Safety and Compliance for Machines from China

Many businesses are drawn to the affordability of machines from China, but a critical question arises: Do these machines meet EU safety standards and have the correct documentation?

Here are some specific tips to quickly assess whether an imported machine is safe and legally compliant.

Understanding Machines from China in the Context of EU Requirements

A machine from China, or any non-EU country, is a technical device intended for sale or use within the European Union. Once it crosses into the EU, it must comply with EU directives or regulations. For machines, this primarily involves the Machinery Directive 2006/42/EC, soon to be replaced by the EU Machinery Regulation 2023/1230.

Fake CE Marks and “Turkish Certifications”

Machines from China often come with documents suggesting CE marking compliance. Common issues include:

• “Turkish CE Certificates” – Turkey is not an EU member. A document issued in Turkey is not necessarily valid in the EU unless it meets all EU requirements and the manufacturer has proper authorization.
• “China Export” Logo – This resembles the EU’s CE mark but is unrelated. The visual difference is subtle, but the consequences during inspections can be severe.

The CE mark should guarantee that the machine has undergone procedures confirming compliance with essential requirements. If in doubt, request a declaration of conformity (EC or EU) and contact details of the authorized representative in the EU who holds the technical documentation.

What is a Declaration of Conformity?

A declaration of conformity is a document where the manufacturer (or their EU representative) declares that the machine meets the requirements of applicable regulations, such as the Machinery Directive 2006/42/EC or the new Regulation 2023/1230.

What Should a Correct Declaration Include?

1. Manufacturer’s name and address – if outside the EU, an EU representative must be indicated.
2. Precise machine identification (model, type, serial number).
3. List of regulations (directives, regulations) with which the product complies.
4. Reference to harmonized standards (if the manufacturer refers to them).
5. Signature of the person authorized to represent the manufacturer or importer.

If the declaration includes phrases like: “Declaration valid upon completion of documentation” – be cautious. Such a declaration is dubious. It should be specific, not conditional.

Who Holds the Technical Documentation?

Both the old Machinery Directive and the new Machinery Regulation clearly state that documentation should be stored within an EU member state. If the documents indicate an address in Turkey or China, that’s an error. Market surveillance authorities (e.g., in Poland, UDT or PIP) have the right to request access to the documentation. Not having it in the EU is a significant problem during inspections or accidents.

Why is “Pseudo-CE” from China Cheaper?

Designing a machine with full safety requirements involves substantial engineering work. Many cheaper machines from China lack these elements or have them in rudimentary form. Their manufacturer saved on design and certification, shifting the responsibility to the machine importer – who must ensure the device complies with EU regulations.

Machines from China: Potential Consequences

Risk of Accidents and Claims

If a machine lacks proper safeguards, there’s a risk of accidents. In the event of an incident, authorities will check if the machine complies with regulations. The absence of a valid CE mark and declaration means legal and financial troubles.

Penalties and Withdrawal from the Market

Market surveillance can order machine withdrawal from the market and impose administrative penalties. Such situations often lead to production stoppages and the need for urgent corrections.

Adapting Machines from China to Regulations

If you’ve already purchased a machine and find the documentation incomplete, you can adapt it later. This process may include:

1. Analysis of the current state
   • Are there proper guards?
   • Does the control system ensure the correct safety level?
   • Is there an operation manual in the user’s language?
2. Risk assessment
   • Identifying all possible hazards.
   • Adapting the safety system (e.g., to PN-EN ISO 13849-1 standards).
3. Modernization
   • Installing missing movable guards or enclosures.
   • Replacing components, e.g., with certified safety sensors.
   • Modifying the control system to meet requirements.
4. Completing documentation
   • Documenting detailed machine data, diagrams, and standards list.
   • Translating documents into the required language.
   • Issuing a reliable declaration of conformity (with the signature of an authorized person in the EU).

This process can be costly. Therefore, it’s wise to ensure before purchase that the Chinese supplier provides the correct documents and real support.

Note – adapting a machine to essential requirements often involves recreating the manufacturer’s documentation, including all safety functions.

Machines from China: The Role of the Importer and Authorized Representative

If the Chinese manufacturer has not appointed an authorized representative in the EU, this role often falls to the importer. The importer thus becomes the entity “placing the machine on the market” and assumes responsibility for:

• Preparing full documentation (if the manufacturer hasn’t).
• Ensuring machine compliance with regulations.
• Applying the CE mark (if it was missing or incorrect).

Many importers are unaware that they are formally treated almost equally with the manufacturer. Ignoring this responsibility can lead to serious consequences.

How to Avoid Problems?

Before ordering a machine from China, pay attention to a few simple points:

1. Request a sample declaration of conformity (EC/EU) and check who is indicated as the entity holding the documentation in the Union.
2. Secure the purchase in the sales agreement by making payment conditional on a properly issued declaration of conformity.
3. Request access to documentation regarding safety systems.
4. If you lack the qualifications to assess the documentation’s correctness, consult a company like ours for help in conducting a safety audit.

If the supplier responds evasively, it’s a warning sign. Price should not be the only criterion.

In Conclusion

• Not all Chinese machines are bad, but vigilance is needed to ensure they have the correct CE mark and appropriate documentation.
• If the declaration of conformity comes from Turkey and the manufacturer has no formal representative in the EU, you may face market surveillance issues.
• As an importer, you become de facto responsible for the machine’s safety.
• In case of deficiencies, you must carry out adaptation to requirements (guards, locks, manual, declaration), which can be expensive and time-consuming.
• The simplest advice: check documents before purchase and clearly establish who the manufacturer is and who holds the documentation within the Union.

Remember, the goal is safe and legally compliant machine operation, not just having a symbolic “CE” on the nameplate.

Still have doubts?
Consider consulting with an experienced engineering office or industrial automation integrator who can assess the machine’s condition, propose safety measures, and assist with formalities. Sometimes it’s worth investing in an audit to avoid costly corrections, downtime, and fines.

In safety matters, it’s always worthwhile to approach the topic professionally, even if it initially seems like an additional cost. In return, you gain assurance that your employees work on equipment that meets EU safety standards.

FAQ: Machines from China and Safety