The Machinery Regulation(EU)2023/1230 vs. Machinery Directive 2006/42/EC – What Is New?

The Machinery Regulation (EU)2023/1230 was published in 2023 but does not formally replace the Machinery Directive 2006/42/EC until 2027. F2 Labs performed a deep dive into the two EU regulations to figure out what is new, what is staying, and what has been removed.

Not much has changed, but it is different. The major new thing is that Annex IV from 2006/42/EC has been split into two categories in (EU)2023/1230 – Annex I, Part A and Part B. Part A has stricter requirements than Part B. Part A requires a compliance procedure from Article 25(2.) while Part B requires a compliance procedure from Article 25(3.) Keep in mind – most machinery does not fall into Annex I. Machinery that does not match the equipment in the Annex I list requires a compliance procedure from Article 25(4.).

Let’s break these compliance procedures down for each of the three scenarios.

Annex I, Part A covers –

1. Removable mechanical transmission devices. including their guards.
2. Guards for removable mechanical transmission devices.
3. Vehicle servicing lifts.
4. Portable cartridge-operated fixing and other impact machinery.
5. Safety components with fully or partially self-evolving behavior using machine learning approaches ensuring safety functions.
6. Machinery that has embedded systems with fully or partially self-evolving behavior using machine learning approaches ensuring safety functions that have not been placed independently on the market, with respect only to those systems.

Annex I, Part A equipment can use these compliance modules:

Annex I, Part B covers –

1. Circular saws (single- or multi-blade) for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics of the following types:
   1.1. sawing machinery with fixed blade(s) during cutting, having a fixed bed or support with manual feed of the workpiece or with a demountable power feed;
   1.2. sawing machinery with fixed blade(s) during cutting, having a manually operated reciprocating saw-bench or carriage;
   1.3. sawing machinery with fixed blade(s) during cutting, having a built-in mechanical feed device for the workpieces, with manual loading and/or unloading;
   1.4. sawing machinery with movable blade(s) during cutting, having mechanical movement of the blade, with manual loading and/or unloading.
2. Hand-fed surface planing machinery for woodworking.
3. Thicknesses for one-side dressing having a built-in mechanical feed device, with manual loading and/or unloading for woodworking.
4. Band-saws with manual loading and/or unloading for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics, of the following types:
   4.1. sawing machinery with fixed blade(s) during cutting, having a fixed or reciprocating-movement bed or support for the workpiece;
   4.2. sawing machinery with blade(s) assembled on a carriage with reciprocating motion.
5. Combined machinery of the types referred to in points 1 to 4 and in point 7 for working with wood and material with similar physical characteristics.
6. Hand-fed tenoning machinery with several tool holders for woodworking.
7. Hand-fed vertical spindle moulding machinery for working with wood and material with similar physical characteristics.
8. Portable chainsaws for woodworking.
9. Presses, including press-brakes, for the cold working of metals, with manual loading and/or unloading, whose movable working parts may have a travel exceeding 6 mm and a speed exceeding 30 mm/s.
10. Injection or compression plastics-moulding machinery with manual loading or unloading.
11. Injection or compression rubber-moulding machinery with manual loading or unloading.
12. Machinery for underground working of the following types:
    12.1. locomotives and brake-vans;
    12.2. hydraulic-powered roof supports.
13. Manually loaded trucks for household refuse collection, incorporating a compression mechanism.
14. Devices for the lifting of persons or of persons and goods involving a hazard of falling from a vertical height of more than 3 m.
15. Protective devices designed to detect the presence of persons.
16. Power-operated interlocking movable guards designed to be used as safeguards in machinery referred to in points 9, 10 and 11 of this Part.
17. Logic units to ensure safety functions.
18. Roll-over protective structures (ROPS).
19. Falling-object protective structures (FOPS).

Annex I, Part A equipment can use these compliance modules:

Equipment that is in scope of the Machinery Regulation but does not match any of the equipment listed in Annex I is only able to use Internal Production Control (Module A) as the compliance module. This means there is no legal reason to involve a Notified Body in your Machinery Regulation evaluation unless your equipment is listed in Annex I. Even then you can possibly avoid it. This is the same policy as in the current Machinery Directive.

What are each of these compliance modules and what do they mean?

Internal Production Control, Module A – this means you have the equipment tested by an accredited lab using applicable harmonized standards, compile all documentation that validates compliance (your Technical File with all reports, critical component data sheets, manuals, drawings, schematics, etc), draft an EU declaration of conformity, mark the equipment with a CE marking, and then sell as many as you can to customers in the EU.

Interestingly – Internal Production Control is allowed for all Annex IV (under the current Machinery Directive 2006/42/EC) equipment as long as all applicable to MD Annex I EHSR’s (essential health and safety requirements) are validated by checking against harmonized standards. The new Machinery Regulation (EU)2023/1230 split Annex IV from 2006/42/EC and made it into two sections: Annex I, Part A and Part B in the new regulation. Part A requires Notified Body involvement no matter what. Part B equipment can be made compliant by following Module A only if harmonized standards under the Machinery Regulation that address each risk matching an EHSR from Annex II of that regulation. That means you can, possibly, comply with the Machinery Regulation without contracting with a Notified Body.

EU Type-Examination, Module B – this means you have the above evaluation (Internal Production Control, Module A) performed by an accredited test lab and send the documentation (Technical File including EU declaration of conformity) along with a sample of the product to an EU Notified Body that is authorized to issue a certificate for your product category. That can be a little tricky for a few reasons – one: you probably want one that speaks English and two: you cannot change Notified Bodies once you start, so if your product does not pass the EU type-examination you will not be able to go to another Notified Body. You will need to work with the original Notified Body that gave you the failing report and resolve the identified issues, if there are any. Note that you are not finished with an EU type-examination. That is a Notified Body checking that the product was tested to the appropriate standards and the resultant evaluation and test data is valid. In other words, it is a part of a process you may need to follow.

Conformity to Type Based on Internal Production Control, Module C – this is Internal Production Control (Module A) + EU type-Examination of your product (Module B). So, this module is A + B = Module C. This is the usual process for Annex IV equipment under the current Machinery Directive 2006/42/EC that we deal with at F2 Labs. Essentially, it means this: You have the product tested by a lab, the resulting documentation is sent to a Notified Body. They approve it and issue the EU type-examination certificate. Then it is up to you and your quality system to manufacture each unit identically to the unit that passed the evaluation(s).

Conformity to Type Based on Full Quality Assurance, Module H – this is Internal Production Control (Module A) + EU type-Examination of your product (Module B) + audits of your quality system = Module H. These audits can be unannounced as well and they are performed by a Notified Body.

Conformity Based on Unit Verification, Module G – this involves completing Internal Production Control, Module A, for the product and then releasing the Technical File to a Notified Body – and then the Notified Body conducts the testing on the equipment. This is the most stringent method as it requires a Notified Body to perform the testing, presumably after you have already assured compliance: through testing pre-emptively with an ISO accredited test laboratory. You also must involve a Notified Body for every unit that is destined for the EU.

Other Changes in the Machinery Regulation –

Article 1, 2., (f) in the Machinery Directive 2006/42/EC is moved to Article 1, 2., (p), (i-vi) in the Machinery Regulation (EU)2023/1230. The new regulation also added reference to the Radio Equipment Directive (RED) 2014/53/EU along with the Low Voltage Directive (LVD)2014/35/EU. It addresses the below equipment that can now be excluded from the Machinery Regulation in favor of the LVD or RED. See below –

This Regulation does not apply to:

(p) the following electrical and electronic products, insofar as they fall within the scope of Directive 2014/35/EU or of Directive 2014/53/EU:
(i) household appliances intended for domestic use which are not electrically operated furniture;
(ii) audio and video equipment;
(iii) information technology equipment;
(iv) ordinary office machinery, except additive printing machinery for producing three-dimensional products;
(v) low-voltage switchgear and control gear;
(vi) electric motors;

This is relevant because presently our methodology is to apply the RED to equipment in scope of the Machinery Directive which requires safety testing to the LVD, Anenx I. While the LVD is addressed the same way in the Machinery Directive (Annex I, 1.5.1 Electricity Supply) and the Machinery Regulation (Annex II, 1.5.1 Electricity Supply), the wording is different in the RED.

That brings us to another change. The EU started New Legislative Framework in 2008 that sought to align all Directives and Regulations regarding certain common elements… like the EU declaration of conformity and the Technical File. Since the Machinery Directive 2006/42/EC was written in 2006 it does not align with the “NLF” as it is called.

The requirement for an EU address, which is an EU Contact listed on EU declarations of conformity, is not in the new Machinery Regulation. This requirement is listed in Annex II, 1., A, 2. in the Machinery Directive but is conspicuously absent in the Machinery Regulation.

The last new change we will address in this article is Article 10 in the new Machinery Regulation. Article 11 spells out, in plain English, what your obligations are as manufacturer. It is a short, succinct list of 10 items. It is very easy to read and understand.

More later. We will take this Regulation apart word by word before the 2027 implementation date. Finally, yes, you can claim compliance with both the Machinery Directive and the Machinery Regulation now if your equipment complies with both. No need to wait.

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