Proposal for a Directive of the European Parliament and of the Council on the exploitation and marketing of natural mineral waters (Recast)
Date: 2007-12-21
Institutions: European Commission
Subjects: approximation of laws, labelling, marketing, mineral water, water treatment

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 21.12.2007 
COM(2007) 858 final 

2007/0292 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on the exploitation and marketing of natural mineral waters 

(Recast) 

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1. 

2. 

3. 

4. 

5. 

EXPLANATORY MEMORANDUM 

On 1 April 1987 the Commission decided1 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. 

The  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 waters2 has been initiated by the Commission. The new 
Directive was to have superseded the various acts incorporated in it3. 

In  the  meantime  Council  Decision  1999/468/EC  of  28  June  1999  laying  down  the 
procedures  for the exercise of implementing powers conferred on the Commission4 
has  been  amended  by  Decision  2006/512/EC,  which  introduced  a  regulatory 
procedure  with  scrutiny  for  measures  of  general  scope  designed  to  amend  non-
essential  elements  of  a  basic  instrument  adopted  in  accordance  with  the  procedure 
referred to in Article 251 of the Treaty, including by deleting some of those elements 
or by supplementing the instrument by the addition of new non-essential elements. 

In accordance with the joint statement of the European Parliament, the Council and 
the Commission5 on Decision 2006/512/EC, for this new procedure to be applicable 
to instruments adopted in accordance with the procedure laid down in Article 251 of 
the  Treaty  which  are  already  in  force,  those  instruments  must  be  adjusted  in 
accordance with the applicable procedures. 

It is therefore appropriate to transform the codification of Directive 80/777/EEC into 
a recast in order to incorporate the amendments necessary for the adjustment to the 
regulatory procedure with scrutiny. 

1 
2 

3 
4 

5 

COM(87) 868 PV. 
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. 
See Annex IV, Part A of this proposal. 
OJ  L  184,  17.7.1999,  p.  23.  Decision  as  amended  by  Decision  2006/512/EC  (OJ  L  200,  22.7.2006, 
p. 11). 
OJ C 255, 21.10.2006, p. 1. 

EN 

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(cid:208) 80/777/EEC (adapted) 

2007/0292 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on 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 ⌦ 95 ⌫ thereof, 

Having regard to the proposal from the Commission6, 

Having regard to the opinion of the European Economic and Social Committee7, 

Acting in accordance with procedure laid down in Article 251 of the Treaty8, 

Whereas: 

(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  waters9 
has  been  substantially  amended  several  times10.  Since  further  amendments  are  to  be 
made, it should be recast in the interests of clarity. 

(cid:216) new 

(2) 

The  laws  of  the  Member  States  define  natural  mineral  waters.  Those  laws  lay  down 
the  terms  on  which  natural  mineral  waters  are  recognised  as  such  and  govern  the 
conditions  for  exploiting  springs.  They  furthermore  stipulate  specific  rules  for 
marketing the waters in question. 

(cid:208) 80/777/EEC Recital 1 (adapted) 

6 
7 
8 
9 

10 

OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ L 229, 30.8.1980, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 of the European 
Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). 
See Annex IV, Part A. 

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(3) 

The  differences  between  those  laws  hinder  the  free  movement  of  natural  mineral 
waters, creating disparate competitive situations, and consequently directly affect the 
functioning of the ⌦ internal ⌫ market. 

(cid:208) 80/777/EEC Recital 2 (adapted) 

(cid:208) 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 recognised 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. 

(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. 

(cid:208) 96/70/EC Recital 2 

(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  those  agreements,  similar  products  imported  from  third 
countries may be allowed to enter the Community as natural mineral waters. 

(cid:208) 80/777/EEC Recital 4 

(7) 

Care should be taken to ensure that natural mineral waters retain at the marketing stage 
those  characteristics  which  enabled  them  to  be  recognised  as  such.  Therefore,  the 
containers used for packaging them should have suitable closures. 

(cid:208) 80/777/EEC Recital 5 

(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 20 
March  2000  on  the  approximation  of  the  laws  of  the  Member  States  relating  to  the 
labelling, presentation and advertising of foodstuffs11. Accordingly, this Directive may 

(cid:208) 80/777/EEC Recital 6 

11 

OJ L109, 6.5.2000, p. 29. Directive as last amended by Commission Directive 2006/142/EC (OJ L 368, 
23.12.2006, p. 110). 

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be  limited  to  laying  down  the  additions  and  derogations  which  should  be  made  to 
those general rules. 

(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. 

(cid:208) 96/70/EC Recital 6 (adapted) 

(cid:216) new 

(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 Commission12. 

(11)  Power  should  be  conferred  on  the  Commission  in  particular  to  adopt  limits  for  the 
levels  of  constituents  of  natural  mineral  waters,  any  necessary  provisions  for  the 
indication on the labelling of high levels of certain constituents, the conditions of use 
of ozone-enriched air for the treatment of natural mineral water, the information on the 
treatments of natural mineral water, methods of analysis to determine the absence of 
pollution  of  natural  mineral  waters,  as  well  as  the  sampling  procedures  and  the 
methods  of  analysis  necessary  for  checking  the  microbiological  characteristics  of 
natural mineral waters. Since those measures are of general scope and are designed to 
amend  non-essential  elements  of  this  Directive,  inter  alia,  by  supplementing  it,  they 
should be adopted in accordance with the regulatory procedure with scrutiny provided 
for in Article 5a of Decision 1999/468/EC. 

(12)  When,  on  imperative  grounds  of  urgency,  the  normal  time-limits  for  the  regulatory 
procedure with scrutiny cannot be complied with, the Commission should be able to 
use the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for 
the  adoption  of  amendments  to  this  Directive  necessary  in  order  to  ensure  the 
protection of public health. 

(13)  The  new  elements  introduced  into  this  Directive  only  concern  the  committee 
procedures. They therefore do not need to be transposed by the Member States. 

(14)  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 Directives set out in 
Annex IV, Part B, 

12 

OJ  L  184,  17.7.1999,  p.  23.  Decision  as  amended  by  Decision  2006/512/EC  (OJ  L  200,  22.7.2006, 
p. 11). 

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HAVE ADOPTED THIS DIRECTIVE: 

(cid:208) 80/777/EEC 

Article 1 

1.  This  Directive  concerns  waters  extracted  from  the  ground  of  a  Member  State  and 
recognised  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 recognised as natural mineral waters by the responsible authority of a 
Member State. 

The waters referred to in the first subparagraph may be so recognised 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. 

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 that period. 

(cid:208) 96/70/EC Art. 1 pt. 1 

3. This Directive shall not apply to: 

(cid:208) 80/777/EEC 

(a) 

(b) 

waters which are medicinal products within the meaning of Directive 2001/83/EC of 
the European Parliament and of the Council13; 

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 recognised shall be published in the Official Journal of the European Union. 

13 

OJ L 311, 28.11.2001, p. 67. 

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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. 

Natural mineral water  springs  may be  exploited and their  waters bottled only in accordance 
with Annex II. 

Article 3 

(cid:208) 96/70/EC Art. 1 pt. 2 (adapted) 
(cid:214) new 

Article 4 

1. Natural mineral water, in its state at source, may not be the subject of any treatment other 
than: 

(a) 

(b) 

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; 

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  (cid:214) by  the 
Commission (cid:213) in accordance with the procedure laid down in Article 12 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  (cid:214) by  the 
Commission (cid:213) in accordance with the procedure laid down in Article 12 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. 

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The measures referred to in points (b)(i) and (c)(i), designed to amend non-essential elements 
of  this  Directive  by  supplementing  it,  shall  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny referred to in Article 14(2). 

(cid:216) new 

⌦ The  first  subparagraph ⌫  shall  not  constitute  a  bar  to  the  utilisation  of  natural  mineral 
waters and spring waters in the manufacture of soft drinks. 

(cid:208) 96/70/EC Art. 1 pt. 2 (adapted) 

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. 

(cid:208) 96/70/EC Art. 1 pt. 2 

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. 

(cid:208) 96/70/EC Art. 1 pt. 2 (adapted) 

(cid:208) 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 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 °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, those values ⌦ must ⌫ 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 
⌦ shall ⌫ be considered as guide figures and not as maximum permitted concentrations. 

(cid:208) 80/777/EEC (adapted) 

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2. At source and during its marketing, a natural mineral water shall be free from: 

(cid:208) 80/777/EEC  

(a) 

(b) 

(c) 

(d) 

parasites and pathogenic micro-organisms; 

Escherichia  coli  and  other  coliforms  and  faecal  streptococci  in  any  250 ml  sample 
examined; 

sporulated sulphite-reducing anaerobes in any 50 ml sample examined; 

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. 

Any  containers  used  for  packaging  natural  mineral  waters  shall  be  fitted  with  closures 
designed to avoid any possibility of adulteration or contamination. 

Article 6 

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 ⌦ point (d) of the first subparagraph of Article 4(1), ⌫ shall have added to it, 
as appropriate, the indication ‘fully de-carbonated’ or ‘partially de-carbonated’. 

(cid:208) 80/777/EEC (adapted) 

2. Labels on natural mineral waters shall also give the following mandatory information: 

(cid:208) 96/70/EC Art. 1 pt. 3 

(a) 

(b) 

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a statement of the analytical composition, giving its characteristic constituents; 

the place where the spring is exploited and the name of the spring; 

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(c) 

information  on  any  treatments  referred  to  in  points  (b)  and  (c)  of  the  first 
subparagraph of Article 4(1). 

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

(cid:208) 96/70/EC Art. 1 pt. 3 (adapted) 

(cid:208) 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 prohibited to market natural mineral water from one and the same spring under 
more than one trade description. 

(cid:208) 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  ⌦ of  exploitation ⌫  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. 

(cid:208) 80/777/EEC 

Article 9 

1.  It  shall  be  prohibited,  both  on  packaging  or  labels  and  in  advertising  in  any  form 
whatsoever , 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 authorisation to exploit 
it, the results of analyses or any similar references to guarantees of authenticity; 

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(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. 

(cid:208) 80/777/EEC (adapted) 

However,  the  indications  listed  in  Annex  III  shall  be  authorised  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 recognised scientific methods, in accordance with Annex I, Section I, 
point 2. 

Member  States  may  authorise  the  indications  ‘stimulates  digestion’,  ‘may  facilitate  the 
hepato-biliary functions’ or similar indications. They may also authorise the inclusion of other 
indications, provided that the latter do not conflict with the principles ⌦ provided for ⌫ in 
the  first  subparagraph  and  are  compatible  with  those  ⌦ provided  for ⌫  in  the  second 
subparagraph. 

(cid:208) 80/777/EEC 

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 that information. 

Member States which intend taking such measures shall inform the other Member States and 
the Commission of them beforehand. 

(cid:208) 96/70/EC Art. 1 pt. 5 (adapted) 
(cid:214) new 

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) 

(b) 

(c) 

(d) 

satisfies the conditions of exploitation laid down in Annex II, points 2 and 3, which 
shall be fully applicable to spring waters; 

satisfies the microbiological requirements laid down in Article 5; 

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

has  not  undergone  any  treatment  other  than  those  referred  to  in  Article  4.  Other 
treatments  may  be  authorised  (cid:214) by  the  Commission. (cid:213)  in  accordance  with  the 
procedure laid down in Article 12. 

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The  measures  referred  to  in  point  (d),  designed  to  amend  non-essential  elements  of  this 
Directive by supplementing it, shall be adopted in accordance with the regulatory procedure 
with scrutiny referred to in Article 14(2). 

(cid:216) new 

In addition, spring waters shall comply with the provisions of Council Directive98/83/EC14. 

(cid:208) 96/70/EC Art. 1 pt. 5 

5. In the absence of Community provisions on the treatment for spring waters referred to in 
point (d) of the first subparagraph of paragraph 4, Member States may maintain ⌦ their ⌫ 
national provisions on the treatments. 

(cid:208) 96/70/EC Art. 1 pt. 5 (adapted) 

(cid:208) 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-harmonised national provisions governing the properties, 
composition,  conditions  of  exploitation,  packaging  or  labelling  of  natural  mineral  waters  or 
foodstuffs in general. 

(cid:208) 96/70/EC Art. 1 pt. 7 (adapted) 
(cid:214) new 

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 
recognised  the  water  shall  provide  all  relevant  information  concerning  recognition  of  the 
water, together with the results of the regular checks. 

14 

OJ L 330, 5.12.1998, p. 32. 

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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  (cid:214) adopt  those  amendments. (cid:213)  initiate  the 
procedure laid down in Article 12, with a view to adopting those amendments. 

Those measures, designed to amend non-essential elements of this Directive, shall be adopted 
in accordance with the regulatory procedure with scrutiny referred to in Article 14(3). 

(cid:216) new 

The Member State which has adopted safeguard measures may, in that event, retain them until 
the amendments have been adopted. 

(cid:208) 96/70/EC Art. 1 pt. 7 

(cid:208) 96/70/EC Art. 1 pt. 8 (adapted) 
(cid:214) new 

Article 12 

1.  The  following  (cid:214) measures (cid:213)  shall  be  adopted  (cid:214) by  the  Commission (cid:213)  in  accordance 
with the procedure laid down in Article 1214(2): 

(a) 

(b) 

(c) 

limits for the levels of constituents of natural mineral waters; 

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

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 laid down to in Article 12: 

(e) 

(f) 

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

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

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Those  measures,  designed 
this  Directive  by 
supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny 
referred to in Article 14(2). 

to  amend  non-essential  elements  of 

(cid:216) new 

(cid:208) 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. 

(cid:208) 1882/2003 Art. 3 and Annex III 
pt. 4 (adapted) 
(cid:214) new 

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 Council15, hereinafter referred to as “the Committee”. 

2. Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/EC16 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. 

(cid:214) 2.  Where  reference  is  made  to  this  paragraph,  Article  5a(1)  to  (4),  and  Article  7  of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. (cid:213) 

(cid:214) 3. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6), and Article 7 
of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. (cid:213) 

3. The Committee shall adopt its rules of procedure. 

(cid:208) 80/777/EEC 

Article 15 

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

15 
16 

OJ L 31, 1.2.2002, p. 1. 

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(cid:216) new 

Article 16 

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

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 

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

Article 17 

(cid:208) 80/777/EEC 

Article 18 

This Directive is addressed to the Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

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(cid:208) 80/777/EEC 

ANNEX I 

I. 

1. 

DEFINITION 

‘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  characterised  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. 

⌦ The ⌫  characteristics  ⌦ referred  to  in  point  1 ⌫,  which  may  give  natural 
mineral water properties favourable to health, shall have been assessed: 

(cid:208) 80/777/EEC (adapted) 

(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. 

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. 

EN 

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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-ionised 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); 

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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. 

a demonstration of the absence of parasites and pathogenic micro-organisms; 

1.3.2. 

a  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 recognised 
methods, shall 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 

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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; 

‘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; 

‘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. 

(b) 

(c) 

________

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1. 

2. 

(cid:208) 80/777/EEC (adapted) 

ANNEX II 

CONDITIONS FOR THE EXPLOITATION AND MARKETING OF NATURAL 
MINERAL WATER 

Exploitation of a natural mineral water spring shall be subject to permission from the 
responsible authority of the country where the water has been extracted, after it has 
been established that the water in question complies with the provisions laid down in 
Annex I, ⌦ Section I ⌫. 

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. 

(cid:208) 80/777/EEC 

To that end, in particular: 

(a) 

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

(b) 

(c) 

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; 

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 authorised 
for distribution to the ultimate consumer shall bei 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 authorised. 

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. 

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4. 

The responsible authority in the country of origin shall carry out periodic checks to 
see whether: 

(cid:208) 80/777/EEC (adapted) 

(a) 

(b) 

the  natural  mineral  water  in  respect  of  which  exploitation  of  the  spring  has 
been authorised complies with Annex I, Section I; 

the  provisions  of  ⌦ points ⌫  2  and  3  are  being  applied  by  the  person 
exploiting the spring. 

________

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(cid:208) 80/777/EEC 

ANNEX III 

INDICATIONS AND CRITERIA LAID DOWN IN ARTICLE 9(2) 

Indications 

Criteria 

Low mineral content 

Very low mineral content 

Rich in mineral salts 

Mineral salt content, calculated as a fixed 
residue, not greater than 500 mg/l 

Mineral salt content, calculated as a fixed 
residue, not greater than 50 mg/l 

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 

Contains chloride 

Contains calcium 

Sulphate content greater than 200 mg/l 

Chloride content greater than 200 mg/l 

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 

Acidic 

Bivalent iron content greater than 1 mg/l 

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 

— 

— 

________ 

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(cid:207) 

ANNEX IV 

Part A 
Repealed Directive with list of 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 
(OJ L 375, 31.12.1980, p. 77) 

Council Directive 85/7/EEC 
(OJ L 2, 3.1.1985, p. 22) 

Point B.1.o of Annex I to the 1985 Act of Accession 
(OJ L 302, 15.11.1985, p. 214) 

Directive 96/70/EC of the European Parliament and 
of the Council 
(OJ L 299, 23.11.1996, p. 26) 

Article 1, third indent only 

Article 1, point 10 only 

Regulation (EC) No 1882/2003 of the European Parliament 
and of the Council 
(OJ L 284, 31.10.2003, p. 1) 

Annex III, point 4 only 

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

Directive 

Time-limit for 
transposition 

Permission of trade in 
products complying with 
this Directive 

Prohibition of trade in 
products not complying 
with this Directive 

80/777/EEC 

80/1276/EEC 

85/7/EEC 

96/70/EC 

- 

- 

- 

- 

18 July 1982 

18 July 1984 

- 

- 

- 

- 

28 October 1997 

28 October 199817 

_____________ 

17 

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. 

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ANNEX V 

CORRELATION TABLE 

Directive 80/777/EEC 

This Directive 

Article 1(1) 

Article 1(2) 

Article 1(1) 

Article 1(2) 

Article 1(3), first and second indents 

Article 1(3)(a) and (b) 

Article 1(4) 

Article 1(5) 

Article 2 

Article 3 

Article 1(4) 

Article 1(5) 

Article 2 

Article 3 

Article 4(1)(a) 

Article 4(1), first subparagraph, (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(3) 

Article 4(4) 

Article 5(1) 

Article 5(2) 

Article 4(1), second subparagraph 

Article 4(2) 

Article 4(3) 

Article 4(1), third subparagraph 

Article 5(1) 

Article 5(2) 

Article 5(3), first and second indents 

Article 5(3)(a) and (b) 

Article 6 

Article 7(1) 

Article 7(2) 

Article 7(2a) 

Article 8 

Article 6 

Article 7(1) 

Article 7(2) 

Article 7(3) 

Article 8 

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Article 9(1) 

Article 9(2)(a), (b) and (c) 

Article 9(3) 

Article 9(4) 

Article 9(1) 

Article  9(2), 
subparagraphs 

Article 9(3) 

________ 

first, 

second 

and 

third 

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 10(1) 

Article 10a 

Article 9(5) 

Article 10 

Article 11 

Article 11(1), first to fourth indents 

Article 12(a) to (d) 

Article 11(2), first and second indents 

Article 12(e) and (f) 

Article 11a 

Article 12(1) 

Article 12(2) 

Article 12(3) 

Article 13 

Article 14 

Article 15 

Article 16 

________ 

________ 

Article 17 

Article 13 

Article 14(1)  

Article 14(2) and (3) 

________ 

________ 

Article 15 

________ 

________ 

Article 16 

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) 

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Annex I(I)(2), second subparagraph 

Annex I(I)(2), second subparagraph 

Annex I(I)(3) 

Annex I(II), 1.1 

Annex I(II), 1.2 

Annex I(II), 1.3 

Annex I(II), 1.3.1 

Annex I(II), 1.3.2 

Annex I(I)(3) 

Annex I(II), 1.1 

Annex I(II), 1.2 

Annex I(II), 1.3 

Annex I(II), 1.3.1 

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(III) 

Annex II 

Annex III 

________ 

________ 

Annex I(II), 1.4 

Annex I(III) 

Annex II 

Annex III 

Annex IV 

Annex V 

____________ 

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