cross
  • About us
  • Blog
  • NEWSLETTER
    • Request a demo

    Spain · National · Royal Decree

    Royal Decree 665/1997 · Carcinogens, mutagens or reprotoxic substances

    In force, as amended

    Current official Spanish title: Real Decreto 665/1997, de 12 de mayo, sobre la protección de los trabajadores contra los riesgos relacionados con la exposición a agentes cancerígenos, mutágenos o reprotóxicos 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

    Sets specific controls for occupational exposure to carcinogens, mutagens or reprotoxic substances. Its current scope includes reprotoxic substances following the 2024 reform.

    Who it applies to

    Activities involving actual or potential exposure to agents defined in Article 2 and substances, mixtures or processes in Annex I. Asbestos also requires attention to its specific legislation.

    Key provisions

    Assess the nature, degree and duration of exposure, including exposure routes and particularly susceptible workers.

    Article 3

    Prioritise substitution with a less hazardous substance, mixture or process where technically possible.

    Article 4

    Where substitution is impossible, use a closed system; if that is also impossible, apply the exposure reduction required for the agent type. Meeting a limit does not replace these duties.

    Article 5

    Offer specific health surveillance; where Annex III bis sets a biological limit, surveillance is mandatory for work with that agent and workers must be informed before assignment.

    Article 8

    Retain the list of exposed workers and medical records for at least forty years for carcinogens or mutagens and five years for reprotoxic substances after exposure ends, with the required confidentiality safeguards.

    Article 9

    History and versions

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

    BOE-A-1997-11145

    Royal Decree 846/2026 amended Articles 2, 6, 8 and 11, final provision 1 and Annexes I, III and III bis, and added the sole transitional provision on biological lead limits.

    Publication: 23/10/2026 · Effective date: 24/10/2026

    BOE-A-2026-22080

    Royal Decree 612/2024 extended the title and scope to reprotoxic substances, amended Articles 1–6 and 8–11, additional provisions 1–2, final provisions 1–2 and Annexes II–III, and added Annex III bis.

    Publication: 03/07/2024 · Effective date: 04/07/2024

    BOE-A-2024-13419

    Royal Decree 395/2022 amended Annex III.

    Publication: 25/05/2022 · Effective date: 26/05/2022

    BOE-A-2022-8521

    Royal Decree 427/2021 amended Annexes I and III.

    Publication: 16/06/2021 · Effective date: 17/06/2021

    BOE-A-2021-10029

    Royal Decree 1154/2020 amended Articles 6.2 and 9.4, the title of the sole additional provision, final provision 1 and Annexes I and III, and added additional provision 2.

    Publication: 23/12/2020 · Effective date: 24/12/2020

    BOE-A-2020-16833

    Royal Decree 598/2015 amended Articles 2.1–2, 4 and 10.1(c) and the title of Annex I.

    Publication: 04/07/2015 · Effective date: 05/07/2015

    BOE-A-2015-7458

    Royal Decree 349/2003 amended the decree and extended its protection to mutagens; consult the source for each affected provision.

    Publication: 05/04/2003 · Effective date: 29/04/2003

    BOE-A-2003-6934

    Royal Decree 1124/2000 amended Articles 1, 2 and 5 and the sole repealing provision, and added Annex III.

    Publication: 17/06/2000 · Effective date: 27/06/2000

    BOE-A-2000-11372
    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-1997-11145preambulo, CAPÍTULO I, Article 1, Article 2, CAPÍTULO II, Article 3, Article 4, Article 5, Article 6, Article 7, Article 8, Article 9, Article 10, Article 11, Article 12, Additional provision first, Repealing provision sole, Final provision first, Final provision second, Final provision third, firma, Annex I, Annex II
    17/06/200027/06/2000BOE-A-2000-11372Article 1, Article 2, Article 5, Repealing provision sole, Annex III
    05/04/200329/04/2003BOE-A-2003-6934Article 1, Article 2, Article 3, Article 4, Article 5, Article 6, Article 8, Article 10, Article 11, Repealing provision sole, Final provision first, Final provision second, Annex I, Annex II, Annex III
    04/07/201505/07/2015BOE-A-2015-7458Article 2, Article 4, Article 10, Annex I
    23/12/202024/12/2020BOE-A-2020-16833Article 6, Article 9, Additional provision first, Additional provision second, Final provision first, Annex I, Annex III
    16/06/202117/06/2021BOE-A-2021-10029Annex I, Annex III
    25/05/202226/05/2022BOE-A-2022-8521Annex III
    03/07/202404/07/2024BOE-A-2024-13419no, Article 1, Article 2, Article 3, Article 4, Article 5, Article 6, Article 8, Article 9, Article 10, Article 11, Additional provision first, Additional provision second, Final provision first, Final provision second, Annex II, Annex III, Annex III bis
    23/10/202624/10/2026BOE-A-2026-22080Article 2, Article 6, Article 8, Article 11, Transitional provision sole, Final provision first, Annex I, Annex III, Annex III bis

    Transitional provisions and application notes

    • Until 31 December 2028, the biological lead limit is 30 µg Pb/100 ml of blood. For exposure before 9 April 2026 with levels above 30 but below 70, continued work requires periodic surveillance and a downward trend under the transitional provision. Annex III bis sets a limit of 15 after the transition unless the law changes.

      Transitional provision sole

    • For cadmium and inorganic compounds, Annex III retains a transitional limit until 11 July 2027 of 0.002 mg/m³ respirable fraction, combined with biological monitoring at ≤0.002 mg Cd/g urinary creatinine. The general value is 0.001 mg/m³. This summary does not replace the annex’s complete table and conditions.

      Annex III

    • Annex III bis also sets specific triggers for health surveillance and a regime for lead exposure before 9 April 2026. These must be distinguished from Annex III’s airborne lead limit of 0.03 mg/m³.

      Annex III bis

    Official BOE legal relationships

    Earlier references (5)
    Subsequent references (8)

    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-2026-22080

    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.

    Request a Demo

    Discover all that Sabentis can do for your organization.

    Try Sabentis

    request a demo
    stars 5
    GetApp Software Advice Capterra