The declaration of conformity is the document that formally certifies machinery conformity with the essential health and safety requirements, as established by applicable European directives and regulations. Each piece of machinery is issued a single EC declaration of conformity, even if it refers to multiple product directives or regulations. A manufacturer applying the conformity assessment procedure based on internal production control must draft and sign the EC declaration of conformity before placing the machinery on the market or putting it into service, ensuring that it accompanies the machinery. By doing so, the manufacturer assumes full responsibility for the conformity of the machinery’s design and construction. Unlike in countries such as the United States, Brazil, or the Eurasian Economic Union, where approval from accredited third-party entities is always required, in the European Union, a manufacturer following the conformity assessment procedure based on internal production control must independently draft the EC declaration of conformity. This document is commonly thought of as the “certification” of the machinery.

The signatory of the EC declaration of conformity should hold sufficient authority within the company, and their mandate should preferably be in written form. This individual could be a director, CEO, or another decision-maker with equivalent responsibility.

A notable difference lies in terminology: while the Machinery Regulation (EU) 2023/1230 requires an EU declaration of conformity, the Machinery Directive 2006/42/EC requires a EC declaration of conformity. The Machinery Regulation aligns with the current European legislative framework, adopting the most up-to-date terminology used in recent EU directives and regulations. However, aside from this formal distinction, the responsibilities associated with signing the declaration of conformity remain virtually unchanged.

The EC declaration of conformity for the Machinery Directive 2006/42/EC must be accompanied by a translation into the language of the destination country of the machinery. The original version and the translated version must be clearly identifiable, for example, by stating that the copy is a translation of the original. In contrast, under the Machinery Regulation (EU) 2023/1230, the manufacturer may provide only one version in the language of the destination country—if this version is a translation, it is not explicitly required to indicate it as such.

The Machinery Regulation (EU) 2023/1230 introduces a new requirement: the EU declaration of conformity must specify the harmonised standards applied during the design process, including their publication date, and, in the case of partial application, the specific parts that were followed. The Machinery Directive 2006/42/EC only requires this information when appropriate, leaving it to the manufacturer’s discretion whether to include it or not. It is naturally advisable to ensure that the EU declaration is truthful, meaning that, under the Machinery Regulation (EU) 2023/1230, in-depth knowledge of harmonised standards becomes absolutely essential.

The manufacturer must provide the EC declaration of conformity to the user, importer, or distributor, while also keeping a copy for at least ten years from the machinery’s manufacturing date. For the Machinery Directive 2006/42/EC, delivering and storing the document typically involves printing a physical copy. However, the Guide to application of the Machinery Directive 2006/42/EC explicitly states that if the declaration is provided in digital format, following the Machinery Regulation’s (EU) 2023/1230 requirements may ensure conformity. The Machinery Regulation (EU) 2023/1230, recognising technological advancements, expressly allows the declaration to be made available in electronic format, ensuring access via a dedicated online portal. For most European directives and regulations, simply affixing the CE marking on the product is sufficient, and there is no requirement to provide the EC declaration of conformity to the buyer. However, under both the Machinery Directive 2006/42/EC and the Machinery Regulation (EU) 2023/1230, every unit must be accompanied by its declaration of conformity.

If machinery is not disassembled for transport, the manufacturer may provide the EC declaration of conformity at the time of shipment. However, if the machinery requires on-site assembly, the manufacturer should issue the EC declaration of conformity only after putting it into service, following installation. This is because the assembly process could affect the effectiveness of the machinery’s safety devices. The manufacturer should therefore ensure that the installation has been carried out correctly before issuing a declaration that formally certifies the machinery’s safety.