------------
[1]   COM(87) 868 PV.
[2]   See Annex 3 to Part A of the Conclusions.
[3]   Carried out pursuant to the Communication from the Commission to the European Parliament and the  Council  –  Codification  of  the  Acquis
      communautaire, COM(2001) 645 final.
[4]   See Annex IV, Parts A and B of this proposal.
[5]   OJ C
[6]   OJ C
[7]   OJ L 229, 30.8.1980, p. 1. Directive as last amended by Regulation (EC) N° 1882/2003 of the European Parliament and of the  Council  (OJ  L
      284, 31.10.2003, p. 1).
[8]   See Annex IV, Parts A and B.
[9]   OJ L109, 6.5.2000, p. 29. Directive as last amended by Directive 2003/89/EC (OJ L 308, 25.11.2003, p. 15).
[10]  OJ L 184, 17.7.1999, p. 23.
[11]  OJ L 311, 28.11.2001, p. 67.
[12]  OJ L 330, 5.12.1998, p. 32.
[13]  OJ L 31, 1.2.2002, p. 1.
[14]  However, trade in products placed on the market or labelled before the date and not conforming  with  this  Directive  may  continue  until
      stocks run out.