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What it regulates
It extended Royal Decree 665/1997 to reprotoxic agents, revised preventive measures and added biological limit values. This is a 2024 reform; the receiving regulation was amended again in 2026.
Who it applies to
Activities involving actual or potential occupational exposure to carcinogenic, mutagenic or reprotoxic agents within Royal Decree 665/1997.
Key provisions
It extended the regulation’s title, scope and definitions to incorporate reprotoxic substances or mixtures in the specified categories and distinguish threshold from non-threshold agents.
Sole article: scope and definitionsIt adapted assessment, substitution, prevention, exposure reduction and hygiene measures. Meeting a limit value does not by itself replace the other preventive duties.
Sole article: Articles 3 to 6 of Royal Decree 665/1997It revised health surveillance, records, reporting to authorities and training. The reform differentiated record retention for carcinogens or mutagens and reprotoxic agents while preserving health-data confidentiality.
Sole article: Articles 8 to 11It replaced the occupational exposure table and introduced an annex on binding biological limits and health surveillance. The original 2024 tables must not be presented as the complete current version after the 2026 reform.
Annexes III and III bisHistory and versions
Initial publication: 03/07/2024 · Initial entry into force: 04/07/2024
BOE-A-2024-13419Published on 3 July 2024 and effective from 4 July 2024. It incorporated protection against reprotoxic agents into Royal Decree 665/1997. Royal Decree 846/2026, published on 23 October 2026, subsequently amended articles and annexes of the receiving regulation; current consultation must include that development.
Published on 3 July 2024 and effective from 4 July 2024. It incorporated protection against reprotoxic agents into Royal Decree 665/1997. Royal Decree 846/2026, published on 23 October 2026, subsequently amended articles and annexes of the receiving regulation; current consultation must include that development.
BOE-A-2024-13419This instrument’s amendments are incorporated into Royal Decree 665/1997 · Carcinogens, mutagens or reprotoxic substances. The latest published wording of the receiving text checked is dated 2026-10-23; that date belongs to the receiving instrument and is not a new publication of this amending instrument.
BOE-A-1997-11145Incorporation of this amendment into consolidated receiving texts
| Publication | Effective date | Official reference | Receiving text | Affected provisions |
|---|---|---|---|---|
| 03/07/2024 | 04/07/2024 | BOE-A-2024-13419 | Royal Decree 665/1997 · Carcinogens, mutagens or reprotoxic substances | Introductory note, 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 |
Transitional provisions and application notes
Limits and transitional periods must be read in the current consolidation, specifying the agent, unit, reference period and applicable date. This record does not reproduce historical tables as current limits.
Limits and transitionsProtection against reprotoxic agents is not limited to pregnant workers: the scope includes risks to sexual function, fertility and offspring development under the legal definitions.
Reproductive risk
Official BOE legal relationships
Earlier references (3)
- Amends · BOE-A-1997-11145
- Transposes · DOUE-L-2022-80424
- In accordance with · BOE-A-1995-24292
