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Applying for the approval of natural mineral water


Natural mineral water is water that is used for drinking and is microbiologically wholesome water originating in an aquifer and emerging from a spring which is protected against contamination and from which water is extracted through one or more water intakes which are natural or have been made usable artificially.

Natural mineral water differs from ordinary drinking water in terms of:

  1. composition and the content of characteristic minerals, trace elements, or other constituents of the composition; and, where appropriate, in terms of specific effect;
  2. natural purity;
  3. the stability of the characteristics thanks to the underground origin of the water and its protection from any pollution risk.

Pursuant to Directive 2009/54/EC of the European Parliament and of the Council and Commission Directive 2003/40/EC, natural mineral waters may be marketed if the water extracted from the ground of a Member State is recognised as a natural mineral water by the responsible authority of that Member State. Natural mineral waters extracted from the ground of a third country and imported into the Community must be recognised as natural mineral waters by the responsible authority of at least one Member State. In Estonia, the Health Board (article in Estonian) recognises natural mineral waters.

The obligation on a producer of natural mineral waters derives from the following legislation:

Requirements for the submitter

A source of mineral water may be put into service and the water bottled only after it has been established that the water meets the requirements laid down for mineral water and a water permit (or, for mineral water from another country, a permit from the responsible authority in the country of origin) has been issued. Mineral water must be bottled at the point of extraction. As the characteristic constituents of the mineral water must remain unchanged from the point of origin to the final consumer, the extracted water must not be treated. The use of only a few methods of treating mineral water, such as the addition of carbon dioxide or the removal of volatile or undesirable constituents (only if this does not alter the composition of the water in relation to the essential constituents that give it its characteristic properties), is allowed.

In order to extract natural mineral water, an environmental permit must be obtained from the Environmental Board under the requirements of the Water Act and the regulation(s) of the Minister of the Environment.

The production of natural mineral water, i.e. all processes in the plant, must comply with strict food safety rules. Producers of natural mineral waters (like all food businesses) must apply for a licence from the Agriculture and Food Board. The Agriculture and Food Board is the competent authority that approves food business operators and supervises food business operators under the Food Act and the Water Act. Before a natural mineral water certification procedure can be started at the Health Board, the establishment must have been inspected by the Agriculture and Food Board and a licence issued.

Applying for the approval of natural mineral water

The quality of natural mineral waters is subject to a series of requirements, compliance with which is subject to rigorous checks during the natural mineral water approval procedure. The water must come from uncontaminated underground sources, be naturally clean and microbiologically safe. The composition of the mineral salts in the water must also be stable. During the procedure for the approval of natural mineral water, compliance with the above criteria is assessed and a decision is issued as a result of the assessment.

For a water to be approved as a natural mineral water, the following must be submitted to the Health Board:

Paying the state fee

For the procedure for the approval of natural mineral water, for the assessment of conformity of water extraction and treatment facilities, for the issuing of the certificate of approval and the extension of its validity, and for the notification of the European Commission and the Member States, a state fee is charged at the rate provided for in the State Fees Act. During the approval procedure for natural mineral water, the following must be paid:

  • a state fee of €415 for starting the approval procedure for natural mineral water pursuant to subsection 293 (1) of the State Fees Act.
  • a state fee of €685 for the assessment of the conformity of water extraction and treatment equipment for natural mineral water at the point of extraction.
  • a state fee of €80 for issuing or renewing a decision approving a natural mineral water and for notifying the European Commission and the responsible authorities in the Member States. In addition, the producer of the natural mineral water must pay the accommodation costs and travel expenses to and from the point of extraction for two representatives of the Health Board involved in assessing the compliance of the point of extraction of the natural mineral water, the source, the extraction equipment, and the treatment process. This obligation only applies if the Health Board has to incur costs that are not covered by the state fee in the framework of the procedure for the recognition of the extra-Community underground mineral water.

Cross-border activities

In the case of a company wishing to market its natural mineral water in another EU Member State, it is necessary that the natural mineral water in question has a valid certificate of approval and that the name and other details of the product can be found on a list of products kept up to date by the European Commission. The list of natural mineral waters recognised by the competent authorities of the Member States of the European Union is available on the website of the European Commission.