Substantial modifications

THE DOUBT:

What is a Substantial Modification of a Machinery and what are its implications?

CONSIDERATIONS: 

Until 2021, there was no definition of “Substantial Modification” in the text of the Machinery Directive. Furthermore, nothing was said about substantial modifications made by an entity other than the original manufacturer of the machinery. This issue was addressed during the revision of the text of the Machinery Directive. In the first draft, published in April 2021, a definition was added, so here is what is written in the text of the New Machinery Directive, in the initial considerations:

[New Machinery Regulation – May 2023] – Whereas:

(26) […] Machinery or related products should comply with the essential health and safety requirements when placed on the market or put into service. Where such products are subsequently modified, by physical or digital means, in a way that is not foreseen or planned by the manufacturer and which affects the safety of such products by creating a new hazard or increasing an existing risk, the modification should be considered as substantial when new significant protective measures are required.
However, repair and maintenance operations which do not affect the machinery or related product’s compliance with the relevant essential health and safety requirements should not be considered to be substantial modifications. In order to ensure the compliance of such a product with the relevant essential health and safety requirements, the person that carries out the substantial modification should be required to perform a new conformity assessment before placing the modified product on the market or putting it into service. In order to avoid an unnecessary and disproportionate burden, the person carrying out the substantial modification should not be required to repeat tests and produce new documentation in relation to machinery or related products that are part of an assembly of machinery, and that are not affected by the modification.

In the April text, any modification that has an impact on the EHSR (Essential Health and Safety Requirements) is a substantial modification. That language was changed in the final text

[REGULATION (EU) 2023/1230 – June 2023]  – Article 3 – Definitions

(16) ‘substantial modification’ means a modification of machinery or a related product, by physical or digital means after that machinery or related product has been placed on the market or put into service, which is not foreseen or planned by the manufacturer, and which affects the safety of that machinery or related product, by creating a new
hazard, or by increasing an existing risk, which requires:

• (a) the addition of guards or protective devices to that machinery or related product the processing of which necessitates the modification of the existing safety control system; or
• (b) the adoption of additional protective measures to ensure the stability or mechanical strength of that machinery or related product;

What are the implications of a substantial modification?

Let’s look at it step by step. Here is what the April 2021 draft of the new Machinery Regulation stated:

[New Machinery Regulation – Avril 2021] – Article 15: Other cases in which obligations of manufacturers apply

A natural or legal person, other than the manufacturer, the importer or the distributor, that carries out a substantial modification of the machinery product shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer set out in Article 10 for the part of the machinery product that is affected by the modification or, if the substantial modification has an impact on the safety of the machinery product as a whole, for the entire machinery product. 

Those who wrote the April 2021 draft therefore reasoned as follows: a machine will always have an “original manufacturer” and may have subsequent “new partial manufacturers” for the part of the machine that was modified. The term “original” and “new partial” is a GT Engineering terminology, just to make the concept clear.

Those new manufacturers have to demonstrate that only some aspects of the original machine were affected. For example, in case of a revamping, where the impact energies did not change, the company carrying out the modification from an electromechanical to a programmable logic will not become responsible of the structural part of the machinery. They will be the “new partial manufacturer”, they will place their CE Marking for the part of the machine modified, draw a Declaration of conformity, but will not be held responsible if the machinery has a mechanical structural problem.

That means the “new partial manufacturer” has to:

• Do a risk assessment
• Prepare a Technical File
• Affix the CE Marking
• Draw up and sign a EU declaration of conformity

This approach was changed with the June 2022 text.

[New Machinery Regulation – May 2023] – Article 18: Other cases in which obligations of manufacturers apply

A natural or legal person, that carries out a substantial modification of a machinery or related product shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer set out in Article 10 for that machinery or related product or, if the substantial modification has only an impact on the safety of a part of an assembly of machinery, for the affected machinery of this assembly as demonstrated in the risk assesment.

The person who carries out the substantial modification shall in particular, but without prejudice to other obligations set out in Article 10, ensure and declare on its sole responsibility that the machinery or related product concerned is in conformity with the applicable requirements of this Regulation and shall apply the relevant conformity assessment procedure as provided in Article 25 (2), (3) and (4) of this Regulation.

Added to this is what must be stated in the new EC Declaration of Conformity, and detailed in Annex V of the New Machinery Regulation. Even if the substantial modification is of a part of the machine, the whole machine must be mentioned in the EC Declaration, as in the Plate. However, one can write “Substantially Modified machinery” and this means that the responsibility of the person who modifies a machine is only for the modified part.

[New Machinery Regulation – May 2023] – ANNEX V EU declaration of conformity and EU declaration of incorporation

Part A EU declaration of conformity of machinery and related products No …
The EU declaration of conformity shall contain the following particulars:
   1. The machinery or related product (product, type, model, batch or serial number) or substantially modified machinery or related product.

In short, with the final text of May 2023, the form changes but not the substance.

CONCLUSIONS:

In the lack of a clear definition of what was a substantial modification, countries and organisations have, over time, given their own interpretation, such as the one assumed by the German baua. A substantial modification is now (June 2022 draft) defined as any modification that has an impact on safety but also involves the addition of safety features not foreseen by the original machine manufacturer.

So, for example, the addition of a new access to a robotic island is in principle not a substantial modification, nor is any modification for the improvement of safety as this neither creates a new hazard nor increases the existing risk.

Today, the person who makes a substantial modification becomes the “new manufacturer” and assumes all responsibility in the event of an accident on the machine, as if he had designed and built it himself.

In both drafts of the New Machinery Regulation, it is made clear that, following a substantial modification, the person who makes it becomes a kind of ‘New Partial Manufacturer’, i.e. responsible only for the part he modified. He will have to affix a new CE marking, sign his own EU Declaration of Conformity, but make it clear in the documentation he will provide to the customer that his responsibility only relates to the modified part of the machinery. The ‘original manufacturer’ therefore remains responsible for the part of the machinery not affected by the modification.