Guide for control of packaged waters

Guide 5813/04.02.00.01/2021/3_EN came into force on 20.10.2021

1 Application

Guide for control of packaged waters applies to

Packaged domestic water
Packaged spring water
Packaged natural mineral water

This document provides guidelines for monitoring, quality requirements and recommendations under food safety regulations, and labelling of packaged domestic water, packaged spring water and packaged natural mineral water. As it is not intended to provide an exhaustive review of all relevant stipulations, this guide should be examined together with the applicable legislation.

In order to understand water control on the whole, this guide also makes references to domestic water legislation provided for in the Health Protection Act (763/1994), since in practice the notification/approval process is simultaneously managed by the municipal control unit for both pieces of legislation. Most of such references are, however, limited to references to Implementation Guidelines I-III (in Finnish) published online by the National Supervisory Authority for Welfare and Health (Valvira).

With regard to the surveys, references are made to applicable legislation that provides for the requirements and recommendations for analysing packaged water without repeating all the related obligations in this context. A summary of the microbiological and chemical quality requirements and recommendations for different types of packaged water set out in relevant legislative texts is annexed to this guide (Annex 1).

This guide does not apply to packaged industrially processed mineral water because the legislation on packaged water does not concern processed mineral waters. Industrially processed mineral waters are classified as foodstuffs fortified with minerals. As industrially processed mineral waters were previously considered to fall within the legislation on packaged water, the exclusion is further clarified in section 5.2 below (subheading: Industrially processed mineral waters).

Actions undertaken by public authorities must be based on legal competencies and must be in strict compliance with the law. Authoritative guidelines are not by reason of their legislative nature binding on other authorities or operators. Ultimately, the question of the application of legislation will be resolved by the court of law.

This guide includes both verbatim quotes from laws and regulations and interpretations of the application of the provisions. The interpretations included in the guide represent Finnish Food Authority's views on the appropriate application of the law.

1.1 Legislation

The laws covering packaged household water, packaged spring water and packaged natural mineral water are listed below. Although the provisions are partly the same across the different waters, there are some differences as well.

Food Act 297/2021.
Decree of the Ministry of Agriculture and Forestry on Packaged Water 166/2010.

The Decree of the Ministry of Agriculture and Forestry on Packaged Water governs the entry into force of Directive 2009/54/EC of the European Parliament and of the Council on the exploitation and marketing of natural mineral waters (hereinafter EU Directive) and the 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 (hereinafter EU Directive).

The treatment of natural mineral water and spring water with aluminium oxide to remove fluoride is subject to the Commission Regulation 115/2010 (hereinafter EU Regulation)
Health Protection Act 763/1994
Decree of the Ministry of Social Affairs and Health 1352/2015 (hereinafter Decree on Domestic Water).

Note! The Decree on Domestic Water applies to packaged domestic water and packaged spring water. Natural mineral waters fall outside the scope of domestic water legislation.

The Decree on Domestic Water implements Council Directive 98/83/EC (the so-called Drinking Water Directive) and Council Directive 2013/51/EURATOM (radioactive substances in water).

Regulation 1169/2011 of the European Parliament and of the Council (hereinafter Regulation on the Provision of Food Information to Consumers).

Note! Further labelling requirements for packaged water are set out in Decrees 166/2010 and 834/2014 of the Ministry of Agriculture and Forestry, and for packaged spring water and natural mineral water in EU Directives 2009/54/EC and 2003/40/EC and Commission Regulation 115/2010.

2 Packed water - general information

2.1 Definitions

Packaged water

Packaged water means natural mineral water, spring water or domestic water intended to be supplied to consumers or mass caterers in bottles or containers (Ministry of Agriculture and Forestry 166/2010).

In this context, the term 'packaged water' also refers to potable water dispensers which are not directly connected to a domestic water network and which dispense water to consumers. This dispensing does not need to be performed against payment. The inclusion of potable water dispensers in the definition of packaged water differs from the interpretation used with other foodstuffs available in vending machines, which, as a rule, are considered loose foods. The difference is that spring water and natural mineral water need to be packaged at their source and cannot be sold loose.

In exceptional circumstances, water utility companies may have to distribute household water in various large containers. This type of household water is not considered packaged domestic water. It is governed by the stipulations of the Decree on Domestic Water 1352/2015 (Valvira's guideline for domestic water III).

Domestic water

Domestic water refers to all water:

intended for drinking, cooking or other household use regardless of whether it is supplied via a distribution system or in tanks, bottles or containers, or whether it is extracted with the consumer's own equipment;
used in food premises referred to in the Food Act for making, processing or preserving foodstuffs or placing such foodstuffs on the market (Health Protection Act 763/1994, section 16; amendment 942/2016).

Natural mineral water, water used for medical purposes and water used exclusively for laundry, cleaning, washing, sanitation or other similar purposes is not considered domestic water.

Spring water

Spring water means spring water as defined in EU Directive 2009/54/EC (Ministry of Agriculture and Forestry 166/2010).

According to Article 9(4) of said Directive, the term 'spring water' shall be reserved for water which is intended for human consumption in its natural state, is bottled at the source, and which

satisfies the conditions of exploitation laid down in Annex II, points 2 and 3, which shall be fully applicable to spring waters;
satisfies the microbiological requirements laid down in Article 5;
satisfies the labelling requirements of Article 7(2), points b and c, and Article 8;
has not undergone any treatment other than those referred to in Article 4.

In addition, spring water must comply with the provisions of EU Directive 98/83/EC on the quality of water intended for human consumption. In Finland, the aforementioned Directive is enforced with the Decree on Domestic Water 1352/2015 (Ministry of Social Affairs and Health).

Hence, spring water also falls within the definition of 'domestic water'.

Food legislation does not provide a definition for the spring itself. According to general knowledge, a spring is the place where groundwater or perched water issues from the ground, a swamp or the bottom of a waterway. If a controlling authority is not sure whether the water is spring water or ordinary groundwater, the matter should be clarified by the relevant authority referred to in the Water Act. Every new spring water catchment established for commercial purposes requires authorisation from the authority stipulated in the Water Act.

Natural mineral water

Natural mineral water means microbiologically wholesome water, within the meaning of EU Directive 2009/54/EC, Article 5, originating in an underground water table or deposit and emerging from a spring tapped at one or more natural or bore exits (2009/54/EC Annex 1).

Natural mineral water can be clearly distinguished from ordinary drinking water:

by its nature, which is characterised by its mineral content, trace elements or other constituents and, where appropriate, by certain effects;
by its original purity, both characteristics having been preserved intact because of the underground origin of such water, which has been protected from all risk of pollution.

Any water drawn from Finnish soil and placed on the market as natural mineral water must be recognised by the Finnish Food Authority as natural mineral water (Ministry of Agriculture and Forestry 166/2010).

Waters originating from third countries and introduced in Finland as natural mineral waters must have been recognised as natural mineral water in another EU member state or an EFTA state party to the EEA Agreement (Iceland, Liechtenstein, Norway). In the event that a third-country natural mineral water is imported directly to Finland, such recognition is carried out by the Finnish Food Authority.

Natural mineral waters must comply with the quality requirements laid down in, and may be exploited and bottled only in accordance with, the above Directive.

Naturally carbonated natural mineral water means water the carbon dioxide content of which from the spring after decanting, where applicable, and bottling is the same as at the source, taking into account where appropriate the reintroduction of a quantity of carbon dioxide from the same water table or deposit equivalent to that released in the course of those operations and subject to the usual technical tolerances (2009/54/EC Annex 1).
Natural mineral water fortified with gas from the spring means water the carbon dioxide content of which from the same water table or the same deposit after decanting, where applicable, and bottling is greater than that established at the source (2009/54/EC Annex 1)
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 (2009/54/EC Annex 1).

An overview of the quality requirements, recommendations and controls for packaged water. Text above.

3 Domestic water

3.1 Notification of operations

Before commencing operations, a food business operator who packages domestic water must submit a notification of food business operations as required under section 10 of the Food Act (297/2021) to the municipal food control authority for the purposes of registering operations. Also notification must be made without delay if operations are suspended or terminated. The notification is made primarily via the Environmental Health Care e-notification service (Ilppa) or by contacting the local food control unit in place of business directly. Information about municipal food control authorities can be found on the Food Authority website (select the municipality from the search menu). The food control authority will notify the relevant health protection authority of the operator packaging domestic water.

The establishment of a new water abstraction point for commercial purposes generally also requires authorisation by an environmental permit authority as provided by the Water Act (587/2011).

3.2 Conditions for operations

The place where domestic water is packaged, treated or stored constitutes a food premises and must, therefore, meet the structural, technical and functional requirements laid down in food safety regulations. Own-check monitoring needs to be sufficient in relation to the scale and quality of the operations (see section 7). Packaging materials and labelling must conform to the requirements (see sections 3.5 and 6).

3.3 Water quality requirements and surveys

Water quality and surveys must comply with the requirements of the Decree on Domestic Water 1352/2015 prior to packaging and during marketing, and must also meet the requirements on marketed packaged water set out in Decree 166/2010. The quality of the water must be controlled throughout the supply chain via own-check monitoring.

Operators using their own wells are advised to carry out the necessary water analyses before making the final decision on the initiation of operations. In Finland, for example, fluoride, arsenic and uranium may cause problems. Their detection after the launch may make the operations unprofitable.

Before packaging

Before packaging, water quality is controlled both by samples taken by public authorities under the Health Protection Act and via own-check sampling under the Food Act. The quality of and the surveys on packaged domestic water must comply with the requirements of the Decree on Domestic Water 1352/2015. The point of collection is the faucet prior to packaging. For more information regarding the surveys under the Health Protection Act, please see Implementation Guidelines I-III by the National Supervisory Authority for Welfare and Health (Valvira).

The relevant food safety authority assesses the adequacy of the own-check measures referred to in the Food Act on the basis of the scale and quality of the operations.

The frequency of own-check sampling before packaging is determined on the basis of the following criteria:

Scope and risks of the operations
Possible treatment of water inside the food premises
Samples and resulting surveys performed under the Decree on Domestic Water on the basis of health protection legislation.

Where the samples collected under the Decree on Domestic Water on the basis of health protection legislation coincide or almost coincide with the launch of the operations, duplicate samples are usually not required.

In regard to chemical analyses, surveys performed by the health protection authority usually suffice, provided that the analyses do not reveal any defects or problems before packaging.

It should be noted that sampling performed by smaller water utility companies under the Decree on Domestic Water on the basis of the Health Protection Act tends to be quite infrequent. Operators packaging water from their own well or water supplied by a very small water utility company may, therefore, need to take pre-package own-check samples more often than those packaging water provided by bigger utility companies.

The own-check samples collected by an operator under the Food Act serve to ensure the quality of its products. Abnormal findings and own-check measures are discussed in greater detail in section 7 below.

b. After packaging

Quality requirements and recommendation for packagede domestic water

Decree of the Ministry of Social Affairs and Health 1352/2015: quality requirements (Annex 1, paragraphs 1 and 2);
Decree of the Ministry of Agriculture and Forestry 166/2010: reference values for total bacterial counts.

Packaged domestic water must conform to the requirements laid down in the Decree on Domestic Water 1352/2011 throughout the food supply chain. The total colony counts in packaged domestic water during marketing are controlled by the reference values quoted in Decree 166/2010 of the Ministry of Agriculture and Forestry. Own-checks performed under the Food Act should ensure that the total colony counts observed immediately after packaging are roughly equivalent to those observed before packaging. Otherwise, the quality of the packaged domestic water will deteriorate too much during the food supply chain. The analyses performed during marketing are examined at the 'best before' date.

Packaged domestic water's date of minimum durability (best before date) must be indicated on the label. According to Finnish Food Authority's Food guide for Finnish food inspectors and food business operators (17068/2, in Finnish), a foodstuff may also be sold or used after the 'best before' date, provided that its quality has not been substantially impaired.

This rule also applies to domestic water. Responsibility for the quality of domestic water lies with the seller or its supplier.

Packaged domestic water should always meet the relevant quality recommendations. In the event of an abnormal result, the operator should assess the safety of the water and, if necessary, take the necessary action (see section 7 below).

3.4 Water treatment

The treatment of domestic water at food premises is permitted provided that the post-treated water complies with the quality specifications set out in the Decree of the Ministry of Social Affairs and Health 1352/2015. The purpose of such treatment is to improve the quality of the water with regard to a certain variable, but it must not impair the quality of the water as a foodstuff in other respects. Water treatment must be justified on the grounds of food safety or to create a foodstuff-like property. Any added constituents (e.g. salts) which will remain in the domestic water must be listed on the label in accordance with the relevant food labelling legislation. The relevant food safety authority must be notified of the treatment and significant changes therein prior to their commencement.

3.5 Labelling

Packaged domestic water labels must contain the following information:

general statements as indicated in the EU Food Information Regulation 1169/2011;
the information stipulated in the Decree of the Ministry of Agriculture and Forestry on supplying food information to the consumers (834/2014), section 4 (language requirements) and section 5 (batch ID);
water source (name of the water utility company, etc.);
indication of any pre-packaging treatments which have changed the physical, chemical or microbiological properties of the water.

The mandatory nutritional information provided for in EU Regulation 1169/2011 does not apply to packaged domestic water (Annex V).

3.6 Regular monitoring of operations

Food premises are subject to regular monitoring according to a food control plan prepared by the municipal environmental health monitoring unit. The frequency and content of inspections shall be determined on the basis of a risk assessment. The principles for the risk assessment of food premises and the frequency of inspections are set out in Finnish Food Authority guideline 10503.

Regular inspections focus on controlling water treatment and own-check monitoring. Examination of the results of such own-check monitoring constitutes an essential part of the inspections.

If the product or the conditions at the food premises are not in line with the requirements, the food safety authority shall take necessary measures. Finnish Food Authority guideline 100011 provides instructions on the use of administrative coercive measures.

Where appropriate, a control unit may combine inspections performed under different pieces of legislation to one visit to achieve positive synergy. Inspection reports drawn up based on such a visit must, however, be separated based on the legislation on which they are founded.

4 Spring water

4.1 Notification of operations

Before commencing operations, a food business operator who packages spring water must submit a notification of food business operations as required under section 10 of the Food Act (297/2021) to the municipal food control authority for the purposes of registering operations. Also notification must be made without delay if operations are suspended or terminated. The notification is made primarily via the Environmental Health Care e-notification service (Ilppa) or by contacting the local food control unit in place of business directly. Information about municipal food control authorities can be found on the Food Authority website (select the municipality from the search menu). The food control authority will notify the relevant health protection authority of the operator packaging spring water.

The establishment of a new water abstraction point for commercial purposes generally also requires authorisation by an environmental permit authority as provided by the Water Act (587/2011).

4.2 Conditions for operations

The conditions for the exploitation and marketing of spring water are set out in EU Directive 2009/54/EC. The text refers to natural mineral water, but the provisions concerning spring water are stipulated in Article 9, paragraph 4 of the Directive. Articles 4-9 on spring water and Annex II, paragraphs 2 and 3.

Spring water must be bottled at the source and recovery equipment must be installed so as to avoid any possibility of contamination.

The source must be protected against contamination.
Spring water must preserve the properties it possesses at the source.
The catchment, pipes and reservoirs must be made of suitable, inert materials and must prevent any chemical, physico-chemical or microbiological alteration of the water.
The conditions of exploitation, particularly washing and bottling equipment, must meet hygiene requirements.

Where spring water is found to be contaminated and no longer presents the microbiological characteristics laid down in Article 5 of the Directive, its packaging and other recovery must be immediately discontinued.

Spring water may only be subjected to permitted treatments. The permitted methods of treatment are listed in section 4.4 below.

The place where spring water is packaged, treated or stored constitutes a food premises and must, therefore, meet the structural, technical and functional requirements laid down in food safety regulations. Own-check monitoring needs to be sufficient in relation to the scale and quality of the operations (see section 7). Packaging materials and labelling must conform to the requirements (see sections 4.5 and 6).

Spring water must be packaged at the source. Water cannot be transported elsewhere in tanker lorries or other vehicles and packaged thereafter without losing its spring water status. According to the Commission's interpretation, water may be conveyed through a pipeline to the place of packaging, but the quality of the water must remain constant. Spring water can also be utilised in food premises in the manufacture of other foodstuffs.

4.3 Water quality requirements and surveys

Spring water quality must be controlled via own-check monitoring throughout the supply chain (catchment, possible treatment, packaging, storage, transportation and sales). The essential characteristics of the water must be examined by accredited methods in a laboratory approved within the meaning of section 5 of the Food Act. Operators using their own wells are advised to carry out extensive water analyses before making the final decision on the initiation of operations. In Finland, for example, fluoride, arsenic and uranium may cause problems. Their detection after the launch may make the operations unprofitable.

a. Before packaging

Pre-packaged spring water must meet the requirements and recommendations laid down in EU Directive 2009/54/EC (Article 5) and the Decree on Domestic Water 1352/2015. Before packaging, the quality of the water must be examined with samples collected by the authorities under the Health Protection Act and, where appropriate, with own-check samples in compliance with the Food Act. The point of collection is the faucet prior to packaging.

The own-check samples collected by an operator under the Food Act serve to ensure the quality of its products. The need for own-check sampling depends on the scale and quality of the operations. These are assessed based on the following:

Scope and risks of the operations
Possible treatment of spring water inside the food premises
Where the samples collected under the Decree on Domestic Water on the basis of health protection legislation coincide or almost coincide with the launch of the operations, duplicate samples are not usually required and the sampling can focus on the microbiological analyses stipulated in EU Directive 2009/54/EC, Article 5.
In regard to chemical analyses, surveys performed by the health protection authority usually suffice, provided that the analyses do not reveal any defects or problems before packaging.
It should be noted that sampling performed in small water catchments under the Decree on Domestic Water tends to be quite infrequent, and that the nature and frequency of own-check samples in accordance with the Food Act may need to be adjusted accordingly.

Abnormal findings and own-check measures are discussed in greater detail in section 7 below.

b. After packaging

Quality requirements and recommendations for packaged spring water

2009/54/EC, Article 5 (microbiological requirements)
1352/2015 (Ministry of Social Affairs and Health), Annex 1, section 1 (chemical and microbiological quality requirements and recommendations)
166/2010, Annex (total colony count reference values).

Requirements and recommendations concerning the quality of packaged spring water are set out in three legislative acts:

EU Directive 2009/54/EC
Decree of the Ministry of Agriculture and Forestry 166/2010
- at the time of packaging and during marketing, the microbiological and chemical characteristics of packaged water must meet the requirements set out in the Decree on Domestic Water 1352/2015;
- during marketing, however, the total colony counts (72 h, 20-22oC and 24 h, 37oC) are controlled by the Decree of the Ministry of Agriculture and Forestry 166/2010.

Packaged spring water's date of minimum durability (best before date) must be indicated on the label. According to Finnish Food Authority's Food guide for Finnish food inspectors and food business operators (17068), a foodstuff may also be sold or used after the 'best before' date, provided that its quality has not been substantially impaired. This rule also applies to spring water. Responsibility for the quality of spring water lies with the seller or its supplier.

Packaged spring water should always meet the relevant quality recommendations. In the event of an abnormal result, the operator should assess the safety of the water and, if necessary, take the necessary action (see section 7 below).

4.4 Water treatment

The methods of treating spring water are subject to strict restrictions. Treatment is only permitted in accordance with EU directives 2003/40/EC and 2009/54/EC or EU Regulation 115/2010 adopted pursuant to 2009/54/EC. The treatment shall be notified to the supervisory food safety authority.

Permitted treatments are

the removal of iron, manganese, sulphur compounds and arsenic by treatment with ozone-enriched air (EU Directive 2003/40/EC: conditions for using ozone-enriched air for the treatment of natural mineral waters and spring waters).

The treatment may not alter the composition of the water as regards the essential constituents which give it its properties. The same principle may be applied if the water contains other harmful constituents. All treatment techniques must be approved by the Commission.

The removal of fluoride is governed by EU Regulation 115/2010 on the conditions for the use of activated alumina for the removal of fluoride from natural mineral waters and spring waters.

Where spring water is marketed as spring water, the only ingredient that may be added is carbon dioxide. The purity of the gas used must comply with EU food additive legislation. Spring water can be used in the manufacture of other foods. Water disinfection treatments are prohibited. See section 7 of this Guide for measures where spring water is microbiologically contaminated.

4.5 Labelling

Labels must contain the following information:

General statements as indicated in the EU Food Information Regulation 1169/2011 (Art. 9). The mandatory nutritional information stipulated in the regulation does not apply to spring waters (Art. 29, Annex V).
The information stipulated in the Decree of the Ministry of Agriculture and Forestry on supplying food information to consumers (834/2014), including section 4 (language requirements) and section 5 (batch ID).
In addition, Article 9(4) of Directive 2009/54/EC provides for the term 'spring water' (subparagraph 1) and for labelling requirements (point c). Labels must clarify and declare:
1. the place where the spring is exploited and the name of the spring (Article 7, paragraph 2b);
2. information on any treatments as referred to in Article 4 (Article 7, paragraph 2c).

Labels of waters treated with ozone-enriched air must bear the words 'water subjected to an authorised ozone-enriched air oxidation technique' (EU Directive 2003/40/EC, Article 6).

Fluoride removal treatment according to EU Regulation 115/2010 must be indicated with words 'water subjected to an authorised adsorption technique' (EU Regulation 115/2010, Article 4).

Spring water may only be marketed under one trade name (Article 8, paragraph 2). Finnish Food Authority has interpreted the restriction against multiple trade names to apply, in particular, to situations where an operator/packager wishes to sell water from the same source under several trade names. However, cases where the same spring water is sold simultaneously under a chain store's trade name and the packager's own trade name, are not considered to be in breach of the stipulation on multiple trade names provided for in the Directive. The labelling of such 'private label' waters must also indicate the place where the spring is exploited and the name of the spring, and it must not be misleading to consumers.

According to Finnish Food Authority's interpretation, spring water used as a raw material in the manufacture of a foodstuff can be mentioned on the labelling of the said foodstuff but only if it does not contain any other water.

Moreover, spring water labels must conform to Article 8 of the Directive (text refers to natural mineral water, but the said Article also applies to spring water).

Since the mineral content of many spring waters remains constant, the labelling may indicate the exact composition of the constituents characteristic to the water, provided that the information does not mislead the consumer. Possible variations in concentrations must be taken into account in the information provided to consumers and the concentrations must be based on sufficiently recent laboratory analyses. If composition data is provided, Finnish Food Authority recommends that the data given covers the constituents characteristic to spring water (e.g. minerals, fluoride).

4.6 Regular monitoring of operations

The Food Act provides for the regular monitoring of operations performed at food premises. The frequency and content of inspections shall be determined on the basis of a risk assessment. For own-checks and the assessment thereof, please see section 7 below. Responsibility for quality assurance and appropriate use and storage of packaged spring water lies with the actor in the food supply chain responsible for the packaging, storage, transportation, provision or supply of the product at the given time.

If the product or the conditions at the food premises are not in line with the requirements, the food safety authority shall take the necessary measures. Finnish Food Authority guideline 100011 provides instructions on the use of administrative coercive measures.

5 Natural mineral water

5.1 Notification of operations

Before commencing operations, a food business operator who packages natural mineral water must submit a notification of food business operations as required under section 10 of the Food Act (297/2021) to the municipal food control authority for the purposes of registering operations. Also notification must be made without delay if operations are suspended or terminated. The notification is made primarily via the Environmental Health Care e-notification service (Ilppa) or by contacting the local food control unit in place of business directly. Information about municipal food control authorities can be found on the Food Authority website (select the municipality from the search menu).

In addition, before placing natural mineral on the market, the operator must apply to the Finnish Food Authority for recognition of the natural mineral water. Recognition requires the water to meet the criteria laid down in EU Directive 2009/54/EC and the municipal food control authority must have been notified of operations for the purposes of registration. The Finnish Food Authority will notify recognition to the European Commission for inclusion on the List of Natural Mineral Waters recognised by Member States.

This notification must be accompanied by a statement (recognition documents) regarding the fulfilment of the requirements laid down in EU Directive 2009/54/EC.

The control of natural mineral waters is not governed by health protection legislation or the regulations regarding the quality of domestic water.

5.2 Conditions for operations

Natural mineral water obtained from Finnish soil must be recognised by the Finnish Food Authority. This recognition is conditional on the stability of the mineral content. The Finnish Food Authority reports all recognised natural mineral waters and any revoked recognitions to the European Commission. The list of recognised waters is published in the Official Journal of the European Union and on the European Commission's website.

Recognised natural mineral waters must meet the following requirements:

The water must comply with the provisions of Annex I to EU Directive 2009/54/EC.

Conditions for exploitation and marketing of natural mineral water:

Exploitation and packaging of water is subject to Annex II to EU Directive 2009/54/EC.
Water must meet the quality requirements set out in the said Directive (see section 5.3 below).
Water has not been treated or has been treated only in the permissible manner (see section 5.4 below).

Natural mineral water is packaged at its source. Natural mineral water cannot be transported elsewhere in tanker lorries or other vehicles and packaged thereafter without losing its natural mineral water status. Natural mineral water may be used in the manufacture of other foodstuffs.

The place where natural mineral water is packaged, treated or stored constitutes a food premises and must, therefore, meet the structural, technical and functional requirements laid down in food safety regulations. The materials used in the conveyance and treatment of water must be sufficiently inert so as not to cause any observable changes in the quality of the water prior to packaging. Own-check monitoring must be sufficient in relation to the scale and quality of the operations across the entire supply chain (see section 7 below). Packaging materials and labelling must conform to the requirements (see sections 5.5 and 6).

Industrial mineral waters

There is a large range of unflavoured and flavoured industrial mineral waters on the market. These waters are made of domestic water which is fortified with mineral salts or earth-alkali salts and flavoured with, for example, aromas. Water used in industrial mineral waters must comply with the requirements of the Decree on Domestic Water.

Earlier legislation (Decision of the Ministry of Trade and Industry 1658/1995, repealed by Decree 166/2010) assumed industrial mineral waters to contain at least 500 mg/l of mineral salts. The requirement for a total quantity of minerals has since been replaced by the provisions laid down in EU Regulation 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods. Finnish Food Authority has prepared a guide for control of fortified foods, which is observed in the manufacture and marketing of industrial mineral waters.

5.3 Water quality requirements and surveys

Quality requirements and recommendation for natural mineral water

EU Directive 2009/54 quality requirements (Article 5 and Annex 1)
Decree of the Ministry of Agriculture and Forestry 166/2010 on total bacteria count reference values
EU Directive 2003/40 maximum limits, which, if exceeded, may pose a risk to public health.

The definition of natural mineral water and the conditions and requirements for the application of the definition are set out in Annex I to EU Directive 2009/54/EC. The annex defines the required geological and hydrological, physical, chemical and physio-chemical surveys, microbiological analyses at the source and, where appropriate, the pharmacological, physiological and clinical analyses to be performed. The requirements for microbiological quality are also referred to in Article 5 of the said Directive.

The need for and adequacy of post-recognition own-checks regarding the chemical, physical and microbiological variables is determined with the relevant food safety authority by considering the scale of the operations and the possible sources of contamination and other potential hazards.

Natural mineral water must comply with microbiological standards (2009/54/EC, Article 5) at the source and during marketing. The total colony count shall be measured within the 12 hours following packaging, the water being maintained at 4 ± 1^oC during this 12-hour period. During marketing, own-check analyses are carried out at a sufficient frequency. This frequency is determined operator-specifically.

The essential characteristics of the water must be examined by accredited methods in a laboratory approved within the meaning of section 5 of the Food Act.

Packaged natural mineral water's date of minimum durability (best before date) must be indicated on the label. According to Finnish Food Authority's Food guide for Finnish food inspectors and food business operators (17068), a foodstuff may also be sold or used after the 'best before' date, provided that its quality has not been substantially impaired. This rule also applies to natural mineral waters. Responsibility for the quality of natural mineral water lies with the seller or its supplier.

5.4 Water treatment

The treatment of natural mineral water is subject to strict restrictions. Treatment is permitted only in accordance with EU Directive 2009/54/EC or the Commission regulations adopted thereunder.

The treatment shall be notified by the operator to the competent food safety authority prior to its commencement.

The permitted methods of treatment are listed in Article 4 of EU Directive 2009/54/EC. The authorised methods are further laid down in EU Directive 2003/40/EC (Conditions for using ozone-enriched air for the treatment of natural mineral waters and spring waters) and in EU Regulation 115/2010 (Conditions for use of activated alumina for the removal of fluoride from natural mineral waters and spring waters).

The only ingredient permitted to be added to natural mineral water marketed as natural mineral water is carbon dioxide. The gas needs to be adequately pure for food use. Additional requirements for carbonated natural mineral waters are provided for in Directive 2009/54/EC, Article 7, Annex I, section III.

Disinfection treatments are prohibited. For measures in situations where the source of natural mineral water is microbiologically contaminated, see chapter 7 below.

5.5 Labelling

Any containers used for packaging natural mineral waters need to be fitted with closures designed to avoid any possibility of adulteration or contamination (EU Directive 2009/54/EC, Article 6).

Labels must include:

General statements as indicated in the EU Food Information Regulation 1169/2011 (Art. 9). The nutrition declaration requirements under the Regulation do not apply to natural mineral waters (Art. 29).
Labelling, such as section 4 (language requirements) and section 5 (batch ID), required under the Decree of the Ministry of Agriculture and Forestry on supplying food information to consumers (834/2014).
In addition, EU Directive 2009/54/EC lays down that the following information must be included in the labelling of natural mineral waters:
1. The sales description must be ”natural mineral water” or ”naturally carbonated natural mineral water'”, ” 'natural mineral water fortified with gas from the spring” or ” 'carbonated natural mineral water” (Article 7, section 1).
2. The analytical composition of the natural mineral water (characteristic constituents, Article 7, section 2.a).

If the water has been treated with ozone, the label must include the indication “water subjected to an authorised ozone-enriched air oxidation technique” in proximity to the statement of the analytical composition (EU Directive 2003/40/EC, Article 6).

If the natural mineral water has been subject to fluoride removal treatment, in accordance with EU Regulation 115/2010, the label must include the indication “water subjected to an authorised adsorption technique” must be added in proximity to the statement of the analytical composition (EU Regulation 115/2010, Article 4).

If the water contains fluoride in excess of 1.5 mg/l, the wording “contains more than 1.5 mg/l of fluoride: not suitable for regular consumption by infants and children under 7 years of age” must be clearly marked on the packaging in immediate proximity to the trade name. In addition, the label must indicate the actual fluoride content in relation to the physico-chemical composition in terms of essential constituents (2003/40/EC, Article 4).

the place where the spring is exploited and the name of the spring (Article 7, paragraph 2b).
information on all authorised treatments authorised in Article 4(1) points b and c) (Article 7, paragraph).
the sales description of natural mineral waters which have undergone total or partial elimination of free carbon dioxide by exclusively physical methods must include the words “fully decarbonated” or “partially decarbonated” accordingly (Article 7, paragraph 1, subparagraph 2).
water recognised as natural mineral water may only be marketed under one trade name (Article 8 paragraph 2). For example, spring water may not be marketed both as natural mineral water and spring water. The Finnish Food Authority’s interpretation is that the same natural mineral water may, however, be sold under many different trademarks (e.g. a store’s private label) if the use of these does not mislead the consumer. To prevent consumers from being misled, the name of the food (natural mineral water) and the spring from which the spring water originates (name of the spring and place of exploitation) must be clearly indicated in conjunction with or in immediate proximity to the commercial trademark.
the expressions and requirements provided for in Article 9 are set out in Annex III to the Directive.

Where natural mineral water is used as a raw material in food, it can be mentioned on the labelling of the food, but only where the food contains no other water.

It is prohibited, both on packaging or labels and in advertising in any form whatsoever, to use indications, designations, trademarks, brand names, pictures or other signs, whether figurative or not, which: a) in the case of a natural mineral water, suggest a characteristic which the water does not possess, in particular as regards its origin, the date of the authorisation to exploit it, the results of analyses or any similar references to guarantees of authenticity.

All indications attributing to a natural mineral water properties relating to the prevention, treatment or cure of a human illness are prohibited. However, the indications listed in Annex III to EU Directive 2009/54/EC are authorised if they meet the relevant criteria laid down in that Annex. Article 9 provides more provisions on about optional indications.

5.6 Regular monitoring of operations

The Food Act provides for the regular monitoring of operations performed at food premises. The frequency and content of inspections shall be determined on the basis of a risk assessment. For own-checks, the assessment thereof and abnormal findings, please see section 7 below. Responsibility for the quality assurance and appropriate use and storage of packaged natural mineral water lies with the actor in the food supply chain responsible for the packaging, storage, transportation, provision or supply of the product at the given time.

6 Packaging and packaging materials

Materials used for packaging water must comply with the requirements for materials and articles intended to come into contact with foodstuffs. The general requirements for such materials are set out in EU Regulation 1935/2004. According to the Regulation, materials and articles may not, under foreseeable conditions of use, transfer their constituents to food in quantities which could endanger human health, bring about an unacceptable change in the composition of the food, or bring about a deterioration in the organoleptic characteristics thereof.

In addition to Regulation 1935/2004, materials in contact with foodstuffs must comply with any material-specific regulations. Material-specific regulations are currently limited to a few different materials, such as plastics 10/2011 (EU), recycled plastics 282/2008 (EU), regenerated cellulose film 697/2005 (Ministry of Trade and Industry), ceramic 165/1996 (Ministry of Trade and Industry) and active and intelligent materials 450/2009 (EU). Laws concerning food contact materials are listed on the Ministry of Agriculture and Forestry's website.

Consumer packages used for packaging water are mainly made of plastic and must meet the requirements set out in the Regulation on plastic materials and articles. Other possible materials include, for example, metal and multilayer cardboard. In the absence of any material-specific legislation, manufacturers or importers of such food contact materials must provide other safety references, such as laws or recommendations adopted by an EU member state, recommendations and guidelines of a trade association, or legislation in force in a non-EU country.

The water packager must ensure the compliance and suitability of materials or articles by asking the supplier (manufacturer or importer) to present documents which prove the compliance and suitability of the said material or article for packaging water. In these documents, the manufacturer or importer must declare that the material or article complies with the requirements laid down in the above-mentioned framework regulation, material-specific legislation or other safety reference, and must demonstrate the basis on which the declaration is presented. The documents must indicate the applicable types of food contact (types of food, temperature, contact time) and the surveys and analyses used to prove the characteristics of the material or the article. If the material contains constituents with legislative threshold values, this must also be stated. The same applies to any food additives (dual-use additives) used in the manufacture of the material.

The Regulation on plastic materials and articles provides for requirements for the content of the declaration of compliance regarding the conformity of plastic materials. Corresponding information must be requested for other materials.

Finnish Food Authority guideline 17018 contains instructions on the control of food contact materials and the attestation of conformity. For control of contact materials at food premises, please see Oiva Evaluation Guidelines (14.1).

Food contact material legislation does not apply to permanent materials in public or private water utility companies. The materials used in wells, pipelines and treatment devices by an operator packaging or treating water must, however, be suitable to be in contact with domestic water. The invariability of water prior to packaging is ensured by using materials which are as inert as possible. Materials used in water treatment equipment must comply with the requirements of the Decree on Domestic Water 1352/2015, section 20, and the Health Protection Act 763/1994. If necessary, Valvira provides guidance on suitable materials for water treatment equipment.

7 Own-check monitoring and abnormal findings

Own-check monitoring

An operator packaging water must have an own-check monitoring plan based on risk assessment and management. The risk assessment needs to take into account conditions inside and around the catchment and the resulting risks, such as contamination sources. Other potential operations-based risks include, for example, dead-end pipelines with no water flow, poor cleanability of the network and equipment, inefficient cleaning routines and the use of materials not suitable for the intended use. The risk assessment should also address, for example, the durability and suitability of the packaging for transportation and consumer use and the prevention of water contamination during treatment.

Any water treatment measures performed inside the food premises, their impact on the packaged water and the maintenance of the treatment must be described in the plan.

The food business operator must ensure that the water plumbing works performed inside the food premises are carried out hygienically and by someone with adequate professional skills. The same applies to operators who use their own wells.

An operator who stores packaged water or supplies or provides it to consumers is responsible for the proper storage and cleaning of bottles and containers.

Own-check monitoring includes a sampling plan to monitor the quality of the water before and after packaging, and to determine and ensure minimum durability. Sampling should be concentrated immediately after packaging to obtain information at the start of the supply chain, which will allow the operator to react more quickly to changes in water quality. This also makes the practical implementation easier. Surveys performed close to the best before date indicated on the label reveal information about the water's shelf life and help to determine the correct minimum durability. Own-check sampling must observe the surveys to be conducted on packaged domestic water and spring water under the Decree on Domestic Water.

In regard to own catchments, the sampling plan also needs to take into account any variables monitored due to local environmental risks with which the operator can demonstrate to the controlling authority that its product does not cause any adverse impacts on health. The tracked variables may include, for example, PAHs (polycyclic aromatic hydrocarbons), VOCs (volatile organic compounds), THMs (trihalomethanes) and pesticides.

Packagers of spring water or natural mineral water are recommended to perform so-called trend monitoring regarding certain indicator variables. This allows them to track the trends in analysis results and take any corrective measures in time. The use of continuous metrics (e.g. pH and opacity) is also recommended.

The frequency of own-check sampling depends, for example, on the extent of the operations, possible water treatments and the frequency of sampling conducted at the catchment under the Decree on Domestic Water 1352/2015. Regarding chemical analyses, in the absence of problems, samples collected regularly from packaged domestic water or spring water on the basis of the Decree on Domestic Water may suffice. The packager reviews the results as part of its own-check monitoring.

Small operators who package and supply small quantities of water to a limited geographical area may replace part of the microbiological analyses with samples under the Decree on Domestic Water.

In the case of spring water or natural mineral water, it should be noted that own-check sampling covers microbiological tests in accordance with EU Directive 2009/54/EC. Some of the surveys must be scheduled around the best before date to ensure the microbiological integrity of the spring water or natural mineral water throughout the marketing period.

The table attached as Annex 1 to this guideline presents the requirements and recommendations for the quality of domestic water, spring water and natural mineral water before and after packaging.

Abnormal results

If packaged water is found to contain microbes or substances in quantities which are not in compliance with the quality requirements, the packaging of such water must be immediately stopped.

The source of the problem must be identified by ascertaining whether the contamination is caused by the pipeline, by post-contamination during packaging or by contamination of the water source itself. In addition, the necessary measures must be taken including, for example, the suspension of production, product recall and the elimination of the problem.

These measures also include the examination of own-check records and sample results, and the assessment of sampling. Quality problems detected before packaging must be investigated together with the operator and the municipal food safety and health protection authorities.

If necessary, the piping can be cleaned and disinfected. If the contamination of spring water or natural mineral water is caused by the source, the water can no longer be used as all disinfection treatments are prohibited under EU directives 2009/54/EC and 2003/40/EC.

Some of the threshold values for packaged water are recommendations. Where the recommended threshold values are exceeded, the operator must identify the reason for the alteration and, where appropriate, assess the need for measures with the relevant food safety authorities. Total colony counts usually increase during the food supply chain. If the increase is exceptional and, in particular, if it is recurrent, the cause for the deterioration of quality needs to be determined. Possible causes include erroneous storage after the best before date, storage in a warm place, exposure to light, or external contamination. Although the increase in total colony counts alone does not make the water harmful to health, the deviations indicate a deterioration in quality in the food supply chain.

Introduced by Merja Virtanen

Approved by Sari Sippola

Annex 1. Requirements and recommendations for the quality of domestic water, spring water and natural mineral water before and after packaging. (pdf)

Coming into force

This guidance has come into force on 20.10.2021 and it replaces the previous version (The Finnish Food Authority Ruokavirasto´s guidance 17057/1, published on 19.12.2019).

Updates in version 3

Corrected Food Act number 23/2006 to new number 297/2021.
Modified points 3.1; 4.1 and 5.1 “Notification of activities” to comply with the new Food Act.
Changed the interpretation of the sale of spring water and natural mineral water under several different brands in sections 4.5 and 5.5.
Fixed broken links to websites.