Regulations
Harmonised machinery standards: conformity and limits of application
Guide to harmonised standards for machines: standards A, B and C, presumption of conformity and regulatory updating.
Harmonised standards are one of the most important tools to demonstrate the conformity of machines to essential health and safety requirements. For manufacturers, they are not simply a list to include in the CE or EU declaration of conformity: they are technical references that must be selected, applied and documented consistently.
A correct use of harmonised standards enables you to design according to the state of the art, simplify the demonstration of conformity and build a more solid technical file. A surface use, on the other hand, can generate a false feeling of safety and become a problem in case of control, dispute or injury. Reference
What are the technical standards
Technical standards are documents drawn up by regulatory bodies and technical committees. They meet requirements, methods, design criteria, tests and good practices recognised for a particular category of products, a safety function or a specific risk.
In general, technical standards are voluntary. However, in the machine sector, when a standard is harmonised and published in the Official Journal of the European Union, it can generate compliance with the requirements covered by that standard.
When a standard is harmonised
A standard is harmonised when its reference is published under the applicable European legislation. For Directive 2006/42/EC, the list of harmonised standards is published and updated by the European Commission. References must be read by considering subsequent notices and decisions, because certain standards can be replaced, limited or withdrawn.
With the Regulation (EU) 2023/1230 the concept of presumption of conformity remains central: a product compliant with harmonised standards or parts of them, whose references are published in the Official Journal, is presumed to comply with the essential health and safety requirements covered by those standards.
Presumption of conformity: what really means
Presumption of conformity does not mean that the machine automatically complies with everything. It means that, for the requirements specifically covered by the applied harmonised standard, the manufacturer can rely on a technical presumption of conformity.
Type A, B and C standards
In the machine sector, standards are often classified in type A, B and C. This classification helps to understand the level of specificity of the technical reference and the correct way to apply it.
Type A standards: define general principles of design and methodology, such as EN ISO 12100 for risk analysis and reduction.
Type B rules: they treat safety aspects or devices applicable to many machines, such as safety distances, guards, two-hand controls or safety-related control systems.
Type C standards: they concern specific machine categories and can provide very detailed requirements for a family of products.
When there is an applicable C-type standard, this is often the most specific reference. However, it must always be verified its scope and the relationship with the standards A and B recalled.
How to verify if a standard is harmonised
Control must be done on official sources. The most important reference is the list published by the European Commission, which provides a consolidated summary of the harmonised standards for the Machinery Directive and its updating decisions.
- Check the full title of the standard and the exact code, including year and any amendments.
- Check whether the standard is present in the official list and whether there are limitations or termination dates of the presumption.
- Read the standard’s Annex ZA/ZB to understand what requirements are covered.
- Document in the technical file which parts of the standard have been applied and for which functions or risks.
- Return to the statement only the rules actually applied and relevant.
Common specifications in Machinery Regulation
The Regulation (EU) 2023/1230 also introduces reference to common specifications. These are common specifications which the Commission may adopt under certain conditions to provide technical requirements for compliance when harmonised standards are not available or are not adequate in the time required.
For manufacturers this means that, in the transition to the Regulation, it will not be enough to monitor only the harmonised standards: it will be necessary to follow also any common specifications and their impact on the design and technical documentation.
Manufacturers' frequent errors
declare standards not actually applied
use obsolete versions without checking the harmonisation status
confuse technical standard, harmonised standard and legislative requirement
believe that a C-type standard eliminates the need for risk analysis
do not document which parts of the standard have been applied
do not verify the limitations of the publication in the Official Journal.
How Waves Engineering can support you
Waves Engineering supports manufacturers in identifying the applicable standards, checking the harmonisation status, assessing the covered requirements and building consistent technical documentation. Our work links standards, risk analysis, design solutions, testing and declaration of conformity.
FAQ
Is a technical standard always mandatory?
Not in general. Technical standards are voluntary, but they can become fundamental to demonstrate the state of the art and, if harmonised, generate presumption of conformity for the covered requirements.
How do I understand if a standard is harmonised?
The official list published by the European Commission must be checked and read any restrictions, withdrawal dates and references to ZA/ZB attachments.
Can I declare a standard if I applied it only partially?
It is only possible if the declaration of conformity and the technical file are consistent. General declarations must be avoided: it must be documented which parts of the standard have been used and for what requirements.
