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(3) It is necessary to exclude from the scope of this Directive natural mineral waters and waters which are medicinal products, since such types of water are covered by Directives 2009/54/EC Directive 2009/54/EC of the European Parliament and of the Council of 18 June 2009 on the exploitation and marketing of natural mineral waters (OJ L 164, 26.6.2009, p. 45). and 2001/83/EC Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). of the European Parliament and of the Council respectively. However, Directive 2009/54/EC deals with both natural mineral waters and spring waters, and only the former category should be exempted from the scope of this Directive. In accordance with the third subparagraph of Article 9(4) of Directive 2009/54/EC, spring waters should comply with this Directive and, with regard to microbiological requirements, spring water should comply with Directive 2009/54/EC. In the case of water intended for human consumption put into bottles or containers intended for sale, or used in the manufacture, preparation or treatment of food, such water should, as a matter of principle, continue to comply with this Directive until the point of compliance, namely the tap, and should after that point be considered as food if it is intended to be, or reasonably expected to be, ingested by humans, in accordance with Regulation (EC) No 178/2002 of the European Parliament and of the Council Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 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 (OJ L 31, 1.2.2002, p. 1). . In addition, food business operators that have their own water source and use it for the specific purposes of their business should be able to be exempted from this Directive provided that they comply with relevant obligations, in particular regarding hazard analysis and critical control point principles and remedial actions under relevant Union legislation on food. Food business operators that have their own water source and act as water suppliers should comply with this Directive in the same way as any other water supplier.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-28 · Text as adopted (Official Journal); later amendments are not incorporated in this text.