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Spain: Technical-sanitary criteria for the quality of drinking water, its control and supply

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In brief

The new Royal Decree 3/2023 has been published, which establishes the technical-sanitary criteria for the quality of drinking water as well as its control and supply. In this way, the European regulations have been transposed to the national level, with the main goal of improving health protection against the contamination of water intended for human consumption, regardless of its final purpose.

In more detail

The new Royal Decree 3/2023, of 10 January 2023, establishing the technical-sanitary criteria for the quality of drinking water, its control and supply (“New Royal Decree“) came into force on 12 January 2023. The New Royal Decree transposes Directive (EU) 2020/2184 on the quality of water intended for human consumption, which was approved with the purpose of reinforcing the protection of people’s health against the possible adverse effects that may occur due to the contamination of water intended for consumption. It should be emphasized that drinking water is understood to be water intended for human use, whether for drinking, cooking, hygiene, food preparation or similar domestic purposes (“Drinking Water“).

The new standard repeals Royal Decree 140/2003, which had been regulating the sanitary criteria for the quality of water for human consumption until now, and transposes to the national level the harmonized minimum requirements to be observed by materials in contact with water for human consumption, as provided for in the European Directive. The New Royal Decree, in line with the European standard, aims to protect human health and also seeks to facilitate access to Drinking Water, contributing to the United Nations’ sustainable development objective, which arose as a result of the lack of access to Drinking Water by the population, especially by vulnerable groups or those at risk of social exclusion. Therefore, the ultimate aim of the regulation is to guarantee the availability and minimum access to Drinking Water, by increasing the confidence of citizens in tap water and the promotion of such water by the administration, at state, autonomous and local level.

It is since Law 14/1986, on General Health, that provisions aimed at the improvement of water supply systems have been foreseen, already establishing some sanitary criteria for water for human consumption, which have been modified. However, the new Royal Decree presents a novel approach based on risk assessment and management of:

  • Water catchment areas, with the aim of reducing the Drinking Water treatment necessary for its production.
  • The supply areas, the focus on risk management of these not being a novelty, given that they were already introduced with Royal Decree 902/2018.
  • Indoor installations in priority buildings, focusing attention on certain priority buildings, including hospitals, educational centers and sports or leisure centers.

In other words, the New Royal Decree seeks to achieve global control of Drinking Water pollution prevention along the supply chain. The standard itself already provides for criteria and measures to be applied in water catchment areas and, with respect to supply areas and priority buildings, provides for the implementation of the Water Sanitation Plan (PSA, by its acronym in Spanish), already foreseen since 2018 following the recommendation of its approach made by the World Health Organization in 2004.

In addition, in accordance with the provisions of the European standard, the Drinking Water quality parameters are updated with respect to those provided for in the previous standard. These new parameters can be consulted in Annex I of the new Royal Decree.

In view of the above, the relevance of the New Royal Decree should be emphasized, as it introduces the requirements harmonized by the European standard and broadens the approach to the management of risks of Drinking Water contamination, in order to improve its quality and guarantee its general availability.

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Montserrat has extensive experience in pharmaceutical and health law, as well as in compliance, contract law, licensing, competition law and acquisitions in the pharmaceutical sector. She is the coordinator of the healthcare practice in the Barcelona office.
She assists healthcare companies throughout the life cycle of healthcare products (drugs, IVD and medical devices, combination products, cosmetics and food supplements), from R&D to commercialization and more specifically in the areas of clinical trials (agreements, regulatory procedures, processing of personal data), market access (pricing and reimbursement), products and companies regulations (MA/CE-marking, vigilances, required licenses, product classification, labelling), commercial relations between healthcare industries (distribution, (co)promotion, manufacturing, supply, licensing, partnership agreements), relations with healthcare professionals and/or patients including compliance (anti-gift and transparency laws); communication and advertising, e-health (connected devices, telemedicine, hosting of health data) and product liability. Her practice encompasses both advisory and litigation matters.
She also has considerable experience in the drafting of codes of professional ethics and conducting compliance audits, and advising on advertising and promotion of medicines and medical devices, including via the internet, online advertising and social media. Montserrat advises on a wide range of agreements related to the pharmaceutical industry, such as license and distribution agreements, clinical trial agreements, and supply and manufacturing agreements.

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