Machine regulation
The substantial modifications of machines in the new Regulation
All machines and work equipment may be modified during their lifetime because of production needs or technological upgrades; it often becomes difficult to understand the extent to which modifications require a new CE marking for the product.
In this article, we analyze the current requirements and the updates that will be introduces by the New Machinery Regulation.
The current situation
The scope of the current Machinery Directive concerns the placing of new products, or products that are deemed new, within the European market; a new product is one that is placed on the market for the first time.
A product can also be considered new if:
• it is a product already operating in a foreign market (e.g., in America) and is imported as a used product into Europe.
• it is a product already placed on the market that undergoes substantial changes.
If the product falls into one of these three cases, then its CE marking or re-marking is required in order to allow it circulate freely in Europe.
The current text of the Machinery Directive does not clarify what “substantial modifications” are. We can find this definition within the text of the Blue Guide edition 2022 (O.J. 2022/C 247/01), a very important guide that explains the foundational concepts of the European market and covers across different Product Directives.
A change on a product placed on the market or put into service is defined as substantial when:
- it changes the original performance, purpose, or type of the product without this being provided for in the original risk assessment;
- it changes the nature of the hazard or increases the level of risk with reference to relevant Union harmonization legislation.
According to the last version of the Blue Guide:
“…the person making the substantial change is required to meet the same requirements as the original manufacturer, such as in terms of preparing technical documentation, drawing up an EU declaration of conformity and affixing the CE marking on the product.”
The Blue Guide leaves room for product-specific directives to establish, on a case-by-case basis and more precisely, the requirements for defining a modification as substantial. An obligation is set for the person making the change to repeat the conformity assessment but only to the extent that these changes have made changes on the product.
For example: if the modification did not lead to changes in the machine’s safety circuits, it will not be necessary to repeat the calculation of the Performance Level of the safety circuits but it will be possible to refer to the original document; however, it is always up to the person making the modification to demonstrate that it is not necessary to update all elements of the technical documentation.
The new Machinery Regulation
In the latest available edition of the new Regulation, there is mention of a substantive change as required by the Blue Guide.
Recital 23 (introductory considerations to the new text) specifies that a product within the European market must always meet all essential health and safety requirements even when it undergoes substantial physical or digital modifications.
A change is defined as substantial when new safety measures are required.
“…the modification should be considered as substantial when new significant protective measures are required.”
In Article 3 in Section 16,, substantial modification is defined punctually from the perspective of the new Regulation.
Substantial change is a physical or digital modification of a product already placed on the market that was not considered by the original manufacturer and that affects the safety of the product by creating new hazards or increasing risks and requires:
• New protective measures;
• Modifications to safety control circuits;
• Mechanical modifications for stability or structural strengthening.
“(16) ‘substantial modification’ means a modification of a machinery or 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:
(i) the addition of guards or protective devices to that machinery or related product whose processing modifies the existing safety control system, or
(ii) the adoption of additional protective measures to ensure the stability or mechanical strength of that machinery or related product.”
Article 15 then defines the obligations of natural or legal persons who make changes to products already placed on the market.
“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…”
The natural or legal person who makes substantial changes on the product must declare under his or her sole responsibility that the product complies with the health and safety requirements of the Regulation by following the process of risk analysis, creation of the technical file, declaration of conformity and CE marking of the product.
“The person who carries out the substantial modification shall in particular and 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…”
The requirements of Article 15 do not apply to non-professional and private persons who modify a machine for their exclusive use.
If the modifications are already part of the original risk analysis (e.g., purchase of an optional accessory, modification of a recipe, etc…) the modification does not result in a different liability from the original one.
Ordinary and extraordinary maintenance or repair work on a product is not considered a substantial modification.
The increasing in safety measures for a product does not require a new CE marking of the product, but they do require the natural or legal person making the change to properly document all changes and any safety improvements that have been made.
Conclusions
The new Regulation clearly states what is meant by substantial modification by expanding its scope to include products already placed on the market as required by the Blue Guide. From this discussion it will certainly be clearer and more consolidated what to do when making changes to a product already placed on the market.
What can we do for you?
At WAVES ENGINEERING we can help you manage changes to your machines, we are also ready and updated to assist you in the transition to the new Machinery Regulations.
For any additional information, to request a quote, or even just to get to know us visit our contact section!
WAVES Engineering S.r.l.