Understanding the New EU Declaration of Conformity for Machinery

The EU Declaration of Conformity, as outlined in Regulation (EU) 2023/1230, commonly referred to as the Machinery Regulation, introduces significant changes to ensure machinery compliance with safety and health requirements. This new declaration will fully replace the previous Machinery Directive 2006/42/EC by January 2027. If you’re currently designing or building new machinery, it’s crucial to consider these changes now.

Failing to complete the construction and commissioning of machinery before 2027 means you’ll need to adapt to the new guidelines before market introduction, potentially incurring additional costs and delays. Understanding and applying these new regulations now is not just an investment in compliance but also a safeguard against future risks. While the CE certification process remains similar, there are notable differences in how conformity is declared.

Manufacturer’s Sole Responsibility Statement

Regulation (EU) 2023/1230 introduces a critical component in the EU Declaration of Conformity: a clear statement of the manufacturer’s sole responsibility for ensuring the machine’s compliance with legal requirements. According to the declaration requirements, the manufacturer must unequivocally state:

“This Declaration of Conformity is issued under the sole responsibility of the manufacturer.”

This statement emphasizes that the manufacturer bears full responsibility for ensuring the machine meets all applicable requirements of the Machinery Regulation (EU) 2023/1230 and other relevant EU legal acts. This requirement aims to increase manufacturers’ awareness of their pivotal role in ensuring machinery safety and underscores their legal responsibility. It also facilitates market surveillance authorities in identifying the responsible entity in case of non-compliance. Including such a statement in the EU Declaration of Conformity is not only a formal legal requirement but also a manifestation of the manufacturer’s conscious approach to product safety and compliance.

Requirement to Specify Conformity Assessment Procedure

Regulation (EU) 2023/1230 mandates that manufacturers clearly specify which conformity assessment procedure was applied to a particular machine or related product. Manufacturers must indicate the appropriate conformity assessment module according to the regulation’s rules, such as Module A (internal production control), Module B (EU-type examination), or Module H (full quality assurance).

If the conformity assessment involved collaboration with a notified body, the declaration must include the body’s name, identification number, and the certificate issued as part of this procedure. The new regulations emphasize transparency in the conformity assessment process, enabling full traceability of the product’s compliance with safety and health requirements.

Specifying the procedure aims to enhance the declaration’s credibility and facilitate market surveillance authorities in verifying product compliance with regulations.

References to Harmonized Standards – Flexibility in Application

The new Machinery Regulation (EU) 2023/1230 allows manufacturers to refer to harmonized standards more specifically and flexibly. It is now possible to reference not only the entire standard but also specific parts that were applied during the machine’s design process.

For example, with the standard PN-EN 60204-1:2018 concerning electrical equipment of machines, a manufacturer can declare compliance only in the scope of:

• Section 13.1.3: “Cables of different circuits must be routed in separate cable ducts to avoid electromagnetic interference.”
• Section 13.4.2: “External cable ducts should provide adequate protection against mechanical damage.”

Simultaneously, the manufacturer may consciously opt out of fully applying Section 10.2.1 regarding the color coding of control elements, deeming that the control panel colors do not impact safety and have been customized to client requirements.

This precise approach allows not only for meeting legal requirements but also builds the manufacturer’s image as a responsible and aware designer who can selectively and effectively apply harmonized standards. Such documentation flexibility enables better project adaptation to individual needs while maintaining full compliance with essential safety requirements.

Additional Contact Information – A New Requirement for Transparency

Regulation (EU) 2023/1230 introduces a new obligation to provide additional contact information for the manufacturer or their authorized representative in the EU Declaration of Conformity. In addition to traditional information such as name and full address, details enabling quick and direct contact, such as an email address and phone number, must also be included.

This requirement aims to increase the manufacturer’s accessibility in case of the need to verify machine compliance, obtain additional information, or clarify doubts by market surveillance authorities. It is also a practical convenience for machine users who may need to contact the manufacturer regarding technical or safety issues.

The obligation to provide detailed contact information highlights the regulation’s pursuit of greater transparency and accountability for manufacturers regarding the products they offer. This ensures that users and control authorities have quick access to key information about conformity assessment.

Comparison of EU and EC Declarations of Conformity

Declaration Element	EC Declaration of Conformity	EU Declaration of Conformity
1. Manufacturer and Representative Data	Name and full address of the manufacturer and, if applicable, their authorized representative.	Name and address of the manufacturer and, if applicable, their authorized representative. Additionally, contact details such as email and phone are required.
2. Person Preparing Documentation	Name and address of the person in the EU authorized to prepare the technical documentation.	No explicit requirement for such indication.
3. Machine Identification	Description of the machine (function, model, type, serial number, trade name).	Subject of the declaration: machine or related product identification, allowing history reconstruction, may include a photo for identification.
4. Legal Basis	Statement that the machine meets the relevant requirements of the directive and other EU legal acts.	Explicit statement: “This Declaration of Conformity is issued under the sole responsibility of the manufacturer.” Additionally, a requirement to indicate compliance with EU harmonization legislation (including Regulation 2023/1230).
5. Harmonized Standards	Reference to applied harmonized standards or technical specifications, if applicable.	Detailed references to harmonized standards, common specifications, or other technical specifications, with the publication date in the EU Official Journal. Parts of standards must be indicated if applied partially.
6. Notified Body	Name, address, and identification number of the notified body and the EC-type examination or full quality assurance certificate number, if applicable.	Requires detailed reference to the name, number, and certificate of the notified body. Indicates conformity assessment procedure modules (e.g., B, C, G, H).
7. Conformity Assessment Procedures	No detailed reference.	Detailed description of conformity assessment procedures (e.g., modules A, B, C, G, H).
8. Additional Information	Place and date of declaration issuance. Identity and signature of the authorized person.	Place and date of issuance. Name, surname, position of the signing person. Possibility of using an electronic signature.
9. Machines for Permanent Installation	No additional requirements.	For lifting machines permanently installed in buildings: the installation site address must be provided.

Comparison table of EC and EU Declaration of Conformity requirements

Template for EU Declaration of Conformity for Machinery

EU DECLARATION OF CONFORMITY
In accordance with Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and amending Regulation (EU) 1020/2019 and repealing Directive 2006/42/EC

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1. Machine Identification
   • Machine Name: Hydraulic Press HP-500
   • Type/Model: HP-500
   • Serial Number: 12345-2024
   • Year of Manufacture: 2024
2. Manufacturer’s Data
   • Name: Example Ltd.
   • Address: Machine Street 10, 00-001 Warsaw, Poland
   • Email: contact@example.com
   • Phone: +48 123 456 789
3. Installation Address (for permanently installed machines)
   • If applicable: Industrial Street 5, 01-234 Krakow, Poland
4. Manufacturer’s Statement
   • “This Declaration of Conformity is issued under the sole responsibility of the manufacturer.”
5. Subject of the Declaration
   • The Hydraulic Press HP-500 meets the requirements of Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery.
6. Basis of Compliance
   • The machine complies with the following EU harmonization legislation requirements:
     • Regulation (EU) 2023/1230
7. Harmonized Standards
   • Applied harmonized standards:
     • PN-EN 60204-1:2018, Sections 13.1.3 and 13.4.2 (cable routing, mechanical protection)
     • Partially applied other technical specifications, omitted Section 10.2.1 (control panel colors).
8. Conformity Assessment Procedures
   • Applied module: Module B – EU-type examination conducted by a notified body.
   • Notified body:
     • Name: Machine Certification Institute
     • Identification Number: 1234
     • Certificate: 2024-XYZ-567
9. Signature and Date
   • Signed on behalf of: Example Ltd.
   • Place and date of issuance: Warsaw, 27.11.2024
   • Name: Jan Kowalski
   • Position: Technical Director
   • Signature: (handwritten or qualified electronic signature)

Summary of Changes in the EU Declaration of Conformity

The new regulations introduced by the Machinery Regulation (EU) 2023/1230 change the approach to the EU Declaration of Conformity, introducing more precise requirements and new elements. Here are some key changes to note:

1. Responsibility Statement – the manufacturer must now clearly declare that they take full responsibility for the machine’s compliance with the regulation. This emphasizes who is actually responsible for the product’s safety and compliance.
2. Precise Indication of Standards and Procedures – the declaration can refer to specific parts of harmonized standards. If only selected parts of a standard were used, this must be clearly indicated. Additionally, the conformity assessment module (e.g., A, B, C) must be provided, giving a fuller picture of the procedures used.
3. Contact Information – besides traditional information such as the manufacturer’s name and address, an email address and phone number must be provided. This facilitates contact and increases transparency.
4. Installation Address for Lifting Machines – if a machine is permanently installed, such as in a building, the declaration must include the installation site’s address.
5. Qualified Electronic Signature – the possibility of signing the declaration electronically is a practical solution that allows for easier documentation storage.

These changes are not only new legal requirements but also an opportunity to demonstrate that the manufacturer understands their responsibility and cares about user safety. It’s worth starting to apply these requirements now – it’s a step towards professionalism and preparation for upcoming regulatory changes.

As you can see, this approach not only meets formalities but also reflects your awareness as a manufacturer. Such a declaration can be treated as proof of reliability, not just an unnecessary document.

FAQ: EU Declaration of Conformity