Presumption of conformity

Author: CEmarking TEAM | Last edited: 22.06.2020

The aim of the European Union is to provide you as a manufacturer with the best possible support in meeting your CE obligations. Your CE obligations consist, among other things, of fulfilling all essential health and safety requirements that apply to your products. And this for each harmonised legal regulation to which your products are subject.

What are essential health and safety requirements

Essential health and safety requirements are binding regulations for the design and construction of products. These regulations are intended to ensure a high level of safety and health protection for persons and, where applicable, for pets, property and the environment. The essential health and safety requirements for machines are defined in the Annex I to the Machinery Directive. The products/machine in question must meet all the essential health and safety requirements of Annex I that apply. The route via the presumption of conformity is the ideal route.

Harmonised Standards

Harmonized standards are important tools for meeting the essential health and safety requirements of the Machinery Directive and other European harmonization legislation.

You as a manufacturer decide whether or not to refer to harmonised standards. The voluntary nature of harmonized standards is intended to prevent technical standards from constituting an obstacle to the marketing of products containing innovative solutions which are not (yet) included in harmonized standards. As harmonised standards are developed and adopted on the basis of consensus between the parties concerned, their specifications provide a good indication of the state of the art at the time of their adoption. The evolution of the state of the art is reflected in subsequent amendments or revisions of the harmonized standards. The level of safety achieved by the application of a harmonised standard sets a standard which all manufacturers of corresponding products must take into account.

benefit of meeting harmonized standards

The reference to harmonised standards is a central element of the "new approach to technical harmonisation and standardisation", which is followed in the Machinery Directive. The Machinery Directive sets out the mandatory essential health and safety requirements for machinery, while detailed technical specifications for meeting these essential health and safety requirements are laid down in harmonised European standards.

If you use harmonized standards when designing and manufacturing your product, the legislator automatically assumes that your product conforms to the essential health and safety requirements of the harmonization legislation which the standard covers. This is known as the "presumption of conformity".

If you use only part of the harmonised standard or if the harmonised standard does not fully cover all the essential health and safety requirements to be complied with, there is a presumption of conformity only to the extent that the harmonised standard covers the essential health and safety requirements.

In order for manufacturers to know which essential health and safety requirements of the harmonisation legislation a harmonised standard covers, this is explicitly specified in the harmonised standard. This is usually done in a separate information annex in the harmonized standard.
Where a harmonised standard only partially covers essential requirements, the harmonised standard shall clearly indicate that this is the case. In some cases, the scope of a harmonised standard also indicates with sufficient clarity the relevant requirements, for example where there are clear references to the safety risks covered.

Machinery manufactured in accordance with harmonised standards, the references of which have been published in the Official Journal of the European Union, is therefore presumed to conform to the essential health and safety requirements of the Machinery Directive covered by that harmonised standard. For machinery referred to in Annex IV, the harmonised standards approach cannot be used if the standards concerned do not cover all the relevant essential health and safety requirements of the Directive.

When does a harmonised standard give presumption of conformity

Only when the title of a harmonised standard is published in the notices of the Commission in the C series of the Official Journal of the European Union does that harmonised standard confer a presumption of conformity with the essential health and safety requirements.

The presumption of conformity ceases when a harmonised standard is replaced by a new or revised standard. Presumption of conformity shall also cease on the "date of cessation of presumption of conformity" published in the Official Journal of the Union. The presumption of conformity ceases for all machinery placed on the market after the "date of cessation of presumption of conformity" published in the Official Journal of the Union.