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What it regulates
Regulated the design, certification and marketing of personal protective equipment under Directive 89/686/EEC. It remains relevant to older PPE documentation and the origins of CE marking. Spain expressly repealed it in 2020, while Regulation (EU) 2016/425 had already become generally applicable on 21 April 2018.
Who it applies to
Historical selection of product requirements relevant to workplace protection: safety, ergonomics, compatibility, information, categories and conformity. Employers’ duties to assess risks, select, provide and maintain PPE belong to the occupational prevention framework, including Royal Decree 773/1997. The full administrative rules for assessment bodies are not presented as workplace duties.
Key provisions
Conformity depended on Annex II essential requirements and the applicable assessment procedure. CE marking did not by itself identify the right PPE for every hazard or user.
Article 4Annex II required adequate protection, harmlessness, ergonomics, fit, compatibility and manufacturer information on use, maintenance and limits. Performance had to be related to the hazard and intended conditions.
Annex IIDistinguished three certification categories, with enhanced controls for fatal risks or serious irreversible harm. This is a historical classification; current PPE categories and procedures must be checked under Regulation (EU) 2016/425.
Article 7Section 10, amended in 1995, governed the EC declaration and visible, legible, durable marking. The Order of 20 February 1997 removed paragraph four of Annex IV; it did not repeal the entire marking regime.
Article 10History and versions
BOE publication: 28/12/1992 · Initial entry into force: 29/12/1992
BOE-A-1992-28644Published on 28 December 1992 and effective from 29 December 1992. The 1993 correction, 1994 transitional extension, Royal Decree 159/1995 and the 1997 Order form part of its development. Regulation (EU) 2016/425 replaced the former directive with general application from 21 April 2018; express Spanish repeal followed through Royal Decree 542/2020. This entry is not an inventory of every historical harmonised-standard resolution.
Correction published on 24 February 1993.
BOE-A-1993-5139Order of 16 May 1994: extends the transitional period until 30 June 1995.
BOE-A-1994-12437Royal Decree 159/1995: amendments to conformity, marking and annexes, among other provisions.
BOE-A-1995-5920Order of 20 February 1997: removes paragraph four of Annex IV.
BOE-A-1997-4842Regulation (EU) 2016/425: successor regime; Articles 46–48 cover EU repeal and transition.
DOUE-L-2016-80531Royal Decree 542/2020, sole repealing provision 1 (e): Spanish repeal from 1 July 2020.
BOE-A-2020-6472Text versions of the selected OSH provisions
| Publication | Effective date | Official reference | Affected provisions |
|---|---|---|---|
| 28/12/1992 | 29/12/1992 | BOE-A-1992-28644 | Article 1, Article 2, Article 3, Article 4, Article 5, Article 6, Article 7, Article 8, Article 9, Article 10, Transitional provision sole, Annex I, Annex II, Annex III, Annex IV, Annex VI |
| 01/06/1994 | 02/06/1994 | BOE-A-1994-12437 | Transitional provision sole |
| 08/03/1995 | 09/03/1995 | BOE-A-1995-5920 | Article 4, Article 5, Article 6, Article 7, Article 10, Annex I, Annex II, Annex IV |
| 06/03/1997 | 07/03/1997 | BOE-A-1997-4842 | Annex IV |
Transitional provisions and application notes
Article 47 of Regulation (EU) 2016/425 allowed continued making available of compliant legacy products placed on the market before 21 April 2019. EC type-examination certificates and approval decisions remained valid until 21 April 2023 unless they expired earlier. These are product and certification transitions, not a universal expiry date for all PPE in use.
Official referenceThe former national period until 30 June 1995, extended by the Order of 16 May 1994, has ended. It must not be confused with the EU transition of 2018–2023.
Transitional provision soleRoyal Decree 542/2020 expressly repealed this decree from 1 July 2020, without prejudice to EU Article 47 transitions. The Spanish repeal date did not postpone the Regulation’s direct applicability.
Official reference
Official BOE legal relationships
This record covers the history of the selected occupational safety and health provisions. The official analysis also provides the relationships affecting other subjects in the legislation.
Official BOE legal relationships
