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What it regulates
It sets health and safety requirements for placing machinery on the market and putting it into service. Its preventive relevance lies in reducing risks through design and providing safe-use information. Product conformity must be coordinated with employers’ duties concerning work equipment.
Who it applies to
OSH selection: Articles 5 and 15, general principles and preventive provisions of Annex I, commencement and the conditions governing new Chapter VII. Inclusion is justified by its express protection of workers using machinery. This is not a complete guide to marketing, certification or every product category.
Key provisions
Article 5 requires the manufacturer or representative to ensure essential requirements are met, hold the technical file, supply instructions, assess conformity, issue the EC declaration and affix the marking before marketing or commissioning.
Article 5Annex I’s general principles require assessment of intended use and reasonably foreseeable misuse. Risk assessment must guide design and manufacture through an iterative risk-reduction process.
Annex IAnnex I, section 1.1.2, prioritises eliminating or reducing risks through safe design, adopting protective measures and communicating residual risks. Risk information does not replace necessary design and protective measures.
Annex ISection 1.7.4 governs instructions, including intended use and foreseeable misuse. Where there are no original instructions in Spanish, the required translation must be supplied at least in Spanish, subject to the section’s conditions and exceptions.
Annex IArticle 15 preserves requirements protecting people, particularly workers, when machinery is used. CE marking does not replace workplace risk assessment or the safe-use measures required by Royal Decree 1215/1997.
Article 15History and versions
Initial publication: 11/10/2008 · Initial entry into force: 29/12/2009
BOE-A-2008-16387Published on 11 October 2008, generally effective from 29 December 2009. Royal Decree 494/2012 amended Articles 2, 4 and 11 and Annex I for pesticide application machinery, effective from 17 June 2012. Royal Decree 302/2026 amended Article 2(2) and added Chapter VII from 30 May 2026. The 2027 EU transition is contextual; no unsupported current national repeal is asserted.
Original text and general commencement in 2009, except Article 14.
BOE-A-2008-16387RD 494/2012 extends environmental requirements for pesticide-application machinery, effective from 17 June 2012. It is retained as context, not as an amendment to the selected occupational safety provisions.
BOE-A-2012-3815Royal Decree 302/2026, Article Two: adds definitions of crisis-relevant goods and internal market emergency mode, and new emergency Chapter VII, effective from 30 May 2026.
BOE-A-2026-8023Text versions of the selected OSH provisions
| Publication | Effective date | Official reference | Affected provisions |
|---|---|---|---|
| 11/10/2008 | 29/12/2009 | BOE-A-2008-16387 | Article 2, Article 4, Article 5, Article 11, Article 15, Final provision fourth, Annex I |
| 10/04/2026 | 30/05/2026 | BOE-A-2026-8023 | Article 2, Chapter VII, Article 22, Article 23, Article 24, Article 25, Article 26 |
Transitional provisions and application notes
General commencement was 29 December 2009. Article 14 on notified bodies took effect the day after publication on 11 October 2008. Historical assessments must distinguish that exception.
Final provision fourthThe amendment by Royal Decree 302/2026 took effect on 30 May 2026, but Articles 23–26 require the EU activation described in Article 22 and designated crisis-relevant goods. There is no automatic general exemption; paragraphs 3–5 address conditions and continuing effects.
Article 22Regulation (EU) 2023/1230 sets general application from 20 January 2027, with exceptions and transitional provisions. The official corrigendum supplies that date; neither the uncorrected original’s 14 January date nor general replacement before that date should be assumed as of 14 November 2026.
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
