2021/0664/E
EC/EFTA
ES Spain
  • S00S - HEALTH, MEDICAL EQUIPMENT
2022-01-17
2021-10-26

This decree affects any facility (fixed or mobile) in which Legionella is able to proliferate and spread and which are identified by the concurrence of two factors: using water and producing, or being susceptible to produce, aerosols.

Royal Decree laying down sanitary requirements for the prevention and control of legionellosis.

This Royal Decree has been drafted in order to protect the population from exposure to Legionella in facilities susceptible to its proliferation and spread by updating Royal Decree 865/2003 of 4 July 2003 laying down hygiene and health measures for the prevention and control of legionellosis in accordance with current technical and epidemiological knowledge of the disease and based on the experience acquired through its application.

This decree affects any facility (fixed or mobile) in which Legionella is able to proliferate and spread and which are identified by the concurrence of two factors: using water and producing, or be susceptible to produce, aerosols. Since there are other factors (e.g. design, maintenance, location, etc.) that affect a facility’s level of risk, the classification of facilities according to their probability of proliferation and dispersion of Legionella has
been eliminated. Instead, the risk category of each facility will be determined by its corresponding assessment results.
The obligation to notify these facilities (cooling towers or evaporative condensers) has been maintained as in the current legislation. However, it is possible for regional health authorities to extend the scope of this requirement to other facilities.
The regulations emphasise the responsibilities with regard to the design and materials used in the equipment and appliances used by facilities susceptible to multiplication and spread of the germ in question. Similarly, the use and maintenance instructions for aerosol cooling equipment or humidifiers for home use must include cleaning or disinfection guidelines to be observed by users.
Furthermore, the obligation to monitor Legionella extends to all facilities subject to the circumstances covered by the Royal Decree and not only to those identified as high-risk (facilities referred to in Article 2.2.1 of Royal Decree 865/2003 of 4 July 2003).
The two instruments identified for the control of Legionella are the Health Plan (PSL) (established on a voluntary basis) and the Legionella Prevention and Control Plan (PPCL). The first is based on continuous risk assessment of the facility following the recommendations of the World Health Organisation and adaptation of measures and
controls according to the assessment results). For the first plan, the aspects to be integrated are set out (Evaluation of the system: identification of hazards, ranking of risks and identification of critical areas where improvements need to be made and a description of corrective and preventive measures to mitigate risks; Control and verification measures; Management and communication and evaluation of the PSL). Furthermore,
for the second plan, the articles and corresponding annexes set out the general and specific aspects to be observed and the measures and actions to be taken by the facility manager or the companies responsible for the prevention and control of Legionella at a facility.