Natural Mineral Waters, Spring Waters and Other Bottled Waters Guidance F (PDFDrive)

25 G U I DA N C E N OT E
Guidance for Enforcement of Legislation

Applicable to: Natural Mineral Waters,
Spring Waters and Other Bottled Waters
Applicable to: Natural Mineral Waters, Spring Waters
Guidance Note No. 25: Guidance for Enforcement of Legislation
and Other Bottled Waters

Guidance for Enforcement of Legislation
Applicable to: Natural Mineral Waters,
Spring Waters and Other Bottled Waters
Published by:
Food Safety Authority of Ireland
Abbey Court
Lower Abbey Street
Dublin 1
Tel: +353 1 817 1300 Fax: +353 1 817 1301

Email: info@fsai.ie Website: www.fsai.ie
©2010
Applications for reproduction should be made to the FSAI Information Unit
ISBN 1-904465-71-4
CONTENTS
INTRODUCTION 2
OUTLINE 5
1 NATURAL MINERAL WATER 6
1.1 Directive 2009/54/EC on the exploitation and marketing
of natural mineral waters 7
1.2 Commission Directive 2003/40/EC: Establishing the list, concentration
limits and labelling requirements for the constituents of natural mineral
waters and the conditions for using ozone enriched air for the treatment
of natural mineral waters and spring waters 62
1.3 Commission Regulation 115/2010 laying down the conditions for use
of activated alumina for the removal of fluoride from natural mineral waters
and spring waters 70
1.4 Sampling and analysis of natural mineral waters by official agency (HSE) 75
2 SPRING WATER 80
2.1 Directive 2009/54/EC on the exploitation and marketing
of natural mineral waters 80
2.2 Commission Directive 2003/40/EC establishing the list, concentration
limits and labelling requirements for the constituents of natural mineral
waters and the conditions for using ozone enriched air for the treatment
of natural mineral waters and spring waters 93
2.3 Commission Regulation 115/2010 laying down the conditions for use of
activated alumina for the removal of fluoride from natural mineral waters
and spring waters 97
2.4 Council Directive 98/83/EC on the quality of water intended for
human consumption 102
2.5 Microbiological criteria for spring water 103
2.5.1 Microbiological criteria of Article 5 of Directive 2009/54/EC 103
2.5.2 Microbiological criteria of Annex I of Council Directive 98/83/EC 110
2.6 Chemical and physical criteria for spring water 113
2.7 Sampling and analysis of spring water by official agency (HSE) 113
3 ‘OTHER BOTTLED WATER’ 115

3.1 Council Directive 98/83/EC on the quality of water intended for
human consumption 115
3.2 Treatment of ‘other waters’ 126
3.3 Labelling of ‘other waters’ 126
3.4 Chemical and physical criteria for ‘other waters’ 126
3.5 Microbiological criteria for ‘other waters’ 127
3.6 Sampling and analysis by the environmental health service of the HSE 129
3.6 Specific methods of analysis 146
APPENDIX I. EXAMPLES OF LABELS FOR NATURAL MINERAL

WATER AND SPRING WATER PRODUCTS 153
List of Tables
TABLE 1.1 SUMMARY OF MICROBIOLOGICAL LIMITS

FOR NATURAL MINERAL WATERS 76
TABLE 1.2 CRITERIA FOR CHEMICAL CONSTITUENTS

NATURALLY PRESENT IN NATURAL MINERAL WATERS 77
TABLE 1.3 PERFORMANCE CHARACTERISTICS FOR

ANALYSING THE CHEMICAL CONSTITUENTS 78
TABLE 2.1 SUMMARY OF MICROBIOLOGICAL LIMITS FOR

SPRING WATERS AT SOURCE AND IN PACKAGE 111
TABLE 2.2 MINIMUM FREQUENCIES OF SAMPLING AND ANALYSIS

FOR MONITORING PURPOSES OF SPRING WATER AND
OTHER WATER BY THE OFFICIAL AGENCY (HSE) 114
TABLE 3.1 CHEMICAL, PHYSICAL AND MICROBIOLOGICAL

INDICATOR PARAMETERS SUBJECT TO ‘CHECK
MONITORING’ BY THE ENVIRONMENTAL HEALTH
SERVICE OF THE HSE 130
TABLE 3.2 CHEMICAL, PHYSICAL AND MICROBIOLOGICAL

PARAMETERS APPLICABLE TO ‘OTHER WATERS’ 131
TABLE 3.3 CHEMICAL PARAMETERS FOR WHICH PERFORMANCE

CHARACTERISTICS ARE SPECIFIED 147
TABLE 3.4 MICROBIOLOGICAL PARAMETERS FOR WHICH

METHODS ARE SPECIFIED 151
1
INTRODUCTION
There are three classes of bottled water namely, natural mineral water, spring water or other
bottled water. Natural mineral water is derived from a natural spring extracted from the ground
and packaged at source, complies with the legal requirements for natural mineral water and is
recognised by the responsible authority. In Ireland, the National Standards Authority of Ireland
(NSAI) has been nominated by the Food Safety Authority of Ireland (FSAI) as the responsible
authority. Spring water is intended for human consumption in its natural state, complies with the
legal requirements for spring water and is packaged at source. ‘Other water’ is water intended
for human consumption and is not a natural mineral water or spring water.
The treatments permitted for natural mineral water and spring waters are very limited and
therefore, the source of the water used to package natural mineral water and spring water is
required to be of very good quality in its natural state. In order to maintain the quality of the
source of natural mineral water or spring water, the food business operator shall take suitable
precautions to protect the source from any contamination. Other packaged water may be treated
as necessary using normal water treatment technologies in order to ensure the product is suitable
for human consumption.
This document provides guidance on the requirements of food establishments in accordance with
specific legislation applicable to natural mineral water, spring water and ‘other bottled water’
Guidance is provided on the following pieces of legislation:
• Directive 2009/54/EC on the exploitation and marketing of natural mineral waters (and spring
waters)
• Commission Directive 2003/40/EC (Establishing the list, concentration limits and labelling
requirements for the constituents of natural mineral waters and the conditions for using
ozone-enriched air for the treatment of natural mineral waters and spring waters)
• Commission Regulation 115/2010/EC with respect to the legislative requirements for natural
mineral waters and spring waters and
• Council Directive 98/83/EC with respect to the legislative requirements for ‘other bottled
waters’
2
The Irish Statutory Instrument, S.I. No. 225 of 2007 (as amended) gives effect to the following
pieces of legislation:
• Council Directive 80/777/EEC as amended on the exploitation and marketing of natural

mineral waters
• Council Directive 98/83/EC on the quality of water intended for human consumption and
• Commission Directive 2003/40/EC establishing the list, concentration limits and labelling
requirements for the constituents of natural mineral waters and the conditions for using
ozone-enriched air for the treatment of natural mineral waters and spring waters
In 2009, Directive 2009/54/EC was published which is a recast of Council Directive 80/777/
EEC and its amendments. However, since Directive 2009/54/EC is a recast of Council Directive
80/777/EEC with no material modification, S.I. No. 225 of 2007 (as amended) remains applicable
as the Statutory Instrument for Directive 2009/54/EC.
In addition, all food businesses producing natural mineral waters, spring water or ‘other waters’
are subject to the general requirements of food law including:
• Regulation 178/2002 laying down the general principles and requirements of food law,
establishing the European Food Safety Authority and laying down procedures in matters of
food safety
• Regulation 852/2004 Regulation on food hygiene. This Regulation sets out the rules
which apply to all food, from the farm to the point of sale to the consumer. It places the
responsibility for the safety of food on food producers
Note: In accordance with Regulation 852/2004/EC, a hazard analysis, from catchment through
distribution, which takes into consideration microbiological, physical and chemical hazards, should
be undertaken by the food business operator according to HACCP principles. This should provide
the basis for determining the appropriate combination of control measures to reduce, eliminate
or prevent, as necessary, these hazards to the production of safe natural mineral waters, spring
waters and other waters.
All relevant EU and Irish legislation can be found on the FSAI website at www.fsai.ie/legislation.
3
IS 432 on packaged water can be used as a guide to the interpretation of the requirements of
Directive 2009/54/EC and Council Directive 98/83/EC and Regulation 852/2004. In addition,
the following is the list of references which are used as a guide to the interpretation of the
requirements of Regulation 852/2005:
• IS 340:2007 on the hygiene of the catering sector

• IS 341:2007 on the hygiene in food retailing and wholesaling
The following category of products is not considered natural mineral waters, spring water or
‘other waters’:
• Waters with medicinal claims as no medicinal claims are permitted on foods

• Waters used for curative purposes in thermal or hydro-thermal establishments
• Waters not intended for human consumption
• Packaged ice
• Flavoured natural mineral water drinks, flavoured spring water drinks and flavoured other
drinks
4
OUTLINE
Section 1 is applicable to the production of natural mineral water. Guidance is provided for the
interpretation of Directive 2009/54/EC, Commission Directive 2003/40/EC and Commission
Regulation 115/2010.
Section 2 is applicable to the production of spring water. Guidance is provided for the
interpretation of Directive 2009/54/EC, Commission Directive 2003/40/EC and Commission
Regulation 115/2010 and Council Directive 98/93/EC.
Section 3 is applicable to the production of other bottled water. Guidance is provided for the
interpretation of Council Directive 98/93/EC. Table 1 below summarises the specific sections of
the legislation applicable to other bottled water.
Appendix 1 provides examples of labels for natural mineral water, spring water and ‘other
water’.
See summary of legislation applicable to natural mineral water, spring water and ‘other water’
below.
EU Legislation Natural Mineral Spring Water ‘Other

Water Water’
Directive 2009/54/EC All Article 9 (4) & n/a
Article 9(5)
Commission Directive 2003/40/EC All Article 5 & n/a
Article 6
Commission Regulation 115/2010 All All n/a
Council Directive 98/83/EC n/a All All
5
SECTION 1. NATURAL MINERAL WATER
Natural mineral waters must be bottled at source. Recognition of natural mineral water is a legal
requirement and the NSAI is the responsible authority for this recognition. The environmental
health service of the Health Service Executive (HSE) is the responsible authority for the
enforcement of the all other requirements of the above legislation in natural mineral water
establishments. If, during inspections or otherwise, the NSAI or environmental health service of
the HSE has information which is of relevance to the other agency, this information should be
shared with the agency, either by direct contact with the relevant personnel or via the Service
Contracts Division of the FSAI (www.fsai.ie).
Directive 2009/54/EC and the labelling and compositional criteria specified in Commission
Directive 2003/40/EC applies to all natural mineral water producers. In addition, if natural mineral
water is treated with ozone enriched air, the conditions of use of this treatment, as outlined in
Commission Directive 2003/40/EC, must be complied with. Commission Regulation 115/2010/EC
applies to natural mineral waters which are treated for the removal of fluoride.
6
1.1 Directive 2009/54/EC on the exploitation and marketing of natural mineral
waters
Reference Requirements of Interpretation

Directive 2009/54/EC
Extraction This Directive concerns In Ireland, the NSAI (www.nsai.ie)
Article 1(1) waters extracted from is the responsible authority for the
the ground of a Member recognition of natural mineral water.
State and recognised by
the responsible authority
The NSAI reviews the data submitted
of that Member State as
by the food business operator which
natural mineral waters
provides information on:
satisfying the provisions
of Annex 1, Section 1 • Geological/ topographical/hydrogeological
(as outlined below). data
• Microbiological, physical and chemical
The waters referred (hydrochemical, physico-chemical) data
to above may be so The NSAI reviews microbiological and
recognised only if the chemical data submitted by the food business
responsible authority in operator from the previous two years.
the country of extraction A complete chemical analysis audit (as
has certified that they described in Council Directive 98/83/EC)
satisfy the provisions of is also carried out by the NSAI. Following
Annex 1, Section 1 (as an inspection and review of data, the NSAI
outlined below), and issues a ‘Certificate of Recognition’ and
that regular checks are ‘Conditions of Exploitation’ to natural mineral
made on the application water establishments which have met the
of the provisions of recognition criteria of this Directive. Each
Annex II, point 2 (as natural mineral water source recognised by the
outlined below). NSAI will have a unique chemical fingerprint.
The validity of the The conditions of exploitation will include:
certification referred i. Tolerances for each chemical constituent.
to above may not The chemical composition should not be
exceed a period of five outside the specified tolerance limits and
years. It shall not be
ii. The specific boreholes which the recognition
necessary to repeat the
by the NSAI applies to -
recognition procedure
if the certification is The chemical composition of natural mineral
renewed before the water is usually stable. However, in some
end of that period. circumstances, the composition may change,
e. g. over a period of time (decades),
the hardness of the water may change.
This is a natural change in the water.
7
In this case, the NSAI reviews the data and
amends the conditions of exploitation.
Generally, one aquifer provides one source
of natural mineral water. However, a number
of boreholes can be sourcing natural mineral
water from the same single aquifer.
If an additional aquifer is used, the food

business operator must demonstrate that
the natural mineral water has the same
chemical fingerprints as the natural mineral
water already recognised by the NSAI. If the
chemical fingerprint is different, a separate
recognition process for this aquifer is required.
A copy of Certificate of Recognition’ and

‘Conditions of Exploitation’ can be obtained
from the food business operator. Copies
of these documents should be obtained
by the environmental health service of
the HSE in advance of inspection.
NSAI certification is valid for a period

not exceeding five years. It is not
necessary to repeat the recognition
procedure if the certification is renewed
before the end of that period.
8
Imports This Directive also Verification of imported natural mineral waters
Article 1(2) concerns water extracted And environmental health officer (EHO)
from the ground of third of the HSE must verify if imported natural
countries, imported mineral water products from other Member
into the community and States or from third countries are from a
recognised as a natural recognised source. Similarly, if imported
mineral water by the natural mineral water is used as an ingredient
responsible authority in a product, the natural mineral water must
of a Member State. be from a source recognised in the EU.
The validity of the The list of recognised natural mineral

certification of natural waters sourced within the EU and from
mineral water from third third countries is published on the EU
countries may not exceed website at: http://ec.europa.eu/food/food/
a period of five years. labellingnutrition/water/index_en.htm.
The validity of the certification of natural

mineral water from third countries may
not exceed a period of five years.
Medicinal This Directive shall This legislation does not apply to
products not apply to: medicinal products. No medicinal claims
Article 1(3) (a) Waters which are can be made on natural mineral water,
medicinal products spring water or ‘other waters’.
within the meaning of
relating to medicinal
products for human use
Medicinal This Directive shall This legislation does not apply to waters
products not apply to: sourced for curative purposes in thermal
Article 1(3) (b) Natural mineral or hydromineral establishments. These
waters used at source products are considered medicinal products
for curative purposes in and not governed by food legislation.
thermal or hydromineral
establishments
9
Recognition The grounds for granting The NSAI issues a ‘Certificate of Recognition’
Article 1(4) the recognition referred and ‘Conditions of Exploitation’ to all natural
to in Art 1(1) and Art. mineral water establishments which have met
1(2) shall be stated in due the recognition criteria of this Directive.
form by the responsible The list of Irish natural mineral waters
authority of the member recognised by the NSAI is published on the
state and shall be EU website at: http://ec.europa.eu/food/
officially published. food/labellingnutrition/water/index_en.htm
Recognition Each Member State shall The list of Irish natural mineral waters
Article 1(5) inform the Commission recognised by NSAI is published on the EU
of the cases where the website at: http://ec.europa.eu/food/food/
recognition referred labellingnutrition/water/index_en.htm.
to in Art 1(1) and Art.
1(2) has been granted
or withdrawn. This
list of natural mineral
waters so recognised
shall be published in
the official journal of
the European union.
Enforcement Member States shall take
Article 2 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 water.
Exploitation Natural mineral water See Annex II following
Article 3 springs may be exploited
and their waters bottled
only in accordance
with Annex II.
10
Treatments Natural mineral water, in The following treatments are permitted
Article 4(1) its state at source, may provided this does not alter the essential
not be the subject of any chemical composition which gives the
treatment other than: water its properties or microbiological
composition of the water:
(a) The separation of
their unstable elements, (a) Food business operators must demonstrate
such as iron and sulphur that micro-filtration or decanting does not
compounds, by filtration alter the essential chemical composition or
or decanting, possibly microbiological composition of the water
preceded by oxygenation,
(b) Treatment with ozone-enriched air and
in so far as this treatment
must be notified to and controlled by the
does not alter the
environmental health service of the HSE
composition of the waters
as regards the essential (c) Any treatment to separate undesirable
constituents which give constituents, other than a and b above,
them their properties must be notified to and controlled by the
environmental health service of the HSE.
Food business operators must demonstrate
(b) The separation of
that any treatment does not alter the
iron, manganese and
essential chemical composition or the
sulphur compounds and
microbiological composition of the waters
arsenic from certain
by treatment with Information on treatments described in
ozone-enriched air in (a): The essential chemical composition of
so far as such treatment the natural mineral water is determined
does not alter the by the NSAI and will be outlined in the
composition of the waters certification of recognition. Food business
as regards the essential operators must be able to demonstrate that
constituents which give any micro-filtration or decanting does not
them their properties, alter the essential chemical composition or
and provided that the: microbiological composition of the water. This
(i) Treatment complies can be demonstrated by comparison of water
with the conditions for composition before and after micro-filtration
use to be laid down or decanting. Micro-filtration could take place
by the Commission at any point from the well head to bottling.
following consultation
with EFSA
11
(ii) T
reatment is notified Information on treatment described in (b):
to, and specifically The use of ozone-enriched air in natural
controlled by, the mineral water establishments for the
competent authorities separation of iron, manganese and sulphur
compounds and arsenic must comply with
the requirements of this directive. Food
(c) The separation of business operators must apply to their local
undesirable constituents environmental health service of the HSE for
other than those specified authorisation for the use of this treatment.
in (a) or (b), in so far as
Such treatment shall only commence
this treatment does not
following receipt of written approval from
alter the composition
the HSE. Records of ozone use shall be
of the waters as
retained by the food business operator.
regards the essential
constituents which give
them their properties, The environmental health service of the
and provided that the: HSE must specifically control the use
(i) T
reatment complies of this treatment in the food business
with the conditions for operator authorised to use this treatment.
use to be laid down In addition, see Article 5 of Commission
by the Commission Directive 2003/402/EC below.
with EFSA Information on treatment described in
(ii) T
reatment is notified (c): The use of any other treatments for
to, and specifically the separation of undesirable constituents
controlled by, the from natural mineral water other than:
competent authorities • Iron compounds
• Sulphur compounds
(d) The total or partial • Manganese compounds or
elimination of free carbon
• Arsenic
dioxide by exclusively
physical methods
12
Food business operators must apply to
their local environmental health service
of the HSE for the authorisation of use of
such treatment(s). Treatments shall only
commence following receipt of written
approval from the HSE. The environmental
health service of the HSE must specifically
control the use of this treatment in
notifying the food business operator.
Information on treatment described in

(d): Carbon dioxide maybe removed
from natural mineral water prior to
packaging by physical methods only.
The sales description of natural mineral

waters which have undergone the total or
partial elimination of free carbon dioxide by
exclusively physical methods shall have added
to it as appropriate, the indication on the label:
(a) ‘Fully de-carbonated natural mineral water’
or
(b) ‘Partially de-carbonated natural mineral
water’
As outlined in Council Directive 2000/13/
EC as amended, the sales description, net
quantity and date of minimum durability
must appear in the same field of vision.
Note: Natural mineral waters may also

be treatment with activated alumina
in order to remove fluoride. The
fluoride removal treatment must be in
accordance with Commission Regulation
115 of 2010 as outlined below.
13
Treatments This article shall not Once natural mineral water is mixed with
Article 4(1) constitute a bar to the other ingredients it is no longer classified
utilisation of natural as a ‘natural mineral water’. This product
mineral waters in the is now categorised as a soft drink and may
manufacture of soft drinks. be labelled ‘natural mineral water drink’
(see label example VI in Appendix I).
Natural mineral water may be used as

ingredients in soft drinks and other flavoured
water products. In this case, Directive
2009/54/EC does not apply as the final
product is outside the scope of this particular
legislation. However, if natural mineral water
is used as an ingredient and listed in the
ingredients list, the water must meet the
all the requirements of Directive 2009/54/
EC (except labelling requirements).
There is no requirement to declare

the name of the natural mineral
water source on the packaging.
14
Treatments Natural mineral water, Nothing may be added to natural mineral
Article 4(2) in its state at source, water, with the exception of carbon
may not be the subject dioxide (as outlined in the conditions laid
of any addition other down in Annex I, Section III below).
than the introduction
or reintroduction of In the case of effervescent natural
carbon dioxide under mineral water, the sales descriptions
the conditions laid on the label may be:
down in Annex I,
(a) ‘Naturally carbonated mineral water’,
Section III as follows:
(b) ‘Natural mineral water fortified with gas
Annex I, Section from the spring’ or
III: supplementary (c) ‘Carbonated natural mineral water’
qualifications relating
to effervescent natural
mineral water
At source or after must appear in the same field of vision.
bottling, effervescent
give off carbon dioxide Flavoured water products
spontaneously and in a Natural mineral water to which flavourings are
clearly visible manner added cannot be sold as a flavoured natural
under normal conditions mineral water. However, natural mineral
of temperature and water may be used as an ingredient in soft
pressure. They fall into drinks and other flavoured water drinks.
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
15
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.
Treatments Any disinfection treatment Disinfection treatments, e.g. UV treatments
Article 4(3) by whatever means and, or the addition of bacteriostatic elements
subject to Article 4(2) are prohibited for use on natural mineral
above, the addition of water. Comparison of the microbiological
bacteriostatic elements, composition pre and post permitted
or any other treatment treatment for natural mineral water will
likely to change the viable indicate if disinfection is taking place.
colony count of the
natural mineral water,
shall be prohibited.
16
Micro criteria The revivable total colony The production of microbiologically safe
Article 5(1) count of natural mineral bottled natural mineral water is dependent on
waters at source shall maintaining a high level of hygienic controls,
conform to their normal from the protection of the source, the
viable colony count and extraction and up to the bottling and capping.
give satisfactory evidence
of the protection of Table 1.1 provides a summary of the
the source against all microbiological criteria which apply to natural
contamination. This total mineral water at source and in the package.
colony count shall be
determined under the
conditions laid down in Data analysis of microbiological results of
Annex 1, Section II, Point ‘at source water’ over a period of time
1.3.3 (as outlined across). provides an indication of typical Total Viable
Count (TVC) levels. These TVC levels should
remain stable and thus act as an indicator
that the source has adequate protection
against microbiological contamination.
Annex 1, Section II, Point 1.3.3

The total colony count shall be
determined under the following conditions
(Annex 1, Section II, Point 1.3.3):
Determination of the revivable total

colony count per millilitre of water
(a) at 20 to 22ºC in 72 hours on agar-agar or
an agar-gelatine mixture
(b) at 37ºC in 24 hours on agar-agar
17
Micro criteria After bottling, the total After bottling, the total colony
Article 5(1) colony count at source count shall not exceed:
may not exceed 100 per • 100 cfu/ml at 20ºC to 22ºC in 72 hours and
millilitre at 20 to 22ºC in • 20 cfu/ml at 37ºC in 24 hours
72 hours on agar-agar or
TVC is only valid if it is determined within 12
and 20 per millilitre at
hours of bottling (the water being maintained
37ºC in 24 hours on agar-
at 4ºC ± 1ºC during this 12-hour period)
agar. The total colony
as water in its natural environment contains
count shall be measured
microorganisms. On storage, the number
within the 12 hours
of microorganisms will initially increase
following bottling, the
until all the naturally available nutrients in
water being maintained
the water are utilised. The number will
at 4ºC - 1ºC during
then decrease due to lack of nutrients
this 12-hour period.
and after a period will increase again.
Therefore, EHOs responsible for the

supervision of natural mineral water
establishments should sample for all relevant
microorganisms including sampling for total
colony counts within 12 hours of bottling.
Microbiological sampling at the marketing
stage (distribution and retail stage) should
not include TVC as the time post bottling
is unknown and therefore, results of
such analysis cannot be interpreted.
If TVC counts (within 12 hours of bottling)

exceed the legislative limits, then the bottled
water is in breach of the legislation. Product
which has not left the control of the food
business operator must not be released
onto the market. If product has reached
the consumer, the food business operator
must consult with the competent authority
regarding appropriate control actions.
18
EHOs are advised to review the source
protection and the various stages of production
for hygiene practises which may establish
the cause for breach in legislative limits.
Please see the FSAI’s Guidance Note 10

Food Recall and Traceability (Revision 2). The
following definitions are from this report:
Unsafe food: Food that is injurious to health

or unfit for human consumption as detailed
in Article 14 of Regulation (EC) No.178/2002
laying down the general principles and
requirements of food law, establishing the
European Food Safety Authority and laying
down procedures in matters of food safety.
Recall: The removal of an unsafe food from

the market when it may have reached the
consumer and the notification of the consumer.
Withdrawal: The removal of an

unsafe food from the market before
it has reached the consumer.
Micro criteria At source, these values At source, the total colony count
Article 5(1) should not normally should not normally exceed:
exceed 20 per millilitre at • 20 cfu/ml at 20 to 22ºC in 72 hours and
20 to 22ºC in 72 hours • 5 cfu/ml at 37ºC in 24 hours
and 5 per millilitre at 37ºC
in 24 hours respectively,
on the understanding that These are guide figures and not maximum
they are to be considered permitted concentrations. EHOs are advised
as guide figures and not to review the source protection and the
as maximum permitted various stages of production for hygiene
concentrations. practices which may establish the cause
for breaches in the legislative limits. See
above for action to take if TVC levels in
the bottle are above the legislative limits.
19
Micro criteria At source and during their Where the packaged water is deemed
Article 5(2) marketing, natural mineral to be unsafe by reason that it may be
waters shall be free from: injurious to health or unfit for human
(a) Parasites and consumption, the food business operator
pathogenic shall initiate the procedure to withdraw or
microorganisms recall the batch of product in question.
(b) Escherichia coli and

other coliforms and Where the product in question has reached
faecal streptococci the consumer, the food business operator shall
in any 250 millilitre accurately and effectively inform consumers
sample examined of the reason for the withdrawal of the
product and if necessary, recall product that
(c) Sporulated sulphite- has already been released for purchase.
reducing anaerobes
in any 50 millilitre
Where the packaged water product does
sample examined
not comply with the legal requirements
(d) Pseudomonas for microbiological criteria, the packaged
aeruginosa in any water business operator shall:
250 millilitre sample • Take action to ensure that the
examined water is not consumed
• Where necessary, recall the
product and notify consumers
Escherichia coli
The presence of E. coli in natural mineral water
is considered an index of faecal contamination
of the water. As such, the water is considered
injurious to health and therefore, unsafe as
defined in Regulation 178 of 2002. Natural
mineral water containing E. coli shall be
withdrawn from the market and where it has
reached the consumer, the consumers must be
notified and EHOs should ensure that the food
business operator takes the necessary measures
to remove the product from consumers.
20
• N
otify trade customers.
• Notify consumers.
• Remove affected batch of bottled
water from the food chain.
water from consumers.
See FSAI’s Guidance Note 10 Product
Recall and Traceability (Revision 2)
Enterococci (Faecal streptococci)

The presence of enterococci in natural
mineral water is considered an index of
faecal contamination of the water. As such,
the water is considered injurious to health
and therefore, unsafe. In accordance with
Article 19 of Regulation 178 of 2002, natural
mineral water containing enterococci shall be
withdrawn from the market and where it has
reached the consumer, the consumers must be
notified and EHOs should ensure that the food
business operator takes the necessary measures
• Notify trade customers.
water from the food chain.
water from consumers.
See the FSAI’s Guidance Note 10 Product
Recall and Traceability (Revision 2).
21
Coliforms
The presence of coliforms (in the absence of
E. coli or enterococci) in natural mineral water
is not a strong indication of potential presence
of enteric pathogens. Such bottled water should
not be considered as unsafe for consumption.
However, the presence of coliforms should
prompt investigation by the EHO and the
food business operator. The FSAI should be
informed of each case of coliform detected in
bottled water and each result must be dealt
with on a case by case basis (rapidalert@fsai.ie).
Pseudomonas aeruginosa
The presence of Ps. aeruginosa (in the
absence of E. coli or enterococci) in natural
mineral water is not a significant health risk
for the general population. The presence of
Ps. aeruginosa should prompt investigation
by the EHO and food business operator
as to the cause of the contamination.
Ps. aeruginosa is however, a risk for the severely

immunocompromised sub-population found
in certain areas of hospitals like intensive care
units. The FSAI should therefore be informed
of each case of Ps. aeruginosa detected in
bottled water (rapidalert@fsai.ie). The FSAI will
then advise the Health Protection Surveillance
Centre (HPSC) of such findings. Each result
must be dealt with on a case by case basis.
22
In all cases of contamination, EHOs are also
advised to investigate immediately to identify
the cause of contamination, e.g. review the
microbiological status of the source water,
the level of hygiene controls in the extraction
and bottling process. This may indicate the
cause for breach in the legislative limits.
See the FSAI’s Guidance Note 10 Food Recall and
Traceability (Revision 2). See above for definitions
of ‘unsafe’ food, ‘recall’ and ‘withdrawal’.
Micro criteria Without prejudice to the TVC counts for natural mineral water are
Article 5(3) provisions of paragraph 1 generally very low but can vary from source to
and 2 and the conditions source. Microbiological data for the previous
of exploitation laid two years are reviewed by the NSAI prior
down in Annex II, at to recognition. The ‘normal viable colony
the marketing stage: counts’ are determined from these data.
(a) The revivable total

colony count of natural
mineral waters may only
be that resulting from the
normal increase in the
bacteria content which
it had at source, and
(b) The natural mineral

waters may not contain
any organoleptic defects
23
Food contact Any containers used The possibility of adulteration or
materials. for packaging natural contamination can be reduced with the use
Article 6 mineral waters shall of tamper-proof or tamper-evident closures
be fitted with closures on the packaged water containers.
designed to avoid any
possibility of adulteration Material used for wrapping and packaging
or contamination. are not to be a source of contamination.
Wrapping materials are to be stored in such
a manner that they are not exposed to a risk
of contamination. Wrapping and packaging
operations are to be carried out so as to
avoid contamination of the products. Where
appropriate, and particularly in the case
of cans and glass jars, the integrity of the
container’s construction and its cleanliness
is to be ensured. Wrapping and packaging
material re-used for foodstuffs is to be easy
to clean and, where necessary, to disinfect
(Chapter X of Annex II of 852/2004).
All food contact materials must comply

with Regulation 1935/2004
(S.I. No. 587 of 2007) and with Regulation
2023/2006 on good manufacturing practice.
Additionally, the packaging must comply with

any material specific requirements. For example,
plastics must comply with Directive 2002/72/
EC and must be supplied with Declarations
of Compliance to this effect. Recycled plastics
must comply with Regulation (EC) no 282/2008.
At present (2010), there are no specific
additional requirements for glass. However,
Regulation 372/2007 outlines restrictions on
the gaskets used in lids for glass containers.
24
Labelling The sales description of ‘Sales description’ (this is not trade description)
Article 7(1) natural mineral waters The sales description on the label of natural
shall be “natural mineral mineral waters shall be ‘natural mineral
water”, or, in the case water’. This is the legal name which must
of effervescent natural be provided to provide sufficient information
mineral waters as defined for consumers. In addition, a trade name
in Annex I, Section may also be used (see Article 8 (2) below).
II, as appropriate,
• “ naturally carbonated The sales description of natural mineral
natural mineral water”, water which contains added carbon dioxide
• “ natural mineral water shall be one of the following options:
fortified with gas from • ‘Naturally carbonated’
the spring” or natural mineral water’
• “ carbonated natural • ‘Natural mineral water fortified
mineral water”. with gas from the spring’
• ‘Carbonated natural mineral water’.

See Appendix I for examples of labels.

Labelling The sales description of The sales description of natural mineral
Article 7(1) natural mineral waters waters which have undergone the total or
which have undergone partial elimination of free carbon dioxide by
any of the treatments exclusively physical methods shall have added
referred to in point d of to it as appropriate, the indication on the label:
the first subparagraph (a) ‘Fully de-carbonated natural mineral
of Article 4(1) shall water’ or
have added to it, as
appropriate, the indication (b) ‘Partially de-carbonated natural mineral
“fully de-carbonated” or water’
“partially de-carbonated”. As outlined in Council Directive 2000/13/
25
Labelling Labels on natural Labels on natural mineral waters shall also
Article 7(2) mineral waters shall give the following mandatory information:
also give the following
mandatory information: (a) Analytical composition
(a) A statement of the The label on natural mineral water shall give a
analytical composition, statement of the analytical composition giving its
giving its characteristic characteristic constituents. In order to comply
constituents with this requirement, the average composition
of the water shall be declared on the label.
(b) The place where the
spring is exploited and the The average composition on the label should
name of the spring, and reflect the composition of the well water.
(c) Information on any Examples of ions which may appear in the

treatments referred statement of analytical composition are
to in Article 4(1) listed below. Such ions shall be declared
point (b) and (c) in units of milligrams per litre (mg/L). The
chemical name or symbol shall be used
to define the ions listed. Examples:
• Calcium or Ca
• Magnesium or Mg
• Sodium or Na
• Potassium or K
• Other cations
• Bicarbonate or HCO3
• Chloride or Cl
• Sulphate or SO4
• Nitrate or NO3
As outlined below, Commission Directive

2003/40/EC states that the fluoride content
shall be provided in the analytical composition
for all natural mineral waters with a fluoride
concentration exceeding 1.5 mg/l.
26
Nutrition and health claims under Regulation
1924/2006, as amended, may also be made on
natural mineral water, e.g. source of calcium. If
these claims are made, they must comply with
the requirements of Regulation 1924/2006,
as amended. The content of the specified ion,
which the claim relates to, must be provided
in the analytical composition on the label.
(b) The place where the spring is exploited and

the name of the spring
The label shall state the place where the spring
is exploited and the name of the spring. The
location of the source of the water should be
readily identifiable and distinguishable from the
information provided on the product label.
(c) Permitted treatments requiring

addition labelling
• ozone enriched air: where the natural
mineral water has been treated with ozone
enriched air, the label shall include the
following information “water subjected
to an authorised ozone-enriched air
oxidation technique”. This information
shall be printed in the same field as the
information on the analytical composition
• other permitted treatments: Where the
natural mineral water has undergone a
separation process which is controlled
by the HSE, the label shall provide
information on such a treatment
• the removal of fluoride with activated
alumina as outlined below in Commission
Regulation 115 of 2010: ‘water
subjected to an authorised adsorption
treatment’ in proximity to the statement
of the analytical composition
27
As outlined below, Commission Directive
2003/40/EC states that natural mineral waters
with a fluoride concentration exceeding
1.5 mg/l shall bear on the label the words
‘contains more than 1.5 mg/l of fluoride: not
suitable for regular consumption by infants
and children under 7 years of age’. This
information shall be placed in immediate
proximity to the trade name and in clearly
visible characters. The fluoride content shall
be stated in the analytical composition table.
Labelling In the absence of There are no national provisions in Ireland.

Article 7(3) Community provisions
on information on any
treatment referred to in
paragraph 2 (c), Member
States may maintain their
national provision.
Note: Labelling of natural mineral waters must also comply with the
requirements of the general labelling legislation (Council Directive
2000/13/EC as amended, S.I. No. 483 of 2002 as amended).
28
Labelling The name of a locality, A spring is a body of ground water that
Article 8 (1) hamlet or place may occur emerges at some point. A spring may have
in the wording of a trade more than one natural or bore exits. All
description provided natural mineral water from these boreholes is
that it refers to natural considered to be from the one spring source.
mineral waters, the spring
of which is exploited at
If food business operators advise that
the place indicated by that
natural mineral water packed in their
description and provided
establishment is from more than one spring,
that it is not misleading
the food business operator must be able to
as regards the place of
demonstrate that there are two separate
exploitation of the spring.
sources of natural mineral waters, e.g.
composition differences of natural mineral
water from each spring. In this case, each
source of natural mineral water requires a
separate recognition process by the NSAI.
Trade description
The name of the 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.
When the labels or inscriptions on the

containers in which the mineral waters are
offered for sale include a trade description
different from the name of the spring or
the place of its exploitation, this place or
the name of the spring shall be indicated
in letters at least one and half times the
height and width of the largest of the
letters used for that trade description.
29
Labelling It shall be prohibited Trade description
(trade to market natural According to the general labelling rules, a
description) mineral waters from trade mark/trade descriptions/brand names
Article 8(2) one and the same spring is permitted in addition to the name of the
under more than one food, i.e. natural mineral water. However,
trade description. trade descriptions cannot appear instead of
the legal or customary name, as it does not
provide sufficient information for consumers.
Note:
• It is not permitted to market natural
mineral water from one and the same spring
under more than one trade description. If
a natural mineral water is bottled under
one trade description, all other natural
mineral water products from this source
must carry the same trade description
• Water recognised as natural mineral water
may also be sold as spring water provided
it meets the requirements for spring water
(see Section 2). Similarly, such spring water
shall only be marketed under one trade
description. This trade description can
be different to the trade description used
on the natural mineral water product
• Water recognised as natural mineral water
may also be sold as ‘other waters’ provided
it meets the requirements for other water
(see Section 3). ‘Other waters’ may be
sold under more than one trade description
30
Note: When the labels or inscriptions
on the containers in which the mineral
waters are offered for sale include a trade
description different from the name of the
spring or the place of its exploitation, this
place or the name of the spring shall be
indicated in letters at least one and half times
the height and width of the largest of the
letters used for that trade description.
See Appendix I for examples of labels.

Labelling When the labels or See note above.
Article 8 (3) inscriptions on the
containers in which the
are offered for sale
include a trade description
different from the name
of the spring or the place
of its exploitation, this
place or the name of the
spring shall be indicated
in letters at least one and
a half times the height
and width of the largest
of the letters used for
that trade description.
Labelling The first paragraph shall The above shall also apply to all types
Article 8 (3) apply, mutatis mutandis of advertising of natural mineral waters,
and with the same e.g. posters, TV advertisements etc.
intention as regards the
importance attributed
to the name of the
spring or the place of its
exploitation, with regards
to the trader description
used in advertising, in
whatsoever form, relating
to natural mineral waters.
31
Labelling It shall be prohibited , The labelling or advertising of the products
Article 9 (1) both on the packaging or shall not mislead the consumer.
labels and in advertising
in any form whatsoever, The use of the term ‘mineral water’ is not
to use indications, permitted on spring or ‘other water’.
designations, trademarks,
brand names, pictures
or other signs, whether A statement of the analytical composition
figurative or not, which: is required for natural mineral water.
(a) In the case of natural
mineral water, suggest Although not required, it is permitted
a characteristic to provide a statement of the analytical
which the water composition on the label of spring
does not possess, water and other packaged waters.
particularly regarding
its origin, the date of
the authorisation to
exploit it, the results
of the analyses or
any similar references
to guarantees of
authenticity
(b) In the case of drinking
water packaged in
containers, which
does not satisfy the
provision of Annex I,
Section I, it is liable
to cause confusion
with a natural mineral
water, in particular,
the description
‘mineral water’
Labelling All indications attributing Medicinal claims on foods are prohibited. All
Article 9 (2) to natural mineral waters indications attributing to natural mineral water
properties relating to the properties relating to the prevention, treatment
prevention, treatment or or cure of a human illness are prohibited.
cure of a human illness
32
Labelling However, the indications Annex II: Indications and Criteria
Article 9 (2) listed in Annex II shall be laid down in Article 9 (2)
authorised if they meet The label of natural mineral water may indicate
the relevant criteria laid the following properties provided that the
down in Annex II, or specific criteria are met. If an indication/
in the absence thereof, claim is made on the natural mineral water,
criteria laid down in the content of the specified ion must be
national provisions and provided in the compositional panel
provided they have been
drawn up on the basis of Indication Criteria
physico-chemical analyses Low mineral content Mineral salt content,
and, where necessary, calculated as a fixed residue,
pharmacological, not greater than 500 mg/l
Very low mineral Mineral salt content,
physiological and clinical
content calculated as a fixed residue,
examinations carried out not greater than 50 mg/l
according to recognised Rich in mineral salts Mineral salt content,
scientific methods, in calculated as a fixed residue,
accordance with Annex greater than 1,500 mg/l
I, Section I, point 2. Contains bicarbonate Bicarbonate content
greater than 600 mg/l
Contains sulphate Sulphate content greater
than 200 mg/l
Contains chloride Chloride content
Contains calcium Calcium content greater
than 150 mg/l
Contains magnesium Magnesium content
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 250mg/l
Contains sodium Sodium content greater
than 200 mg/l
Suitable for the
preparation of
infant food
Suitable for a low- Sodium content less than 20
sodium diet mg/l
May be laxative
May be diuretic
33
Criteria are not specified for
the following indications:
• Suitable for the preparation of infant
food: As recommended in the FSAI report
Recommendations for a National Infant Feeding
Policy, 1999 natural mineral waters should
not be used either to reconstitute formula
or as an infant drink. If water is used to
mix foods for infants, the water (not being
natural mineral water) should be cooled
boiled water. Milk (breast milk or formula)
and cooled boiled water should be the only
drinks given up to about the age of four
months and should constitute the great
majority of the drinks given during infancy.
• May be laxative: This claim
has not been authorised.
• May be diuretic: This claim
has not been authorised.
Nutrition and health claims under Regulation

natural mineral water, e.g. source of, high in. If
these claims are made, they must comply with
the requirements of Regulation 1924/2006,
as amended. The content of the specified ion
must be provided in the compositional panel.
34
Labelling Member States may Only indications outlined in Annex II are
Article 9 (2) authorise the indications authorised in Ireland. Such indications on
‘stimulates digestion’, imported products should be verified with the
‘may facilitate the hepato- competent authority of the country of origin.
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.
Labelling Member States may As recommended in the FSAI’s report
Article 9 (3) adopt special provisions 'Recommendations for a National Infant Feeding
regarding indications- Policy, 1999 natural mineral waters should
both on packaging or not be used either to reconstitute formula
labels and in advertising or as an infant drink. If water is used to
–concerning the suitability mix foods for infants, the water (not being
of a natural mineral water natural mineral water) should be cooled
for the feeding of infants. boiled water. Milk (breast milk or formula)
Such provisions may and cooled boiled water should be the only
concern the properties drinks given up to about the age of four
of the water which months and should constitute the great
determine the use of majority of the drinks given during infancy.
those indications.
Member States which

intend taking such
measures shall inform
the commission of
them beforehand.
35
Labelling Member States shall adopt No additional measures are adopted in Ireland.
Article 9 (3) the measures necessary
to ensure that trade in
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, labelling or
advertising of natural
mineral waters or
foodstuffs in general.
Article 9 (4) & Article 9 (5) do not apply to natural mineral water.
Enforcement Member States shall adopt
Article 10 the measures necessary
to ensure that trade in
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, labelling or
advertising of natural
mineral waters or
foodstuffs in general.
36
Enforcement Where a Member State
Article 11(1) has detailed grounds
for considering that a
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.
Enforcement At the request of
data any Member State or
Article 11(2) the Commission, the
Member State which has
recognised that water
shall provide all relevant
information concerning
recognition of that water,
together with the results
of the regular checks.
Article 11(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 deliver its
opinion forthwith and take
appropriate measures.
37
Article 11(4) If the Commission
considers that
amendments to this
Directive are necessary
in order to ensure the
protection of public
health, it shall adopt
those amendments.
Those measures,
designed to amend non-
essential elements of
this Directive, shall be
adopted in accordance
with the regulatory
procedure with scrutiny
14(2). On imperative
grounds of urgency, the
Commission may have
recourse to the urgency
procedure referred
to in Article 14(3).
The Member State which
has adopted safeguard
measures may, in that
event, retain them
until the amendments
have been adopted.
38
Article 12 The following measures
shall be adopted by
the Commission:
(a) L imits for the
concentrations of
constituents of natural
mineral waters
(b) A
ny necessary
provisions for the
indication on the
labelling of high levels
of certain constituents
(c) T
he conditions of use
of ozone-enriched
air referred to in
point (b) of the first
subparagraph of Article
4(1)
(d) T
he information
on the treatments
7(2)(c)
(e) M
ethods of analysis,
including limits of
detection, to verify the
absence of pollution of
(f) T
he sampling
procedures and the
methods of analysis
necessary for checking
the microbiological
characteristics of
39
Those measures, 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).
Article 13 Any decision likely to To date, no decisions were
have an effect on public adopted by the Commission.
health shall be adopted
by the Commission
of the European Food
Safety Authority.
Article 14 1. The Commission shall This article relates to Commission
be assisted by the procedures. Not applicable to natural
Standing Committee mineral water producers.
on the Food Chain
and Animal Health,
set up by Article 58
of Regulation (EC)
No 178/2002.
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.
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.
40
Article 15 This Directive shall not The requirements of the Directive do not apply
apply to natural mineral to natural mineral water products intended for
waters intended for export outside the EU. EHOs should check
export to third countries. where the product will be marketed, i.e. within
the EU or outside EU, prior to inspection.
All products exported must comply with the
specific legislation of the importing country.
Article 16 Directive 80/777/EEC, In 2009, Directive 2009/54/EC was published

as amended by the acts which is a recast of Council Directive 80/777/
listed in Annex IV, Part EEC and its amendments. However, since
A, is hereby repealed, Directive 2009/54/EC is a recast of Council
without prejudice to Directive 80/777/EEC with no material
the obligations of the modification, S.I. No. 225 of 2007 (as
Member States relating amended) remains applicable as the statutory
to the time-limits for instrument for Directive 2009/54/EC.
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.
Article 17 & Article 18: Directive is applicable to all Member
States and entered into force on 8th July, 2009.
41
Annex 1 of Directive 2009/54/EC
I of Annex I : Definition:
Definition ‘Natural mineral water’ Annex 1 relates to the recognition of natural
1. means microbiologically mineral water. In Ireland, the NSAI is the
wholesome water, responsible authority for the recognition
within the meaning of of natural mineral water. Following an
Article 5, originating in inspection, the NSAI issues a ‘Certificate of
an underground water Recognition’ and ‘Conditions of Exploitation’
table or deposit and to all natural mineral water establishments
emerging from a spring which have met the recognition criteria of
tapped at one or more this directive. Guidance on the recognition
natural or bore exists. requirements is available in the NSAI’s
Irish Standard on Packaged water.
Natural mineral
water can be clearly Information obtained during an inspection
distinguished from either by the NSAI or the environmental
ordinary drinking water: health service of the HSE which may be of
(a) By its nature, which relevance to the other should be passed onto
is characterised by that agency either directly or via the FSAI.
its mineral content,
trace elements or Each natural mineral water source
other constituents and recognised by the NSAI will have
, where appropriate, a unique chemical fingerprint. The
by certain effects conditions of exploitation will include:
(b) By its original purity iii. Tolerances for each chemical constituent.
The chemical composition should not be
both characteristics outside of the specified tolerance limits and
having been preserved iv. The specific boreholes which the
intact because of the recognition by the NSAI applies to
underground origin of
such water, which has Natural mineral water must retain its
been protected from original purity. Only limited treatments are
all risks of pollution. permitted as outlined under Article 4 above.
The water source shall be protected

from all risks of pollution. Methods
to protect the source against risk
are outlined in Annex II below.
42
Definition 2. These characteristics The food business operator must
referred to in Point 1, submit data on the following areas,
which may give natural which is for review by the NSAI:
mineral water properties • Geological and hydrogeological data
favourable to health, must • Microbiological, physical and chemical
have been assessed: (hydrochemical and physico-chemical)
(a) F rom the following • If necessary, pharmacological,
points of view: physiological and clinical data
(i) G
eological and
hydrological The NSAI reviews microbiological and chemical
(ii) P
hysical, chemical data submitted by the food business operator
and physico- from the previous two years. A complete
chemical chemical analysis audit (as described in Council
Directive 98/83/EC) is also carried out by
(iii) Microbiological
the NSAI. Following an inspection and review
(iv) If necessary, of data, the NSAI issues a ‘Certificate of
pharmacological, Recognition’ and ‘Conditions of Exploitation’
physiological and to natural mineral water establishments which
clinical have met the recognition legislative criteria.
(b) A
ccording to the
criteria listed in
Section II
(c) A
ccording to scientific
methods approved
by the responsible
authority
The analyses referred
to in (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 17th July, 1980.
This is particularly the
43
case when the water
in question contains,
per kg, both at source
and after bottling, a
minimum of 1,000
milligrams of total solids
in solution or a minimum
of 250 milligrams of
free carbon dioxide.
Definition 3. The composition, The conditions of exploitation will include
temperature and other tolerances for each chemical constituent.
essential characteristics The chemical composition should not
of natural mineral water be outside of these tolerance limits.
must remain stable within
the limits of natural The chemical composition of natural mineral
fluctuation; in particular, water is usually stable. However, in some
they must not be affected circumstances, the composition may change.
by possible variations Example, over a period of time (decades)
in the rate of flow. the hardness of the water may change.
This is a natural change in the water. In
Within the meaning of this case, the NSAI reviews the data and
Article 5(1), the normal amends the conditions of exploitation.
viable colony count of
natural mineral water TVC counts for natural mineral water are
means the reasonably generally very low but can vary from source to
constant total colony source. Microbiological data for the previous
count at source before two years are reviewed by the NSAI prior
any treatment, the to recognition. The ‘normal viable colony
qualitative and quantitative counts’ are determined from these data.
composition of which,
as taken into account
in the recognition of
that water is checked
by periodic analysis.
44
II of Annex I: Requirements and criteria for applying the definition
Requirements Requirements for Food business operators must have a
and criteria geological and hydrological and geological survey carried
1.1 hydrological surveys: out by a qualified professional in this area. A
There shall be a copy of the survey should be maintained for
requirement to supply inspection as long as the well is in production.
the following particulars:
The survey should include:
Requirements The exact site of the • Approximate size and location of the
and criteria catchment with indications groundwater catchment area by a line on an
1.1.1 of its altitude, on a appropriate map
map with a scale of not • Origin and nature of the terrain in and
more than 1:1000 adjacent to the groundwater catchment area
Requirements A detailed geological • Geology of the groundwater catchment area
and criteria report on the origin and
1.1.2 nature of the terrain • Hydrogeology of the groundwater system
feeding the water source
Requirements The stratigraphy of the
and criteria hydrogeological layer • Geotechnical properties of the construction
1.1.3 site
Requirements A description of the • Identification of other abstraction points and

and criteria catchment operations water features (boreholes, wells and springs)
1.1.4 within the catchment area
Requirements The demarcation of the • Identification of activities being carried out in

and criteria area or details of other the groundwater catchment area
1.1.5 measures protecting the • Assessment of the risk of these activities
spring against pollution. contaminating the groundwater. Food
business operators must define the control
measures in place for each risk identified
Where appropriate, the location of
sites from which there is a risk of
contamination to the groundwater, should
be shown on a map of the area.
45
During the groundwater catchment
area study, the following should be
defined where practicable and where
necessary, shall be quantified:
• Recharge zone
• Response of the water table to
meteorological events during the different
seasons, e.g. rainfall or drought
• Correlation of the groundwater chemistry
and microbiology to meteorological events
and seasonal land use activities
• Effect of abstracting groundwater from the
production well on the other abstraction
points and on surface water flow (streams
and rivers)
• Geotechnical characteristics of the ground
conditions at the well construction site
to assist in design specifications for the
foundations and source protection
The progression of a well construction

and development shall include:
• Identify project area
• Study the catchment area
• E stablish the nature of the hydro geological
system
• Drill and test exploration boreholes
• Drill and test production boreholes
• Test the source to establish suitability
46
Survey Requirements for physical, chemical and physio-chemical surveys:
requirement These surveys shall establish:
1.2
Survey The rate of flow The survey should also include the following:
requirement of the spring
• Rate of flow of the spring
1.2.1
• Relationship between the nature of the
Survey The temperature of the terrain and the nature and types of minerals
requirement water at source and the in the water
1.2.2 ambient temperature
A chemical analysis of the water must be
Survey The relationship between carried out to establish the following:
requirement the nature of the terrain • Dry residues at 180˚C and 260˚C
1.2.3 and the nature and types
of minerals in the water • Electrical conductivity or resistivity, with
the measurement temperature having to be
Survey The dry residues at specified
requirement 180˚C and 260˚C
• Hydrogen ion concentration (pH)
1.2.4
• Anions and cations
Survey The electrical conductivity • Non-ionised elements

requirement or resistivity, with the • Trace elements
1.2.5 measurement temperature
• Radioactinological properties at source (the
having to be specified
NSAI requires food business operators to
Survey The hydrogen ion send samples for α and ß radiation analysis
requirement concentration (pH) ever four years)
1.2.6
• Toxicity of certain constituent elements of
Survey The anions and cations the water, taking account of the limits laid
requirement down for each of them
1.2.7
Survey The non-ionised elements
requirement
1.2.8
47
Survey The trace elements As part of the recognition process, each
requirement natural mineral water establishment is
1.2.9 required to carry out the following chemical
sampling and analysis programme:
Survey The radioactinological
requirement properties at source • Annual samples from authorised borewells
1.2.10 (source) and packed product, for a range of
chemical parameters
Survey Where appropriate,
requirement the relative isotope • Monthly samples of source water analysed
1.2.11 levels of the constituent for a range of chemical analysis
elements of water, • Quarterly samples of source water analysed
oxygen (16O — 18O) for a range of chemical analysis
and hydrogen (protium,
deuterium, tritium) • Annual sample of source water analysed for
heavy metals
Survey The toxicity of certain
requirement constituent elements • Sample of source water analysed for trace
1.2.12 of the water, taking metals, trace organics and radioactivity every
account of the limits laid four years
down for each of them • Daily samples of source water analysed for a
range of chemical parameters
48
Micro criteria Criteria for microbiological analyses at source:
at source 1.3 These analyses shall include:
Micro criteria A demonstration A microbiological analysis of the water must
at source of the absence of demonstrate that the water meets the specified
1.3.1 parasites and pathogenic microbiological criteria. See Article 5 above.
microorganisms As part of the recognition process, each
Micro criteria A quantitative natural mineral water establishment is required
at source determination of the to carry out the following microbiological
1.3.2 revivable colony count sampling and analysis programme:
indicative of faecal • Annual samples from authorised borewells
contamination: (source) and packed product, for a range of
(a) A
bsence of Escherichia micro parameters
coli and other coliforms • Monthly samples of source water analysed
in 250 ml at 37˚C and for a range of micro analysis
44,5˚C
• Annual sample of source water analysed for
(b) Absence of faecal pathogens and parasites, e.g. Enterovirus,
streptococci in 250 ml Helminths, Cryptosporidium and Giardia
(c) A
bsence of sporulated • Daily samples of source water analysed for a
sulphite-reducing range of micro parameters
anaerobes in 50 ml
• Samples of each batch of packaged product
(d) A
bsence of for a range of micro parameters
Pseudomonas
aeruginosa in 250 ml
Micro criteria Determination of the

at source revivable total colony
1.3.3 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
49
1.4 Requirements for clinical and pharmacological analyses
Clinical and The analyses, which
pharmaco- shall be carried out
logical in accordance with
analyses 1.4.1 scientifically recognised
methods, shall be
suited to the particular
characteristics of the
and its effects on the
human organism, such
as diuresis, gastric and
intestinal functions,
and compensation for
mineral deficiencies.
Clinical and The establishment of
pharmaco- the consistency and
logical analy- concordance of a
ses 1.4.2 substantial number of
clinical observations may,
if appropriate, take the
place of the analyses
referred to in point
1.4.1. Clinical analyses
may, in appropriate
cases, take the place of
the analyses referred to
in point 1.4.1 provided
that the consistency
and concordance of a
substantial number of
observations enable
the same results
to be obtained.
50
III of Annex I: Supplementary qualifications relating to effervescent natural mineral waters
This section is outlined
in Article 4(2) above.
Annex II Conditions for exploitation and marketing of natural mineral water
Exploitation Exploitation of a natural The NSAI is the responsible authority
and mineral water spring shall for the exploitation and recognition
marketing 1 be subject to permission of natural mineral water.
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.
Exploitation Equipment for exploiting The catchment area is the surface area
and the water shall be so within which rainfall can either directly or
marketing 2 installed as to avoid indirectly enter the ground water system
any possibility of into which the well is trapped and which
contamination and to can contribute to the yield of the well.
preserve the properties, The catchment area should be included
corresponding to those in the HSE food safety inspections of the
ascribed to it, which the establishment. As the groundwater is not
water possesses at source. treated, protection and management of the
To that end, in particular: well and ground water catchment area should
(a) T
he spring or outlet be a Critical Control Point in the HACCP
shall be protected plan of the establishment. Protection of
against the risks of the source must be managed effectively.
pollution
The production well and groundwater
catchments areas shall be protected
from hazards. The food business
operator must manage the groundwater
source to avoid contamination.
51
Site location
Consideration should be given to the
following areas in relation to site location:
• The potential risk of contamination from
other activities in the vicinity and the
necessary controls implemented to minimise
the risk of contamination
• Protection and maintenance of the
grounds of the establishment to avoid the
establishment of breeding sites for rodents
and insects
• Procedures in place for the management of
all waste generated on site
• Site maintenance and cleanliness
• Site design and layout to facilitate the
operation of good hygiene practices
Site security/site access

The site should be adequately secured to
prevent unauthorised access. The packaged
water operator shall have security measures
in place, e.g. fencing intruder alarms, to ensure
that only authorised staff have access to
water source, production and storage areas.
Areas for identification and protection

on the groundwater production site
The food business operator shall identify
the groundwater protection zones, identify
permitted and not acceptable activities
in protection zones and put in place a
well field management programme.
52
Examples of protection zones:
• Inner protection zone: consisting of the
borewell within a purpose built enclosure.
Borewell security is necessary. The bore
well must be capped and the caps locked
for protection. The hut should be locked
and alarmed. An intruder alarm system
should be installed on the production
borehole with access to the borehole head
limited to authorised personnel. Boreholes
should have sampling valves for sampling at
source. Review the pipework entering the
establishment. Storage silos and pipework
must also be protected.
• Outer protection zones for the

production well, e.g. fields surrounding the
well. The food business operator should liaise
with the county council on activities on the
surrounding land, review ongoing planning
applications and annual land use surveys etc.
Contamination sources
The water packager shall ensure that the
boreholes and groundwater are protected
from sources of contamination. Possible
contamination sources include:
• Connections between the ground surface and
the underlying aquifer from surface activity
can be a source of contamination and should
be controlled
53
• All fuel and liquid storage tanks should be
located above ground, rest on impervious
bases and be bunded. Tanks for petrol diesel
or other liquid hydrocarbons should not be
located within 100 metres of the well or
observation boreholes
• The ground underlying any storage tank in

the construction area shall be investigated
and categorised with regards to permeability
and potential hydraulic contact with the
aquifer
• The drilling or excavation of new abstraction

points within the capture area shall be
avoided as it could seriously impact on the
performance and quality of the source used
for packaging
• The use of land in the groundwater

catchment area should be monitored at
defined intervals to detect changes in
activities and a risk assessment of these
activities to contaminate the source should
be undertaken
i. Planning applications for developments
in the groundwater catchment area
shall be critically assessed for potential
contamination of the groundwater system
during the development and following
completion of the development. Food
business operators should have evidence
that they reviewed planning applications
on the local area for developments in the
specified protection zones which may
impact on the protection of the aquifer.
A log of this review and each outcome
should be maintained on file.
54
ii. Agricultural activity on the land should be
limited. Pesticides and herbicides shall not
be used in the area of the well. Controlled
use of rodenticide is acceptable.
Agreements should be in place between
the food business operator and county
council or owner of the land regarding
restricted agricultural activities within the
protection zone.
• In the event of a contamination incident
involving the aquifer or surface water, the
food business operator should seek advice
from the HSE for action to take
• All pipes valve arrays and power cables

to and from the well and packaging
establishment shall be adequately secured and
protected
• Chemicals should be segregated and stored

in a bunded area or over suitable drip trays.
Where the bunds provided have drains, the
drains shall be locked at all times. The bunds
on the site should be integrity tested every
three years. The volume of bunds should
exceed by 10% the volume of the largest unit
in the bund
• All wastewater from the site shall be

discharged to an appropriate waste water
collection system
• Waste compactors should be located in a

bunded area
55
• Agricultural contamination sources include:
- Storage and use of fertilisers, pesticides and
weed killers
- Run off from silage pits
- Spreading of manure
- Septic and slurry tanks
- Fuel storage tanks
- Burial of offal
- Disposal of other farm wastes
- Animal access
• Commercial contamination sources include:

- Petrol and service stations
- Underground storage tanks
- Cemeteries
- Construction sites
- Railway lines (weed killer) and roads
- Waste from hospitals
- Dry cleaners and laundries
- Junk yards

• Industrial contamination sources include:
- Storage of chemicals above or below
ground
- Chemical spillages
- Disposal of solvents and waste products
- Effluent establishments and settlement
lagoons
- Disposal of effluent sludge
- Leaks from pipelines
- Inadequately protected wells (operating/
abandoned)
- Use of weed killers, pesticides
56
• Residential contamination sources include:
- Storage of heating oil
- Septic tanks and sewerage lines
- Use of garden chemicals
- Disposal of hazardous household products
- Other contamination sources include
- Municipal dumps
- Storm drains and sewerage lines
- Road maintenance depots
- Incinerators
Natural protection
In general, the deeper the well, the greater
the protection from the surface activities.
However, this may vary depending on the soil
type. The flow of the ground water may also
protect the water from environmental factors.
(b) T
he catchment, Requirements for food contact materials
pipes and reservoirs All material, from the point of extraction
shall be of materials through to bottling, which comes in contact
suitable for water with natural mineral water must comply
and so built as to with food contact material legislation.
prevent any chemical,
physico-chemical
All processing equipment which comes
or microbiological
into direct contact with the water shall
alteration of the water
be manufactured in compliance with good
manufacturing practice so that under normal
conditions of use it will not transfer its
constituents to the water in quantities that
could endanger human health and/or impart
odours or taint to the product. All product
contact piping shall be made from materials that
are supplied labelled “for food contact” and
comply with food contact material legislation.
The surfaces in contact with the water shall
be resistant to corrosion when cleaned with
food grade cleaning and sanitising agents.
57
(c) The conditions of c) Hygiene requirements
exploitation, particularly All processing equipment which comes into
the washing and bottling direct contact with natural mineral water shall
equipment, shall meet be manufactured in compliance with good
hygiene requirements; in manufacturing practice so that under normal
particular, the containers conditions of use have an adverse effect on
shall be so treated or the microbiological or chemical composition of
manufactured as to the spring water. Equipment shall be installed
avoid adverse effects on so that there is adequate access under, around
the microbiological and and inside the equipment to enable effective
chemical characteristics of cleaning. Equipment shall be maintained at
the natural mineral water defined intervals and procedures shall be in
place to ensure that the maintenance activity
does not result in product or equipment
contamination. Product contact surfaces shall
be non-toxic and easy to clean and maintain.
Hygiene requirements of Regulation 852/2004

are applicable throughout production.
Plastic bottles may be blow moulded on site.

An extensive certificate of compliance should
accompany the delivery of all plastic material
for use with food. Sterilisation of bottles and
caps is permitted. The sterilised material should
be free from residues following this process.
If a different water supply is used for

cleaning, this water must be potable. This
water supply must be strictly controlled.
Normally, separate pipes are used for
the supply of this cleaning water.
58
(d) The transport of Transport of natural mineral waters
natural mineral water Natural mineral waters must be
in containers other packaged in containers for the final
than those authorised consumer on site (typically 0.5, 1 and
for distribution to the 10 litre containers). The derogation
ultimate consumer mentioned does not apply to Ireland.
Reservoirs/Storage tanks
However, point (d) Natural mineral water sourced from one or
need not be applied to more boreholes from a single aquifer can be
mineral waters extracted, stored in the same storage tanks. Natural
exploited and marketed mineral water sourced from a different aquifer
in the territory of a should be stored in a separate storage tank.
Member State if, in
that Member State on
17 July 1980, transport
of the natural mineral
water in tanks from the
spring to the bottling
plant was authorised.
Similarly, point (d)

need not be applied to
spring waters extracted,
exploited and marketed in
the territory of a Member
State if, in that Member
State on 13 December
1996, transport of the
spring water in tanks from
the spring to the bottling
59
Exploitation Where it is found If in-house or official control testing results
and marketing during exploitation that indicate that the raw water is polluted,
3 the natural mineral production must stop immediately.
water is polluted and The problem must be rectified prior to
no longer presents re-commencement of production.
the microbiological
characteristics laid down If the natural mineral water from a particular
in Article 5, the person borehole becomes contaminated, the food
exploiting the spring shall business operator must inform the NSAI.
forthwith suspend all The NSAI then suspends permission for the
exploitation, particularly exploitation of natural mineral water from
the bottling process, until these boreholes. The food business operator
the cause of pollution may continue to exploit natural mineral
is eradicated and the water from additional recognised boreholes
water complies with the provided that they are not contaminated.
provisions of Article 5.
Boreholes can be disinfected to rectify

the contamination problem. Example:
hypochloride is permitted as a disinfectant.
Food business operators must be able to
demonstrate that there is no carryover
of disinfectant into the natural mineral
water, e.g. residue analysis sampling.
Causes for contamination

Causes from contamination
include the following:
• Contamination of boreholes may be caused
by the development of a biofilm on the
inside casing or piping down the borehole.
Food business operators generally monitor
for biofilm development by sampling
for the presence of TVCs and coliform.
As a control measure, food business
operators may replace the borehole
casing/piping to prevent contamination.
• Piping into the establishment
• Equipment used and/or
• Poor hygiene practices of staff
60
Exploitation The responsible authority As outlined above, the NSAI is the
and marketing in the country of origin authority responsible for the recognition
4 shall carry out periodic of natural mineral water.
checks to see whether:
(a) T
he natural mineral Environmental health officers of the HSE are
water in respect of responsible for official control inspections in
which exploitation of such establishments. Official control inspections
the spring has been shall be carried out in accordance with the
authorised complies FSAI’s Guidance Note No.1 for Health Boards on
with the provisions of the Inspection of a Food Business (Revision 1)
Annex I, Section I
(b) T
he provisions of
points 2 and 3 are
being applied by the
person exploiting the
spring
61
1.2 Commission Directive 2003/40/EC: Establishing the list, concentration limits
and labelling requirements for the constituents of natural mineral waters and the
conditions for using ozone enriched air for the treatment of natural mineral waters
and spring waters

Commission Directive
2003/40/EC
Chemical This Directive establishes All natural mineral waters shall comply with
criteria the list of constituents of the maximum concentration limits set out
Article 1 & 2 natural mineral waters in Table 1.2 for the constituents listed.
which may present a risk
Chemical
to public health, the limits Analysis of official control samples of
criteria
for admissible levels of natural mineral water for the parameters
Article 3
these constituents, the listed below (from Annex I of 2003/40/
deadlines for application EC) shall be in accordance with Table 1.3
of these limits and the
labelling requirements
for certain constituents.
These constituents
must be present in the
water naturally and
may not result from
contamination at source.
It also defines the
conditions for using
ozone-enriched air for
separating compounds of
iron, manganese, sulphur
and arsenic from natural
mineral waters or spring
waters, and the labelling
requirements for waters
which have undergone
such treatment.
1) By 1 January 2006 at
the latest, natural mineral
waters shall, at the time of
packaging, comply with the
maximum concentration
limits set out in Annex
I for the constituents
listed in that Annex.
62
2003/40/EC
2. However, in the case
of fluorides and nickel,
the deadline referred
to above is extended
until 1 January 2008.
3. By way of derogation
from paragraph 1, during
the procedure for official
recognition of natural
mineral waters collected
within their territory, the
competent authorities of
the Member States may
take a lower reference
value for nitrates and
nitrites, provided that the
same reference value is
applied to all applications
made to them.
For the purposes
of official controls,
the Member States
shall comply with the
specifications listed in
Annex II for analysing
the constituents
listed in Annex I.
63
2003/40/EC
Labelling 1) Natural mineral Natural mineral waters with a fluoride
Article 4 waters with a fluoride concentration exceeding 1.5 mg/l shall
concentration exceeding bear on the label the words ‘contains
1.5 mg/l shall bear on the more than 1.5 mg/l of fluoride: not
label the words ‘contains suitable for regular consumption by infants
more than 1.5 mg/l of and children under 7 years of age’.
fluoride: not suitable
for regular consumption This information shall be placed in
by infants and children immediate proximity to the trade name
under 7 years of age’. and in clearly visible characters.
2. The label information The fluoride content shall be stated in

laid down in paragraph the analytical composition table.
1 of this Article shall
be placed in immediate
proximity to the trade Article 7(2) (a) of Directive 80/777/
name and in clearly EEC now replaced with Article 7(2)
visible characters. (a) of Directive 2009/54/EC.
3. Natural mineral waters

which, under the terms of
paragraph 1 of this Article,
bear label information,
shall indicate the actual
fluoride content in
relation to the physico-
chemical composition
in terms of essential
constituents, as laid
down in Article 7(2)(a) of
Directive 80/777/EEC.
64
2003/40/EC
Treatments 1. Without prejudice Treatment of natural mineral
Article 5 to the provisions of water with ozone enriched air
Article 4(1)(b) of 1. Food business must apply to their local
Directive 80/777/ environmental health service of the HSE for
EEC, application of authorisation for the use of this treatment.
the treatment of Such treatment shall only commence
natural mineral waters following receipt of written approval from
with ozone-enriched the HSE. Records of ozone use should be
air must be notified retained by the food business operator. The
in advance to the environmental health service of the HSE must
competent authorities, specifically control the use of this treatment
who shall ensure that: in the food business operation authorised to
(a) Use of such treatment use this treatment.
is justified by the
composition of the
(a) The HSE shall ensure that the use of this
water in terms of
treatment is justified by the composition of
compounds of iron,
the water in terms of compounds of iron,
manganese, sulphur
manganese, sulphur and arsenic. The food
and arsenic;
business operator must demonstrate that
the untreated water contain the specific
(b) The operator takes all compounds (iron, manganese, sulphur and
measures necessary arsenic) which may be removed using this
to guarantee that the treatment.
treatment is effective
and safe and to allow
(b) The food business operator shall be
it to be checked
able to demonstrate the effectiveness
by the competent
of this treatment to the environmental
authorities
health service of the HSE when requested.
Comparisons of chemical composition pre
and post treatment should demonstrate the
effectiveness of the treatment.
65
2003/40/EC
2. Ozone-enriched air 2.
treatment of natural (a) The physico-chemical composition of the
mineral waters must natural mineral waters in terms of essential
comply with all the constituents shall not be modified by the
following conditions: treatment. The food business operator
must demonstrate, e.g. comparison
(a) T
he physico-chemical of chemical analysis data pre and post
composition of the treatment, that the essential chemical
natural mineral waters composition of the natural mineral water
in terms of essential (as determined by the food business
constituents shall operator) is not altered by this treatment.
not be modified by
the treatment (b) The use of this treatment is likely to
reduce the microbiological composition
(b) T
he natural mineral of the natural mineral water. Therefore,
water before natural mineral water must comply with
treatment must the microbiological criteria specified
comply with the in Article 5(1) and 5 (2) Directive
microbiological 2009/54/EC of for natural mineral
criteria laid down in water prior to this treatment.
Article 5(1) and (2) of
Directive 80/777/EEC (c) The treatment shall not lead to the
formation of residues with a concentration
(c) T
he treatment shall exceeding the maximum limits laid down
not lead to the in Annex III below or residues which
formation of residues could pose a risk to public health. The
with a concentration HSE’s environmental health service shall
exceeding the monitor treated natural mineral waters
maximum limits laid for compliance with the residue criteria
down in Annex III outlined in Annex III. Sampling should
or residues which take place at the point of bottling.
could pose a risk
to public health
66
2003/40/EC
Annex III
Maximum limits for residues from
treatment of natural mineral
waters by ozone-enriched air
Treatment residue Maximum limit (*)
(μg/l)
Dissolved ozone 50
Bromates 3
Bromoforms 1
(*) Compliance with the maximum
limits is monitored by the competent
authorities in the Member States at the
time of bottling or other form of packaging
intended for the final consumer.
Treatments Pursuant to Article 7(2) Addition labelling requirements
and Labelling (c) of Directive 80/777/ Where the natural mineral water has been
Article 6 EEC, the labelling of treated with ozone enriched air, the label
natural mineral waters shall include the following information
which have been treated “water subjected to an authorised ozone-
with ozone-enriched air enriched air oxidation technique”. This
shall bear, in proximity to information shall be printed in proximity to
the analytical composition the information on the analytical composition.
of characteristic
constituents, the words
Article 7(2)(a) of Directive 80/777/
‘water subjected to an
EEC is now replaced with Article 7(2)
authorised ozone-enriched
(a) of Directive 2009/54/EC.
air oxidation technique’.
Article 7 Without prejudice to the Articles 5 and 6 of Directive 2009/54/
provisions of Article 9(4) EC also apply to spring waters
(b) of Directive 80/777/
EEC, the provisions of
Articles 5 and 6 of this
Directive shall apply
to spring waters.
67
2003/40/EC
Article 8 The Member States
shall take the necessary
measures to permit the
marketing of products
complying with the
present Directive by 1
January 2004 at the latest.
2) Without prejudice
to the deadlines set
out in Article 2(1)
and (2), the Member
States shall prohibit the
marketing of products
not complying with the
present Directive from
1 July 2004. However,
products packaged and
labelled prior to 1 July
2004 may be sold until
stocks are exhausted.
68
2003/40/EC
Article 9 The Member States
shall bring into force the
laws, Regulations and
administrative provisions
necessary to comply
with this Directive by
31 December 2003 at
the latest. They shall
forthwith inform the
Commission thereof.
The provisions adopted
pursuant to this paragraph
shall contain a reference
to this Directive or shall
be accompanied by such
reference at the time of
their official publication.
Member States shall
determine how such
reference is to be made.
69
1.3 Commission Regulation 115/2010 laying down the conditions for use of activated
alumina for the removal of fluoride from natural mineral waters and spring waters
115/2010/EC
Treatment The treatment of Natural mineral water may be treated with
Article 1 (1) natural mineral waters activated alumina in order to remove fluoride.
and spring waters with
activated alumina in
order to remove fluoride,
hereinafter ‘the fluoride
removal treatment’,
shall be allowed.
Natural mineral waters

and spring waters
together are referred to
hereinafter as ‘water’.
Treatment The fluoride removal The removal of fluoride with activated alumina
Article 1 (2) treatment shall be shall be in accordance with this Regulation.
performed in accordance
with the technical
requirements as set
out in the Annex.
Treatment The release of residues The food business operator shall
Article 2 into the water as a implement and monitor the critical
result of the fluoride processing steps set in the Annex.
removal treatment shall
be as low as technically
feasible according to
the best practices and
shall not pose a risk to
public health. To ensure
this, the operator shall
implement and monitor
the critical processing
steps set in the Annex.
70
115/2010/EC
Treatment The application of The application of a fluoride removal
Article 3 (1) a fluoride removal treatment shall be notified to the HSE
treatment shall be at least three months prior to use.
notified to the competent
authorities at least three
months prior to use.
Treatment With the notification, The food business operator shall submit
Article 3 (2) the operator shall relevant information, documentation and
communicate to the analytical results on the treatment to the HSE
competent authorities which demonstrate compliance with the Annex.
relevant information,
documentation and
analytical results on
the treatment which
show that it complies
with the Annex.
Labelling The label on water Natural mineral water which has undergone
Article 4 which has been the this treatment for the removal of fluoride shall
subject of a fluoride had the following indication on the label:
removal treatment shall • ‘Water subjected to an authorised
include, in proximity to adsorption technique’
the statement of the
analytical composition,
This indication shall be in proximity to the
the indication ‘water
statement of the analytical composition.
subjected to an authorised
adsorption technique’.
Marketing Products which were No such products were on the market
Article 5 placed on the market in Ireland prior to 10 August 2010.
by 10 August 2010 and
which do not comply
with Article 4, may
continue to be marketed
until 10 August 2011.
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115/2010/EC
Annex: Technical requirements for the use of activated alumina for
the removal of fluoride from natural mineral waters and spring waters
The following critical processing steps shall be implemented and monitored appropriately:
1 Before the activated
alumina is used for the
treatment of water it
shall be subjected to an
initialisation procedure
which includes the use of
acidic or alkaline chemicals
to remove any residues
and a backwash treatment
to remove fine particles.
2 A regeneration procedure
shall be applied at
intervals ranging from
one to four weeks
depending on the water
quality and throughput.
It shall include the use
of appropriate chemicals
to remove the adsorbed
ions in order to restore
the adsorption capacity
of the activated alumina,
and to remove any
possibly formed biofilms.
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This procedure shall be
done in the following
three stages:
– Treatment with sodium
hydroxide to remove
fluoride ions and replace
them with hydroxide ions
– Treatment with an
acid to remove residual
sodium hydroxide and
activate the medium
– Rinsing with drinking

or demineralised water
and conditioning with the
water as the final step in
order to ensure that the
filter has no impact on the
overall mineral content
of the treated water
3 The chemicals and
reagents used for
the initialisation and
regeneration procedures
relevant European
standards (European
Standards developed by
the European Committee
for Standardisation
(CEN)) or applicable
national standards
relating to the purity of
the chemical reagents
used for treatment
of water intended for
human consumption.
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115/2010/EC
4 The chemicals and
reagents used for
the initialisation and
regeneration procedures
relevant European
standards (European
Standard EN 12902
(2004): Products used
for treatment of water
intended for human
consumption. Inorganic
supporting and filtering
materials) or applicable
national standards
used for treatment
human consumption.
5 The processing steps
shall be subject to good
manufacturing practices
and HACCP principles set
out in Regulation (EC) No
852/2004 of the European
Parliament and of the
Council on food hygiene
(OJ L 139, 30.4.2004, p.1).
6 The operator shall
establish a monitoring
programme in order
to ensure the proper
functioning of the
processing steps in
particular as regards
the maintenance of the
essential characteristics
of the water and its
fluoride content.
74
1.4 Sampling and analysis of natural mineral waters by official agency (HSE)
Minimum frequencies of sampling and analysis for the purpose of monitoring by the official agency
are not specified in Directive 2009/54/EC for natural mineral waters. The following frequency of
sampling at the establishment is recommended:
• Quarterly microbiological sampling

• Biannual chemical sampling
The volume of product produced in the establishment must be considered when sampling.
Frequencies may vary depending on production periods. The frequencies can be adjusted
accordingly when statistical trends on the microbiological/chemical qualities are established.
To establish a profile of the microbiological and chemical composition of the water during
production, it is suggested that samples should be taken at various locations, e.g. at well head,
before and after any treatment and the finished product.
Ice produced from natural mineral water
Ice produced from natural mineral water is not covered by Directive 2009/54/EC. However,
if it is claimed that the ice cubes are produced using natural mineral water then that water
must meet the requirements of legislation applicable to natural mineral water (except labelling
requirements).
75
Table 1.1 Summary of microbiological limits for natural mineral waters
Microbiological Limit at Limit in Reference Recommended
parameter source package frequency of analysis
of in house testing
by food business
operator***
TVC @ 20-22˚C ≤20 cfu/ml* ≤100cfu/ml** Article 5 (1) Daily
for 72hrs of Directive
2009/54/EC
TVC @ 37˚C <5 cfu/ml* <20cfu/ml** Article 5 (1) Daily
2009/54/EC
Coliforms 0 in 250mls 0 in 250mls Article 5 (2b) Daily
@ 37˚C of Directive
2009/54/EC
Escherichia coli 0 in 250mls 0 in 250mls Article 5 (2b) Daily
@ 44.5˚C of Directive
2009/54/EC
Sporulated 0 in 50 mls 0 in 50mls Article 5 (2c) Monthly
sulphite reducing of Directive
anaerobes 2009/54/EC
Enterococci 0 in 250mls 0 in 250mls Article 5 (2b) Daily
(faecal of Directive
streptococci) 2009/54/EC
Pseudomonas 0 in 250mls 0 in 250mls Article 5 (2d) Monthly
aeruginosa of Directive
2009/54/EC
Parasites and Absent Absent Article 5 (2a) Yearly
pathogenic of Directive
micro-organisms 2009/54/EC
*figures are legislative guide figures
** Samples must be measured within 12 hours of bottling and maintained at 4 ± 1˚C during this
12 hour period.
*** Sourced from IS 432 of 2010
76
Table 1.2 Criteria for chemical constituents naturally present in natural mineral
waters
Constituents Maximum limits (mg/l)
Antimony 0.005
Arsenic 0.01 (as total)
Barium 1.0
Boron For the record (*)
Cadmium 0.003
Chromium 0.05
Copper 1.0
Cyanide 0.07
Fluorides 5.0
Lead 0.01
Manganese 0.5
Mercury 0.001
Nickel 0.02
Nitrates 50
Nitrites 0.1
Selenium 0.01
If the constituents listed above are present in the natural mineral water above the
specified limits, the natural mineral water may pose a risk to public health
* The maximum limit for boron will be fixed, where necessary, following an opinion of the
European Food Safety Authority and on a proposal from the Commission by 1 January 2006.
77
Table 1.3 Performance characteristics* for analysing the chemical constituents
Constituents Accuracy of Precision of Detection Notes
parametric parametric limit in % of
value in % ** value*** parametric
value****
Antimony 25 25 25
Arsenic 10 10 10
Barium 25 25 25
Boron See Table 1.1
Cadmium 10 10 10
Chromium 10 10 10
Copper 10 10 10
Cyanides 10 10 10 Note 1
Fluorides 10 10 10
Lead 10 10 10
Manganese 10 10 10
Mercury 20 10 20
Nickel 10 10 10
Nitrates 10 10 10
Nitrites 10 10 10
Selenium 10 10 10
*Analytical methods for measuring concentrations of the constituents listed in Table

1.2 must be able to measure, as a minimum, concentrations equal to the parametric
value with a specified accuracy, precision and detection limit. Whatever the sensitivity
of the method of analysis used, the result will be expressed using at least the same
number of decimal places as for the maximum limit laid down in Table 1.2.
**Accuracy is the systematic error and is the difference between the average
value of a large number of repeated measurements and the exact value.
***Precision is the random error and is expressed in general as the standard

deviation (within a batch and between batches) of a sample of results from the
average. Acceptable precision is equal to twice the relative standard deviation.
78
****The detection limit is:
– Either three times the relative standard deviation within a batch of a
natural sample containing a low concentration of the parameter
– Or five times the relative standard deviation within a batch of a virgin sample
Note 1: The method should make it possible to determine total cyanide in all its forms.
79
SECTION 2. SPRING WATER
The environmental health service of the HSE is the responsible authority for the enforcement of
all food legislation in spring water establishments. Unlike natural mineral water, there is no legal
requirement for recognition of spring water. Article 9 (4 & 5) of Directive 2009/54/EC apply to
spring water. The provisions of Council Directive 98/83/EC on the quality of water (sold in bottles
or containers) intended for human consumption apply to spring water. In addition, the provisions
of Article 5 and 6 of Commission Directive 2003/40/EC apply to spring water which is treated
with ozone-enriched air. All requirements of Commission Regulation 115/2010 apply to spring
water which is treated with activated alumina for the removal of fluoride.
2.1 Directive 2009/54/EC on the exploitation and marketing of natural

mineral waters
2009/54/EC
Definition Definition: The description ‘spring waters’ should not
Article 9(4) The term ‘spring waters’ be used in the marketing of any products
shall be reserved for a which are not spring waters as defined.
water which is intended
for human consumption Unlike natural mineral water, spring water
in its natural state, and does not have a unique chemical fingerprint.
bottled at source which:
However, it must be bottled at source in
its natural state and only limited treatments
are permitted as outlined below.
Exploitation (a) Satisfy the conditions Annex II, Point 2 and 3 outlined below.
Article 9(4a) of exploitation laid down
in Annex II, Point 2 and
3, which shall be fully
applicable to spring waters
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2009/54/EC
Source Equipment for exploiting A spring is a body of groundwater that
protection the water shall be so emerges at some point. A spring may
Annex II, installed as to avoid have more than one natural or bore exits.
Point 2 any possibility of All spring water from these boreholes is
contamination and to considered to be from the one source.
preserve the properties,
corresponding to those (A) Protection against the
ascribed to it, which the risk of pollution
water possesses at source.
The catchment area is the surface area
To that end, in particular:
within which rainfall can either directly or
indirectly enter the groundwater system
(a) The spring or outlet into which the well is trapped and which
shall be protected against can contribute to the yield of the well.
the risks of pollution
The catchment area should be included
in the HSE food safety inspections of the
establishment. As the groundwater is not
treated, protection and management of the
well and ground water catchment area should
be a Critical Control Point in the HACCP
plan of the establishment. Protection of
the source must be managed effectively.
The production well and groundwater

catchments areas shall be protected
from hazards. The food business
operator must manage the groundwater
source to avoid contamination.
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2009/54/EC
Site location
Consideration should be given to the
following areas in relation to site location:
• The potential risk of contamination from
other activities in the vicinity and the
necessary controls implemented to minimise
the risk of contamination
• Protection and maintenance of the
grounds of the establishment to avoid the
establishment of breeding sites for rodents
and insects
• Procedures in place for the management of
all waste generated on site
• Site maintained and cleanliness
• Site design and layout to facilitate the
operation of good hygiene practices
Site security/Site access

The site should be adequately secured to
prevent unauthorised access The packaged
water operator shall have security measures
in place, e.g. fencing intruder alarms, to ensure
that only authorised staff have access to
water source, production and storage areas.
Areas for identification and protection

on the groundwater production site
The protect the source, the food business
operator should identify the ground water
protection zones, identify permitted and not
acceptable activities in protections zones
and put in place a well field management
programme. Examples of protection zones:
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2009/54/EC
• Inner protection zone: consisting of the
borewell within a purpose built enclosure.
Borewell security is necessary. The bore
well must be capped and the caps locked
for protection. The hut should be locked
and alarmed. An intruder alarm system
should be installed on the production
borehole with access to the borehole
head limited to authorised personnel.
Boreholes should have sampling valves for
sampling at source. Review the pipework
entering the establishment. Storage silos
and pipework must also be protected
• Outer protection zones for the

production well, e.g. fields surrounding
the well. Food businesses should liaise
with County Councils on activities on the
surrounding land, review ongoing planning
applications and annual land use surveys
etc.
Contamination sources
The water packager shall ensure that the
boreholes and groundwater are protected
from sources of contamination. Possible
contamination sources are outlined in
Section 1, Annex II, Part 2 above.
Natural protection
In general, the deeper the well the greater
the protection from the surface activities.
However, this may vary depending on the soil
type. The flow of the ground water may also
protect the water from environmental factors
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2009/54/EC
Food contact (b) The catchment, pipes (b) Requirements for food
materials and reservoirs shall be contact materials
Annex II, of materials suitable for All material which comes in contact with
Point 2 water and so built as to spring water must comply with food contact
prevent any chemical, material legislation. All processing equipment
physico-chemical which comes into direct contact with the
or microbiological water shall be manufactured in compliance
alteration of the water with good manufacturing practice so that under
normal conditions of use, it will not transfer
its constituents to the water in quantities that
could endanger human health and/or impart
odours or taint to the product. All product
contact piping shall be made from materials
that are supplied labelled ‘for food contact’
and comply with food packaging legislation.
The surfaces in contact with the water shall
be resistant to corrosion when cleaned with
food grade cleaning and sanitising agents.
Plastic bottles may be blow moulded on

site. An extensive certificate of compliance
should accompany the delivery of all
plastic material for use with food.
Sterilisation of bottles and caps is permitted.
The sterilised material should be free
from residues following this process.
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2009/54/EC
Hygiene (c) The conditions of (c) Hygiene requirements
requirements exploitation, particularly All material, which comes in contact
Annex II, the washing and bottling with spring water must comply with
Point 2 equipment, shall meet food contact material legislation.
hygiene requirements; in
particular, the containers
All processing equipment which comes
shall be so treated or
into direct contact with spring water shall
manufactured as to
be manufactured in compliance with good
avoid adverse effects on
manufacturing practice so that under
the microbiological and
normal conditions of use, it does not have
chemical characteristics
an adverse effect on the microbiological or
of the spring water
chemical composition of the spring water.
Equipment shall be installed so that there is
adequate access under, around and inside
the equipment to enable effective cleaning.
Equipment shall be maintained at defined
intervals and procedures shall be in place
to ensure that the maintenance activity
does not result in product or equipment
contamination. Product contact surfaces shall
be non-toxic and easy to clean and maintain.
Hygiene requirements of Regulation 852/2004

are applicable throughout production.
If a different water supply is used for

cleaning, this water must be potable. This
water supply must be strictly controlled.
Normally, separate pipes are used for
the supply of this cleaning water.
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2009/54/EC
Transport (d) The transport of spring (d) Transport of spring waters
Annex II, water in containers other Spring waters must be packaged in
Point 2 than those authorised containers for the final consumer on site.
for distribution to the
ultimate consumer
The derogation mentioned in point (d)
across does not apply to Ireland, as no Irish
establishment was authorised to transport
However, point (d) spring water from its source to the bottling
need not be applied to establishment on 17th July 1980.
exploited and marketed in
the territory of a Member
State if, in that Member
State on 17 July 1980,
transport of the spring
water in tanks from the
spring to the bottling
Similarly, point (d)

need not be applied to
exploited and marketed
in the territory of a
Member State if, in that
Member State on 13
December 1996, transport
of the spring water in
tanks from the spring
to the bottling plant
was authorised.
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2009/54/EC
Contamination Where it is found during If the spring water source is polluted, the
Annex II, exploitation that the food business operator shall suspend the
Point 3 spring water is polluted exploitation of the spring water until the
and no longer presents cause of pollution is eradicated. Exploitation
the microbiological of the spring water can recommence when
characteristics laid down the water complies with the microbiological
in Article 5, the person criteria outlined below for spring waters.
exploiting the spring shall
forthwith suspend all
exploitation, particularly
the bottling process, until
the cause of pollution
is eradicated and the
water complies with the
provisions of Article 5.
Microbiological (b) Satisfy the See Section 2.5 below for guidance
criteria microbiological on microbiological criteria.
Article 9(4b) requirements laid
down in Article 5
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2009/54/EC
Labelling (c) Satisfy the labelling The label of spring water shall bear the
Article 9(4c) requirements of following mandatory information:
Article 7(2), point (b)
& (c) and Article 8. Spring name
The label shall state the place where the
Labels on spring waters spring is exploited and the name of the
shall also give the following spring. The location of the source of the
mandatory information water should be readily identifiable from
the information provided on the label.
Article 7(2b): the
place where the spring Information requirements of
is exploited and the Article 4(1) point (b) and (c).
name of the spring, and Permitted treatments requiring
addition labelling:
Article 7(2c): • Ozone enriched air: where the spring water
information on any has been treated with ozone enriched air the
treatments referred label shall include the following information
to in Article 4(1) “water subjected to an authorised ozone-
point (b) and (c). enriched air oxidation technique”. This
information shall be printed in proximity
to the information on the analytical
composition.
• Other permitted treatments: Where the
spring water has undergone a separation
process which is authorised by the HSE, the
label shall provide information on such a
treatment
• The removal of fluoride with activated
alumina as outlined below in Commission
Regulation 115 of 2010: ‘water subjected
to an authorised adsorption treatment’ in
proximity to the statement of the analytical
composition.
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2009/54/EC
Article 8: Trade description
(1) The name of a locality, According to the general labelling rules, a
hamlet or place may trade mark/trade descriptions/brand names
occur in the wording is permitted in addition to the name of
of a trade description the food, i.e. spring water. However, trade
provided that it refers to descriptions cannot appear instead of the legal
spring waters the spring or customary name, as it does not provide
of which is exploited at sufficient information for consumers.
the place indicated by that
description and provided
that it is not misleading Note:
as regards the place of • It is not permitted to market spring water
exploitation of the spring. from one and the same spring under more
than one trade description. If a spring water
(2) It shall be prohibited is bottled under one trade description,
to market spring waters all other spring water products from
from one and the same this source must carry the same trade
spring under more than description
one trade description. • Spring water may also be sold as ‘other
water’. ‘Other waters’ may be sold under
(3) When the labels more than one trade description
or inscriptions on the
containers in which the
spring waters are offered Note: When the labels or inscriptions on the
for sale include a trade containers in which the spring waters are
description different offered for sale include a trade description
from the name of the different from the name of the spring or
spring or the place of its the place of its exploitation, this place or
exploitation, this place or the name of the spring shall be indicated
the name of the spring in letters at least one and half times the
shall be indicated in height and width of the largest of the
letters at least one and letters used for that trade description.
a half times the height
and width of the largest See label example IV and
of the letters used for V in Appendix I.
that trade description.
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2009/54/EC
The first paragraph shall In all forms of adverting of the spring water,
apply, mutatis mutandis whose trade description is different from
and with the same the name of the spring or the place of its
intention as regards the exploitation, this name of the spring shall
importance attributed be highlighted so that the consumer is
to the name of the clearly aware of the spring source used.
spring or the place of its
exploitation, with regards As outlined above, unlike natural mineral
to the trader description water, spring water does not have a unique
used in advertising, in chemical fingerprint. Therefore, an analytical
whatsoever form, relating composition table is not mandatory for spring
to natural mineral waters. water but is permitted to be included on the
label. Nutritional claims under Regulation
spring water, e.g. source of calcium. However,
the nutritional labelling (Group 1 or Group
2 format) does not apply to bottled water. If
nutritional claims are made on spring water,
the claim must comply with the requirements
of the Annex to Regulation 1924/2006, as
amended. In addition, the content of the
specified ion, which the claim relates to, must
be provided on the label of the spring water.
Note: Labelling of spring waters must also comply with the requirements of the general label-
ling legislation (Council Directive 200/13/EC as amended, S.I. No. 483 of 2002, as amended).
Treatment (d) Have not undergone See Section 1 of guidance note on natural
Article 9(4d) any treatment other mineral water (Article 4) for list of permitted
than those referred treatments. The same limited treatments
to in Article 4. Other which are permitted on natural mineral
treatments may be water are permitted on spring water.
authorised by the
Commission
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2009/54/EC
In addition, spring water See specific requirements of Council
shall comply with the Directive 98/83/EC in Section 3 of guidance
provisions of Council note on other bottled water. The chemical
Directive 98/83/EC on the and microbiological criteria of Council
quality of water intended Directive 98/83/EC apply to spring water.
for human consumption. In addition, the microbiological criteria of
Directive 2009/54/EC apply to spring water.
A summary of these microbiological and
chemical criteria are provided below.
Treatment In the absence of There are no Irish provisions on the
Article 9(4d) Community provisions use of treatments of spring waters.
on the treatments for
spring waters referred to
in 4 (d) above, Member
States may maintain
their national provisions
on the treatments.
Labelling It shall be prohibited The labelling or advertising of the products
Article 9(1b) both on the packaging or shall not mislead the consumer.
labels and in advertising
in any form whatsoever,
The use of the term ‘mineral water’ is
to use indications,
not permitted on spring. A statement
designations, trademarks,
of the analytical composition is not a
brand names, pictures
mandatory requirement however it may
or other signs, whether
be used on the label of spring water.
figurative or not, which:
(b) In the case of

drinking water packaged
in containers, which
does not satisfy the
provision of Annex I,
Section I, are liable to
cause confusion with a
natural mineral water, in
particular the description
‘mineral water’.
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2009/54/EC
Marketing The first subparagraph Once spring water is mixed with other
Article 4(1) shall not constitute a ingredients it is not longer classified as a
bar to the utilisation spring water. This product is now categorised
of spring waters in the as a soft drink and may be labelled as spring
manufacture of soft drinks. water drink (see Label VII in Appendix I).
Spring water may be used as ingredients in soft

drinks and other flavoured water products.
In this case, Directive 2009/54/EC does not
apply as the final product is outside the scope
of this particular legislation. However, if spring
water is used as an ingredient and listed in
the ingredients list, the water must meet
the requirements of Directive 2009/54/EC.
If spring water is used as an ingredient,

there is no requirement to declare
the name of the spring water source
on the packaging of the product.
92
2.2 Commission Directive 2003/40/EC establishing the list, concentration limits
and labelling requirements for the constituents of natural mineral waters and the
conditions for using ozone enriched air for the treatment of natural mineral waters
and spring waters
The provisions of Article 5 and 6 of Commission Directive 2003/40/EC establishing

the list, concentration limits and labelling requirements for the constituents of
natural mineral waters and the conditions for using ozone-enriched air for the
treatment of natural mineral waters and spring waters apply to spring water.

2003/40/EC
Only Article 5 and 6 apply to spring water, all other articles of Commission
Directive 2003/54/EC apply to natural mineral waters.
Article 5 1. Without prejudice to Treatment of spring water
the provisions of Article with ozone enriched air:
4(1)(b) of Directive 1. Food business operators must apply to
80/777/EEC, application of their local environmental health service of
the treatment of natural the HSE for authorisation for the use of
mineral waters with this treatment. Such treatment shall only
ozone-enriched air must commence following receipt of written
be notified in advance to approval from the HSE. Records of ozone
the competent authorities, use shall be retained by the food business
who shall ensure that: operator. The environmental health service
of the HSE must specifically control the
(a) Use of such treatment use of this treatment in the food business
is justified by the operator authorised to use this treatment.
composition of the water
in terms of compounds
(a) The HSE shall ensure that the use of this
of iron, manganese,
treatment is justified by the composition
sulphur and arsenic
of the water in terms of compounds of
iron, manganese, sulphur and arsenic. The
(b) The operator takes food business operator must demonstrate
all measures necessary that the untreated water contains the
to guarantee that the specific compounds (iron, manganese,
treatment is effective sulphur and arsenic) which may be
and safe and to allow it removed using this treatment.
to be checked by the
competent authorities.
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2003/40/EC
2. Ozone-enriched air (b) The food business operator shall be able
treatment of natural to demonstrate the effectiveness of this
mineral waters must treatment to the environmental health
comply with all the service of the HSE when requested.
following conditions: Comparisons of chemical composition
pre and post treatment should
(a) The physico-chemical demonstrate the effectiveness of the
composition of the natural treatment.
mineral waters in terms
of essential constituents
2.
shall not be modified
by the treatment (a) The physico-chemical composition
of the spring waters in terms of
essential constituents shall not be
modified by the treatment. The food
water before treatment
business operator must demonstrate,
must comply with
e.g. comparison of chemical analysis
the microbiological
data pre and post treatment, that the
criteria laid down in
essential chemical composition of the
Article 5(1) and (2) of
spring water (as determined by the food
Directive 80/777/EEC
business operator) is not altered by this
treatment.
(c) The treatment shall
(b) The use of this treatment is likely to
not lead to the formation
reduce the microbiological composition
of residues with a
of the spring water. Therefore,
concentration exceeding
spring water must comply with the
the maximum limits laid
microbiological criteria specified in Article
down in Annex III or
5(1) and 5 (2) Directive 2009/54/EC of
residues which could pose
for spring water prior to this treatment.
a risk to public health
Summary of microbiological criteria specified in

Article 5(1) and 5 (2) Directive 2009/54/EC:
Spring water shall be free from parasites,
pathogenic microorganisms, Escherichia
coli, coliforms, enterococci (faecal
streptococci), sporulated sulphite-reducing
anaerobes and Pseudomonas aeruginosa.
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2003/40/EC
TVC counts after bottling of spring
water, shall not exceed:
• 100 cfu/ml at 20ºC to 22ºC in 72 hours and
• 20 cfu/ml at 37ºC in 24 hours
TVC counts at source of spring water,

should not normally exceed:
• 20 cfu/ml at 20 to 22ºC in 72 hours and
• 5 cfu/ml at 37ºC in 24 hours
(c) This treatment shall not lead to the

formation of residues with a concentration
exceeding the maximum limits laid down in
Annex III below or residues which could pose
a risk to public health. The food business
operator must demonstrate that these
criteria are met. The environmental health
service of the HSE shall monitor treated
spring waters for compliance with the residue
criteria outlined in Annex III. Sampling
should take place at the point of bottling.
Annex III
Maximum limits for residues
from treatment of spring waters
by ozone-enriched air
Treatment Maximum limit (*)
residue (μg/l)
Dissolved ozone 50
Bromates 3
Bromoforms 1
(*) Compliance with the maximum limits is
monitored by the competent authorities in the
Member States at the time of bottling or other
form of packaging intended for the final consumer.
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2003/40/EC
Article 6 Pursuant to Article 7(2) Addition labelling requirements
(c) of Directive 80/777/ Where spring water has been treated
EEC, the labelling of with ozone enriched air the label shall
natural mineral waters include the following information “water
which have been treated subjected to an authorised ozone-enriched
with ozone-enriched air air oxidation technique”. This information
shall bear, in proximity to shall be printed in proximity to the
the analytical composition information on the analytical composition.
of characteristic
constituents, the words
Article 7(2)(a) of Directive 80/777/
‘water subjected to an
EEC now replaced with Article 7(2)
authorised ozone-enriched
(a) of Directive 2009/54/EC.
air oxidation technique’.
Article 7 Without prejudice to the Article 5 and 6 of Commission Directive

provisions of Article 9(4) 2003/40/EC apply to spring waters.
(b) of Directive 80/777/
EEC, the provisions of
Articles 5 and 6 of this
Directive shall apply
to spring waters.
96
2.3 Commission Regulation 115/2010 laying down the conditions for use of activated
alumina for the removal of fluoride from natural mineral waters and spring waters
Commission Regulation 115/2010 lays down the conditions for use of activated alumina for
the removal of fluoride from natural mineral waters and spring waters. All requirements of
Commission Regulation 115/2010 apply to spring water which is treated with activated alumina
for the removal of fluoride.

Commission Regulation
115/2010/EC
115/2010/EC
Article 1 (1) The treatment of Spring water may be treated with activated
natural mineral waters alumina in order to remove fluoride.
and spring waters with
activated alumina in
order to remove fluoride,
hereinafter ‘the fluoride
removal treatment’,
shall be allowed.
Natural mineral waters
and spring waters
together are referred to
hereinafter as ‘water’.
Article 1 (2) The fluoride removal The removal of fluoride with activated alumina
treatment shall be shall be in accordance with this regulation.
performed in accordance
with the technical
requirements as set
out in the Annex.
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Article 2 The release of residues The food business operator shall
into the water as a implement and monitor the critical
result of the fluoride processing steps set in the Annex.
removal treatment shall
be as low as technically
feasible according to
the best practices and
shall not pose a risk to
public health. To ensure
this, the operator shall
implement and monitor
the critical processing
steps set in the Annex.
Article 3 (1) The application of The application of a fluoride removal

a fluoride removal treatment shall be notified to the HSE
treatment shall be at least three months prior to use.
notified to the competent
authorities at least three
months prior to use.
Article 3 (2) With the notification The food business operator shall submit
the operator shall relevant information, documentation
communicate to the and analytical results on the treatment
competent authorities, to the HSE which demonstrate
relevant information, compliance with the Annex.
documentation and
analytical results on
the treatment which
show that it complies
with the Annex.
98
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Article 4 The label on water which Spring water which has undergone this
has been the subject of a treatment for the removal of fluoride shall
fluoride removal treatment have the following indication on the label:
shall include, in proximity • ‘Water subjected to an authorised
to the statement of the adsorption technique’.
analytical composition,
the indication ‘water
This indication shall be in proximity to the
subjected to an authorised
statement of the analytical composition.
adsorption technique’.
Article 5 Products which were No such products were on the market

placed on the market in Ireland prior to 10 August 2010.
by 10 August 2010 and
which do not comply
with Article 4, may
continue to be marketed
until 10 August 2011.
Annex: Technical requirements for the use of activated alumina for the
removal of fluoride from natural mineral waters and spring waters
The following critical processing steps shall be implemented and monitored appropriately:
1 Before the activated
alumina is used for the
treatment of water it
shall be subjected to an
initialisation procedure
which includes the use of
acidic or alkaline chemicals
to remove any residues
and a backwash treatment
to remove fine particles.
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2 A regeneration procedure
shall be applied at intervals
ranging from one to
four weeks depending
on the water quality and
throughput. It shall include
the use of appropriate
chemicals to remove the
adsorbed ions in order
to restore the adsorption
capacity of the activated
alumina, and to remove
any possibly formed
biofilms. This procedure
shall be done in the
following three stages:
– Treatment with sodium
hydroxide to remove
fluoride ions and replace
them with hydroxide
ions
– Treatment with an acid

to remove residual
sodium hydroxide and
activate the medium
– Rinsing with drinking or

demineralised water and
conditioning with the
water as the final step
in order to ensure that
the filter has no impact
on the overall mineral
content of the treated
water
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3 The chemicals and reagents
used for the initialisation
and regeneration
procedures shall comply
with the relevant European
standards (European
Standards developed by
the European Committee
for Standardisation (CEN))
or applicable national
standards relating to the
purity of the chemical
reagents used for treatment
human consumption.
4 The chemicals and reagents

used for the initialisation
and regeneration
procedures shall comply
with the relevant European
standards (European
Standard EN 12902
(2004): Products used
for treatment of water
intended for human
consumption. Inorganic
supporting and filtering
materials) or applicable
national standards
used for treatment
human consumption.
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5 The processing steps
shall be subject to good
manufacturing practices
and HACCP principles set
out in Regulation (EC) No
852/2004 of the European
Parliament and of the
Council on food hygiene
(OJ L 139, 30.4.2004, p.1).
6 The operator shall establish

a monitoring programme
in order to ensure the
proper functioning of
the processing steps in
particular as regards
the maintenance of the
essential characteristics
of the water and its
fluoride content.
Ice produced from spring water

Ice produced from spring water is not covered by Directive 2009/54/EC. However, if
it is claimed that the ice-cubes are produced using spring water then that water must
meet the requirements of Directive 2009/54/EC (except labelling requirements).
2.4 Council Directive 98/83/EC on the quality of water intended for human
consumption
The provisions of Council Directive 98/83/EC on the quality of water intended for human
consumption apply to spring water. Guidance on the requirement of this Directive is
provided in Section 3.1. Guidance on the microbiological criteria and chemical criteria
of Council Directive 98/83/EC is provided in Section 2.5 and 2.6 respectively.
102
2.5 Microbiological criteria for spring water
The microbiological criteria outlined in Article 5 of Directive 2009/54/EC and Annex I of
Council Directive 98/83/EC apply to spring water. The food business operator must be able
to demonstrate that the spring water produced meets the microbiological criteria of Article
5 of Directive 2009/54/EC at source and in the bottle and the microbiological criteria of
Annex I of Council Directive 98/83/EC at the point of bottling. Table 2.1 provides a summary
of the microbiological limits for spring water at source, at bottling and in package. Table 3.3
outlines the list of microbiological parameters of Annex I Council Directive 98/83/EC for which
performance characteristics are specified. It is recommended that sampling of spring water
produced in Ireland should take place at the point of bottling in the food business establishment.
2.5.1 Microbiological criteria of Article 5 of Directive 2009/54/EC

Reference Microbiological Interpretation
requirements of
2009/54/EC
Article 5 of Directive 2009/54/EC: The following criteria are applicable to spring water
at source and in package.
Micro criteria The revivable total colony Table 2.1 provides a summary of the
Article 5(1) count of natural mineral microbiological criteria of Directive
of Directive waters at source shall 2009/54/EC which apply to spring
2009/54/EC conform to their normal water at source and in the package.
viable colony count and
give satisfactory evidence Data analysis of microbiological results
of the protection of of at source water over a period of time
the source against all provides an indication of typical TVC
contamination. This total levels. These TVC levels should remain
colony count shall be stable and thus act as an indicator that
determined under the the source has adequate protection
conditions laid down in against microbiological contamination.
Annex 1, Section II, Point
1.3.3 (as outlined across).
Annex 1, Section II, Point 1.3.3
The total colony count shall be determined
under the following conditions (Annex 1,
Section II, Point 1.3.3):
determination of the revivable total
colony count per millilitre of water
103
requirements of
2009/54/EC
(a) at 20 to 22ºC in 72 hours on agar-
agar or an agar-gelatine mixture,
(b) at 37ºC in 24 hours on agar-agar
Micro criteria After bottling, the total After bottling, the total colony
Article 5(1) colony count at source count shall not exceed:
of Directive may not exceed 100 per • 100 cfu/ml at 20ºC to 22ºC in 72 hours and
2009/54/EC millilitre at 20 to 22ºC in • 20 cfu/ml at 37ºC in 24 hours
72 hours on agar-agar or
and 20 per millilitre at Total viable count is only valid if it is
37ºC in 24 hours on agar- determined within 12 hours of bottling
agar. The total colony (the water being maintained at 4ºC
count shall be measured ± 1ºC during this 12-hour period) as
within the 12 hours water in its natural environment contains
following bottling, the microorganisms. On storage, the number of
water being maintained microorganisms will initially increase until
at 4ºC - 1ºC during all the naturally available nutrients in the
this 12-hour period. water are utilised. The number will then
decrease due to lack of nutrients and
after a period, will increase again.
Therefore, EHOs responsible for the

supervision of spring water establishments
should sample for all relevant microorganisms
including sampling for total colony
counts within 12 hours of bottling.
Microbiological sampling at the marketing

stage (distribution and retail stage) should not
include total viable count as the time post
bottling is unknown and therefore results
of such analysis cannot be interpreted.
104
requirements of
2009/54/EC
If TVC counts (within 12 hours of bottling)
exceed the legislative limits, then the bottled
water is in breach of the legislation. Product
which has not left the control of the food
business operator must not be released
onto the market. If product has reached
the consumer, the food business operator
must consult with the competent authority
regarding appropriate control actions.
EHOs are advised to review the source

protection and the various stages of production
for hygiene practises which may establish
the cause for breach in legislative limits.
Please see the FSAI’s Guidance Note 10 Food

Recall and Traceability (Revision 2). The following
definitions are from this guidance note:
Unsafe food: Food that is injurious to health

or unfit for human consumption as detailed
in Article 14 of Regulation (EC) No.178/2002
laying down the general principles and
requirements of food law, establishing the
European Food Safety Authority and laying
down procedures in matters of food safety.
Recall: The removal of an unsafe food from

the market when it may have reached the
Withdrawal: The removal of an

unsafe food from the market before
it has reached the consumer.
105
requirements of
2009/54/EC
Micro criteria At source, these values At source, the total colony count
Article 5(1) should not normally should not normally exceed:
of Directive exceed 20 per millilitre at • 20 cfu/ml at 20 to 22ºC in 72 hours and
2009/54/EC 20 to 22ºC in 72 hours • 5 cfu/ml at 37ºC in 24 hours
and 5 per millilitre at 37ºC
in 24 hours respectively,
on the understanding that These are guide figures and not maximum
they are to be considered permitted concentrations. EHOs are advised
as guide figures and not to review the source protection and the
as maximum permitted various stages of production for hygiene
concentrations. practises which may establish the cause
for breaches in the legislative limits. See
above for action to take if TVC levels in
the bottle are above the legislative limits.
Micro criteria At source and during Where the packaged water is deemed
Article 5(2) their marketing, natural to be unsafe by reason that it may be
of Directive mineral waters shall injurious to health or unfit for human
2009/54/EC be free from— consumption, the food business operator
shall initiate the procedure to withdraw or
(a) parasites recall the batch of product in question.
and pathogenic
microorganisms; Where the product in question has reached
(b) Escherichia coli and the consumer, the food business operator shall
other coliforms and faecal accurately and effectively inform consumers
streptococci in any 250 of the reason for the withdrawal of the
millilitre sample examined; product and if necessary, recall product that
(c) sporulated sulphite- has already been released for purchase.
reducing anaerobes
in any 50 millilitre Where the packaged water product does
sample examined; not comply with the legal requirements
(d) Pseudomonas aeruginosa for microbiological criteria, the packaged
in any 250 millilitre water business operator shall:
sample examined. • Take action to ensure that the water is not
consumed
• Where necessary, recall the product and
notify consumers
106
requirements of
2009/54/EC
Escherichia coli
The presence of E. coli in spring water is
considered an index of faecal contamination
injurious to health and therefore unsafe as
defined in Regulation 178 of 2002. Spring
water containing E. coli shall be withdrawn
from the market and where it has reached the
consumer, the consumers must be notified
and EHOs should ensure that food business
operators take the necessary measures to
remove the product from consumers.
• Remove affected batch of bottled water from
the food chain.
consumers.
See the FSAI’s Guidance Note No.10 Product

Recall and Traceability (Revision 2)

The presence of enterococci in spring water
is considered an index of faecal contamination
injurious to health and therefore, unsafe. In
accordance with Article 19 of Regulation 178 of
2002, spring water containing enterococci shall
be withdrawn from the market and where it
has reached the consumer, the consumers must
be notified and EHOs should ensure that food
business operators take the necessary measures
107
requirements of
2009/54/EC
the food chain.
consumers.
See the FSAI’s Guidance Note No. 10
Product Recall and Traceability (Revision 2)
Coliforms:
The presence of coliforms (in the absence of
E.coli and enterococci) in spring water is not
a strong indication of potential presence of
enteric pathogens. Such bottled water should
not be considered as unsafe for consumption.
However, the presence of coliforms should
prompt investigation by the EHO and food
business operator. The FSAI should be
informed of each case of coliforms detected
in bottled water and each result must be dealt
The presence of Ps. aeruginosa (in the absence
of E. coli or enterococci) in spring water is not a
significant health risk for the general population.
The presence of Ps. aeruginosa should prompt
investigation by the EHO and food business
operator as to the cause of the contamination.
108
requirements of
2009/54/EC
Ps. aeruginosa is however a risk for the severely
immunocompromised sub-population found
in certain areas of hospitals like intensive care
units. The FSAI should therefore be informed
of each case of Ps. aeruginosa detected in
bottled water (rapidalert@fsai.ie). The
FSAI will then advise the Health Protection
Surveillance Centre of such findings. Each result
must be dealt with on a case by case basis.
In all cases of contamination, EHOs are also

advised to investigate immediately to identify
the cause of contamination, e.g. review the
microbiological status of the source water,
the level of hygiene controls in the extraction
and bottling process. This may indicate the
cause for breach in the legislative limits.
Please see Revision 2 of the FSAI’s

Guidance Note 10 Food Recall and
Traceability. See above for definitions of
‘unsafe’ food, ‘recall’ and ‘withdrawal’.
Micro criteria Without prejudice to the TVC counts for spring water are generally
Article 5(3) provisions of paragraph 1 very low but can vary from source to
of Directive and 2 and the conditions source. Review of microbiological data
2009/54/EC of exploitation laid for the previous years should provide
down in Annex II, at an indication of the ‘normal viable
the marketing stage: colony counts’ for the spring water.
(a) The revivable total

colony count of natural
mineral waters may only
be that resulting from the
normal increase in the
bacteria content which
it had at source, and
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requirements of
2009/54/EC
waters may not contain
any organoleptic defects.
2.5.2 Microbiological criteria of Annex I of Council Directive 98/83/EC

The microbiological criteria in Annex I of Council Directive 98/83/EC are applicable to spring
water at the point of bottling. See Table 2.1 for summary of microbiological limits for spring
water at source and in package. Corrective action required in cases of exceedance of the limits
is outlined in Section 2.5.1.
110
Table 2.1 Summary of microbiological limits for spring waters at source and
in package
Article 5 of Directive 2009/54/EC
Microbiological Limit at Limit in Recommended Reference to

parameter source package frequency of legislation
analysis of in
house testing by
food business
operator***
Note: Legislative limits are specified for the parameters which are subject to audit
monitoring. Indicator values are specified for the parameters which are subject to check
monitoring. Exceeded indicator values are used as a prompt to investigate further.
TVC @ 20-22˚C ≤20 cfu/ml* ≤100cfu/ Daily Article 5(1)
for 72hrs ml** of Directive
2009/54/EC
TVC @ 37˚C <5 cfu/ml* <20cfu/ml** Daily Article 5 (1)
2009/54/EC
Coliforms @ 37˚C 0 in 250mls 0 in 250mls Daily Article 5 (2b)
of Directive
2009/54/EC
Escherichia coli 0 in 250mls 0 in 250mls Daily Article 5 (2b)
@ 44.5˚C of Directive
2009/54/EC
Sporulated sulphite 0 in 50 mls 0 in 50mls Monthly Article 5 (2c)
reducing anaerobes of Directive
2009/54/EC
Enterococci 0 in 250mls 0 in 250mls Daily Article 5 (2b)
(faecal of Directive
streptococci) 2009/54/EC
Pseudomonas 0 in 250mls 0 in 250mls Monthly Article 5 (2d)

aeruginosa of Directive
2009/54/EC
Parasites and Absent Absent Yearly Article 5 (2a)
pathogenic of Directive
microorganisms 2009/54/EC
* Figures are legislative guide figures
** Samples must be measured within 12 hours of bottling and maintained
at 4 ± 1˚C during this 12 hour period.
*** Sourced from IS 432 of 2010
111
Table 2.1 continued
Annex I of Council Directive 98/83/EC
Microbiological Legislative Indicator/ Recommended Reference to

parameter limit at Value frequency of legislation
point of unit analysis of in
bottling house testing by
food business
operator***
Escherichia coli 0/250 ml Annex I , Part

A of Council
Directive 98/83/EC
Enterococci 0/250 ml Annex I, Part A of
Council Directive
98/83/EC
Pseudomonas 0/250 ml Annex I, Part A of
aeruginosa Council Directive
98/83/EC
Colony count 100/ml No Annex I, Part A &
@ 22˚C abnormal Part C of Council
change Directive 98/83/EC
Colony count 20/ml Annex I, Part A of
@ 37˚C Council Directive
98/83/EC
Clostridium 0/100ml Annex I, Part C of
perfringens Council Directive
(including spores) 98/83/EC
Coliforms 0/250ml Annex I, Part C of
Council Directive
98/83/EC
112
2.6 Chemical and physical criteria for spring water
The chemical and physical criteria outlined in Annex I of Council Directive 98/83/EC apply to
spring water. The food business operator must be able to demonstrate that the ‘spring water’
produced meets the chemical and physical criteria of Annex I of Council Directive 98/83/EC at
the point of bottling. In addition, if spring water is treated with ozone enriched air, the spring
water must meet the criteria for maximum residues specified in Section 2.2. It is recommended
that sampling of spring water produced in Ireland should take place at the point of bottling in the
food business establishment. Table 3.2 provides a summary of the chemical and physical criteria
applicable for spring water at the point of bottling. Table 3.3 outlines the list of parameters for
which performance characteristics are specified for the analysis of spring water. All breaches in
the chemical criteria should be notified to the FSAI for a risk assessment. Appropriate follow-up
action will be decided following a risk assessment.
2.7 Sampling and analysis of spring water by official agency (HSE)

Frequency of microbiological sampling
As outlined previously, the microbiological criteria applicable to spring water are provided in
Article 5 of Directive 2009/54/EC and Annex I of Council Directive 98/83/EC.
Directive 2009/54/EC does not specify minimum frequencies of sampling and analysis of spring
water by the official agency. Quarterly microbiological sampling by the official agency at the spring
water establishment is recommended for sampling against the criteria in Article 5 of Directive
2009/54/EC. Note: Frequencies may vary depending on production periods. The frequencies can
be adjusted accordingly when statistical trends on the microbiological qualities are established.
To establish a profile of the microbiological composition of the water during production, it is
suggested that samples should be taken at various locations, e.g. at well head, before and after
any treatment and the finished product.
Council Directive 98/83/EC provides minimum frequencies of sampling and analysis for monitoring
purposes of spring water by the official agency. These frequencies are provided in Table 2.2 and
are based on annual volume of production.
Frequency of chemical sampling

As outlined previously, the chemical criteria applicable to spring water are provided in Annex I
of Council Directive 98/83/EC. In addition, if spring water is treated with ozone enriched air, the
spring water must meet the criteria for maximum residues specified in Commission Directive
2003/40/EC.
Council Directive 98/83/EC provides minimum frequencies of sampling and analysis for monitoring
113
purposes of spring water by the official agency. These frequencies are provided in Table 2.2 and
are based on annual volume of production.
Commission Directive 2003/40/EC does not specify minimum frequencies of sampling and analysis
of spring water by the official agency. Biannual sampling by the official agency at the spring water
establishment is recommended for sampling against the criteria in Commission Directive 2003/40/
EC. Note: Frequencies may vary depending on production periods. The frequencies can be
adjusted accordingly when statistical trends on the chemical qualities are established.
Table 2.2 provides minimum frequencies of sampling and analysis for monitoring purposes of
spring water by the official agency against the criteria in Annex I of Council Directive 98/83/
EC. Frequencies are specified for ‘check monitoring’ and ‘audit monitoring’. The microbiological,
chemical and physical criteria for spring water which require check monitoring by the official
agency are provided in Table 3.1.The microbiological, chemical and physical criteria for spring
water which require audit monitoring by the official agency are provided in Table 3.2.
Table 2.2 Minimum frequencies of sampling and analysis for monitoring purposes
of spring water and other water by the official agency (HSE)
Annex II, Table B2 of Council Directive 98/83/EC
Volume (m3) of water produced Check monitoring number Audit monitoring

for offering for sale in bottles of samples per year number of
or containers each day (1) m3 samples per year
≤ 10 1 1
> 10 - ≤ 60 12 1
> 60 1 for each 5 m3 and part 1 for each 100 m3

thereof of the total and part thereof of
volume the total volume
Minimum frequency of sampling and analysis for water put into bottles
or containers intended for sale.
(1)The volumes are calculated as averages taken over a calendar year.
114
SECTION 3. ‘OTHER BOTTLED WATER’
3.1 Council Directive 98/83/EC on the quality of water intended for human
consumption
The environmental health service of the HSE is the responsible authority for the enforcement of
all food legislation in ‘other bottled water’ establishments. Unlike natural mineral water, there is
no legal requirement for recognition of ‘other bottled water’. The provisions of Council Directive
98/83/EC on the quality of water (sold in bottles or containers) intended for human consumption
apply to ‘other bottled water’. ‘Other bottled water’ means drinking water which is bottled and
is neither described as spring water or a recognised natural mineral water. ‘Other bottled water’
can come from a variety of sources, e.g. groundwater, public water supplies.

Council Directive
98/83/EC
Objective 1. This Directive The consumer shall be protected from
Article 1 concerns the quality the adverse effects of any contamination
of water intended for of water intended for human consumption
human consumption. by ensuring that it is wholesome and
2. The objective of this clean. Compliance with Council Directive
Directive shall be to 98/83/EC should ensure this.
protect human health
from the adverse effects
of any contamination
human consumption
by ensuring that it is
wholesome and clean.
Definitions For the purposes This section of the guidance document will
Article 2 (1a) of this Directive: provide interpretation of the requirements of
1. ‘water intended for ‘other water’ sold in bottles or containers.
human consumption’
shall mean:
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98/83/EC
(a) all water either in its
original state or after
treatment, intended for
drinking, cooking, food
preparation or other
domestic purposes,
regardless of its origin
and whether it is supplied
from a distribution
network, from a tanker,
or in bottles or containers
Article 2 (1b) and Article 2(2) do not apply to ‘other water’ sold in bottles or containers.
Article 3 provides for exemptions. Ireland has no exemptions from the requirements
outlined in Council Directive 98/83/EC for ‘other water’ sold in bottles or containers.
Obligations General obligations To be considered wholesome and clean,
Article 4 (1) Without prejudice to the water, at the point of bottling must, at
their obligations under minimum meet the chemical, physical and
other Community microbiological criteria outlined in Annex
provisions, Member States 1 Part A and B of Council Directive 98/83/
shall take the measures EC. These parameters are summaries as the
necessary to ensure legislative criteria outlined in Table 3.2. In
that water intended for addition, the bottled water should be free
human consumption is parasites, examples: Cryptosporidium spp and
wholesome and clean. Guardia spp and other substances which, in
For the purposes of the numbers or concentrations are considered
minimum requirements potentially dangerous to public health.
of this Directive, water
intended for human
consumption shall be
wholesome and clean if it:
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(a) Is free from any For all ground water, the potential
microorganisms contaminants in the water will depend on
and parasites and geological factors and on the activities being
from any substances carried out in the water catchment area.
which, in numbers or Hence, in part, the type of monitoring required
concentrations, constitute will be site specific. (If there was a chemical
a potential danger to factory in the catchment area, the water
human health, and would need to be tested for the presence
of the potential chemical contaminants from
(b) Meets the minimum this source). It is worth noting that changes
requirements set out in in the level of ammonia and potassium
Annex I, Parts A and B in water samples from a particular well
and if, in accordance with is, usually, an indication of pollution.
the relevant provisions of
Articles 5 to 8 and 10 and Food business operators should be able
in accordance with the to demonstrate that any process, e.g.
Treaty, Member States disinfection of boreholes, rinsing of bottles
take all other measures with detergent does not contaminate
necessary to ensure that the water. Sampling of the water for
water intended for human residues following these processes should
consumption complies indicate if there is contamination.
with the requirements
of this Directive.
Obligations Member States shall
Article 4 (2) ensure that the measures
taken to implement
this Directive in no
circumstances have
the effect of allowing,
directly or indirectly,
either any deterioration
of the present quality
human consumption so
far as that is relevant for
the protection of human
health or any increase in
the pollution of waters
used for the production
of drinking water.
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Quality 1. Member States shall (1)The microbiological, physical and chemical
standards set values applicable criteria in Annex I of Council Directive 98/83/
Article 5 to water intended for EC apply to ‘other waters’ produced in Ireland
(1, 2, 3) human consumption for (see Table 3.2). In addition, Table 3.2 provides
the parameters set out a list of indicator parameters which can be used
in Annex I. to provide information on the organoleptic
and microbiological quality of the water, as
well as information on the effectiveness of
2. The values set in drinking-water treatment (particularly of
accordance with disinfection) where it is used, in order to
paragraph 1 shall not be determine whether or not water intended for
less stringent than those human consumption complies with the relevant
set out in Annex I. As parametric values laid down in this Directive.
regards the parameters
set out in Annex I,
(2) and (3). There are no additional
Part C, the values
standards set in Irish law.
need be fixed only for
monitoring purposes
and for the fulfilment of
the obligations imposed
in Article 8
3. A Member State shall

set values for additional
parameters not included
in Annex I where the
protection of human
health within its national
territory or part of it so
requires. The values set
should, as a minimum,
satisfy the requirements
of Article 4(1)(a).
Point of compliance. Article 6 (1a, b & d), Article 6 (2) and 6 (3) do not
apply to water put into bottles or containers intended for sale.
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Council Directive
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Point of The parametric values In the case of water put into bottles or
compliance set in accordance with containers intended for sale, the point of
Article 6 (1c) Article 5 shall be complied compliance with the criteria listed in Table
with, in the case of 3.2 is at the point at which the water is
water put into bottles or put into the bottles or containers.
containers intended for
sale, at the point at which
the water is put into the
bottles or containers.
Monitoring Member States shall take Guidance on minimum frequency of sampling
Article 7 (1) all measures necessary and analyses for monitoring the compliance of
to ensure that regular ‘other water’ to Council Directive 98/83/EC by
monitoring of the quality the official agency (HSE) is provided in Section
of water intended for 3.6. The frequency of sampling is dependent
human consumption is on the volume of product produced annually.
carried out, in order to
check that the water
available to consumers
meets the requirements
of this Directive and in
particular the parametric
values set in accordance
with Article 5. Samples
should be taken so that
they are representative
of the quality of the
water consumed
throughout the year.
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In addition, Member States
shall take all measures
necessary to ensure that,
where disinfection forms
part of the preparation
or distribution of
water intended for
human consumption,
the efficiency of the
disinfection treatment
applied is verified, and that
any contamination from
disinfection by-products
is kept as low as possible
without compromising
the disinfection.
Monitoring To meet the obligations The environmental health service of the
Article 7 (2) imposed in paragraph 1, HSE shall establish appropriate chemical and
appropriate monitoring microbiological monitoring programmes
programmes shall be in ‘other bottled water’ establishments.
established by the Table 3.1 lists the parameters subject to
competent authorities check monitoring by the HSE environmental
for all water intended health service. Table 3.2 list the parameters
for human consumption. subject to audit monitoring by the
Those monitoring HSE environmental health service.
programmes shall
meet the minimum
requirements set
out in Annex II.
Monitoring The sampling points shall The criteria of Annex II apply at the point of
Article 7 (3) be determined by the bottling. However, to establish a profile of
competent authorities the microbiological and chemical composition
and shall meet the of the water during production, samples may
relevant requirements also be taken at various locations, e.g. at well
set out in Annex II. head, before and after any treatment and the
finished product. HSE EHOs should request
food business operators to install taps at
sampling points if these are not available.
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Council Directive
98/83/EC
Monitoring Community guidelines for
Article 7 (4) the monitoring prescribed
in this Article may be
drawn up in accordance
with the procedure laid
down in Article 12.
Monitoring (a) Member States Official control microbiological samples
Article 7 (5) shall comply with the shall be analysed in accordance with the
specifications for the specification in Table 3.2. Official control
analyses of parameters chemical samples shall be analysed in
set out in Annex III accordance with the specification in Table 3.3.
(b) Methods other

than those specified in
Annex III, Part 1, may
be used, providing it
can be demonstrated
that the results obtained
are at least as reliable
as those produced by
the methods specified.
Member States which have
recourse to alternative
methods shall provide
the Commission with
all relevant information
concerning such methods
and their equivalence.
(c) For those parameters

listed in Annex III, Parts
2 and 3, any method
of analysis may be
used provided that it
meets the requirements
set out therein.
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Council Directive
98/83/EC
Monitoring Member States shall Monitoring of additional parameters
Article 7 (6) ensure that additional should be carried out, if there is reason
monitoring is carried to suspect that they may be present in
out on a case-by-case amounts or numbers which constitute
basis of substances and a potential danger to human health.
microorganisms for
which no parametric
value has been set in
accordance with Article
5, if there is reason to
suspect that they may
be present in amounts
or numbers which
constitute a potential
danger to human health.
Remedial action Article 8 (2) does not apply to ‘other waters’ sold in bottles or containers.
Remedial Remedial action and The food business operator shall investigate
action Article restrictions in use the cause of chemical or microbiological
8 (1,3, 4, 1. Member States shall contamination. Appropriate enforcement
5, 6, 7) ensure that any failure measures shall be taken to ensure that the
to meet the parametric microbiological and chemical criteria are
values set in accordance met. If a bottled water sample fails to comply
with Article 5 is with the provisions of Annex 1 Part A or B
immediately investigated of Directive 98/83/EC, the EHO may seize,
in order to identify the remove, detain or direct the withdrawal
cause. from the market of the bottled water.
Water which is non-compliant with the

indicator parametric set out in Annex I, Part
C, Member States shall consider whether
that non-compliance poses any risk to human
health. Member states shall take remedial action
to restore the quality of the water where
that is necessary to protect human health.
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Council Directive
98/83/EC
3 Whether or not any
failure to meet the
parametric values has
occurred, Member
States shall ensure that
any supply of water
intended for human
consumption which
constitutes a potential
danger to human health
is prohibited or its use
restricted or such other
action is taken as is
necessary to protect
human health. In such
cases, consumers shall
be informed promptly
thereof and given the
necessary advice.
4. The competent
authorities or other
relevant bodies shall
decide what action
under paragraph 3
should be taken, bearing
in mind the risks to
human health which
would be caused by
an interruption of the
supply or a restriction
in the use of water
intended for human
consumption.
123
Council Directive
98/83/EC
5. Member States may
establish guidelines to
assist the competent
authorities to fulfil
their obligations of the
paragraph above.
6. In the event of non-

compliance with the
parametric values or
with the specifications
set out in Annex I, Part
C, Member States shall
consider whether that
non-compliance poses
any risk to human
health. They shall take
remedial action to
restore the quality of
the water where that
is necessary to protect
human health.
7. Member States shall

ensure that, where
remedial action is taken,
consumers are notified
except where the
competent authorities
consider the non-
compliance with the
parametric value to be
trivial.
Article 9 relates to derogation none of which apply to Ireland.
124
Council Directive
98/83/EC
Article 10 Quality assurance of
treatment, equipment
and materials
Member States shall take
all measures necessary to
ensure that no substances
or materials for new
installations used in the
preparation or distribution
human consumption or
impurities associated
with such substances
or materials for new
installations remain
in water intended for
human consumption in
concentrations higher
than is necessary for
the purpose of their
use and do not, either
directly or indirectly,
reduce the protection of
human health provided
for in this Directive; the
interpretative document
and technical specifications
pursuant to Article 3 and
Article 4 (1) of Council
Directive 89/106/EEC
of 21 December 1988
on the approximation
of laws, regulations and
administrative provisions
of the Member States
relating to construction
products (1) shall
respect the requirements
of this Directive.
125
Council Directive
98/83/EC
Article 11-Artiel 16 do not apply to ‘other waters’ sold in bottles or containers.
Article 17 Transposition in S.I. No. 225 of 2007 (as amended) transposes
national law Council Directive 98/83/EC into Irish law
Article 18 Entry into force Council Directive 98/83/EC applies
from 24th November 1998
Article 19 This Directive Council Directive 98/83/EC
is addressed to applies to all Member States
Member States
3.2 Treatment of ‘other waters’

Unlike natural mineral water and spring water there are no restrictions on the treatments
permitted on other bottled water. Bacteriostatic treatments, e.g. use of a UV lamp is
permitted to reduce the microbial composition of water to the specified criteria. Unlike
natural mineral water and spring water, there are no additional labelling requirements
if other waters have undergone any treatment. Treatment of ‘other waters’ should
be carefully controlled by the food business operator to ensure its effectiveness.
3.3 Labelling of ‘other waters’

Labelling of bottled water must comply with the requirements of the general labelling
legislation (Council Directive 200/13/EC as amended, S.I. No. 483 of 2002 as amended).
There is no restriction on the use of trade names on bottled water. The source of the
water is not mandatory. There are no additional labelling requirements, if ‘other waters’
have undergone any treatment. Nutritional and health claims under Regulation 1924/2006,
as amended, may also be made on ‘other waters’, e.g. source of calcium. If these claims are
made they must comply with the requirements of Regulation 1924/2006, as amended. The
content of the specified ion, which the claim relates to, must be provided on the label.
3.4 Chemical and physical criteria for ‘other waters’

The chemical and physical criteria which apply to ‘other water’ at the point of bottling
is provided in Tables 3.2. The food business operator must be able to demonstrate that
the ‘other bottled water’ produced meets the chemical and physical legislative criteria as
outlined in Table 3.2 at the point of bottling. Table 3.1 and Table 3.2 also list indicator
parameters for ‘other’ waters which can be used to provide information on organoleptic,
microbiological quality and the effectiveness of drinking water treatment. Minimum
sampling and analysis by the official agencies for monitoring purposes is provided in
Section 3.6. Breaches in the chemical criteria should be notified to the FSAI for a risk
assessment. Appropriate follow-up action will be decided following a risk assessment.
126
3.5 Microbiological criteria for ‘other waters’
The microbiological criteria of Council Directive 98/83/EC apply to ‘other water’ at the
point of bottling and are provided in Tables 3.2. The food business operator must be
able to demonstrate that the ‘other bottled water’ produced meets the microbiological
legislative criteria as outlined in Table 3.2 at the point of bottling. Table 3.1 and Table 3.2
also list indicator parameters for ‘other’ waters which can be used to provide information on
organoleptic, microbiological quality and the effectiveness of drinking water treatment. Minimum
sampling and analysis by the official agencies for monitoring purposes is provided in Section 3.6.
Regulation 178/2002 as amended (Article 14), states that food shall not be placed on the
market if it is unsafe, i.e. injurious to health or unfit for human consumption. Therefore,
E. coli and/or enterococci should be absent from other bottled water sampled at the retail
stage/during marketing.
Action to take in the event of non-compliance with the microbiological criteria:

Where the packaged water is deemed to be unsafe by reason that it may be injurious to
health or unfit for human consumption, the food business operator shall initiate the procedure
to withdraw or recall the batch of product in question.
Where the product in question has reached the consumer the food business operator shall
accurately and effectively inform consumers of the reason for the withdrawal of the product
and if necessary recall product that has already been released for purchase.
Where the packaged water product does not comply with the legal requirements
for microbiological criteria the packaged water business operator shall:
• Take action to ensure that the water is not consumed
• Where necessary, recall the product and notify consumers
Escherichia coli
The presence of E. coli in ‘other water’ is considered an index of faecal contamination
of the water. As such, the water is considered injurious to health and therefore
unsafe as defined in Regulation 178 of 2002. ‘Other water’ containing E. coli shall
be withdrawn from the market and where it has reached the consumer, the
consumers must be notified and EHOs should ensure that food business operators
take the necessary measures to remove the product from consumers.
• Remove affected batch of bottled water from the food chain.
• Remove affected batch of bottled water from consumers.
See the FSAI’s Guidance Note No.10 Product Recall and Traceability (Revision 2).
127
The presence of enterococci in ‘other water’ is considered an index of faecal
contamination of the water. As such the water is considered injurious to health and
therefore unsafe. In accordance with Article 19 of Regulation 178 of 2002, other water
containing enterococci shall be withdrawn from the market and where it has reached the
consumer, the consumers must be notified and EHOs should ensure that food business
operators take the necessary measures to remove the product from consumers.
• Remove affected batch of bottled water from the food chain.
• Remove affected batch of bottled water from consumers.
See the FSAI’s Guidance Note No.10 Product Recall and Traceability (Revision 2).
Coliforms
The presence of coliforms (in the absence of E. coli or enterococci) in other water is not a
strong indication of potential presence of enteric pathogens. Such bottled water should not be
considered as unsafe for consumption. The presence of coliforms should prompt investigation
by the EHO and food business operator as to the source of the contamination. The FSAI should
be informed of each case of coliforms detected in bottled water and each result must be dealt
The presence of Ps. aeruginosa (in the absence of E. coli or enterococci) in other water
is not a significant health risk for the general population. The presence of Ps. aeruginosa
should prompt investigation by the EHO and food business operator as to the cause of
the contamination. Ps. aeruginosa is however a risk for the severely immunocompromised
sub-population found in certain areas of hospitals like intensive care units. The FSAI
should therefore be informed of each case of Ps. aeruginosa detected in bottled water
(rapidalert@fsai.ie). The FSAI will then advise the Health Protection Surveillance
Centre of such findings. Each result must be dealt with on a case by case basis.
TVCs
If TVC counts exceed the legislative limits, then the bottled water is in breach of the legislation.
Product which has not left the control of the food business operator must not be released onto
the market. If product has reached the consumer, the food business operator must consult with
the competent authority regarding appropriate control actions. In all cases of contamination,
EHOs are also advised to investigate immediately to identify the cause of contamination, e.g.
review the microbiological status of the source water, the level of hygiene controls in the
extraction and bottling process. This may indicate the cause for breach in the legislative limits.
128
Unsafe food: Food that is injurious to health or unfit for human consumption as detailed in
Article 14 of Regulation (EC) No.178/2002 laying down the general principles and requirements
of food law, establishing the European Food Safety Authority and laying down procedures in
matters of food safety.
Recall: The removal of an unsafe food from the market when it may have reached the
Withdrawal: The removal of an unsafe food from the market before it has reached
the consumer.
3.6 Sampling and analysis by the environmental health service of the HSE
Minimum frequencies of sampling and analysis for other water sold in bottles or containers
are provided in Council Directive 98/83/EC. The parametric values provided in Council
Directive 98/83/EC (microbiological, chemical and physical criteria) apply at the point
at which the water is put into the bottled or containers. Therefore, the sampling of
‘other bottled water’ produced in Ireland against the criteria of Council Directive
98/83/EC should take place at the point of bottling in the food business operator.
‘Other waters’ which are sampled at retail can be analysed for the chemical and
microbiological parameters outlined in Council Directive 98/83/EC. However, inspectors
should be aware that these criteria apply at the point of bottling. Regulation 178/2002 as
amended (Article 14), states that food shall not be placed on the market if it is unsafe,
i.e. injurious to health or unfit for human consumption. Therefore, ‘other bottled water’
sampled at the retail stage/during marketing should be absent from contamination which is
considered injurious to health or unfit for human consumption, e.g. E. coli or enterococci.
Minimum frequencies of sampling and analysis by the official agency for other water
sold in bottles or containers are outlined in Table 2.2 above. The frequencies provided
in Table 2.2 are based on annual production volumes of water sold in containers or
bottles. Frequencies are provided for ‘audit monitoring’ and ‘check monitoring’.
Check monitoring: The purpose of check monitoring is regularly to: provide information on
the organoleptic and microbiological quality of the water supplied for human consumption, as
well as information on the effectiveness of drinking-water treatment (particularly of disinfection)
where it is used, in order to determine whether or not water intended for human consumption
complies with the relevant parametric values laid down in this Directive. Table 3.1 lists the
parameters which must be subject to check monitoring by the official agency. Table 3.2 lists
the indicator values which are specified for each parameter subject to check monitoring.
129
Audit monitoring: The purpose of audit monitoring is to provide the information
necessary to determine whether or not all of the parametric values of Council
Directive 98/83/EC are being complied with. Table 3.2 lists the parameters which
must be subject to audit monitoring and the legislative criteria for each.
Table 3.3 outlines the list of parameters for which performance characteristics are
specified. Analysis of official control samples should be in accordance with this table.
Table 3.1 Chemical, physical and microbiological indicator parameters subject to

‘check monitoring’ by the environmental health service of the HSE
Chemical Indicator Parameters
Parameter:
Aluminium (Necessary only when used as a flocculant. In all other cases, the parameters
are in the list for audit monitoring)
Ammonium
Conductivity
Hydrogen ion concentration
Iron
Nitrite (Necessary only when chlorination is used as a disinfectant. In all
other cases, the parameters are in the list for audit monitoring)
Physical Indicator Parameters
Taste
Colour
Odour
Turbidity
Microbiological Indicator Parameters
Colony count (TVC) @ 22ºC and 37ºC

Coliform bacteria
Clostridium perfringens (including spores) (Necessary only if the water originates from
or is influenced by surface water. In all other cases, the parameters are in the list for
audit monitoring)
Escherichia coli (E. coli)
130
Table 3.2 Chemical, physical and microbiological parameters applicable to
‘other waters’
Parameter Legislative Indicator Note Recommended
criteria parametric frequency of
value/unit analysis (by
Parametric food business
value/unit operator)
Ref: IS 432/2010:
Note: Legislative limits are specified for the parameters which are subject to audit
monitoring. Indicator values are specified for the parameters which are subject to check
monitoring. Exceeded indicator values are used as a prompt to investigate further.
Chemical parameters
Acrylamide 0.10ug/l The parametric Every 4 years
value refers to the
residual monomer
concentration
in the water as
calculated according
to specifications
of the maximum
release from the
corresponding
polymer in contact
with the water.
Aluminium 200ug/l Yearly
Ammonium 0.50mg/l Monthly
Antimony 5.0ug/l Yearly
Arsenic 10.0ug/l Yearly
Benzene 1.0ug/l Yearly
Benzo(a)pyrene 0.010ug/l Yearly
Boron 1.0mg/l Yearly
Bromate 10.0ug/l Where possible, Yearly
without
compromising
disinfection, Member
States should strive
for a lower value.
131
Ref: IS 432/2010:
Residues: 50ug/l Apply to spring
dissolved water only which is
ozone treated with ozone
enriched air. Criteria
apply at the time of
bottling or other
form of packaging
intended for the
final consumer.
Residues: 3ug/l Apply to spring

Bromates water only which is
treated with ozone
bottling or other
form of packaging
intended for the
final consumer.
Residues : 1ug/l Apply to spring

Bromoforms water only which is
treated with ozone
bottling or other
form of packaging
intended for the
final consumer.
Cadmium 5.0ug/l Yearly

Chloride 250mg/l The water should Quarterly
not be aggressive.
Chromium 50ug/l Yearly
132
Ref: IS 432/2010:
Copper 2.0mg/l The value applies Yearly
to a sample of
water intended for
human consumption
obtained by an
adequate sampling
method (1) at the
tap and taken so as
to be representative
of a weekly average
value ingested by
consumers. Where
appropriate, the
sampling and
monitoring methods
must be applied
in a harmonised
fashion to be drawn
up in accordance
with Article 7(4).
Member States must
take account of the
occurrence of peak
levels that may cause
adverse effects on
human health.
Cyanide 50ug/l Yearly

1.2 3.0ug/l Every four years
Dichloroethane
133
Ref: IS 432/2010:
Epichloro- 0.10ug/l The parametric Every four years
hydrin value refers to the
residual monomer
concentration
in the water as
to specifications
of the maximum
release from the
corresponding
polymer in contact
with the water.
Fluoride(s) 1.5mg/l Yearly
Iron 200ug/l Yearly
The value applies
to a sample of
water intended for
human consumption
obtained by an
adequate sampling
method (1) at the
tap and taken so as
of a weekly average
value ingested
by consumers.
134
Ref: IS 432/2010:
Lead 10ug/l Where appropriate, Yearly
the sampling and
monitoring methods
must be applied
in a harmonised
fashion to be drawn
up in accordance
with Article 7(4).
Member States must
take account of the
occurrence of peak
adverse effects on
human health.
Member States
must ensure that
all appropriate
measures are taken
to reduce the
concentration of lead
in water intended for
human consumption
as much as possible
during the period
needed to achieve
compliance with the
parametric value.
135
Ref: IS 432/2010:
When implementing
the measures to
achieve compliance
with that value,
Member States must
progressively give
priority where lead
concentrations in
water intended for
human consumption
are highest.
Manganese 50ug/l Yearly
Mercury 1.0ug/l Yearly
136
Ref: IS 432/2010:
Nickel 20ug/l The value applies Yearly
to a sample of
water intended for
human consumption
obtained by an
adequate sampling
method (1) at the
tap and taken so as
of a weekly average
value ingested by
consumers. Where
appropriate, the
sampling and
monitoring methods
must be applied
in a harmonised
fashion to be drawn
up in accordance
with Article 7(4).
Member States must
take account of the
occurrence of peak
adverse effects on
human health.
137
Ref: IS 432/2010:
Nitrate 50.0 mg/l Member States Yearly
must ensure that
the condition that
[nitrate]/50 +
[nitrite]/3 ≤ 1, the
square brackets
signifying the
concentrations in
mg/l for nitrate
(NO3-) and nitrite
(NO2-), is complied
with and that the
value of 0,10 mg/l for
nitrites is complied
with ex water
treatment works
Nitrite 0.50mg/l Member States Yearly
must ensure that
the condition that
[nitrate]/50 +
[nitrite]/3 ≤ 1, the
square brackets
signifying the
concentrations in
mg/l for nitrate
(NO3-) and nitrite
(NO2-), is complied
with and that the
value of 0,10 mg/l for
nitrites is complied
with ex water
treatment works
Oxidisability 5.0mg/lO2 This parameter need Quarterly
not be measured
if the parameter
TOC is analysed
138
Ref: IS 432/2010:
Pesticides 0.10ug/l ‘Pesticides’ means: Every four years
organic insecticides,
organic herbicides,
organic fungicides,
organic nematocides,
organic acaricides,
organic algicides,
organic rodenticides,
organic slimicides,
related products
(inter alia, growth
regulators) and their
relevant metabolites,
degradation and
reaction products.
Only those
pesticides which are
likely to be present
in a given supply
need be monitored.
The parametric
value applies to
each individual
pesticide. In the case
of aldrin, dieldrin,
heptachlor and
heptachlor epoxide
the parametric
value is 0,030µg/l.
139
Ref: IS 432/2010:
Pesticides 0.50ug/l ‘Pesticides’ means: Every four years
– Total organic insecticides,
organic herbicides,
organic fungicides,
organic nematocides,
organic acaricides,
organic algicides,
organic rodenticides,
organic slimicides,
related products
(inter alia, growth
regulators) and
their relevant
metabolites,
degradation and
reaction products.
Only those
pesticides which are
likely to be present
in a given supply
need be monitored.
Pesticides -Total’
means the sum
of all individual
pesticides detected
and quantified in
the monitoring
procedure.
140
Ref: IS 432/2010:
Polycyclic 0.10ug/l The specified Every four years
aromatic/ (sum of compounds
hydrocarbons conc. of are: benzo(b)
specified fluoranthene,
compounds) benzo(k)
fluoranthene,
benzo(ghi)perylene,
indeno(1,2,3-
cd)pyrene.
Selenium 10ug/l Yearly
Sodium 200mg/l Quarterly
Sulphate 250mg/l The water should Quarterly
not be aggressive
Tetrachloro- 10ug/l Every four years
ethene & (sum of
Trichloro- conc. of
ethene specified
parameters)
Total Organic No This parameter need Quarterly
Carbon abnormal not be measured for
change supplies of less than
10,000 m3 a day.
Trihalo- 100ug/l Where possible, Every four years
methanes (sum of without
– Total conc. of compromising
specified disinfection,
compounds) Member States
should strive for a
lower value. The
specified compounds
are: chloroform,
bromoform,
141
Ref: IS 432/2010:
dibromochloro-
methane,
bromodichloro-
methane.
Member States
must ensure that
all appropriate
measures are taken
to reduce the
concentration of
trihalomethanes in
water intended for
human consumption
as much as possible
during the period
needed to achieve
compliance with the
parametric value.
When implementing
the measures to
achieve this value,
Member States
must progressively
give priority to
those areas where
trihalomethanes
concentrations in
water intended for
human consumption
are highest.
142
Ref: IS 432/2010:
Vinyl Choride 0.50ug/l The parametric Every four years
value refers to the
residual monomer
concentration
in the water as
to specifications
of the maximum
release from the
corresponding
polymer in contact
with the water.
Radioactivity 0.10mSv/ To date, no Every two years
Total dose year monitoring
frequencies are
set by the EU
Commission.
Radioactivity 100Bq/l To date, no Every two years

Tritium monitoring
frequencies are
set by the EU
Commission.
Excluding tritium,
potassium -40,
radon and radon
decay products
Microbiological parameters
Escherichia 0/250 ml
coli (E. coli)
Enterococci 0/250 ml
143
Ref: IS 432/2010:
Pseudomonas 0/250 ml
aeruginosa
Colony count 100/ml No

@ 22˚C abnormal
change
Colony count 20/ml

@ 37˚C
Clostridium 0/100ml This parameter need

perfringens not be measured
(including unless the water
spores) originates from or is
influenced by surface
water. In the event
of non-compliance
with this parametric
value, the Member
State concerned
must investigate the
supply to ensure
that there is no
potential danger to
human health arising
from the presence
of pathogenic
microorganisms, e.g.
cryptosporidium.
Member States must
include the results of
all such investigations
in the reports they
must submit under
Article 13(2).
Coliforms 0/250ml
144
Ref: IS 432/2010:
Physical parameters
Colour Acceptable Daily
to
consumers
and no
abnormal
change
Conductivity Within the Water should not Daily
limits of be aggressive
fluctuation,
guide2,500
uS cm -1
at 20˚C
Hydrogen ion Within the Water should not Daily
concentration limits of be aggressive, for
fluctuation, still water put into
guide ≥ 6.5 containers the
and < 9.5 minimum value may
pH units be reduced to 4.5
pH units. For water
put into containers
which is naturally or
artificially enriched
with carbon dioxide,
the minimum
may be lower.
Odour Acceptable Daily
to
consumers
and no
abnormal
change
145
Ref: IS 432/2010:
Turbidity Acceptable In the case of surface Daily
to water treatment,
consumers Member States
and no should strive for a
abnormal parametric value
change not exceeding 1,0
NTU (nephelometric
turbidity units)
in the water ex
treatment works.
Taste Acceptable Daily

to
consumers
and no
abnormal
change
3.6 Specific methods of analysis

Table 3.3 outlined the chemical parameters for which performance characteristics are specified.
These specified performance characteristics are that the method of analysis used, must as a
minimum, be capable of measuring concentrations equal to the parametric value with a trueness,
precision and limit of detection specified. Whatever the sensitivity of the method of analysis used,
the result must be expressed using at least the same number of decimals as for the parametric
value listed in Table 3.2 above.
146
Table 3.4 list the microbiological parameters for which methods are specified. Parameters for
which no method of analysis is specified are as follows:
• Colour
• Odour
• Taste
• Total organic carbon
• Turbidity (for turbidity monitoring in treated surface water the specified performance
characteristics are that the method of analysis used must, as a minimum, be capable of
measuring concentrations equal to the parametric value with a trueness of 25%, precision
of 25% and a 25% limit of detection)
Table 3.3 Chemical parameters for which performance characteristics are specified
Parameters Trueness Precision Limit of Conditions Notes
% of para- % of para- detection
metric metric % of para-
value* value** metric
value**
Acrylamide To be
controlled
by product
specification
Aluminium 10 10 10
Ammonium 10 10 10
Antimony 25 25 25
Arsenic 10 10 10
Benzo(a) 25 25 25
pyrene
Benzene 25 25 25
Boron 10 10 10
Bromate 25 25 25
Cadmium 10 10 10
Chloride 10 10 10
Chromium 10 10 10
Conductivity 10 10 10
147
value**
Copper 10 10 10
Cyanide 10 10 10 The method
should determine
total cyanide
in all forms.
1,2-dichloro- 25 25 10
ethane
Epichloro- To be
hydrin controlled
by product
specification.
Fluoride 10 10 10
Iron 10 10 10
Lead 10 10 10
Manganese 10 10 10
Mercury 20 10 20
Nickel 10 10 10
Nitrate 10 10 10
Nitrite 10 10 10
Oxidisability 25 25 10 Oxidation should
be carried out
for 10 minutes at
100ºC under acid
conditions using
permanganate.
148
value**
Pesticides 25 25 25 The performance

characteristics
apply to each
individual pesticide
and will depend
on the pesticide
concerned. The
limit of detection
may not be
achievable for
all pesticides
at present, but
Member States
should strive
to achieve this
standard.
Polycyclic 25 25 25 The performance

aromatic characteristics
hydro- apply to the
carbons individual
substances
specified at 25%
of the parametric
value in Annex I.
Selenium 10 10 10
Sodium 10 10 10
Sulphate 10 10 10
Tetrachloro- 25 25 10 The performance
ethene characteristics
apply to the
individual
substances
specified at 50%
of the parametric
value in Annex I
149
value**
Trichloro- 25 25 10 The performance

ethene characteristics
apply to the
individual
substances
specified at 50%
of the parametric
value in Annex I
Trihalom- 25 25 10 The performance

ethanes characteristics
— Total apply to the
individual
substances
specified at 25%
of the parametric
value in Annex I.
Vinyl chloride To be
controlled
by product
specification
*Trueness is the systematic error and is the difference between the mean value of the large
number of repeated measurements and the true value.
**Precision is the random error and is usually expressed as the standard deviation (within
and between batch) of the spread of results about the mean. Acceptable precision is twice
the relative standard deviation.
***Limit of detection is either: i)three times the relative within batch standard deviation of a
natural sample containing a low concentration of the parameter, or ii) five times the relative
within batch standard deviation of a blank sample.
For hydrogen ion concentration, the specified performance characteristics are that the method
of analysis used must be capable of measuring concentrations equal to the parametric value with
a trueness of 0,2 pH unit and a precision of 0,2 pH unit.
150
Table 3.4 Microbiological parameters for which methods are specified
Parameter Incubation Incubation Culture Samples Standard
temperature time medium size method
Clostridium 44ºC +/- 1ºC 21 +/- 3 CP agar 50ml Membrane
perfringens hours (For filtration followed
(including composition by anaerobic
spores) see below) incubation of the
membrane on
m-CP agar (see
Note 1). Count
opaque yellow
colonies that
turn pink or red
after exposure
to ammonium
hydroxide
vapours for
20-30 seconds
Colony 21ºC +/- 1ºC 72 hours Agar-agar 1ml I.S.ENISO6222
Count @ or agar
22ºC gelatine
mixture
Colony 37ºC +/- 1ºC 24 hours Agar- agar 1ml I.S. EN ISO 6222
Count @
37ºC
Coliform 37ºC +/- 0.5ºC 250ml I.S. EN ISO
bacteria 9308-1
Escherichia 44.5ºC +/- 250ml I.S. EN ISO
coli (E. coli) 0.25ºC 9308-1
Pseudomonas 36 +/- 2ºC 48 hours 250ml I.S. EN 12780
aeruginosa
Enterococci 36 +/- 2ºC 48 hours 250ml I.S. EN ISO
7899-2
151
Note 1: The composition of m-CP agar is:
Tryptose 30g
Yeast extract 20g
Sucrose 5g
L-cysteine hydrochloride 1g
MgSO4- 7 H2O 0.1g
Bromocresol purple 40g
Agar 15g
Water 1000ml
Dissolve the ingredients of the basal medium adjust pH to 7.6 and autoclave
at 121ºC for 15 minutes. Allow the medium to cool and add:
D-cycloserine 400mg
Polymyxine-B sulphate 25mg
Indoxyl-B-Dglucoside 60mg to be dissolved in 8ml
of sterile water before addition
Phenolphthalein diphosphate 0.5% solution 20ml filter sterilised before addition
4.5% FeCl3.6H2O 2ml filter sterilised before addition
152
APPENDIX I. EXAMPLES OF LABELS FOR NATURAL MINERAL
WATER AND SPRING WATER PRODUCTS
Natural mineral water from one and the same source shall only be sold as natural mineral water
using one trade description (see Label I). In addition, labels must also comply with the general
labelling requirements, e.g. net weight, name of product and date of minimum durability should
be in the same field of vision.
Label I
Murphy’s
(example of trade description)
Example of an indication/
claim. If an indication/claim is
Natural Mineral Water used, the ion must be listed in

the compositional table at the
(example of sales description)
required level as specified in the
criteria (see Article 9(2) Directive
Analytical composition: Contains Calcium 2009/54/EC).
Typical analysis: mg/l
Ca...................................160
Magnesium...................... 20 Bottled at source:
Sodium............................. 11 Murphy’s, Address,
Potassium.......................1.4 etc.. Co. XX, Ireland
This source of natural mineral water may also be sold as a spring water. The spring water shall
only be sold under one trade description. The trade description used for the spring water can
be either:
• The same as that used for the natural mineral water product (see Label II) or
• A different trade description (see Label III)
153
Label II
Murphy’s
Spring Water Example of a

Analytical nutritional claim. If a
composition table is nutritional claim is used,
not mandatory for spring the specified ion must be
water but is permitted listed on the label and
Analytical composition: Contains Calcium
to include on label. shall be in accordance
with Regulation
Ca.......................... 160 1924/2006 as amended.
Magnesium............. 20 Bottled at source:
Sodium.................... 11 Murphy’s, Address,
Potassium..............1.4 etc.. Co. XX, Ireland
Label III
Example of a
Superstore nutritional claim. If a
(example of trade description) nutritional claim is used,
the specified ion must be
Spring Water listed on the label and

shall be in accordance
with Regulation
Analytical 1924/2006 as amended.
composition table is
Typical analysis: mg/l The trade description
not mandatory for spring
Ca.......................... 160 differs from the source
water but is permitted Bottled at source:
Magnesium............. 20 name. Therefore, the
to include on label.
Sodium.................... 11
Murphy’s, source must be at least
Address, Co. XX, 1.5 times the size of the
Potassium..............1.4 etc..
Ireland largest letter in the trade
description
This source of natural mineral water may also be sold as a ‘other water’. There are no restrictions
on the number of trade names which can be used on ‘other waters’.
154
Examples of labels for ‘spring water’ products
Spring water from one and the same source shall only be sold as spring water under one trade
description (see Label IV or V). In addition, labels must also comply with the general labelling
requirements, e.g. net weight, name of product and date of minimum durability should be in the
same field of vision.
Label IV
Murphy’s
Example of a
Spring Water nutritional claim. If a
Analytical nutritional claim is used,
composition table is the specified ion must be
not mandatory for spring listed on the label and
water but is permitted shall be in accordance
to include on the label. with Regulation
Ca...................................160 1924/2006 as amended.
Magnesium...................... 20 Bottled at source:
Sodium............................. 11 Murphy’s, Address,
Potassium..............1.4 etc.. Co. XX, Ireland
Label V
Example of a
Superstore nutritional claim. If a
(example of trade description) nutritional claim is used,
the specified ion must be
Spring Water listed on the label and
shall be in accordance
Analytical (example of sales description)
with Regulation
composition table is
1924/2006 as amended.
not mandatory for spring Analytical composition: Contains Calcium
water but is permitted
Typical analysis: mg/l The trade description
to include on the label.
Ca...................................160 Bottled at source: differs from the source
name. Therefore, the
Magnesium...................... 20
Sodium............................. 11
Murphy’s, source must be at least
Address, Co. XX, 1.5 times the size of the
Potassium..............1.4 etc..
Ireland largest letter in the trade
description.
This source of spring water may also be sold as a ‘other water’. There are no restrictions on the
number of trade names which can be used on ‘other waters’.
155
Examples of permitted labels of soft drinks if a flavour is added to ‘natural mineral
water’ (Label VI) or ‘spring water’ (Label VII)
In addition, labels must also comply with the general labelling requirements, e.g. net weight, name
of product and date of minimum durability should be in the same field of vision.
Label VI
Murphy’s
If a nutritional claim is
made, e.g. ‘contains
Natural Mineral Water Drink
calcium’, the correct With a hint of lemon List of ingredients
required, QUID
nutritional information
required.
{
must be on the label,
i.e. Group 1 or Group 2 Contains XXX Ingredients:
depending on the claims. Natural mineral
water (X%),
Nutritional Information
Lemon Juice from
in Group 1 or 2 format Concentrate
(X%), etc...
Label VII
Murphy’s
Spring Water Drink
If a nutritional claim is List of ingredients
With a hint of lemon
made, e.g. ‘contains required, QUID
calcium’, the correct required.
{
nutritional information
must be on the label, Contains XXX Ingredients:
Spring water
i.e. Group 1 or Group 2 (X%), Lemon
depending on the claims. Nutritional Information
Juice from
in Group 1 or 2 format Concentrate
(X%), etc...
156
NOTES
NOTES
Food Safety Authority of Ireland Údarás Sábháilteachta Bia na hÉireann
Abbey Court, Lower Abbey Street, Cúirt na Mainistreach, Sráid na Mainistreach Íocht.,
Dublin 1 Baile Átha Cliath 1
Tel: +353 1 817 1300

Fax: +353 1 817 1301
Email: info@fsai.ie
Website: www.fsai.ie
ISBN 1-904465-71-4

Natural Mineral Waters, Spring Waters and Other Bottled Waters Guidance F (PDFDrive)

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Natural Mineral Waters, Spring Waters and Other Bottled Waters Guidance F (PDFDrive)

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25 G U I DA N C E N OT E

Guidance for Enforcement of Legislation

and Other Bottled Waters

Tel: +353 1 817 1300 Fax: +353 1 817 1301

Applications for reproduction should be made to the FSAI Information Unit

3 ‘OTHER BOTTLED WATER’ 115

APPENDIX I. EXAMPLES OF LABELS FOR NATURAL MINERAL

TABLE 1.1 SUMMARY OF MICROBIOLOGICAL LIMITS

TABLE 1.2 CRITERIA FOR CHEMICAL CONSTITUENTS

TABLE 1.3 PERFORMANCE CHARACTERISTICS FOR

TABLE 2.1 SUMMARY OF MICROBIOLOGICAL LIMITS FOR

TABLE 2.2 MINIMUM FREQUENCIES OF SAMPLING AND ANALYSIS

TABLE 3.1 CHEMICAL, PHYSICAL AND MICROBIOLOGICAL

TABLE 3.2 CHEMICAL, PHYSICAL AND MICROBIOLOGICAL

TABLE 3.3 CHEMICAL PARAMETERS FOR WHICH PERFORMANCE

TABLE 3.4 MICROBIOLOGICAL PARAMETERS FOR WHICH

• Council Directive 80/777/EEC as amended on the exploitation and marketing of natural

• IS 340:2007 on the hygiene of the catering sector

• Waters with medicinal claims as no medicinal claims are permitted on foods

EU Legislation Natural Mineral Spring Water ‘Other

Reference Requirements of Interpretation

If an additional aquifer is used, the food

A copy of Certificate of Recognition’ and

NSAI certification is valid for a period

The validity of the The list of recognised natural mineral

The validity of the certification of natural

Information on treatment described in

The sales description of natural mineral

Note: Natural mineral waters may also

Natural mineral water may be used as

There is no requirement to declare

(a) Naturally carbonated

(b) Natural mineral water

(c) Carbonated natural

Annex 1, Section II, Point 1.3.3

Determination of the revivable total

Therefore, EHOs responsible for the

If TVC counts (within 12 hours of bottling)

Please see the FSAI’s Guidance Note 10

Unsafe food: Food that is injurious to health

Recall: The removal of an unsafe food from

Withdrawal: The removal of an

(b) Escherichia coli and

Enterococci (Faecal streptococci)

Ps. aeruginosa is however, a risk for the severely

(a) The revivable total

(b) The natural mineral

All food contact materials must comply

Additionally, the packaging must comply with

As outlined in Council Directive 2000/13/

See Appendix I for examples of labels.

(c) Information on any Examples of ions which may appear in the

As outlined below, Commission Directive

(b) The place where the spring is exploited and

(c) Permitted treatments requiring

Labelling In the absence of There are no national provisions in Ireland.

When the labels or inscriptions on the

See Appendix I for examples of labels.

Nutrition and health claims under Regulation

Member States which

Article 16 Directive 80/777/EEC, In 2009, Directive 2009/54/EC was published

The water source shall be protected

Requirements A description of the • Identification of other abstraction points and

(b) Escherichia coli and