Key points at a glance
The Machinery Directive, together with the CE Declaration of Conformity, has been in force since 1985. This applies not only to new machinery but also to modifications, self-built machinery and second-hand machinery. Plant operators must therefore be fully aware of the obligations they face and how to ensure compliance in a legally sound manner.
The CE marking (Communauté Européenne) certifies that the construction and equipment of a machine comply with the applicable EU regulations. If compliance with harmonised standards is demonstrated, the machine is deemed safe and may be put into service. Even though this is a self-declaration, clear requirements must be met.
A wide range of products is subject to the CE conformity requirement, including electronic equipment, toys, machinery, medical devices, load-handling equipment and personal protective equipment. This means that the regulation applies not only to traditional systems (e.g. paint shops) and machinery, but also to power-driven auxiliary equipment and load-handling equipment. It also applies to modifications or extensions to systems. An inspection is particularly necessary when various plant components – some of which may be second-hand – are combined to form a new complete plant. Even unmodified existing plants must meet the so-called minimum requirements. Since 2015, this has been defined as the „state of the art“ under the BetrSichV.
The state of the art describes the level of development of advanced processes, equipment or operating methods which makes it appear certain that a measure or procedure is suitable in practice for protecting the health and safety of employees. When determining the state of the art, particular consideration must be given to comparable processes, equipment or operating methods that have been successfully tested in practice.
Modifications to machinery and plant must be assessed to determine whether they constitute a substantial change. If this is the case, the entire CE procedure must be followed, as with new plant. Even if there is no substantial change, the assessment should be documented.
New risks arising from increased workloads, new substances or changes to working practices may constitute a significant change. The BMAS guidance document (04/2015) provides specific guidance on this matter. Important: Modifications that improve safety (e.g. additional circuit breakers) are not regarded as substantial alterations. Nevertheless, it is mandatory to document the assessment.
We will assess the proposed change, document the results and let you know whether a new CE procedure is required.
The CE Declaration of Conformity generally remains valid for as long as the product is available on the market. However, an update may be required in the event of significant changes to the product or new directives.
Failure to comply with CE conformity requirements may result in various sanctions, such as sales bans, product recalls or fines. Furthermore, in the event of an accident, non-compliance with current legislation may lead to difficulties. It is important to take compliance seriously in order to avoid legal problems.
Self-certification is possible for most machines and plant. However, we recommend seeking professional assistance when verifying CE conformity. We have the necessary expertise and experience to support you in ensuring this is carried out correctly.
Frank Schüle
Graduate Engineer (FH) Head of the Environment, Health and Safety / Fire Safety Department