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What it regulates
It brought work generating exposure to respirable crystalline silica dust within Royal Decree 665/1997 and updated measures and limit values for carcinogenic agents.
Who it applies to
Activities involving exposure to the regulated agents and processes, including crystalline silica generated at work. Application depends on exposure, not merely the sector’s name.
Key provisions
It added work involving exposure to respirable crystalline silica dust generated by a work process to the specific preventive regime for carcinogens.
Sole article: Annex IIt revised aspects of personal hygiene and personal-data processing. Preventive measures and health records must comply with the safeguards laid down in the regulation.
Sole article: Articles 6(2) and 9(4)It replaced the limit-value annex, adding agents and transitional periods for certain exposures. That historical annex was subsequently amended again.
Sole article: Annex IIIHistory and versions
Initial publication: 23/12/2020 · Initial entry into force: 24/12/2020
BOE-A-2020-16833Published on 23 December 2020 and effective from 24 December 2020. It transposed Directive (EU) 2017/2398. Royal Decrees 427/2021, 395/2022, 612/2024 and 846/2026 subsequently amended the receiving framework; updating it does not in itself constitute wholesale repeal of this instrument.
Published on 23 December 2020 and effective from 24 December 2020. It transposed Directive (EU) 2017/2398. Royal Decrees 427/2021, 395/2022, 612/2024 and 846/2026 subsequently amended the receiving framework; updating it does not in itself constitute wholesale repeal of this instrument.
BOE-A-2020-16833This 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 |
|---|---|---|---|---|
| 23/12/2020 | 24/12/2020 | BOE-A-2020-16833 | Royal Decree 665/1997 · Carcinogens, mutagens or reprotoxic substances | Article 6, Article 9, Additional provision first, Additional provision second, Final provision first, Annex I, Annex III |
Transitional provisions and application notes
The silica transition ended on 31 December 2021; hardwood dust and chromium VI had their own dates. These temporary limits cannot continue to be presented as applicable in 2026.
Transitions in the 2020 Annex IIIMining also requires checking the relevant mining-safety instructions. General carcinogen rules and sector-specific requirements are not freely interchangeable alternatives.
Sector-specific interaction
Official BOE legal relationships
Earlier references (3)
- Amends · BOE-A-1997-11145
- Transposes · DOUE-L-2017-82594
- In accordance with · BOE-A-1995-24292
