Understanding the EU Declaration of Incorporation of Incomplete Machinery: New Regulations and Requirements

The “EU declaration of incorporation of incomplete machinery” is not a new document, but it has undergone significant updates. Those familiar with the Machinery Directive 2006/42/EC will recognize this declaration, formally described in Annex II of the directive. With the implementation of the Machinery Regulation 2023/1230, the document has been renamed and its requirements expanded.

The name change is more than a terminological update; it reflects the EU’s commitment to safety standards and compliance. The new regulations introduce additional obligations for manufacturers, including a statement of sole responsibility and the digitization of documentation. These changes aim to enhance transparency, safety, and facilitate the functioning of the internal market.

Why has the European Union decided on these significant changes? What are the implications for manufacturers and importers of incomplete machinery? This article provides detailed insights into the regulatory changes and the steps needed to comply with the new requirements.

How Should the EU Declaration of Incorporation of Incomplete Machinery Look?

What should the “EU declaration of incorporation of incomplete machinery” look like? According to Regulation 2023/1230, this document must meet specific formal requirements. It’s not just a name change; there are clear guidelines on what content must be included.

The declaration must be in written form, dated, and signed by a representative of the manufacturer. It must include precise identification data for the incomplete machinery, such as type, model, and serial number, to clearly identify the product.

The form and structure of the document are outlined in Annex V, Part B of the Machinery Regulation 2023/1230, which specifies what should be included in each section. This new approach ensures transparency and consistency in documentation across the European Union.

The declaration of incorporation includes the following information:

EU Declaration of Incorporation of Incomplete Machinery No. [number]

1. Identification of the Incomplete Machinery
   Product, type, model, batch, or serial number for clear identification.
   Example: “Electric drive XYZ, model: NXZ-300, serial number: 56789.”
2. Manufacturer
   Name and address of the manufacturer, or their authorized representative.
   Example: “Company X Ltd., Industrial St. 10, 00-123 Warsaw, Poland.”
3. Statement of Sole Responsibility
   Declaration issued under the sole responsibility of the manufacturer.
   Example: “This declaration is issued under the sole responsibility of the manufacturer.”
4. Subject of the Declaration
   Identification of the incomplete machinery to trace its history; include a clear color photo if applicable.
   Example: “Incomplete machinery – electric drive XYZ, documentation supplemented with a photo in the annex.”
5. Compliance with Essential Requirements
   Statement of which essential requirements specified in Annex III of the regulation are applied and met, along with confirmation of prepared technical documentation and compliance with other applicable EU harmonization legislation.
   Example:
   • “The electric drive meets essential requirements according to Article 9 of Regulation 2023/1230.”
   • “Compliance with EMC Directive 2014/30/EU and LVD Directive 2014/35/EU.”
6. Harmonized Standards or Common Specifications
   References to applied harmonized standards, common specifications, or other technical specifications, with their issue date. Indicate applied parts if standards are not fully used.
   Example:
   • “Harmonized standards: EN ISO 12100:2010, EN 60204-1:2018 (fully applied).”
   • “Partial application: EN 61000-6-2 (EMC, section 4.2).”
7. Commitment to Provide Information
   Commitment to provide relevant information on the incomplete machinery to national authorities upon justified request, respecting intellectual property rights.
   Example: “Upon request from national authorities, the manufacturer will provide relevant technical documentation, respecting intellectual property rights.”
8. Statement on Usage Restrictions
   Declaration that the incomplete machinery will not be put into service before obtaining the EU declaration of conformity for the final machinery.
   Example: “Incomplete machinery. It cannot be put into service before obtaining the EU declaration of conformity for the final machinery.”
9. Additional Information
   • Signed on behalf of: [manufacturer’s or representative’s name].
   • Place and date of issue: [place, date].
   • Name, position of the responsible person, signature.
     Example:
   • “Signed on behalf of: Company X Ltd.”
   • “Warsaw, December 10, 2023.”
   • “Jan Kowalski, Technical Director.”

Notes:

• All elements meet the requirements specified in Annex V, Part B of the Machinery Regulation 2023/1230.
• A photo or drawing of the incomplete machinery, if required, should be attached as an annex.
• The table layout can be adjusted to meet specific organizational needs if necessary.

What Has Changed?

1. Harmonized Standards – A New Requirement
The EU declaration of incorporation of incomplete machinery now requires the indication of harmonized standards or common technical specifications applied, with precise details on which parts were used if not in full. This requirement was previously only for the full EU declaration of conformity under Directive 2006/42/EC, not for the declaration of incorporation. This change introduces greater precision and facilitates the assessment of compliance for incomplete machinery.

2. Statement of Sole Responsibility
The regulation introduces a new obligation – the declaration must explicitly state that it is issued under the sole responsibility of the manufacturer. This is a clearer approach than the directive, which did not require such a statement.

3. Digital Form of Declaration
A significant advancement is the option to prepare and store the declaration digitally, a step forward from Directive 2006/42/EC, which only allowed for typewritten or handwritten declarations in capital letters. The digital declaration must be accessible for at least 10 years from the date the machinery is placed on the market.

4. No Responsible Person for Technical Documentation
The directive required the identification of a person responsible for preparing technical documentation within the Community, including their name, address, and position. The regulation has removed this requirement – the declaration is signed on behalf of the company, simplifying the formal process.

5. Signature on Behalf of the Company
Under Regulation 2023/1230, the declaration is signed on behalf of the manufacturer or their representative, without the need to specify the name of the person signing the document. This contrasts with the directive, which required full details of the responsible person.

FAQ: EU Declaration of Incorporation of Incomplete Machinery