Safety components under Annex II of the Machinery Regulation: who makes them, which obligations

In brief

A safety component is a physical or digital component, including software, that ensures a safety function, is placed on the market separately and whose failure endangers the safety of persons (Art. 3(3)).
Annex II is an indicative list of 20 entries; components not listed can also be safety components (Art. 7).
Safety components are related products: the manufacturer’s obligations of Art. 10 apply, with declaration and CE marking.
Seven entries are also in Annex I; there a notified body is involved or the standards situation decides.

Art. 3(3)Art. 7Annex IIArt. 10Art. 25

What a safety component is

The definition has four cumulative criteria: the component is designed or intended to perform a safety function; it is placed on the market separately; its failure or malfunction endangers the safety of persons; and it is not necessary for the product to function or can be replaced by normal components (Art. 3(3)). A safety function is a function serving as a protective measure to eliminate or reduce a risk (Art. 3(4)).

Excluded are safety components intended as spare parts to replace identical components and supplied by the manufacturer of the original machinery (Art. 2(2)(a)).

The Annex II list

No.	Safety component	Also in Annex I
1	Guards for removable mechanical transmission devices	Annex I Part A point 2
2	Protective devices designed to detect the presence of persons	Annex I Part B point 15
3	Power-driven interlocking movable guards for the machinery in Annex I Part B points 9, 10 and 11	Annex I Part B point 16
4	Logic units to ensure safety functions	Annex I Part B point 17
5	Valves with additional means for failure detection intended for the control of dangerous movements	—
6	Extraction systems for machinery emissions	—
7	Guards and protective devices protecting persons against moving parts involved in the process	—
8	Monitoring devices for loading and movement control in lifting machinery	—
9	Restraint systems to keep persons on their seats	—
10	Emergency stop devices	—
11	Discharging systems to prevent the build-up of potentially dangerous electrostatic charges	—
12	Energy limiters and relief devices referred to in Annex III 1.5.7, 3.4.7 and 4.1.2.6	—
13	Systems and devices to reduce the emission of noise and vibrations	—
14	Roll-over protective structures (ROPS)	Annex I Part B point 18
15	Falling-object protective structures (FOPS)	Annex I Part B point 19
16	Two-hand control devices	—
17	Components for machinery moving persons between landings: interlocking devices for landing doors, devices preventing fall or uncontrolled upward movement of the carrier, overspeed limiters, energy-accumulating and energy-dissipating shock absorbers, safety devices on hydraulic cylinders used as fall-prevention, electronic safety circuits	—
18	Software ensuring safety functions	—
19	Safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions	Annex I Part A point 5
20	Filtration systems to be installed in cabins to protect against hazardous substances, including pesticides, and filters for them	—

Which obligations apply

Design to the essential requirements of Annex III, with risk assessment (Art. 10(1)).
Technical documentation under Annex IV Part A and conformity assessment under Art. 25 before placing on the market (Art. 10(2)).
EU declaration of conformity and CE marking (Art. 10(2), Art. 24).
Type, year of construction, identification and contact details; instructions under Annex III (Art. 10(5)–(7)).
Keeping documents for at least ten years (Art. 10(3)).

Which procedure

If the component is in Annex I Part A – like self-learning safety components – a notified body is always involved. If it is in Part B – for example logic units or presence detection – internal production control is only permitted where harmonised standards or common specifications cover all relevant requirements. All other safety components follow module A (Art. 25(2)–(4)).

New: software as a safety component

Software that performs a safety function and is placed on the market separately is a safety component (recital 19, Annex II point 18). Whoever distributes it takes on the manufacturer’s obligations – even without delivering a physical product.

Frequently asked questions

Is every safety-related part a safety component?

No. It must be placed on the market separately and meet all the criteria of Art. 3(3). A part built into a machine is assessed with the machine.

What about spare parts?

Identical spare parts supplied by the manufacturer of the original machinery are outside the Regulation (Art. 2(2)(a)).

Does the machine builder need a declaration for purchased safety components?

No, the supplier of the component issues it. You assess the machine as a whole and keep the component’s declaration in your file.

Can the list change?

Yes. The Commission may amend Annex II by delegated acts (Art. 7(2)).

Safety components under Annex II: what counts and who must do what