Harmonised standards and presumption of conformity under the Machinery Regulation

In brief

Conformity with harmonised standards whose references are published in the Official Journal gives presumption of conformity with the Annex III requirements they cover (Art. 20(1)).
Standards are voluntary; other technical solutions are permitted if conformity is demonstrated in the technical documentation (recital 48).
Without standards, the Commission may adopt common specifications, which also give presumption (Art. 20(3), (6)).
For Annex I Part B, the standards situation decides whether module A is permitted (Art. 25(3)).

Art. 20Art. 3(24)Art. 25(3)Annex V Part A

How presumption works

Presumption only applies to the requirements actually covered by the standard or its parts (Art. 20(1)). These are set out in an informative annex of the standard, linking its clauses to the requirements of the act. For the Regulation, standards get such an annex for Annex III; under the Directive it was Annex ZA relating to Annex I of the Directive. What the standard does not cover must be demonstrated otherwise.

The levels at a glance

Instrument	Effect	Reference
Harmonised standard with reference in the Official Journal	presumption of conformity for the requirements covered	Art. 20(1)
Commission standardisation request	European standardisation organisations draft standards for Annex III	Art. 20(2)
Common specification (implementing act)	fallback where standards are missing, delayed or insufficient; also gives presumption	Art. 20(3), (6)
Own technical solution	permitted, without presumption; evidence in the technical documentation	Recital 48, Annex IV
Objection by a Member State	Commission examines a common specification not fully meeting Annex III	Art. 20(8)

Standards under the Directive do not carry over automatically

Presumption is tied to references published for this Regulation. For every standard you want to cite in the declaration, check whether and in which edition it is listed for the Regulation and which requirements it covers – especially for the new topics of software, cybersecurity and self-evolving behaviour.

What goes into the declaration and the file

In the EU declaration of conformity: the harmonised standards or common specifications applied, with edition and date of publication in the Official Journal; for partial application, the parts applied (Annex V Part A point 7).
In the technical documentation: the references of the harmonised standards or common specifications applied (Annex IV Part A).
For an own solution: evidence of how each Annex III requirement is met.
In series production: changes to standards are taken into account adequately (Art. 10(4)).

Type-A, type-B and type-C standards

Machinery safety distinguishes basic safety standards (type A, such as EN ISO 12100), group standards on safety aspects or safeguards (type B) and product standards for particular machinery (type C). A type-C standard generally takes precedence for its machine family; whether it gives presumption depends, as with all standards, on the reference in the Official Journal.

Frequently asked questions

Do I have to apply harmonised standards?

No, they are voluntary. Whoever chooses other solutions demonstrates compliance in the technical documentation (recital 48).

Is the standard number enough in the declaration?

No. The standard with its edition and the date of publication in the Official Journal must be stated (Annex V Part A point 7).

What if there is no standard under the Regulation for my machine yet?

Then there is no presumption and you demonstrate the requirements directly. For Annex I Part B, module A is then not permitted (Art. 25(3)).

Are there special rules in a crisis?

Yes. Emergency procedures for an internal market emergency have been added, including a special presumption of conformity (Arts 25a ff.). They only apply when the emergency mode is activated.

Harmonised standards: when they give presumption of conformity under the Machinery Regulation