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    Spain · National · Royal Decree

    Royal Decree 664/1997 · Exposure to biological agents

    In force, as amended

    Current official Spanish title: Real Decreto 664/1997, de 12 de mayo, sobre la protección de los trabajadores contra los riesgos relacionados con la exposición a agentes biológicos durante el trabajo.

    Original publication and analysisConsolidated textELI identifier
    On this page
    1. What it regulates
    2. Who it applies to
    3. Key provisions
    4. History and versions
    5. Transitional provisions and application notes
    6. Official BOE legal relationships
    7. Official sources
    8. Explore the concepts in Sabentis Explore

    What it regulates

    Governs assessment and prevention of occupational exposure to biological agents, their classification, containment, health surveillance and specified notifications.

    Who it applies to

    Activities in which workers are or may be exposed to biological agents because of their work, subject to Article 4’s distinctions for work not involving deliberate handling.

    Key provisions

    Identify the nature, degree and duration of exposure, considering classification and available information; update the assessment when required.

    Article 4

    Replace hazardous agents with less hazardous ones where the nature of the activity permits.

    Article 5

    Prevent exposure; where technically impossible, reduce it as far as possible through procedures, containment, hygiene, safe waste management and protection.

    Article 6

    Offer specific health surveillance and make effective vaccines available where the corresponding risk exists, explaining benefits and disadvantages.

    Article 8

    Notify first use of group 2, 3 or 4 agents at least thirty days in advance, together with the article’s other notification cases and exceptions.

    Article 10

    History and versions

    Initial publication: 24/05/1997 · Initial entry into force: 24/07/1997

    BOE-A-1997-11144

    Order TES/1287/2021 amended Annexes I and II.

    Publication: 25/11/2021 · Effective date: 26/11/2021

    BOE-A-2021-19371

    Order TES/1180/2020 amended Annex II and replaced Annexes IV and V, with staged applicability under its sole transitional provision.

    Publication: 10/12/2020 · Effective date: 11/12/2020

    BOE-A-2020-15871

    The Order of 25 March 1998 amended Annex II.

    Publication: 30/03/1998 · Effective date: 31/03/1998

    BOE-A-1998-7341

    Order ESS/1451/2013 was issued under this framework on prevention of sharps injuries in the healthcare sector.

    BOE-A-2013-8381
    All text versions recorded by the BOE

    Publication and effective dates are different. The table retains the dates and provisions of each recorded text version; it does not treat future transitional deadlines as requirements already applicable.

    PublicationEffective dateOfficial referenceAffected provisions
    24/05/199724/07/1997BOE-A-1997-11144preambulo, CAPÍTULO I, Article 1, Article 2, Article 3, CAPÍTULO II, Article 4, Article 5, Article 6, Article 7, Article 8, Article 9, Article 10, Article 11, Article 12, Article 13, CAPÍTULO III, Article 14, Article 15, Additional provision sole, Transitional provision sole, Repealing provision sole, Final provision first, Final provision second, Final provision third, firma, Annex I, Annex II, Annex III, Annex IV, Annex V, Annex VI
    30/03/199831/03/1998BOE-A-1998-7341Annex II
    10/12/202011/12/2020BOE-A-2020-15871Annex II, Annex IV, Annex V
    25/11/202126/11/2021BOE-A-2021-19371Annex I, Annex II

    Transitional provisions and application notes

    • The sole transitional provision’s three-month period applied to employers already using group 2, 3 or 4 agents when the decree commenced in 1997. It is a historical provision.

      Transitional provision sole

    • Order TES/1180/2020 applied the new Annexes IV and V to Coronaviridae from 11 December 2020 and to all agents from 19 November 2021. That transition has ended.

      Official reference

    Official BOE legal relationships

    Earlier references (8)
    Subsequent references (4)

    Official sources

    Official sources checked on 14/11/2026. Updating a database record does not by itself mean that the legislation has been amended.

    1. Original publication and analysis
    2. Consolidated text
    3. ELI identifier
    4. BOE-A-2020-15871

    Based on data from Spain’s Official State Gazette (BOE). Consolidated text is informational: consult the official publication for legal purposes. The history includes every subsequent relationship in the retrieved BOE record, but does not guarantee coverage of all judgments or implied changes.

    The official title is retained in Spanish. English and Catalan texts are editorial summaries, not official translations of the legislation.

    Editorial information

    Publication date: 14 November 2026.

    Editorial responsibility: Sabentis editorial team.

    Editorial review by Pablo RodríguezLinkedIn

    Executive Vice President of the International ORP Foundation and Chief Financial Officer of Sabentis.

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