As part of the amendment to the Ordinance on Industrial Safety and Health (BetrSichV) (only in German) of 5 June 2021, the State Committee for Occupational Safety and Safety Technology (LASI) (only in German) addressed, among other things, the question of how to proceed with machines in operation that are not formally compliant, and published a position paper on this on 10 September 2021, which paved the way for official administrative practice. The main question in this context is whether these operators can be obliged under occupational health and safety law or monitoring authority aspects to subsequently assess the safety of the machine and provide it with a CE marking.
The CE marking, as an indication of the product’s conformity with the relevant legislation, fulfills an important role in the system of technical harmonisation regulations, conformity assessment and market surveillance. In principle, the obligation to make a machine available on the market in conformity with the directive applies to its manufacturer, whereby in the scope of the Machinery Directive 2006/42/EC (PDF), the manufacturer in the legal sense is also the person who manufactures the machine and operates it him- or herself. In this system, it is therefore the manufacturer’s primary duty to establish the formal conformity of the machine, for example by affixing the CE marking, before placing it on the market.
Legal implications of formal non-compliance for operators
In contrast to the manufacturer’s obligations, however, the operator’s obligations do not generally begin until after a machine has been placed on the market (exception: manufacturer-operator). Pursuant to § 5(3) BetrSichV, commercial operators may only use work equipment that complies with the applicable legal regulations on safety and health protection. When assessing the safety of work equipment, the operator must therefore not rely on formal markings such as the CE mark, but must assess the hazards of the work equipment, with or without a CE marking, detached from this formal marking as well as the substantive safety of use and rule out identified risks of use. The operator must repeat and verify this assessment at regular intervals. It is not the same as the conformity assessment for a machine, which the manufacturer is obliged to carry out before placing it on the market, possibly with the involvement of a notified body.
In order to effectively enforce the occupational health and safety regulations, the occupational health and safety authorities have a range of measures at their disposal that are aimed at verifying the substantive safety of use, such as requesting information and documents (e.g. the manufacturer’s EU declaration of conformity or technical documentation), up to and including ordering a temporary or permanent ban on use if any uncertainty is identified. However, these measures do not relate to a formally compliant marking of the machines.
Conclusion and practical tips
According to the LASI position paper, operators of machines who are not at the same time manufacturers of the machines have no obligation to subsequently assess the conformity and establish the formal conformity of the machine if a substantive safety inspection has taken place prior to commissioning. For operators who are also manufacturers, there is also no obligation for a subsequent CE marking; the only obligation is in relation to the time before the machine was placed on the market.
For manufacturers, it may nevertheless be advisable to subsequently establish formal conformity, since machines that are not properly marked come into the focus of the authorities much more quickly than machines that are in formal compliance. Authorities then become tempted by the formal non-conformity to also check the substantive safety of the machine. Should it become apparent in this context that a machine is unsafe, the manufacturer may be required from a product safety point of view to reassess the machine, possibly with the involvement of a notified body, and to subsequently establish substantive conformity before further operation.back