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    Spain · National · Order

    Order TES/1287/2021 · Activities and classification of biological agents

    Amending instrument not repealed according to the BOE record; consult the current receiving legislation

    Official title in the original Spanish publication: Orden TES/1287/2021, de 22 de noviembre, por la que se adapta en función del progreso técnico el 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 analysisELI 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

    It updated Annexes I and II to Royal Decree 664/1997: the indicative list of activities and the classification of biological agents. It completes the technical adaptation begun by Order TES/1180/2020.

    Who it applies to

    Work activities involving actual or potential exposure to biological agents under Royal Decree 664/1997. The activity list is indicative, and assessment must address actual conditions.

    Key provisions

    It replaced the indicative list of activities that may involve exposure. Being outside the listed examples does not remove the duty to assess an existing biological risk.

    Sole article: Annex I

    It replaced the classification of agents and its explanatory notes. Identification and classification support assessment but do not replace analysis of exposure routes, tasks and circumstances.

    Sole article: Annex II

    Assessment, risk reduction, hygiene, information, training and health-surveillance duties remain in the receiving regulation. This order updates annexes rather than replacing that system.

    Relationship with Royal Decree 664/1997

    History and versions

    Initial publication: 25/11/2021 · Initial entry into force: 26/11/2021

    BOE-A-2021-19371

    Published on 25 November 2021 and effective from 26 November 2021. It replaced Annexes I and II to Royal Decree 664/1997. At this review date, BOE shows 25 November 2021 as the receiving regulation’s latest published amendment.

    Published on 25 November 2021 and effective from 26 November 2021. It replaced Annexes I and II to Royal Decree 664/1997. At this review date, BOE shows 25 November 2021 as the receiving regulation’s latest published amendment.

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

    BOE-A-2021-19371

    This instrument’s amendments are incorporated into Royal Decree 664/1997 · Exposure to biological agents. The latest published wording of the receiving text checked is dated 2021-11-25; that date belongs to the receiving instrument and is not a new publication of this amending instrument.

    BOE-A-1997-11144
    Incorporation of this amendment into consolidated receiving texts

    The table identifies where this amendment was incorporated. Dates refer to its versions in each receiving text, not a complete history of subsequent amendments to that text.

    PublicationEffective dateOfficial referenceReceiving textAffected provisions
    25/11/202126/11/2021BOE-A-2021-19371Royal Decree 664/1997 · Exposure to biological agentsAnnex I, Annex II

    Transitional provisions and application notes

    • Do not regard an agent as harmless because it is not named in a table. Apply the classification and assessment rules in Royal Decree 664/1997.

      Classification and unlisted agents

    • The 2021 order did not replace Annexes IV and V on containment; read those together with the 2020 reform and the applicable articles of the regulation.

      Containment measures

    Official BOE legal relationships

    Relationships may affect only specific provisions. They do not by themselves determine the status of the whole instrument: consult its history and application notes.

    Earlier references (3)

    Official sources

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

    Sources for the amending instrument

    1. Original publication and analysis
    2. ELI identifier

    The BOE provides no separate consolidated text for this amending instrument. Its original publication and the receiving texts are linked so that the current wording can be consulted.

    Consolidated receiving texts

    1. Royal Decree 664/1997 · Exposure to biological agents

    Official BOE sources consulted on 14 November 2026. This amending instrument should be read together with the current receiving legislation. Consolidation is for information; consult the official publication for legal purposes.

    Sabentis editorial summary. The official title and legal sources are retained in Spanish. This is not an official English translation and does not replace the legal text.

    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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